Adverse reactions and side effects possibly caused by vaccine Gardasil

An Interview with Dr. Diane M. Harper, HPV Expert

Do you believe that the Gardasil vaccine, as it currently stands, could present more risks to a young girl or woman than the possibility of cervical cancer?

"Pap smears have never killed anyone. Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone.

Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit - and only risk - for the young girl. Vaccinating will not reduce the population incidence of cervical cancer if the woman continues to get Pap screening throughout her life.

Has the original Gardasil marketing campaign of "one less" muddied the waters and misinformed the public, who heretofore believed that a Pap smear was sufficient to protect them from cervical cancer?

"If women were participating in Pap screening, or if as a parent you educated your daughter to seek Pap screening at the appropriate age (21 years) for her entire life, then she would have been very unlikely to be at risk for being "one" and would not be "one less." She would not have been "one" to begin with!

Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines as described above, an informed and valued decision would have been able to be made. Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years."

reported reactions have been:
 
injection site pain, rash, headache, hives, allergies, hair-loss, pain, welts, swelling, passing out, fainting, redness, nausea, dizziness, diarrhea, tremors and seizures, vomiting, hot, tingling, shortness of breath, muscle spasms, panic attack, itching, blurry vision, fever, fatigue, joint pain, Bell's palsy, numbness, menstrual cycle affected, speech affected, pityriasis, racing heart, gential warts, severe migraines, lethargic, muscle twitching, blood pressure affected, anaphylactic reaction, abdominal pain, chest pain, possible arthritis, pale.


Also possible pregnancy related issues as well.

In extreme rare cases, death.

It appears while some do react straight away to the first dose, for many I'm reading it is the second and especially the third dose.

This would confirm my thoughts on over vaccinating, particularly the babies and children of a young age in the US with so many vaccines for this and that.
This clearly is causing a major problem, of that there can be no doubt.
Of all the vaccines, it seems currently that the HPV type, sort, like Gardasil and possibly the UK version of GSK's Cervarix are among the worst.

Often nearly every line is Gardasil, then after a bit it jumps and spaces out.

I've left out hundreds of cases by the time I've completed 2009, maybe more, due to repeat in nature of symptoms, or because not so severe or determined to be 100% the vaccines fault, because they were suffering such and such at the time, on other medication, other than vaccine related, as I've included those that have had another vaccine, whether at the same time or not, as the Gardasil one.
Jenny Tetlock Has Passed Away

Jenny Tetlock, a young girl who developed a mysterious, paralyzing illness following a Gardasil injection, passed away on March 15. Jenny likely suffered from a pediatric form of Lou Gehrig’s disease known as ALS or amyotrophic lateral sclerosis.

Ever since Jenny became ill after receiveing a Gardasil shot at age 13, her parents have been looking into the link between the vaccine and disease that ultimately claimed their daughter’s life.  Her mom and dad have been in contact with two other sets of parents whose daughters also seem to have been stricken with what seems to be ALS following Gardasil injections.

Now, US News & World Report says U.S. Food and Drug Administration (FDA) scientists have met with Jenny’s neurologists and are looking into the possibility of a vaccine playing a role in her ALS.  The Centers for Disease Control also plans on reviewing its adverse-event database—VAERS—for cases in which nonGardasil injections led to ALS or other neurological problems.

One parents concerns below
02/23/2009,MN,10.0,,,F,02/17/2009,
My daughter started to get restless in the legs and had many headaches. She was twitching and couldn't stop from jerking movements in head and legs.
We thought maybe she got a hold of some kind of drug. The doctors said she has rheumatic fever. This is triggered by strep throat. The only problem she tested negative for that.
Now she can't even walk. She has no hunger and is very depressed. 10 years old and making drugs that take healthy kids and turn them into this. I didn't like the idea of my child taking this drug and my wife only did because the doctor said he highly recommended it.
Well now that this has happened I have found out that they have had 21 deaths in 2 years. Thanks for telling us that in the side effects. I don't see anything mentioned about this.
My daughter got only one dose and was set to get her second when this happened. This drug needs to be taking off the market. I don't want to see another family go through what we are going through. She has missed 3 weeks of school and I don't see her recovering anytime soon. 1 death is too many and I know that there are many out there that will be permanently disabled over this drug.
PLEASE TAKE THIS DRUG OFF THE MARKET. I will continue to spread the word out to Family & Friends in hope that they won't put their child in the hands of this drug maker. GARDASIL needs to be stopped.
Vac's comments:

Time and time again I read similar to that above, about how the parent did not know.
There are risks and adverse reactions, side effects, that sometimes can even prove fatal.
My mission is to make parents and children aware of those risks.
So that then they can weigh up whether they wish to continue with having the vaccine.
I believe the reason those administering it do not fully disclose this, is simple.
If someone was told about the possibility of death, or any of the other disabilitating  injuries caused by these jabs, they would be more inclined not to want it then.
This would cause obvious conern for those involved, especially the manufacturers, who I still believe on the whole for them, boils down to money, money, money.

So sadly, if they are failing to do the job, I am doing it for them.
The hosting and so forth cost me over 36 pounds for 12 months, but I am not asking for donations.
I'm not interested in money, all I want to do is get the message out to prevent more children suffering and adults, especially at the hands of the HPV type vaccines, which appears from my research to be among the worst of all vaccines that I'm aware of currently on the market.
Another one not happy:

03/02/2009,,16.0,,,F,02/15/2009,"My daughter received her 3rd injection of GARDASIL vaccine on Feb. 9th 2009.  She had severe headaches ever since. We took her to the emergency room on Feb 13th.  They ran a series of tests which included a brain scan.
Nothing abnormal showed but she never got rid of her headache. To this day she is fatigued, dizzy, has headaches, blurry vision and arm pain. These side effects were never mentioned yet when I looked on the web many people said they had the same side effects after the vaccine. I am taking her to her pediatrician tomorrow to have him evaluate her again and we will go from there."
Yet another one

05/18/2009,,17.0,,,F,05/12/2009,
"Daughter received first GARDASIL shot in June 2008. She passed out and hit her head getting a concussion -the Dr believed-. She had to stay in bed for over a week. She had severe headaches and neck pain. After the second shot, in September she also went to bed for about a week and a half. She had achiness all over especially in legs and stomach. The doctor ran CBC and xrays but could only find a slightly elevated protein level in the urine at this time. Because of these, she did not receive third vaccine. Over the winter, her toes started turning blue. She is now being tested for lupus. I will know the results in about one week, but if she has it I am sure it is from GARDASIL. This is a very dangerous vaccine and I wish I would have researched it more before forcing my daughter to receive it. I will never forgive myself for making her take this vaccine against her will.
Info concerning Gardasil from:
http://www.drugs.com/gardasil.html

Before receiving Gardasil

Before receiving Gardasil, tell your doctor if you have:

  • high fever, or signs of infection;

  • a weak immune system;

  • a bleeding or blood-clotting disorder, such as hemophilia; or

  • if you are taking a blood thinner such as warfarin (Coumadin).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Gardasil passes into breast milk or if it could harm a nursing baby. Do not receive Gardasil without telling your doctor if you are breast-feeding a baby.

Gardasil will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

Gardasil will not prevent diseases caused by HPV types other than types 6, 11, 16, and 18. There are over 100 different types of HPV.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You may feel faint after receiving this vaccine, especially within the first 15 minutes after injection.

Other Gardasil side effects may include:

  • pain, swelling, redness, or itching where the shot was given;

  • mild fever;

  • nausea, vomiting, diarrhea, upset stomach;

  • dizziness, tired feeling;

  • runny or stuffy nose, sore throat, cough; or

  • joint or muscle pain.

However we know from those reported incidents what nonsense the above is, as it appears it hardly covers half the reactions many have had.

What other drugs will affect Gardasil?

Before receiving Gardasil, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;

  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with Gardasil. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Video page
Lots of videos from You Tube showing the harmful effects of vaccines such as Gardasil and Cervarix, and a whole lot more, including videos of those that have been effected by them as well.
Victims Photo Page
Lest we never forget those who have tragically suffered as a result of having a vaccine. Here are a collection of photos to remember those who have died and those that are still alive but suffering on a daily basis
Many of the videos on You Tube feature information mainly from news articles, which are in text form below.

Articles 2001
Articles 2002
Articles 2003
Articles 2004
Articles 2005
Articles 2006
Articles 2007
Articles 2008
Articles 2009
The following information was from VAERS itself  http://vaers.hhs.gov This is concerning 2009 only and Gardasil jab only, reported events. The adverts my say be one less, but for many it's one more, one more in pain.
Some I may leave out, so not all are listed here. What is listed here alone is huge enough though as you can see.
Also, please be patient I may be adding more information as you read this, please bookmark, add to Favs.

Vaccine Researcher: Gardasil ‘is a Great Big Public Health Experiment’ (Original sourse here)

 (Diane harper at it again. we'll see if they pull this article under pressure)

Also: Gardsil being blamed for leaving girl in a wheelchair
The squalene in MF59 is not the only cause for concern. One of its components, Tween80 (polysorbate 80) is considered by vaccine manufacturers to be “inert” but is far from it. A study published in December, 2005 discovered that Tween80 can cause anaphylaxis, a sometimes fatal reaction characterized by a sharp drop in blood pressure, hives, and breathing difficulties. Researchers concluded that the severe reaction was not a typical allergic response characterized by the combination of IgE antibodies and the release of histamines; it was caused by a serious disruption that had occurred within the immune system.(5)
http://ezinearticles.com/?Flu-Shots---Beware-of-Toxic-Additives&id=543262
***Ones in bold and blue are where patient has died***

336382,01/02/2009,IL,15.0,15,,F,01/02/2009,Was in reception area immediately after injection of Gardasil and fell to floor and had full body twitching for 5 to 10 seconds.  Was not observed falling.  Mother had back to her while paying receptionist.  No complete loss of consciousness noted.  Has redness on right side of face and c/o of pain in right temple area.  PERL. Pale. Skin warm and dry.  Not involuntary of bodily functions.  Full ROM and good grasp and answers commands appropriately.  No prior Hx of medical conditions except anemia when younger.  BP130/90. Pulse 88reg. Happened at 9:50am and ambulance arrived to take her to ER at 9:57am.  Phone call from mother stating she was discharged to go home at  11:20am

336578,01/06/2009,NJ,19.0,19,,F,01/05/2009,"Information has been received from a Certified Medical Assistant for the Pregnancy Registry for GARDASIL concerning a 19 year old female with penicillin allergy who on 30-JUN-2008 was vaccinated with a 0.5 ml first dose of GARDASIL (LOT # 0250X) and on 29-AUG-2008 received a second dose of GARDASIL (LOT # 0573X). The reporter stated that the patient who had received the GARDASIL vaccine ""is pregnant"". Her LMP was 19-SEP-2008. Expected date of delivery is 26-JUN-2009. There was no concomitant medication. No adverse effect was reported. The patient was seen in the office for medical attention. Follow up information was received on 30-DEC-2008 from a certified medical assistant who stated that there was a elective termination of the pregnancy. It was unknown if the products of conception were examined or if the fetus was normal. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested."

336580,01/06/2009,FL,25.0,,,F,01/05/2009,"Information has been received from a consumer, for the Pregnancy Registry for GARDASIL vaccine, concerning his 25 year old wife general anesthesia allergy who was vaccinated 3 doses of GARDASIL vaccine (Lot # not reported) prior to becoming pregnant.  Concomitant therapy included heart medication.  Consumer's wife is the patient in this case.  Consumer reported that his wife had completed the GARDASIL vaccine series approximately six months to becoming pregnant with their first child.  Consumer reported that they learned at 17 weeks gestation that his wife had lost their baby around 12 weeks of gestation.  Laboratory test was performed previous to pregnancy and during pregnancy.  Consumer reported that his wife will call back with more specific dates and information.  Upon internal review, abortion spontaneous was determined to be an other important medical event.  Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,Pregnancy NOS (LMP = Unknown)  Drug hypersensitivity

336581,01/06/2009,,18.0,18,,F,01/05/2009,"Information has been received from a physician, for the pregnancy registry for GARDASIL, concerning an 18 year old female with a history of 2 pregnancies, 2 elective terminations, 0 live births and no other medical history who on 27-May-2008 was vaccinated with the second dose of GARDASIL (lot#659964/1978U). There was no concomitant medication. Subsequently, she became pregnant and her LMP was 26-Jul-2008. On 30-Aug-2008, about 5 weeks from her LMP, the patient underwent elective termination. Upon internal review, elective termination was determined to be an other important medical event. Additional information has been requested."

336714,01/07/2009,GA,14.0,14,,F,01/07/2009,"Patient had Gardasil shot and then Depo-Provera about 1 week later. 2 months later, this past Friday she passed a mass of tissue vaginally that was approximately 5"" X 2"" and was in pain similar to labor. This child is not sexually active, has experience severe cramping. Concerned may have caused permanent damage to her uterus. Ultrasound today, gyn in the next few."

336726,01/07/2009,,9.0,9,,F,01/05/2009,"My daughter received her second injection of GARDASIL on December 22, 2008.  On December 31, 2008 she had a sudden and severe hives reaction-  inner thighs of both legs and feet, blood red, swelled, very painful and itchy.  We went to the emergency room where she was treated unsuccessfully with BENADRYL and then was given steroids, which after 12 hours reduced the horrific hives.  Then on Friday, January 2, 2009 she started to complain about severe pain in her armpits.  By Sunday night the pain spread up her chest, neck, jaw and lips. We have an appointment at our Dr. this afternoon, but felt that since there was NO other reason - sickness, strange meal, etc. I should report this event immediately.4/14/09-records received-presented to ED 12/30/08- C/O rash on legs began morning of visit to ED. Pruritic. Has had similar rash in past. DX: urticaria. Subsequently developed aches in neck and axillae, legs. Assessment: viral syndrome. 1/12/09 C/O body aches and generalized weakness and low back pain and buring of hands. Now severe headache with photophobia and neck stiffness, slight nausea. 4/28/09-office visit 15/09-C/O musculoskeletal symptoms and rash. Previously seen in ED for allergice reaction. Now have aches in neck, axillae, legs. Impression: Viral syndrome. 1/7/09 continues to C/O leg pain and hand and arm pain. Impression: Myalgia. 1/12/09-second opinion for C/O jaw pain, muscle pain and headache. Light sensitive. Spots in eyes. Impression: Parent child concerns. 1/13/09-seen in ED for worst headache of her life.  Parent refuses LP.  Impression: headache. headache maybe migranoid with photophobia. Myalgia. 1/19/09-C/O blood in urine, fever and sore throat. 3 week history of evolving UTI and strep throat per parent.",,,,Y,,,,,U,12/22/2008,12/31/2008,9,"4/14/09-records received-CT scan brain normal.  4/28/09-records received- Rapid strep negative. Assessment: Acute pharyngitis. WBC 13.0, Antinuclear antibodies direct 95, adenovirus negative. CT head normal.",UNK,UNK,,,4/14/09-records received- Allergies:amoxicillin. Obstructive sleep apnea. Tonsillectomy adenoidectomy.

336730,01/07/2009,MI,21.0,21,,F,01/07/2009,Patient received first dose of GARDASIL and may have been pregnant 7/31/08-LMP-5/15/08 received GARDASIL 16-1608,,,,,,,,,Y,06/19/2008,,,"+ USN ON 7-31-08 with 10W4d on 8-11-08-patient had increased risk downs/on ULTRACET, patient chose termination of pregnancy.",PVT,OTH,,None,AMOXICILLIN,,

336732,01/07/2009,IL,14.0,14,,F,01/06/2009,"GARDASIL administered 12/22/08, within hours patient noticed ""tremors"" (looks like she is having chills). Family and friends noticed episodes too. Episodes are less frequent but still occurring.  1/12/09 Receied PCP medical records of 10/16/08-1/6/2009. FINAL DX: tremors Records reveal patient experienced intermittent bilateral tremors of arms, hands & fingers since 12/22 w/decreasing intensity & duration.  No tx rendered & patient was to RTC if worsened.",,,,,,,,,Y,12/22/2008,12/22/2008,0,None,PVT,PVT,,None,None,,336732,01/07/2009,IL,14.0,14,,F,01/06/2009,"GARDASIL administered 12/22/08, within hours patient noticed ""tremors"" (looks like she is having chills). Family and friends noticed episodes too. Episodes are less frequent but still occurring.  1/12/09 Receied PCP medical records of 10/16/08-1/6/2009. FINAL DX: tremors Records reveal patient experienced intermittent bilateral tremors of arms, hands & fingers since 12/22 w/decreasing intensity & duration.  No tx rendered & patient was to RTC if worsened.",,,,,,,,,Y,12/22/2008,12/22/2008,0,None,PVT,PVT,,None,None,,

336810,01/08/2009,TX,18.0,,,F,12/12/2008,"Information has been received from a physician concerning an 18 year old female with no relevant medical history or allergies who in approximately 2007, also reported as last year was vaccinated intramuscularly with a first, second and third 0.5 ml dose of GARDASIL (lot number and injection site not reported).  There was no concomitant medication.  The physician reported that the patient tested positive for GARDASIL.  The patient called the physician's office and unspecified medical attention was sought.  At time of this report, the patient's event persisted.  Additional information has been requested.",,,,,,,,,N,,,,cervix HPV DNA assay - positive,OTH,OTH,None,,None,,WAES0811USA00270

336823,01/08/2009,MO,18.0,18,,F,01/08/2009,"Within about one minute of receiving Gardasil I immediately started throwing up, became dizzy, covered in sweat, shaking, and felt faint. I was required to lay down for about 45 minutes and then was allowed to leave when these symptoms went away. I did not continue with the other two shots in the series.",,,,,,,,,Y,05/31/2007,05/31/2007,0,,PVT,PVT,,None,None,,

336848,01/08/2009,PA,13.0,13,,F,01/07/2009,"Loss of consciousness approximately ten minutes after GARDASIL, episode lasting less than 30 seconds.",,,,,,,,,Y,01/06/2009,01/06/2009,0,,PVT,PVT,,None,,,

336853,01/08/2009,CO,15.0,15,,F,01/07/2009,"Information has been received from a physician concerning a female patient with a history of mouth ulcers who on an unknown date was vaccinated with a dose of GARDASIL, lot # unspecified. The patient came back to the physician's office 4 hours after getting GARDASIL with ""vulvar ulcers"" diagnosed as ""bipolar aphthosis"". The physician stated that the patient had gotten the shot when she was experiencing symptoms of West Nile virus; however it was not diagnosed after she had been given GARDASIL. The patient became sexually active ""shortly before"" she got GARDASIL. At the time of reporting, the outcome of the event was unknown. Follow-up information was received from the physician who reported that the patient had a history of canker sores. The physician also reported that the patient had a viral illness (not specified) prior to receiving the third dose of GARDASIL. The physician stated that the patient had experienced bipolar aphthosis every month for over one year. Follow-up information was received from the physician, who reported that the patient was vaccinated with the third dose of GARDASIL IM, on 18-AUG-2007. The physician reported that within 4 hours of vaccination, the patient had the first outcome of nonherpetic vulvar ulcers. Major work up negative. Presumed to be bipolar aphthosis. At the time of reporting, the patient had not recovered. The patient had numerous cultures and laboratories (unspecified) and a presumptive positive West Nile virus test. The physician considered the event to be disabling. This is one of two reports from the same source. No further information is available.   2/17/09 Received Immunology Clinic records of 7/15-9/26/2008. FINAL DX: Bechet's disease Records reveal patient did not have symptoms when initially evaluated.  Valtrex d/c.  Had bout of depression w/suicidal ideation.  Being seen by counselor & tx w/meds. Developed oral canker sores that waxed & waned & by 9/18 had over 40+ vulvar ulcers w/exudate & bilateral lymph node adenopathy.  Depression aggravated by eruption,",,,,Y,,,,Y,N,08/18/2007,08/18/2007,0,"Diagnostic laboratory, STD testing  LABS: pathergy test neg.  ESR 32(H), CRP 10.5(H).  CBC, chemistry, LFTs WNL.  HSV/PCR neg.  HSV I (+), HSV II(-).  Biopsy vulvar lesion.",PVT,OTH,Unknown,Vulval ulceration; West Nile viral infection,"Mouth ulceration; Canker sores oral; Viral infection  PMH: PCOS, ? DMII on oral meds.  Allergy: sulfa.",,WAES0812USA02633

336854,01/08/2009,NY,16.0,16,,F,01/07/2009,"Information has been received from a consumer concerning her 16 year old daughter with no medical history or drug allergies who on 06-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Within 24 hours after vaccination the patient started experiencing pain and within 2 days she started vomiting. She was admitted to a hospital on 12-DEC-2008 (enzyme levels were over 800) and released on the 16th. The hospital determined it was pancreatitis. Multiple tests were performed in the hospital including CAT scan and ultrasound but the results were not provided. The patient was not fully recovered yet, however her mother stated that she was better and her enzyme levels were coming back to normal. Additional information has been requested.  3/16/09 Received PCP medical records of 7/31/08-2/13/2009. FINAL DX: acute on chronic pancreatitis w/strictures & pancreatic stones s/p stent placement; pancreas divisum; asymptomatic until 12/10/08. Records reveal patient experienced good health on 12/6/08 when received HPV #1 & flu shot.  RTC 12/10/08 w/cough, cold s/s & chest/upper abdomen pain near diaphragm.  Dx w/muscle strain & URI.  RTC 12/12 w/continued upper abdominal pain w/vomiting, watery diarrhea, pale w/decreased bowel sounds, guarding & rebound.  Sent to hospital for acute abdomen.  RTC 12/17 s/p hospitalization w/resolving pancreatitis.    4/16/09 Received hospital medical records of 12/12-12/15/2008. FINAL DX: pancreatitis, etiology unknown Records reveal patient experienced progressively worsening epigastric pain x 5 days, N/V x 1 day.  Seen by PCP & dx w/musculoskeletal pain.  Continued to worsen &unable to walk or attend school.  ALso had cold s/s during the week & multiple sick contacts. Surgery & GI consult done. Labs & PE improved & able to tolerate diet.  D/C to home W/PCP & GI f/u.",,,,Y,Y,4,,,N,12/06/2008,12/07/2008,1,"Diagnostic laboratory, 12/12/08, enzyme levels over 800  LABS: CT scan & US abdomen abnormal w/pancreatic & common bile duct dilation & calcification of pancreatic head.  MRI/MRCP abnormal w/dorsal duct syndrome, pancreatic stones & stric",OTH,OTH,None,,None  PMH:  Foreign travel 7/08.  Family hx: IBS.,,WAES0901USA00056

336975,01/09/2009,NY,18.0,18,,F,01/09/2009,"Patient given GARDASIL- fainted after getting it, patient complained of headache prior to fainting.",,,,,,,,,Y,01/08/2009,01/08/2009,0,,PVT,PUB,PROZAC; NUVARING,None,AMOXICILLIN,,

337031,01/12/2009,,18.0,18,,F,01/09/2009,"Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 24-NOV-2008 was vaccinated with her initial dose of GARDASIL (lot # 661530/0575X) 0.5 mL intramuscularly in deltoid. On unknown date the patient had a severe reaction to the vaccination and went unresponsive. Her blood pressure was recorded at 54/30. The patient was sent to the local Emergency Room via ambulance. She was not admitted to the hospital and recovered from unresponsive. The last menstrual period was 21-OCT-2008 and estimated delivery date was 28-JUL-2009 (reported as ""27-JUL-2009""). Upon internal review, went unresponsive was considered to be an important medical event. Additional information has been requested.  2/2/09 ER record received for DOS 11/24/08 with DX: Vasovagal episode. Pt was receiving immunizations when had a single episode of syncope.  PE WNL in ER. D/C to f/u up with PCP.",,,,Y,,,,,Y,11/24/2008,11/24/2008,0,"Blood pressure, 54/30. Labs and Diagnostics:  CBC, Chem and EKG all WNL. Serum B-HCG (-).",OTH,OTH,Unknown,Pregnancy NOS (LMP = 10/21/2008),PMH: none,,WAES0901USA00339

337032,01/12/2009,TN,18.0,,,F,01/09/2009,Information has been received from a physician concerning an 18 year old female who in May 2008 was vaccinated with the third dose of GARDASIL and within 1 week experienced right arm pain (2008). The patient saw an unspecified neurologist who said there of the vaccine was nerve damage. Lab diagnostics performed included MRI and CAT scan. All 3 doses were given in the right arm. Unknown if the patient had any problems with the first or second dose. The patient sought medical attention by visiting the physician's office. Nerve damage was considered to be disabling by the physician because the patient was on the golf team and was unable to participate. Additional information has been requested.,,,,,,,,Y,U,05/01/2008,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA00354

337155,01/13/2009,FL,15.0,15,,F,01/12/2009,"Information has been received for the pregnancy registry for GARDASIL from a physician concerning a 15 year old female who on 23-OCT-2008 was vaccinated with a third dose of GARDASIL (lot # 659184/0843X). It was reported that the patient was pregnant since August 2008 (LMP: August 2008). An ultrasound test was performed on 08-DEC-2008, which showed gestation of 22 weeks and 1 day. The physician reported that the patient had an elective termination of her pregnancy. The patient had no previous pregnancies. Upon internal review, elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.",,,,,,,,,U,10/23/2008,10/23/2008,0,"ultrasound, 12/08/08, Pregnant. 22 weeks, 1 day",OTH,OTH,Unknown,Pregnancy NOS (LMP = 8/1/2008),,,WAES0901USA00452

337160,01/13/2009,OK,16.0,16,,F,01/13/2009,"PT RECEIVED GARDASIL, MENACTRA AND ADACEL IMMUNIZATIONS ON 01-12-09.  AFTER INJECTIONS, PT GOT DIZZY AND PALE WHILE SITTING UPRIGHT IN CHAIR IN EXAM ROOM.  PT SLUMPED DOWN, HAD A BRIEF LOC WITH MILD IRREGULAR JERKING OF EXTREMITIES THAT LASTED APPROX 10 SECONDS. + URINARY INCONTINENCE.  PT WOKE STARTLED AND SURPRISED ASKING ""WHAT HAPPENED?""  THE EPISODE WAS WITNESSED BY DR.  DR. DOCUMENTED ""THIS SEEMS TO HAVE BEEN A VASOVAGAL SPELL WITH A SUPERIMPOSED HYPOXIC SEIZURE.""",,,,,,,,,Y,01/12/2009,01/12/2009,0,,UNK,UNK,BENADRYL,"PT PRESENTED TO OFFICE FOR A PHYSICAL.  PT C/O BEING ""TIRED MORE SINCE CHRISTMAS"" WTH INCREASED SLEEPING DURING CHRISTMAS BREAK","ALLERGIC RHINITIS, ALLERGY-INDUCED ASTHMA",NA~ ()~~0~In Patient|NA~ ()~~0~In Sibling|NA~ ()~~0~In Sibling,

337180,01/13/2009,NV,17.0,17,,F,01/13/2009,Pt developed strong daily headaches.  She reports a history of sever headaches in her past history.  She noticed daily headaches after 1st Gardasil vaccine.  The headaches subsequently subsided.  She reports recurrence of headaches within days of 2nd Gardasil vaccine,,,,,,,,,U,01/06/2009,01/08/2009,2,None,PVT,PVT,"Minocycline, celexa, Nuvaring",none,none,Headaches~HPV (Gardasil)~1~18~In Patient,

337242,01/14/2009,NM,20.0,20,,F,01/09/2009,"My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undermined death. There was no sign of trauma to the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her head on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to please take it off until it can be further tested. -not tested long enough to begin with- There will be others that will die if the cause is not found. 1/29/09-records received-COD-undetermined.   6/26/09 Medical records received DOS 10/29/07 to 1/14/08. Assessment: Immunizations and Contraceptive Management. HPV#1 10/29/07 LA Merck Lot# 1062U",Y,11/15/2008,,,,,,,N,01/14/2008,11/15/2008,306,1/29/09-records received-COD-undetermined.  krk 6/23/09-pathology report received: autopsy tissues without evidence of an infectious process.  6/26/09 Medical records received DOS 10/29/07 to 1/14/08. LABS and DIAGNOSTICS: PAP Tests (-).,UNK,UNK,,,"No medical problems-- no allergies -- No drug use, alcohol or smoking. Had all her medical check ups!!!",,

337249,01/14/2009,,27.0,27,,F,01/12/2009,"Diagnosed with rheumatoid arthritis on 01/08/2009 by a rheumatologist at a research center.  I am 28 years old, and first noticed pain in feet about 1 month after 2nd round of GARDASIL.  I didn't think about any connection at the time,  but joint pain, etc had worsened over the year, and my hands, fingers, shoulders, feet really hurt, so I finally went to rheumatologist, everyone saying it sounded like arthritis.  There is not a history in my family of arthritis, and I am a healthy person, work as athletic trainer at university.  After my feet started hurting, I switched shoes, got insoles, thought wearing flip flops a lot may be causing problem.  Nothing has really helped.  I had some blood work last summer, checking for some idea of the problem, no problems.  I can't help fut feel there is a connection between my early onset of arthritis and this vaccine.  I see other people have had similar problems.  I just want to find out if there could be a conneciton, and possibly help with my diagnosis, recovery.  I don't want to be on arathritis meds the rest of my life!  Please contact me with any help in this matter if Merck has some suggestions to help me.",,,,,,,,,U,11/21/2007,01/08/2009,414,,UNK,UNK,,,,,

337301,01/14/2009,PA,16.0,16,,F,01/13/2009,"Information has been received from a Licensed Practical Nurse concerning a 16 year old female who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL. On 02-SEP-2008, the patient was vaccinated with the second dose of GARDASIL. On 05-JAN-2009, at 4:20 p.m. the patient was vaccinated with the third dose of GARDASIL (lot # 661764/0650X) IM in her left arm. The patient fainted as soon as the third dose was given, and had a seizure like symptom. Blood pressure was 102/60, and the pulse was OK. Half an hour later, the patient recovered from fainted and seizure like symptom. Upon internal review, seizure like symptom was considered to be an other important medical event. No further information is available.",,,,,,,,,Y,01/05/2009,01/05/2009,0,"blood pressure, 01/05/09, 102/60; total heartbeat count, 01/05/09, OK",PVT,PUB,Unknown,,Unknown,,WAES0901USA00898

337302,01/14/2009,,17.0,17,,F,01/13/2009,"Information has been received from a nurse practitioner concerning a 17 year old female with no medical history and drug allergies who on 31-DEC-2008 was intramuscularly vaccinated with the third 0.5 ml dose of GARDASIL. She had no problems after receiving the 1st and 2nd doses of GARDASIL. At 22:30 on 02-JAN-2009, 48 hours later, the patient experienced seizure type activity and convulsions, 2 more occurred by 23:30 during which time she was taken to the hospital. It was decided in the emergency room to take the patient to a children's hospital early on 03-JAN-2009. The patient had a total 13 seizures type activities or convulsions but it was unclear the specific time frame. Laboratory tests included an magnetic resonance imaging, ultrasound of the kidney, and ""lots of unspecified lab work"" (one of the results were normal kidney function). The patient has one more episode after being discharged from the hospital on 04-JAN-2009. The patient was put on XANAX and her mother felt it had helped control the seizure type activity and convulsions. The patient started KEFLEX and AZO for urinary tract infection on 02-JAN-2009. The seizures type activities or convulsions was considered to be disabling. Additional information has been requested. 2/2/09-records received for DOS 1/3-15/09-DC DX: Spells. presented to ED with difficulty breathing, rash and episodic jerking. Rash on back, chest and neck and felt short of breath. Rash would come on with shaking and improve when shaking stopped.",,,,Y,Y,3,,Y,Y,12/31/2008,01/02/2009,2,Unknown 2/2/09-records received-Renal ultrasound normal. Labs WNL. MRI brain normal.,OTH,OTH,Unknown,"2/2/09-records received- Dysuria, left flank pain times 5 days. After first dose of Keflex felt lightheaded, fall to ground with",None 2/2/09-records received- PMH: GTC seizure at 8 years of age andmultiple episodes of passing out with exercise and hypoglycemia. Urinary tract infection. Staph knee infection last year.,,WAES0901USA00986

337303,01/14/2009,CT,12.0,12,,F,01/13/2009,"Information has been received from a physician concerning a 12 year old female who on 29-OCT-2008 was vaccinated with the third dose of GARDASIL (lot # 659657/1487U). Concomitant therapy included Varicella virus vaccine (manufacturer unknown), hepatitis A vaccine (manufacturer unknown) and influenza virus vaccine (unspecified). On 25-NOV-2008 the patient came back with a severe hip pain. The pain started in her right hip and spread to both. The patient was sent to a rheumatologist and he performed multiple test and they all came back negative. The rheumatologist did mention that the patient was unable to walk and needed a wheelchair. The physician was informed on 15-DEC-2008 that the patient was walking without a limp. Severe hip pain and unable to walk and needed a wheelchair were considered to be disabling. Additional information has been requested.",,,,Y,,,,Y,Y,10/29/2008,11/25/2008,27,"X-ray, negative; WBC count, negative",OTH,OTH,,,Unknown,,WAES0901USA01014

337337,01/14/2009,KS,22.0,22,,F,01/14/2009,"Sharp stomach pains within 2 hours of shot.  Hands then became tingly and had""pins and needles"", throat then had same feeling. Then had feverish feeling then nausea and itching all over. Then took Benadryl. Then ""sick"" feeling, then wheezing, then chest pain, then went to emergency room.  Felt sick ,could not function. 2/17/09-records received for DOS 1/14/09-presented to ED with C/O difficulty breathing and wheezing, abdominal cramping . Allergic reaction to Gardasil Impression: anaphylaxis.",,,Y,Y,,,,,Y,01/14/2009,01/14/2009,0,,UNK,UNK,,none,"penicillin-all siblings have had reaction, told to avoid by physician",,

337422,01/15/2009,AZ,22.0,22,,F,01/13/2009,Patient received yellow fever and typhoid injections without incident. Approximately 15 mins later GARDASIL inj given. Within mins patient had syncopal episode with tonic movements of both upper extremities and drooling. Treatment was supportive in nature-moved to supine position  when LOC returned. Advised not to drive home. Rested approximately 30 mins.,,,,,,,,,Y,01/06/2009,01/06/2009,0,,OTH,PVT,,,Patient stated she was allergic to CECLOR,,

337428,01/15/2009,WA,12.0,12,,F,01/07/2009,"After first shot of GARDASIL on 2-7-08 had dizziness, headache, missed school. Second shot 5-7-08 had dizziness and severe headache - missed school. Fever 3rd 9-29-08 major dizziness sever headache needed help getting up and walking missed school.",,,,,,,,,Y,02/07/2008,02/07/2008,0,,PVT,OTH,Allergic to most anti biotic,None,Allergic to most anti biotics,Dizziness~Varicella (no brand name)~1~5~In Patient,

337590,01/16/2009,IL,22.0,22,,F,01/15/2009,"Information has been received from a physician concerning a 22 year old female patient with no pertinent medical history and no known drug allergy who on 07-JAN-2009 was vaccinated with the first IM dose of GARDASIL (lot # 659184/0843X).  Concomitant therapy included hormonal contraceptives (unspecified).  On 07-JAN-2009 the patient experienced redness of the eye, bronchospasms and rash pennciallian.  The patient went to ER (it was not known if the patient was admitted).  At the time of this report, the physician stated that the patient was fine.  Redness of the eye, bronchospasms and rash pennciallian were considered to be immediately life-threatening.  Additional information has been requested.",,,Y,Y,,,,,Y,01/07/2009,01/07/2009,0,None,OTH,OTH,Hormonal contraceptives,,None,,WAES0901USA01109

337591,01/16/2009,FL,13.0,13,,F,01/15/2009,"Information has been received from a physician concerning a 15 year old female with no previous medical, family, or social history who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL IM. The patient's mother told the physician that a few weeks after the GARDASIL, the patient had body aches and generalized pain. The patient was seen by her pediatrician and a neurologist, and they both thought that it was from GARDASIL. The neurologist had diagnosed the patient with fibromyalgia. CPK was elevated. At the time of reporting, the patient was being treated with cyclobenzapine hydrochloride (MSD), melatonin, imipramine, and chiropractic therapy for the pain and insomnia. The patient has missed many days from school and volleyball because of the fibromyalgia. At the time of reporting, fibromyalgia persisted. The reporter considered fibromyalgia to be disabling. Additional information has been requested.  1/29/09-According to the general practitioner, fibromyalgia persisted while insomnia was being controlled on medication (not recovered).Onset Date: Approximately December 2007 (""a few weeks after Gardasil"", per pt's mother) 2/17/09-records received for DOS 7/23/08-neurology notes-C/O muscle aches and pains as well as sleep disturbance. Previously evaluated on 5/12/08, continues with pain on an almost daily basis. However no discomfort in past few days. Impression:history of severe pain in legs and arms and along cervical spine. Sleep disturbance resolved with use of Seroquel. No neurological cause of pain. No rheumatology consult at this time due to insurance issues.",,,,,,,,Y,N,12/07/2007,12/08/2007,1,"plasma creatine kinase, elevated 2/17/09-records received-MRI brain normal, MRI cervical spine minimal bulge at C5 to C6. Pseudotumor Chiari malformation and spinal instability ruled o ut. EMG and nerve conductions tudies normal. CPK sligh",OTH,OTH,Unknown,,None,,WAES0901USA01201

337592,01/16/2009,CA,19.0,19,,F,01/15/2009,"Information has been received from a health professional concerning a 19 year old female patient who on 17-DEC-2008 was vaccinated with the first dose of GARDASIL IM into her right arm (lot # 661766/0652X). On 17-DEC-2008 the patient also received MENACTRA and Tdap in her left upper arm. On 17-DEC-2008 (""a few seconds later"") the patient experienced convulsed and passed out. The patient stated that she didn't feel funny after the first two shots. When she received GARDASIL she felt a rush of warmth in her arm then she experienced lightheaded and blacked out. At the time of reporting, the patient had recovered. It is unknown if the patient sought medical attention. Upon internal review, convulsed was determined to be an other important medical event. Additional information has been requested.",,,,,,,,,Y,12/17/2008,12/17/2008,0,Unknown,PVT,OTH,,,Unknown,,WAES0901USA01203

337651,01/16/2009,,,,,F,01/16/2009,"Information has been received from a registered nurse who reported that the one of her patient's mother reported that there was a female patient who was vaccinated with the third dose of GARDASIL (Lot and route unspecified) and three days later she had a seizure. The nurse reported that the patient was sent by ambulance to the hospital and was hospitalized (duration not reported). The nurse reported that the mother also mentioned that the patient, on an unspecified date, had kidney infection. It was unknown if the kidney infection occurred before the third dose of the vaccine or before of the GARDASIL. As of 13-JAN-2009 the outcome of the patient was unknown. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.",,,,,Y,0,Y,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA01615

337693,01/16/2009,WI,15.0,15,,F,01/16/2009,"Syncopal episode following GARDASIL administration. Held in clinic for 15 min following incident, with BP initially 122/64 and 126/76 15 min later.  Given 12oz apple juice while reclining.",,,,,,,,,Y,01/16/2009,01/16/2009,0,,PVT,PVT,None,None,"Allergic ICN, Augmentin",,

337625,01/18/2009,VA,19.0,19,,F,01/18/2009,"Immediately after receiving shot,severe pain in injection arm.Had to rest for 10mins in office.Beginning the next day, had a painful knot in back, pain in left lung if deep breath is drawn, muscle weakness on left side from shoulder to fingertips all the way down to toes, muscle weakness, nausea, headache,rash on neck and itchiness on chest.These symptoms progressed and got worse and by Friday. Call Dr's office. Was told the symptoms I described had nothing to do with the Gardasil Shot. After I pressed the issue, the doctor returned my call, stated their office could do nothing and suggested I should see my primary care physician. The primary care doctor was booked solid so went to urgent care center. The doctor on duty did not know much about gardasil and suggested we go to the emergency room at another hospital if symptoms got worse. I took my daughter home and watched over her. She did begin to feel better and as of today the symptoms have subsided. This was her 2nd gardasil shot, the first was given 7/2008. She is scheduled to receive the 3rd shot on 2/3/2009. I am very afraid to have the 3rd shot administered because of the difficulty she experienced with the 2nd shot and the lack of support she received from her doctor and the urgent care doctor.",,,,Y,,,,,Y,01/06/2009,01/07/2009,1,A blood test was done at the urgent care office for any abnormality and results were okay.,UNK,UNK,yaz birth control,none,none,,

337752,01/20/2009,NY,15.0,15,,F,01/13/2009,"25 days after GARDASIL #3 developed syncopal episodes- recurrent, over course of 6 mos. Neuro and cardio work- ups WNL.  1/22/09 MR received from PCP including multiple neurology and cardiology consults from 8/07-1/13/09. OV 2/4/08 for recurrent sinusitis since 9/2007. HPV#3 given.  Returned 3/3/08 with c/o H/As and dizziness as well as 1 fainting episode over past few days. Tx with abx for sinusitis and vasovagal syncope discussed. Pt fainted after blood draw in office with continued fuzzy vision and inability to get up. Unresponsive x 45 minutes.To ER. Received IVF which caused swelling. Still feeling unwell with photophobia, H/A, lightheadedness and neck soreness. No memory of ambulance ride. Still c/o H/A 3/6/08.  Somewhat better 3/14/08 with exception of exhaustion.  Several more episodes of H/A, fainting, chest ache with racing heart, stomachaches. Episode 9/17/08 face red, extremities grey with tonic-clonic movements of extremities and eyes rolling back. Unresponsive x 45 minutes. Referred to Neuro and Cardiology.  Neuro consult 4/14/08 and 9/25/08 with normal exams. DX: Syncope. Panic attacks. Vasovagal syncope. Cardiolgy consult 10/2/08 for eval of syncope with shock-like, stabbing chest pain which self resolved. Subsequent episode with heart racing and difficulty breathing. No dx mde. Improved by 1/13/09.",,,,Y,,,,,Y,02/04/2008,02/28/2008,24,"Labs and Diagnostics:  CT scan (-). EKG WNL. Echo WNL. EEG WNL. MRI/MRA of brain WNL. Glucose tolerance test (-). Holter monitoring (-). Repeat EEG  CMV IgG Ab (+), IgM (-). Mycoplasma pneumoniae IgG Ab 3.25 (H), IgM (-). Parvo B19 Ab IgG",PVT,PVT,BIAXIN,Sinusitis,PMH:  kidney reflux as toddler. T&A age 4. Ovarian cyst. mild scoliosis. Apnea and reflux as infant. Allergy to sulfa,,

337761,01/20/2009,NM,14.0,14,,F,01/16/2009,"Week of 1/23/2007 pain at site of GARDASIL injection #2 5 week past GARDASIL. Myalgias, hip pain, elbow, wrist, hand, finger, knee, foot pain, fatigue, petechiae legs, decreased ROM, lab NL. Seen by rheumatology, resolved completely 4/3/08. Followed by rheumatology no reoccurrence as of 1/09.  1/29/09 Received PCP medical records which included Rheum & Ortho consults. FINAL DX: Polyarticular reactive arthritis Records reveal patient experienced usual state of good health on 5/18/07, day of HPV#1 & Varicella vaccinations.  RTC 8/23/07 with symptoms x 3 days of pain & swelling of multiple joints; gen aching; fatigue; decreased appetite; difficulty standing, walking & making fist or extending fingers; low grade fever; oral ulcers; scattered petechiae of LEs; searing pain where HPV#2 given 7/18/07.  6/20-23 had illness w/cough, sore throat, fatigue, HA, fever, pain in hips/ankles, stiff joints.

338540,01/20/2009,CA,16.0,16,,F,01/16/2009,"Information has been received from a physician assistant concerning an 18 year old female who on unspecified dates was vaccinated with a first, second and third dose of GARDASIL, lot # unknown. It was reported that the patient had been short of breath since receiving her third dose of GARDASIL. At the time of reporting, the outcome of the event was unknown.  2/3/09 MR received from Pulmonary Med consults dated 9/9/08, 10/27/08 and 1212/10/08 with DX: Shortness of breath/chest tightness.  Allergic rhinitis improved.  Referred by PCP for eval of increasing SOB and chronic cough. Sleeping more lately and waking at night and unable to catch breath. PE WNL. O2 sat 96-98%.  Referred for heart cath later in the yr to r/o pulmonary HTN.",,,,Y,,,,,U,02/29/2008,02/29/2008,0,"Unknown. Labs and Diagnostics:  Stress test -no evidence for EIA or cardiac disease, but borderline VE and VC O2 suggesting possible early pulmonary vascular disease.",OTH,OTH,Unknown,,"Unknown PMH:  Mono 12/07. tonsillectomy 6/08. Allergy to PCN, metal",,WAES0812USA02570

338543,01/20/2009,,,,,F,01/16/2009,"Information has been received from a sonographer concerning her daughter, who an on unspecified date was vaccinated with the first dose of GARDASIL. On the same day, the patient was nauseous and turned green and within a few minutes after vaccination had recovered. The patient sought unspecified medical attention. Additional information has been requested.",,,,Y,,,,,Y,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA02368

338545,01/20/2009,CO,14.0,14,,F,01/16/2009,"Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of asthma and recurrent otitis media; penicillin, KEFLEX, and sulfa drug allergies, who on 13-OCT-2008 was vaccinated with a first dose of GARDASIL (lot # 655205/1426P), intramuscularly.  Concomitant therapy included medroxyprogesterone acetate DEPO-PROVERA.  On October 2008 the patient experienced dizziness.  She experienced the dizziness mainly in the in the morning but the dizziness is progressively getting worse and occurs during the day also.  Laboratory diagnostics studies performed included a CBC, a complete metabolic panel and a TSH on 03-Dec-2008.  The patient sought medial attention through an office visit.  The patient had not recovered.  Additional information has been requested.",,,,Y,,,,,N,10/13/2008,10/01/2008,-12,diagnostic laboratory 12/03/08  -  complete metabolic panel  plasma TSH 12/03/08   - complete blood cell  12/03/08  -,OTH,OTH,DEPO-PROVERA mg,Asthma; Otitis media recurrent; Allergic reaction to antibiotics; Drug hypersensitivity,,,WAES0812USA02344

338546,01/20/2009,CA,26.0,,,F,01/16/2009,"Information has been received from a physician concerning a 26 year old female who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL, lot number 661703/0651X.  Within a week of receiving her first dose the patient experienced blurriness in the left eye, pain and tingling in her hands and feet, and joint pain and headache.  The patient sought medical attention at the physician's office.  Patient recovered.  Additional information has been requested.",,,,Y,,,,,Y,10/28/2008,10/28/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA02177

338572,01/20/2009,ID,18.0,18,,F,01/16/2009,"Information has been received from a physician concerning an 18 year old female patient who on 11-DEC-2008 was vaccinated with the second dose of GARDASIL (lot # not provided).  After receiving the dose the patient was left alone to have some privacy in the room, and then someone came to check on her and she had vomited, felt light headed, dizzy and was hyperventilating.  Patient sought unspecified medical attention.  No lab diagnostics",,,,Y,,,,,N,12/11/2008,12/11/2008,0,None,OTH,OTH,Unknown,,Unknown,,WAES0812USA03380

338576,01/20/2009,,19.0,,,F,01/16/2009,"Information has been received from a nurse practitioner concerning a 19 year old female patient who 1.5 year ago, approximately in July 2007, was vaccinated with the first dose of GARDASIL vaccine 0.5 mL IM.  Approximately thirty days after received GARDASIL vaccine, in approximately August 2007, the patient experienced bilateral facial pain, numbness of her feet and hands, pain in her hands and gastrointestinal upset.  It was noted",,,,Y,,,,,N,07/01/2007,08/01/2007,31,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA03231

338579,01/20/2009,NJ,22.0,,,F,01/16/2009,"Information has been received from a registered nurse concerning a 22 year old female with no medical history and allergy to KEFLEX, who on 02-OCT-2008 was vaccinated with a 0.5ml first dose of GARDASIL (lot# 660612/0229X), intramuscularly. On 4-OCT-2008 the patient developed a raised, ""gum ball sized"", itchy, burning area at the injection site. The reaction resolved without treatment. On 11-Dec-2008 the patient received the deltoid muscle of the right arm and later that night developed itchiness and swelling of both hands. The patient contacted the office by phone on 12-Dec-2008 and was prescribed BENADRYL. There were no laboratory diagnostics performed. The patient had not recovered for the itchiness and swelling of both hands. The patient sought medical attention through a phone call to the doctor's office. Additional information has been requested.",,,,Y,,,,,N,,10/04/2008,,None,OTH,OTH,None,Drug hypersensitivity,,,WAES0812USA02818

338581,01/20/2009,WA,15.0,,,F,01/16/2009,"Information has been received from a physician concerning an approximately 15 year old female who in November 2008, was vaccinated with a dose of GARDASIL vaccine, lot# not reported. It was reported that the patient received the GARDASIL vaccine and waited for 20 minutes and was fine, however she left to the pharmacy and felt light headed and she had to sit down. The physician stated that the patient was fine and was released home after 20 minutes of observation. Patient recovered the same day. Additional information has been requested.",,,,,,,,,Y,11/01/2008,11/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA02632

338582,01/20/2009,TX,24.0,,,F,01/16/2009,"Information has been received from a physician concerning a 24 year old female who ""more than a year ago"" was vaccinated with GARDASIL, 0.5 mL, intramuscularly.  Concomitant therapy included NUVARING.  It was reported that the patient was tested for HPV prior to HPV vaccination: DNA negative for HPV and had a normal PAP smear.  The patient completed her series about a year ago.  The physician stated that at the end of NOVEMBER 2008 the patient had a HPV test, and was positive for the HPV in the high risk panel.  At the time of the report the patient was not recovered.  Additional information has been requested.",,,,,,,,,N,,11/01/2008,,diagnostic laboratory  -  DNA negative for HPV diagnostic laboratory  - 11/??/08   - HPV test positive Pap test   - normal,OTH,OTH,NUVARING,,None,,WAES0812USA02627

338583,01/20/2009,CA,15.0,,,F,01/16/2009,"Information has been received from a physician concerning a 15 year old female patient, who was vaccinated with the first dose of GARDASIL, 0.5ml.  The physician reported that after receiving the HPV vaccine, the patient fainted.  Since then, the patient had been consistently feeling a tingling sensation throughout her body.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  Additional information has been requested.",,,,,,,,,N,,11/13/2008,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA02624

338585,01/20/2009,CA,13.0,13,,F,01/16/2009,"Information has been received from a physician concerning a 13 year old female patient who was vaccinated with the third dose of GARDADIL vaccine (lot# was not available) on unspecified date and played a ""vigorous volleyball"" using the same arm where she received the vaccine the following day after receiving the vaccine. There was no concomitant medication. The physician reported that on 06-NOV-2008 the patient experienced ""serious malaise after vaccination"" and on 17-NOV-2008, the patient brought to the hospital and was admitted for a ""couple of days"", Lab diagnostics Studies Performed included neurological tests when the patient was in the hospital including MRI. The patient sought medical attention through the physician. At the time of report the patient was recovering. Additional information has been requested.  2/23/09 MR received for DOS 11/15-xxxx with  DX:  S1 distribution sensory neuropathy.  Lower extremity weakness and altered sensation. No D/C information available.  Pt presented with 1 wk hx of weakness and fatigue. Had local reaction to recent HPV vax 11/6/08 with fever.  Pt describes heaviness of extremities and difficulty lifting them. Low grade temp with mild intermittant H/As, numbess in foot and toes and low back pain.  Seen by outpt neurologist and found to be areflexic. Instucted to go to ER with worsening sx.  Presented for eval following an episode of dyspnea which self-resolved.  Neuro exam (+) for loss of sensation on the back and decreased in extremities. DTRs and strength WNL. Abdominal reflexes absent.  Admitting DX:  S1 sensory neuropathy.  LE weakness and altered sensation.  2/26/09 Neurology consult received dated 11/14/08 with DX: Generalized weakness with depressed ankle jerks.  S/P Vaccination.  R/O GBS despite normal NCS/EMG. PE (+) for decreased strength, depressed reflexes in upper extremities and ankles, normal sensation.  Instructed to go to ER for further progression of sx which pt did.",,,,Y,Y,,,,N,11/06/2008,11/06/2008,0,"Unknown Labs and Diagnostics:  CBC WNL. CRP (-).  LP with normal cell count, protein and glucose. CSF cx (-).  MRI of lumbar, throacic and sacral spine (+) for L4-5 disc bulge.  EBV IgG and IgM (+) Labs and Diagnostics:  EMG/NCS WNL but l",UNK,UNK,,,Unknown. PMH:  none,,WAES0812USA02603

338586,01/20/2009,FL,20.0,20,,F,01/16/2009,"Information has been received from a healthcare worker concerning a 20 year old female patient with no pertinent medical history and with allergic reaction to CECLOR who on 28APR-2008 was vaccinated with the first dose of GARDASIL (lot# 655604/0052X), on 30-JUN-2008 was vaccinated with the second dose of GARDASIL (lot# 0152X) and on 10-Nov-2008 she received third dose of GARDASIL (lot# 0250X). Concomitant therapy included YAZ. It was reported that the patient was diagnosed with Bell's palsy after receiving the third dose of GARDASIL. It was reported that the patient had not recovered at the time of the report. The patient sought medical attention with a different physician. Follow up information was received on 15-DEC-2008 from a medical assistant who stated that the patient went to the emergency room. Follow up information was received on 15-DEC-2008 from the medical assistant who stated that on 10-DEC-2008 went to the emergency room and diagnosed Bell's palsy by the physician. Additional information has been requested.",,,,Y,,,,,N,04/28/2008,,,Unknown,OTH,OTH,YAZ,Allergic reaction to antibiotics,,,WAES0812USA02593

Vac's comments:
This goes on and on and on, mostly rashes  or passing out and the like, and I admit says a good many then recover in a short period of time.
So from here on in, I'm only going to note down the worst of cases, or any with new symptoms to save time and space here.
However you still might see some of the same as the above from time to time.

338589,01/20/2009,,21.0,21,,F,01/16/2009,"Information has been received from a nurse practitioner concerning a 21 year old female with a penicillin allergy and no medical history who on 14-OCT-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661046/0546X), intramuscularly in the deltoid.  There was no concomitant medication.  After received the vaccine the patient experienced a rash on her back that lasted for 2.5 weeks.  There were no laboratory studies performed.  Follow up information received on 18-DEC-2008 at 13:00 stated that ""the patient was actually in the office about to get the second of GARDASIL and reported that after the first dose she developed a welt in the area of the bra strap at the cup part of the bra"".  Additional information has been requested.",,,,Y,,,,,,10/14/2008,10/14/2008,0,None,OTH,OTH,None,Penicillin allergy,,,WAES0812USA04110

338643,01/20/2009,PA,20.0,20,,F,01/16/2009,"Information has been received from a physician concerning a 20 year old female patient who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). On 17-JUN-2008 the patient experienced flu like symptoms, fever, stomach ache, stomach pain, nausea, vomiting and headache, she lost 23 pounds after receiving the vaccine. The patient's symptoms went away and came back after the second dose GARDASIL vaccine intramuscularly. The patient's flu like symptoms, fever, stomach pain, nausea, vomiting, headache and weight loss persisted. On unspecified date the patient had an Endoscopy done (results not provided). Additional information has been requested.",,,,Y,,,,,N,06/17/2008,06/17/2008,0,Endoscopy,OTH,OTH,Hormonal contraceptives.,,Unknown,,WAES0812USA03770

338644,01/20/2009,CA,16.0,16,,F,01/16/2009,Information has been received from a physician concerning a 16 year old female patient who on 14-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 660612/0229X) 0.5 ml intramuscularly.  After receiving the first dose patient experienced bad cramps and heavy bleeding during her menstrual period.  Patient sought unspecified medical attention.  Patient informed physician about this experience when she came back to receive her second dose of GARDASIL 24-NOV-2008.  Additional information has been requested.,,,,Y,,,,,U,08/14/2008,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA03750

338645,01/20/2009,UT,17.0,17,,F,01/16/2009,"Information has been received from a physician concerning an 18 year old female patient who on 6-DEC-2007 was vaccinated with the first dose of GARDASIL (lot # not provided). On 09-APR-2008 the patient received the second dose of GARDASIL (lot # not provided). A colposcopy done approximately on 3-DEC-2008, ""2 weeks ago"", showed the patient was high risk HPV. Possible exposure to HPV through her boyfriend. Patient went to the doctor's office. At the time of the report the patient had not yet recovered. Additional information has been requested.",,,,Y,,,,,N,04/09/2008,04/09/2008,0,"Colposcopy, 12/03/08, results showed high risk HPV",OTH,OTH,Unknown,,Unknown,,WAES0812USA03738

338646,01/20/2009,PA,12.0,12,,F,01/16/2009,"Information has been received from an office manager at the physician's office, concerning a female patient, who was vaccinated with first, second and third doses of GARDASIL (dose, route, lot # not reported).  The office manager reported that the patient completed her GARDASIL vaccination series a couple of months ago and started experiencing hip pain and headaches.  At the time of the report, the patient had not recovered.  Follow up information was received from the Registered Nurse on 23-DEC-2008 which reported: The patient was vaccinated with three doses of GARDASIL on 19-SEP-2007, 29-NOV-2007 and 03-APR-2008 respectively.  The patient experienced hip pain, headaches, and stomach pain and that were all still ongoing.  The patient also experienced fatigue but that has resolved.  Follow up information has been received from a Registered Nurse on 30-DEC-2008 which reported that the lot number that was administered was: 660387/19670.  The patient was administered the vaccine at her pediatrician's office.  The patient was also administered varicella virus vaccine live (Oka/Merck) (MSD) and hepatitis B virus vaccine rHBsAg (yeast) (MSD) on the same day the patient received her third dose of GARDASIL.

338653,01/20/2009,TX,,,,F,01/16/2009,"Information has been received from a physician concerning an adolescent female patient who on an unspecified date, was vaccinated with GARDASIL. The physician reported that the patient experienced injection site pain and blisters under eye. the outcome is unknown.  Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA04584

338655,01/20/2009,MD,21.0,,,F,01/16/2009,"Information has been received from a physician concerning a 21 year old female patient with no pertinent medical history and no drug reactions/allergies, who in approximately October 2008, a few months ago (exact date unspecified) was vaccinated with an initial dose of GARDASIL vaccine. There was no concomitant medication. Since receiving the GARDASIL vaccine, coincidently the patient had not had her period the past 2 months. The patient was not pregnant and not in a relationship. The patient had no underlying medical conditions that would explain this as she exercised regularly but not to excess, she was thin but not underweight, and she did not have a medical issue such as PCOS (polycystic ovary syndrome). She had an upcoming appointment with her gynecologist. No other symptoms were present. As of 22-DEC-2008, the patient's outcome was unknown.  Additional information has been requested.",,,,Y,,,,,U,,,,None,OTH,OTH,None,,None,,WAES0812USA04543

338657,01/20/2009,VA,25.0,,,F,01/16/2009,"Information has been received from a medical assistant concerning a 25 year old female patient who in approximately September 2008, was vaccinated with her second dose of GARDASIL (Lot not provided).  Following the vaccination the patient experienced tingling from her elbow to her pinky intermittently (off and on for several months).  As of 19-DEC-2008 the patient's symptoms persisted.  Additional information has been requested.",,,,Y,,,,,N,09/01/2008,09/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA04291

338663,01/20/2009,IL,25.0,25,,F,01/16/2009,"Information has been received from a physician concerning a 25 year old female with no pertinent medical history or allergies who on 21-NOV-2008 was vaccinated intramuscularly in her right deltoid with 0.5 ml third dose of GARDASIL (lot # 660557/0072X). Concomitant therapy included an unspecified birth control medication. On 21-NOV-2008 the patient developed an induration ""about the size of a dime"" at the injection site of the right deltoid muscle. The area was painful to touch, The physician added that the patient had a similar knot near her vagina. The patient contacted the office via phone. No laboratory or diagnostics test were performed. At the time of this report, as 18-DEC-2008, the events persisted. Additional information has been requested.",,,,,,,,,N,11/21/2008,11/21/2008,0,None,OTH,OTH,Unknown,,None,,WAES0812USA04143

338664,01/20/2009,PA,11.0,11,,F,01/16/2009,"Information has been received from a licensed practical nurse concerning a 11 year old female patient with no drug/reactions allergies, who on 17-DEC-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 660555/0279X).  Concomitant therapy included HAVRIX and MENACTRA.  The patient fainted and fell about 5 minutes after receiving GARDASIL vaccine causing a laceration on her chin.  The patient came to immediately.  It was not known what the patient hit when she fainted.  The patient's blood pressure was low.  It took about 30-45 minutes until her blood pressure and color returned to normal.  The patient received stitches for the laceration in an emergency room.  At the time of reporting, the patient was recovering.  Additional information has been requested.",,,,Y,,,,,N,12/17/2008,12/17/2008,0,blood pressure - was low,OTH,OTH,,,None,,WAES0812USA04134

338666,01/20/2009,NY,18.0,,,F,01/16/2009,"Information has been received from a physician concerning an 18 year old female who on 14-AUG-2008 was vaccinated with a second dose of GARDASIL (lot #660393/0067X) in the left arm. ""The patient developed a rash at the injection site shortly after receiving the vaccine. The rash was itchy and swollen and continued to spread into fungal infection. The rash was described as a papular erythemic rash"". The patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.",,,,Y,,,,,N,08/14/2008,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA04119

338676,01/20/2009,MA,14.0,14,,F,01/16/2009,"Information has been received from a registered nurse and the patient's mother concerning a 14 year old female patient with no allergies and no pertinent medical history who on 23-MAR-2007 was vaccinated with the first dose of GARDASIL (date also reported as 22-MAR-2007 by the patient's mother), on 23-MAY-2007 the patient received the second dose of GARDASIL the patient's mother reported that in approximately may 2007, the patient experienced severe hair loss. On 24-SEP-2007, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included vitamins (unspecified). In July 2008, the patient came into the doctor's office and stated that her hair started to fall out and she had had dramatic weight loss (onset date not reported). The nurse reported that the patient was going to have various test done. As of 30-DEC-2008, the patient had not recovered. Additional information has been requested.  2/9/09 PCP records received. 2/6/08 WCC with Impression:  Well Teenager.  (Some records illegible) Seen 3/27/08 for bradycardia.   OV 4/24/08 with c/o sore throat and H/A.  Throat hyperemic on PE.  Imp: Pharyngitis.  OV 7/7/08 with c/o losing hair x 1 month, facial hair x 1 month, irregular periods with R sided pain, R foot lump, lump on coccyx, and significant weight loss (169 in 2/08 to 146). Sent for labs. Returned 12/31/08 for f/u of hair loss. No dx noted.",,,,Y,,,,,N,03/23/2007,05/01/2007,39,Unknown. Labs:  Strep test (-). CBC and Chem unremarkable. TSH normal at 2.13. AM Cortisol low at 7.1. Lyme (-). ACTH WNL at 12.2.,OTH,OTH,Vitamins (unspecified),,,,WAES0812USA05222

338682,01/20/2009,NJ,23.0,,,F,01/16/2009,"Information has been received from a physician concerning a 23 year old female patient with depression, who on an unspecified date, was vaccinated with the first dose of GARDASIL and on approximately 29-NOV-2008 was vaccinated with GARDASIL.  Concomitant therapy included TRAZODONE HC1, CLONAZEPAM, METHYLPHENIDATE and YASMIN.  The physician reported that the patient reported feeling weak, dizzy, tremulous over her entire body and her subclavian lymph node was enlarged on the same side where the vaccine was received.  The physician reported that the patient experienced the same reaction after both doses of the GARDASIL vaccine.  The symptoms were more severe after her 2nd dose.  Exact dates of vaccinations were not available.  It was 4 four weeks post dose 2 and patient still did not ""feel herself"".  The patient reported she still felt weak and is unable to concentrate.  At the time of the report, the patient had not recovered.  The patient sought medical attention and was seen at the physician's office.  Additional information has been requested.",,,,Y,,,,,N,11/29/2008,,,Unknown,OTH,OTH,CLONAZEPAM; YASMIN; METHYLPHENIDATE; TRAZODONE HYDROCHLORIDE,Depression,,,WAES0812USA05103

338685,01/20/2009,IN,,,,U,01/16/2009,"Information has been received from a physician concerning a patient who was vaccinated with GARDASIL (dose, site and route not reported) on unspecified date. The patient tested positive for a sexually transmitted disease after received the vaccine. At the time of reporting the outcome was unknown. No further information is available.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0812USA04828

338700,01/20/2009,MO,25.0,25,,F,01/16/2009,Information has been received from a healthcare worker concerning a 25 year old female patient who received second dose of GARDASIL and was found to have genital warts. The patient has stated to the physician that she was not sexually active. Follow up information received on 31-Dec-2008 from the healthcare worker who reported the patient received her first dose of GARDASIL (lot# 660398/1968U) on 30-Oct-2008 and the second dose of GARDASIL (lot#660389/1958U) on 29-Dec-2008. At the time on the report on 31 Dec-2008 the patient was not recovered The patient sought medical attention was seen in the office. Additional information has been requested.

338702,01/20/2009,,14.0,14,,F,01/16/2009,Information has been received from a nurse practitioner concerning a 14 year old female who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # 660616/0570X) 0.5 ml via IM route into her deltoid.  The patient fainted immediately after receiving the vaccine.  She also displayed twitching with tonic-clonic motions of her upper extremities.  This reaction resolved spontaneously.  It was also noted that the patient did not eat breakfast.  Unspecified medical attention was sought in the office.  The patient was observed resting for about 20 minutes after the episode and given a popsicle.  No other treatment and patient was considered fully recovered.  This is one of several reports received from the same source.  Additional information has been requested.,,,,Y,,,,,Y,12/30/2008,12/30/2008,0,None,OTH,OTH,Unknown,,Unknown,,WAES0812USA05263

337797,01/21/2009,NM,18.0,18,,F,01/21/2009,"Headaches, periods were very erratic.  She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, she slept alot during the day which she never did. Never had any other problems prior to the Gardasil shots.  She recieved all three shots in the series.  Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.",Y,08/31/2007,,,,,,,N,01/03/2007,08/31/2007,240,4/7/09-path report received-multiple tissues with extensive autolysis and bacterial overgrowth. Molecular evidence of a Clostridium sp.,UNK,UNK,"Nasonex (Pseudovent 400 substituted for Entex 400 120 capsule),Claritan, Triamcinolene Acetonide cream for rash on wrist.","Went in for sinisitus, and had a sore throat. She had bad sinus allergies. But they still gave her the shots.",Seasonal allergies.  None other.,none~ ()~~0~Patient|none~ ()~~0~Sibling,

337812,01/21/2009,MI,21.0,21,,F,01/20/2009,"Information has been received from a registered nurse concerning a 22 year old female with penicillin and amoxicillin allergy who on 19-JUN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 660555/0279X) while she was pregnant. Concomitant therapy included ADDERALL TABLETS and oral hormonal contraceptives (unspecified). Her last menstrual period was 15-MAY-2008 and the expected delivery date was 19-JUN-2008. On 31-JUL-2008 the patient had a fetal ultrasound that showed a 10 week and 5 days gestational age fetus with positive cardiac activity. A pregnancy Ultra-screening test was performed with abnormal results. It showed an increased risk, 1 in 10, of having a baby with Down's syndrome. On an unspecified date, the patient elected to terminate this pregnancy. After the pregnancy was terminated, on 25-NOV-2008 the patient received the second dose of GARDASIL (Lot 661764/0650X). Upon internal review, the elected termination of pregnancy was determined to be another important medical event. Additional information has been requested.",,,,Y,,,,,Y,06/19/2008,06/19/2008,0,"Ultrasound, 07/31/08, 10 week 5 day gestational age fetus with positive cardiac activity; Diagnostic laboratory, 07/31/08, abnormal pregnancy ultra-screen",OTH,OTH,Adderall tablets; Hormonal contraceptives,Pregnancy NOS (LMP = 5/15/2008); Penicillin allergy,,,WAES0901USA01598

337817,01/21/2009,CA,11.0,11,,F,01/20/2009,"Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  ""Three months after administration of her first dose of GARDASIL"", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  ""One month later"", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  ""White blood cell differential count and white blood cell count"" were normal.  ""Four weeks ago"", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea ""last week"".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened ""every day for one week"" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's ""r",,,,Y,,,,Y,N,09/12/2008,11/18/2008,67,"Stool Giardia lamblia, 12/23/08, negative; WBC count, 12/18/08, 7.3 thou; Red blood cell count, 12/18/08, 4.73 mill; Hemoglobin, 12/18/08, 14.0 g/dL; Hematocrit, 12/18/08, 39.9%; Mean corpuscular volume, 12/18/08, 84 fL; Mean corpuscular, 1",OTH,OTH,None,,None. PMH:  none,,WAES0901USA01174

337950,01/22/2009,,13.0,,,F,01/21/2009,"Information has been received from a representative as reported by a colleague concerning a 13 year old female who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. It was reported that the patient developed low hemoglobin levels after receiving GARDASIL. She was taken to hospital where she received blood infusions. The outcome of the patient was not reported. The reporter considered ""low hemoglobin levels"" to be an other important medical event because the patient received blood infusion. No further information is available.",,,,Y,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA02129

337951,01/22/2009,,14.0,,,F,01/21/2009,"Information has been received from a physician concerning a 14 year old female who was vaccinated with her first 0.5 ml dose of GARDASIL towards the latter part of last year. The patient had a seizure ""a couple days"" after getting GARDASIL and had ""several"" seizures since then. The doctor's nurse said that the patient's father checked with a neurologist who said that the seizures were linked to GARDASIL. The outcome is unknown. The patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.",,,,,,,,,U,07/01/2008,07/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA02073

337952,01/22/2009,,22.0,,,F,01/21/2009,"Information has been received from a nurse practitioner concerning a 22 year old female who on 14-JAN-2009 was vaccinated with a first and only dose of GARDASIL intramuscularly 0.5 mL. There was no concomitant medication. On the same day the patient experienced anaphylactic reaction. She experienced severe vomiting, abdominal pain within the hour of vaccination. She also had hard time breathing and sensation of the throat closing. She went to an emergency room and was given oxygen and intravenous steroids. The patient was discharged after the recovery (The outcome also reported as ""recovering""). Anaphylactic reaction, abdominal pain and abdominal pain were reported to be immediately life-threatening. Additional information has been requested.",,,Y,,,,,,N,01/14/2009,01/14/2009,0,None,OTH,OTH,None,,None,,WAES0901USA01962

337963,01/22/2009,OR,21.0,21,,F,01/14/2009,"Soon after Gardasil, pt developed fever, malaise, confusion.  Admitted to hospital and Dx'd with ADEM vs. cerebral vasculitis.  Has made nearly full recovery.  Question of Gardasil-induced vasculitis or immune-related acute CNS/systemic disorder.  3/3/09 MR received for DOS 9/25-29/2008 with D/C DX:  ACute intracranial process, possible immunization related vs vasculitis vs diffuse encephalomyelitis.  Recent Gardasil vaccination-uncertain relationship to this event.  Leukocytosis-most likely r/t steroids.  Mild hyponatremia during hospitalization.  Hyperglycemia 2' to steroid use.  Pt presented with c/o 1 1/2 wk hx fevers, weakness and altered mental status. Several ER visits prior to this admission.  Pt reports sore throat, tiredness, fatigue, H/A, increased HR and bilateral foot numbness. Pt tx with steroids and d/c for outpt f/u.",,,,,Y,4,,,N,09/19/2008,09/25/2008,6,"MRI showed numerous small white matter T2 lesions.  ANA positive, elevated D-dimer, normal CSF. Labs and Diagnostics:  CXR (+) for RLL pneumonia, later (-).  WBC 19.7K.  D-dimer 1661. CT angiogram of chest (+) for adenopathy. Chemistry WNL",UNK,UNK,Cymbalta - uncertain dates and doses,,"History of depression. PMH:  RAD.  Seasonal allergies.  depression.  s/p sinus surgery. s/p tonsillectomy.  Allergies to sulfa, NSAIDS."

338049,01/23/2009,KY,14.0,14,,F,01/22/2009,"Information has been received from a physician concerning a 13 year old female who was vaccinated with the first dose of GARDASIL, 0.5ml. Subsequently the patient experienced a shaking in her leg. After getting the second dose of GARDASIL 0.5ml the same experience occurred for almost 12 hours. The patient got checked for seizure activity however they did not diagnose her with that. The patient was hospitalized and the length of hospitalization was unknown. The patient did video EEG. At time of the report the patient was not  recovered. Follow-up information has been received from a nurse concerning the patient who received two doses of GARDASIL. The nurse reported that the patient had a grand mal seizure (previously reported as the patient was not diagnosed with seizure activity) and was hospitalized.

338050,01/23/2009,SC,17.0,17,,F,01/22/2009,"Information has been received from a physician concerning a 17 year old female with no drug allergies who had recent urinary tract infection and completed a course of ciprofloxacin on 10-JAN-2009. She was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL on 12-JAN-2009. The patient developed a severe headache a few hours after receiving GARDASIL. The next day she developed a fever of 102F and a maculopapular rash on her face and trunk. On 14-JAN-2009 the patient developed abdominal cramping. She was examined in the office on 15-JAN-2009. A ""rapid influenza test and monocyte test"" were negative. Unspecified blood work was pending. The patient had been unable to attend school due to the severity of the headache. The patient did not recover at the time of reporting. No further information provided. Headache, fever, maculopapular rash and abdominal cramping was considered to be disabling. Additional information has been requested. 1/29/09-Follow-up from Merck on 1.28.09: PCP's nurse reported that the patient was given a Medrol Dose Pak and the symptoms of headache, rash, abdominal pain and fever resolved within a week",,,,Y,,,,Y,Y,01/12/2009,01/12/2009,0,"Diagnostic laboratory, 01/15?/09, rapid influenza test negative; Diagnostic laboratory, 01/15?/09, mononucleosis test negative; Temperature measurement, 01/12/09, 102 F",OTH,OTH,Ciprofloxacin,Urinary tract infection,,,WAES0901USA02024

338500,01/23/2009,,21.0,,,F,01/21/2009,"I took the GARDASIL shot series.  It didn't cause major problems, but when I took the second shot around the above date I noticed a change in my vaginal discharge.  The shot caused me to get bacterial vaginosis.  I had it for nine months till I figured out there was a problem because a month before hand I took myself off birth control and I thought my body was just going through changes.  I talked to my doctor and he told me it wasn't the GARDASIL shot, so I took the third shot in the series.  It immediately caused the bacterial vaginosis yet again.  It's not that it's serious, but every woman should know that this is a possible side effect and may be they should prepare themselves.",,,,,,,,,,,01/20/2008,,,UNK,UNK,,,,,

338217,01/26/2009,MA,14.0,14,,F,01/23/2009,"After waiting in office for 15 minutes after receiving GARDASIL vaccine. Patient complain of left knee feeling hot, painful. I assessed left knee, knee was red, swollen, warm to touch. Reported to Dr.  3/5/09 MR received from PCP.  WCC 1/23/09 with normal exam.  Several minutes after vax pt c/o knees feeling hot L>R. Knees erythemic and warm. Improving 30-40"" later.",,,,,,,,,Y,01/23/2009,01/23/2009,0,,PVT,PUB,,None,PMH:  allergy to Flu vax.

338379,01/27/2009,AZ,14.0,14,,F,01/26/2009,"Information has been received from a physician concerning a 14 year old female who on 17-NOV-2008 was vaccinated with the second 0.5 ml dose of GARDASIL (lot #660553/0070X). Concomitant vaccine included FLUMIST intranasal (cold adapted Ann Arbor master strain). On 22-NOV-2008 the patient developed sepsis shock, high fever, acute renal failure and coma after getting the second dose of GARDASIL and was hospitalized. It was unknown how many days the patient stayed in hospital. Subsequently, the patient recovered on unspecified dates. It was also reported that the patient did not experience any AE after getting the first dose. No additional information was provided. Additional information has been requested.  3/9/09 Received PCP medical records of 11/17/08-12/19/08 as well as partial hospital records. FINAL DX: encephalitis, septic shock Records reveal patient had sore throat & dx w/URI on 11/17/08 when received HPV #2 & flumist vaccines.  RTC 12/19 for hospital recheck w/residual hemipalsy.  Hospital records of 11/22-12/3/2008: FINAL DX: toxic shock syndrome of unknown etiology, posibly menstrual associated vs post vaccination; acute disseminated encephalomyelitis. Records reveal patient had 2 siblings w/N/V/D 1 week prior to her experienced right frontal HA, chills, fever, bilious emesis, right monocular blurred vision, abdominal pain, diarrhea.  Developed increasing confusion, lethargy, photophobia, emesis & became unconscious w/agonal breathing within 24 hours.  Intubated by EMS for respiratory failure, temp 103.3, posturing, pinpoint unreactive pupils.  Neuro, Neurosurgery, Ophtho, Heme & Renal consults done.  Developed DIC likely related to urosepsis & multiorgan failure, acute renal failure, right hypertropia. 

338454,01/28/2009,LA,15.0,,,F,01/27/2009,"Information has been received from a physician concerning an approximately 15 year old female patient who was mentally handicapped who in 2007 was vaccinated with all 3 doses of GARDASIL (Lot numbers not provided). The patient's mother told the physician that in late 2008, the patient was diagnosed with an abnormal PAP and possible cervical cancer related to HPV. As of 22-JAN-2009 the outcome of the patient is not recovered. Upon internal review, possible cervical cancer was considered to be an Other Important Medical Event. Additional information has been requested.",,,,Y,,,,,N,,,,"Pap test, ?/?/08, abnormal",OTH,OTH,Unknown,Mental handicap NOS,,,WAES0901USA03330

338563,01/29/2009,,15.0,,,F,01/28/2009,"Information has been received from a consumer concerning the 15 year old daughter of her friend who ""months an months ago"" was vaccinated with GARDASIL (route and site not reported). Subsequently the patient experienced vomiting, seizures, shakes, black out, abdominal pain and excruciating pain from head to toe and was hospitalized in and out. Per caller, the last time she spoke to the patient's parents, the patient was at home but they are thinking of bringing the patient to another hospital. Per caller, the patient's vomiting, seizures, shakes, black out, abdominal pain and excruciating pain from head to toe persisted. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.",,,,,Y,0,,,N,,,,Unknown,OTH,OTH,Unknown,,None,,WAES0901USA02709

338762,02/02/2009,MA,20.0,20,,F,01/29/2009,"I got the first HPV vaccine, and 1 hr later, I developed a fever of 102.0, was vomiting, and had a severe headache. Ever since 9/20/07, I have had a chronic, 24 hr/day headache. I have seen my PCP, neurologist, and many ER visits. It has been concluded that this occurred from the HPV vaccine. After doing extensive research about GARDASIL, and being advised by healthcare professionals, I got the first dose on 9/20/2007. About an hr later, I got a fever of 102.2, was vomiting, and had a severe headache. Eventually, the other symptoms went away, but the headache continued. It was an intense headache that lasted 24hrs/a day. I saw my PCP several times, and was referred to a neurologist. In the meantime, I got the second dose on 11/14/2007. I did not put two and two together. Since there was a long wait to see the neurologist, I ended up in the emergency room twice in 12/07. The first visit, an MRI, CT, and Lumbar Puncture were performed. I ended back in the ER a few days later for observation. All of the tests came back normal, but the pain was unbearable. I was put on IV MORPHINE, which had little affect. I then got an urgent appt with my neurologist in 12/07. Since 9/07, my life has been turned upside down. I have missed work, had to switch jobs, and have struggled to finish nursing school. I was 100 percent healthy before this immunization I have spent thousands of dollars on medications, copays, alternative options, such as chiropractic care, acupuncture, and massage. I simply can't afford it. I have been on more Rx in the last year and a half than most people have in a lifetime. At 21 years old, I should be able to live a normal life. Within the past month, I have been back in the ER three times. The only thing that ""took the edge off"" was IV DILAUDID. I have tried basic OTC such as ADVIL, TYLENOL, ALEVE, EXCEDRIN, Rx NSAIDS, PREDNISONE, muscle relaxers, anticonvulsants, and tricyclic antidepressants. Caffeine and antihistamine, narcotics, and just about anything else you can of, I have tried. Still, nothing has",,,,Y,Y,2,,Y,N,09/20/2007,09/20/2007,0,"Several tests, including extensive blood work; Cat Scan; MRI; and Lumbar puncture. 2/17/09-records received-CSF pressure 120-130, protein 31.2 and glucose 61, cutlure negative. CBC showed elevated WBC 10,300. Urinalysis revealed 1+ protein",PVT,UNK,"At the time, just oral contraceptives 2/17/09-records received-Current medications Necon and Lorazepam.",

338840,02/03/2009,TX,20.0,,,F,02/02/2009,"Information has been received for the pregnancy registry for GARDASIL from a 20 year old female patient who was vaccinated with the first dose of GARDASIL (lot# not provided) when she was ""around one month pregnant"".  Subsequently the baby had some complications and when patient was three months pregnant she terminated the pregnancy due to the complications.  Patient was then referred to another physician (name not provided) who told the patient that the complications she had with the baby were probably related to GARDASIL.  Upon internal review, the termination of the pregnancy was considered an other important medical event.  No further information is available.",,,,Y,,,,,Y,,,,Unknown,OTH,OTH,Unknown,Pregnancy NOS (LMP = Unknown),,,WAES0901USA03924

338870,02/03/2009,,13.0,,,F,02/02/2009,Information has been received from the mother concerning her 13 year old daughter who on 16-OCT-2008 was vaccinated with a dose of GARDASIL.  On 16-OCT-2008 the patient experienced severe breathing problems and was hospitalized.  At the time of reporting the patient was not recovered.  The patient's sibling experienced heart problems after vaccination with GARDASIL (MSD WAES 0901USA03550).  This is one of two reports received from the same source.  No further information is available.,,,,,Y,0,,,N,10/16/2008,10/16/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,cardiac disorder~HPV (Gardasil)~1~14~In Sibling,WAES0901USA03777

338911,02/03/2009,WI,16.0,16,,F,02/03/2009,"Severe, chronic headaches that began very soon (within days) after first vaccination of Gardasil.  Headaches became progressively worse and currently continue daily- one year later.  Referral was made for vision testing, CT Scan and MRI, with no underlying cause of headaches determined.  Numerous different prescription drugs were prescribed with no effect until current prescription, taken twice daily, was found to help subdue the headaches- though they have not been eliminated.  At their worse, the headaches were debilitating- rendering my daughter unable to function at school with some days missed and numerous visits to the nurses office and then to the doctors office.  At home, she would just curl up into a ball many days- unable to function whatsoever.  The headaches begin when she wakes in the morning and persist throughout the day- every day.  3/13/09 OV dated 12/24/07 received from PCP for 16 yr WCC. Impression:  Acne.  Sent to derm. Left SI joint pain and R lower rib tenderness.  HPV vax given. 3/16/09 Neurology consults received dated 3/14/2008 to 2/2/2009.  Initially seen 3/14/08 for c/o 8-9 wk hx of H/A. Pt reports double vision, dizziness, nausea and lightheadedness with H/A. Recent 6lb weight loss.  PE WNL. DX:  Chronic Tension H/A. Rx meds.  F/u 6/2/08 with no improvement,H/A now daily. Meds increased. F/u 8/1/08 H/A now with photophbia and nausea. 8/8/08 Mom reporting memory difficulties x several weeks. 9/2008 started Cymbalta with some improvement in H/A, however having diarrhea and tiredness.  Changed to Zoloft.",,,,Y,,,,,N,12/24/2007,12/28/2007,4,"Vision screening, CT Scan, MRI, blood tests. Labs and Diagnostics:  MRI/MRA brain WNL. EKG abnormal-borderline QT wave.",UNK,UNK,Minocycline,none,none PMH:  none,,

339092,02/05/2009,FL,19.0,19,,F,02/04/2009,"Information has been received from a 19 year old female patient who on 27-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported).  On 27-JAN-2009 after she received the vaccine she fainted immediately.  As she was coming to she could hear the nurse yelling that she was having a seizure and she then fainted a second time.  She came to and fainted a few more times, then she went to the emergency room in an ambulance.  She was not admitted to the hospital and was released a few hours after she had received the vaccine.  On 27-JAN-2009 the patient was recovered.  Patient sought medical attention was at emergency room.  The patient considered seizure and fainted was determined to be other important medical events.  No further information is available.",,,,Y,,,,,Y,01/27/2009,01/27/2009,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA04400

339149,02/06/2009,,,,,F,02/05/2009,Information has been received from a doctor of pharmacy for the pregnancy registry of GARDASIL concerning a female patient who on an unspecified dates was vaccinated with an unknown number of doses of GARDASIL. It was reported that the patient was pregnant and the fetus had fluid in the brain and heart. It was reported that the patient had four days to decide whether to continue or terminate the pregnancy. The patient sought medical attention with the physician. Upon internal review hydrocephalus was considered to be a congenital anomaly. No further information is available.,,,,Y,,,,,U,,,,Unknown,OTH,OTH,Unknown,Pregnancy NOS (LMP = Unknown),,,WAES0902USA00303

339249,02/09/2009,,17.0,,,F,02/06/2009,"Information has been received from a physician's assistant concerning a 17 year old female who ""within the last month and a half"", on approximately 22-DEC-2008, was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided). It was reported that after receiving GARDASIL, the patient fainted and broke her nose on the floor. Unspecified medical attention was sought. It was reported that the vaccine was discontinued ""within the last month and a half"". The outcome of the patient was not reported. The reporter considered the patient's events to be disabling. Additional information has been requested.",,,,,,,,Y,U,12/22/2008,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902usa00465

339312,02/09/2009,,21.0,,,F,02/09/2009,"Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested."

339414,02/11/2009,,21.0,21,,F,02/10/2009,"Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history and allergic reaction to AUGMENTIN, CECLOR, and sulfonamide allergy who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 658554/0928U) intramuscularly. On 29-FEB-2008 the patient received the second dose of GARDASIL (Lot # 660557/0072X). Concomitant therapy included LOESTRIN 24. It was reported that in December 2007 the patient developed mental illness which consisted of mood disorder after receiving GARDASIL. It was reported that the patient had not yet received the third dose. A serum level test for aluminum was performed (result not provided). It was reported that the patient had been hospitalized due to the disorder, but the reporter did not know the duration of the hospitalization. Additional information has been requested.",,,,

339418,02/11/2009,PA,20.0,,,F,02/10/2009,"Information has been received from a healthcare professional concerning her 20 year old daughter who was vaccinated with all three doses of GARDASIL. One week after receiving the third dose the patient experienced spiking a 104 degree fever and sometime after that the patient experienced a seizure/seizure like activity. Two weeks after the seizure like activity the patient saw a neurologist. At the time of this report, the outcome was unknown. Upon internal review, seizure/seizure like activity was determined to be an other important medical event. Additional information has been requested.",,,,Y,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA00919

339474,02/11/2009,VA,30.0,30,,F,02/11/2009,"Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.",,,Y,Y,,,,,N,01/20/2009,02/03/2009,14,"Elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  EEG and Rheumatology consult are ordered for next month.",UNK,UNK,None,"None,  prophylactic",None,,

339570,02/13/2009,GA,23.0,23,,F,02/13/2009,"I received the Gardasil vaccine and walked out of the room. As I exited I lost vision and hearing and collapsed, still conscious and very nauseated. Difficulty breathing occurred once vision returned. Hearing did not return for 10 minutes and I heard a ringing, metallic sound every time I talked. Vision was yellow and green, and my face had lost all color (pale/green). 15 minutes after the shot I had abdominal cramps and diarrhea. I drank some water and was then freezing cold and very weak. I felt more normal by the end of the day. On the second and third day, I had swelling and tenderness at the injection site.",,,,,,,,,Y,02/11/2009,02/11/2009,0,,UNK,UNK,Birth control (depo provera),None,none,,

339589,02/14/2009,NC,12.0,12,,F,02/14/2009,"Patient given 1st dose of Gardasil Lot # 14484 on 2/4/08.  Patient became ill with Severe Adominal Pain and Nausea.  Patient given 2nd dose of Gardasil Lot # 17574 on 4/16/08.  Patient because ill with Severe adominal pain, and Nausea and treated at pediatricans office on 5/1/08.  Patient given 3rd dose of Gardasil Lot # 0067X on 8/18/08.  Patient returned to Pediatrician on 9/3/08 with Severe adominal pain, severe nausea, and brain freezes or seizure complaints.  Since September of 2008, patient has been placed on a modified school schedule and is being treated by Hospital with little to no improvement.  Student is unable to attend school except for an average of 2 days per week.  Student has become disabled because of pain, nausea, and seizure effects.  2/19/2009 MR received from PCP which include multiple consults and ER visits.  Seen 2/4/08 for c/o congestion, H/A, fever and abd pain. Assess:  Sinustis.  Vax given. WCC 4/16/08 with normal G&D. PE WNL.  Vax given. Returned 5/1/08 with c/o fever, diarrhea, decreased appetitie and po intake. Assess:  Pharyngitis.  Viral syndrome.  OV 6/4/09 for nausea and migraine. Assess: VGE. OV 9/3/08 for H/a, nausea, stomach pain.  Assess: VGE. Returned 9/15/08 with RUQ pain and diarrhea. Rx:  Prilosec. Similar sx 9/22/08, 9/25/08 with fever. Seen 11/10/08 with for daily ""brain freeze' where pt can't think clearly, panics, with H/A after. Missed 20 days of school this yr. Sx continue to present.   Referred to GI 10/6/08 with multiple consults for abd pain with no clear dx-likely functional. Depression noted 1/13/09. Weight gain 2' to eating to lessen pain. IBS dx 2/16/09 2/26/09 Hospital records received for ER visit 9/29/08 and later diagnostic studies with DX:  Abdominal pain. Pt presented with several week hx of RUQ abdominal cramping with nausea. Severity 4-9/10. PE WNL. Referred for out pt

339660,02/16/2009,CO,11.0,11,,F,02/16/2009,"Patient experiences severe flushing episodes, nausea, severe abdominal pain, back pain, difficulty breathing.  Several physicians and tests find nothing causing it.  Alls symptoms developed after the first Gardasil injection.  Symptoms still present two months later.  /24/09 Received vaccine records & PCP medical records of 12/1/08-2/17/2009. FINAL DX: likely dermatographism Records reveal patient experienced HA & dizziness intermittently x 2 yrs.  Meds had been d/c'd but HA & dizziness persisted.  Missed school due to HAs.  Allergy consult done 2/2/09 due to rash & flushing episodes since 12/29/08.  Allergy testing neg except for cedar pollen.  Tx w/antihistamine.  Had been hospitalized w/RLQ pain & dx w/constipation, treated w/enema & diet.  RTC 2/17/09 w/dizziness, flushing, abdominal pain.  Exam revealed orthostatic BP w/tachycardia.  Referred to known Neuro for additional w/u.  3/30/09 Received ER & Outpatient clinic records of 1/25/08-2/11/2009. FINAL DX: convulsive syncope Records reveal patient experienced continued dizziness, HA.  Had outside MRI considered to be abnormal & had been referred to Neuro.  RTC 9/08 off meds & mood markedly improved. 

339686,02/17/2009,,,,,F,02/13/2009,"Information has been received from a Nurse Practitioner concerning a female who approximately 6 months ago was intramuscularly vaccinated with the third dose of GARDASIL, shortly after which the patient experienced seizures.  The patient's mother is still taking the patient to the doctor a lot.  Electroencephalography (EEG) was performed but the result was unspecified.  At the time of reporting, the patient's outcome was unknown.  The nurse practitioner did not administer any of the vaccinations.  Upon internal review, seizures was considered to be an other important medical event.  Additional information has been requested.",,,,,,,,,U,08/01/2008,08/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA01640

339687,02/17/2009,IA,17.0,17,,F,02/13/2009,"Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female with no family history of seizures or drug allergies who received all three doses of GARDASIL and then experienced seizures. All 3 doses were administered at a different facility and the patient just started coming to the nurse's office in December 2008 so the dates or lot number of the GARDASIL administered were not available. The patient was vaccinated with the third dose of vaccine in mid-January 2008. The seizures began in April 2008. In December 2008 the seizures became consistent and occurred daily. Starting 09-FEB-2009 the patient experienced blackouts. A neurologist determined the patient was having monoclonic seizures and prescribed KEPPRA and DILANTIN. The KEPPRA would be discontinued and replaced with LAMICTAL. Neurological tests indicated abnormal electroencephalogram. The nurse also mentioned that the patient has been experiencing headaches but had no further information about them. At the time of reporting the patient was getting worse. The patient was hospitalized and was seen by a neurologist. Additional information has been requested. 

339706,02/17/2009,,14.0,,,F,02/15/2009,"Information has been received from a kindergarten teacher concerning her husband's relative'S churchmember's daughter, a 14 year old girl who on an unspecified date was vaccinated with the third dose of GARDASIL. After getting all three doses of GARDASIL, the patient was treated by a holistic doctor for the following experiences attributed to the GARDASIL vaccine: headache, ""stomach stays inflamed"", blood pressure dropping extremely low causing dizziness and passing out, tremors and seizures. The patient had a sensation that she was going to pass out in bed one night. The next night, on 31-DEC-2008, it happened. Her mattress was moved to the floor for safety reasons. The family decided she cannot be left alone anymore. The patient would not be returning to school. The doctor said she would miss this semester. The school has set her up with online classes so she won't miss any of her credits. It was reported that ""she doesn't feel good enough for any of that as yet, but she's moving in the right direction"". She was sleeping in a hyperbolic chamber at night to help get oxygen into her body. That was helping. She was also on oxygen during the day for the same reason. She was receiving electrolyte drinks. She was to begin nutritional IV's to supply her body with nutrients. The chemicals in her body have built barriers and she is not receiving the nutrients from food that she needs. She has lost weight. She had quit eating for awhile but now the doctor has her eating every two hours. She had an appointment with a homeopathic neurologist scheduled. The family reported problems with the patient's veins. A nurse tried to put a shunt in and it infiltrated after 2 days. The nurse tried 5 times and couldn't get the IV back in. The doctor wanted a central line put in. The patient had ""a little sinus thing going on"" and couldn't get in the hyperbaric chamber for most of the last week. She realy began to have some bad days. She started having small seizures (19-JAN-2009). But her ""sinus thing' got better so she could stand for",,,Y,,Y,0,,Y,N,,12/31/2008,,"plasma iron assay, extremely high",OTH,OTH,Unknown,,Unknown,,WAES0902USA01121

339771,02/18/2009,IL,13.0,13,,F,02/09/2009,"She developed a pulmonary embolism after having 3 rounds of vaccine GARDASIL.  She was a healthy, active teenager. 2/23/09-autopsy report received immediate cause:Massive pulmonary embolism. Mild cardiomegaly. Last several days C/O cough and congestion. 3/9/09-ED records received for DOS 10/26/08-presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, aystole. Expired.",Y,10/26/2008,,,,,,,N,04/28/2008,10/26/2008,181,3/9/09-records received-WBC 17.3.,PVT,PVT,,,"5/7/09-records received-5/7/09-records received-office visit 4/21/00-evaluation for dehydration, vomiting, sore throat and febrile. Impression strep pharyngitis. 9/2/05-routine physical. Assessment:overweight. Office visit 1/4/08-C/O lump in neck noticed in 9/07. Intermittently hurts. Assessment:mild lymphadenopathy.",Bloodclot~HPV (Gardasil)~3~13~Patient,

340315,02/18/2009,CA,11.0,,,F,02/13/2009,"Information has been received from a physician concerning an 11 year old female patient who in July 2008 ""6 months ago"" was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that the patient developed skin tags under each of her arms a few days after receiving her first dose of GARDASIL. It was reported that the number of skin tags increased after receiving her second dose. The patient sought unspecified medical attention. Additional information has been requested.",,,,Y,,,,,U,07/01/2008,07/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA04426

340318,02/18/2009,,,,,F,02/13/2009,"Information has been received from a nurse practitioner concerning a female patient who on an unspecified date received the first dose of GARDASIL. In September 2008, the patient was vaccinated with the second dose of GARDASIL (lot # was not available). In November 2008, the patient developed erythema nodosum on her two legs. The patient's erythema nodosum on her two legs persisted. The patient sought unspecified medical attention. No further information is available.",,,,Y,,,,,N,09/01/2008,11/01/2008,61,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA04393

340319,02/18/2009,IN,,,,F,02/13/2009,"Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL and her hair started falling out. The patient's mother called the clinic. At the time of reporting, the outcome was unspecified. Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA04391


340347,02/18/2009,TX,22.0,,,F,02/13/2009,"Information has been received from a physician concerning a 22 year old female who on 23-Jan-2009 was vaccinated in arm with the second dose of GARDASIL vaccine. On 24-JAN-2009, the patient developed a rash all over her body. It was reported that the patient does not plan on receiving a third dose. Lot number was not available. The patient sought unspecified medical attention. Additional information has been requested.",,,,,,,,,U,01/23/2009,01/24/2009,1,None,OTH,OTH,Unknown,,Unknown,,WAES0901USA03962

340355,02/18/2009,,23.0,23,,F,02/12/2009,"Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history and no known drug allergies, who on 21-NOV-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 661530/0575X) 0.5 ml intramuscularly. There was no concomitant medication. The patient experienced puss-filled boils around the site of injection (2008). The boils ""come and go"" for the last eight weeks. She had had a total of 8-10 boils so far. The patient had a tattoo on her left arm (around the deltoid area) which she had had for years prior to receiving the vaccine. The patient's puss-filled boils around the site of injection persisted. The patient sought medical attention. Additional information has been requested.",,,,Y,,,,,N,11/21/2008,,,None,OTH,OTH,None,,None,No Relevant Data~ ()~~0~In Patient,WAES0901USA03940

340470,02/18/2009,KS,14.0,,,F,02/13/2009,"Information has been received from a consumer concerning her 14 year old female daughter with no pertinent medical history, no drug reactions/allergies, who in April 2008 was vaccinated with the first dose of GARDASIL vaccine and on an unspecified date was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. In July 2008, the patient noticed that her hair began to thin out and within 2 months she lost all her hair. The reporter took her daughter to the dermatologist. The consumer specified they took test but did not provided what type of test. The consumer stated that ""the patient had had wigs and shampoos, name of shampoo unspecified, to help hair grow back, but non of that was working."" The dermatologist as well as the family doctor indicated this was due to GARDASIL vaccine. Therapy with human papilloma virus vaccine was discontinued. At the time of reporting, the patient had not recovered. This is one of two reports received from the same source. Additional information has been requested.",,,,Y,,,,,N,,07/01/2008,,diagnostic laboratory - specified they took test but did not provide what type of test,OTH,OTH,None,,None,,WAES0901USA03289

340480,02/18/2009,FL,17.0,17,,F,02/13/2009,"Information has been received from a physician concerning a 17 year old female patient who on 27-JUN-2008 was vaccinated with first dose of GARDASIL (Lot # 660555/0279X) and on 13-OCT-2008 she received second dose of GARDASIL (Lot # 660555/0279X).  At an unspecified interval after her second dose she developed ""allergies"".  The patient went to an immunologist and allergist for these ""allergies"".  Both specialists diagnosed her with ""psoriasis due GARDASIL"".  Patient was currently beginning treatment for this condition but no specifics known.  At the time on the report on 21-JAN-2009 patient was not recovered.  Patient sought medical attention at the office.  Additional information has been requested.",,,,Y,,,,,N,10/13/2008,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA03093

340486,02/18/2009,AL,14.0,,,F,02/13/2009,Information has been received from physician concerning a 14 year old female who was vaccinated the first dose of with GARDASIL on an unspecified date. Subsequently the patient experienced abnormal wart growth on the inside of her thigh. She was not given any further doses or medication to treat the wart. Additional information has been requested.,,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA02938

340489,02/18/2009,TN,9.0,9,,F,02/13/2009,"Information has been received from a pharmacist concerning her 9 year old daughter who in August 2008, was vaccinated with a first dose of GARDASIL and in October 2008, was vaccinated with a second dose of GARDASIL. There was no concomitant medication. In approximately October 2008 (some time after Dose 2), the patient experienced hair shedding and hair loss. The patient did not seek medical attention. At the time of reporting, the patient's hair shedding and hair loss persisted. Additional information has been requested.",,,,Y,,,,,N,10/01/2008,10/01/2008,0,None,OTH,OTH,None,,None,,WAES0901USA02751

340597,02/18/2009,PA,17.0,17,,F,02/13/2009,"Information has been received from a consumer concerning her 18 year old daughter with asthma who in the summer of 2008, was vaccinated with the first dose of GARDASIL (lot # was not reported). Concomitant therapy included ADVAIR. The patient's mother stated her daughter had 2 doses of the vaccine and reported that around the first week of September 2008 the patient's hair started to fall out. The consumer stated that her daughter's hair started to fall out in clumps and within months all of her fell out. The patient was seen by a rheumatologist, her primary care physician, and a dermatologist; numerous amounts of blood work were done for all auto immune disorders, vitamin deficiency, Lyme disease and many others. The only thing that the blood work has shown is that she was slightly anemic. They still can not find anything that would cause her hair to fall out. The consumer stated that she did not let her daughter get the third dose and stated that she did research that the vaccine can cause alopecia and she can not figure anything else but the vaccine that could cause this. This is one of several reports received from the same source. Additional information has been requested.  4/3/09 Office note received for DOS 2/26/09 with DX:  Alopecia areata, approaching universalis.   Pt presented with c/o progressive, extensive hair loss involving scalp, eyebrows, eyelashes and body hair since 9/2008. PE confirms c/o. Tx: steroids.",,,,Y,,,,,N,04/15/2008,09/01/2008,139,"hematology, for auto immune disorder, vitamin deficiency, Lyme disease",OTH,OTH,ADVAIR,Asthma,"PMH: asthma, Hep C",,WAES0901USA02690

340610,02/18/2009,,19.0,18,,F,02/13/2009,"Information has been received from a 19 year old female with no drug allergy who in January 2008 was vaccinated with the first dose of GARDASIL. She stated she had all 3 doses. On 15-JAN-2009 the patient was told she had papilloma viral infection. No medical attention was sought. At the time of reporting, the patient's HPV infection persisted. No further information is available.",,,,,,,,,N,01/01/2008,01/15/2009,380,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA02043

340640,02/18/2009,CA,15.0,,,F,02/13/2009,"Information has been received from a physician assistant concerning a 15 or 16 year old female patient who on unknown dates was vaccinated with a first and second dose of GARDASIL, lot number not specified. Approximately 2 weeks after the dose was given the patient experienced ""panic attack"", where she felt pain in her chest and rapid breathing, it happened after both doses of GARDASIL. The assistant stated that the Dr. advised not to get the 3rd dose of GARDASIL. Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA01517

340646,02/18/2009,MI,23.0,23,,F,02/13/2009,"Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history and no known drug allergies who on 24-DEC-2008 was vaccinated with the first IM dose of GARDASIL vaccine (lot# 0947X). Concomitant therapy included calcium (unspecified), vitamins (unspecified) and DESOGEN. On 24-DEC-2008 the patient experienced felt dizzy 3 minutes and lay down. The patient became frail and unresponsive for 20-30 seconds. her pupils were equal, dilated and reactive to light. Her blood pressure was 100/50, pulse was 52, and had shallow breathing. About 2-3 minutes after being responsive, the patient fell back into a state of unresponsiveness and was difficult to arouse, This lasted for a few minutes and then she became fully alert. The emergency medical services were called and the patient was given juice boxes and bagel. EKG was normal and blood sugar after the food intake was 112. On 24-DEC-2008 the patient recovered from the adverse events. Additional information has been requested.

(Stacks I've missed out inbetween.)

340333,02/23/2009,,19.0,,,F,02/20/2009,"Information was viewed on the Internet concerning a 19 year old patient who in approximately April 2008 (10 months ago), was vaccinated with the first dose of GARDASIL. Second dose was administered (unspecified date). The mother of the patient reported that prior to first shot, the patient was healthy and active. After the vaccination the patient's back started hurting immediately and about three weeks after the first dose of GARDASIL the patient had her first seizure. After the second dose of GARDASIL the seizures, increased, as did severe stomach pain experienced, fatigue, headache, joint pain, vision problems, hair loss and bleeding gums. The mother reported that the patient has been hospitalized four times, there has been multiple ambulance calls daily seizures, several incidents of cluster seizures where she stopped breathing and turned blue. The mother reported that patient seemed to be improving as time goes by. Therapy with GARDASIL was discontinued. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.",,,,Y,Y,0,,,N,04/01/2008,,,Unknown,OTH,OTH,,,Unknown,,WAES0902USA02626

340334,02/23/2009,FL,20.0,,,F,02/20/2009,"Information has been received from a physician concerning a 20 year old female with respiratory allergies who on 21-FEB-2008, 24-APR-2008 and 16-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (first and second dose lot # unspecified, lot # third dose 660612/0229X). Concomitant therapy included MENACTRA (administered on 21-FEB-2008), ZYRTEC and ALLEGRA. On 04-NOV-2008 the patient went to the physician's office with chest pain and coughing. On 07-NOV-2008 and 14-NOV-2008 the patient came back to the physician's office because the symptoms were still persisting. On 14-NOV-2008 the physician suggested to the patient to go to the hospital. The patient was hospitalized on 15-NOV-2008, a lot of different unspecified tests were done, and the patient was diagnosed with hypercoagulable state and deep venous thrombosis. On an unspecified date the patient was released from the hospital, but the physician did not mention how long the patient was in the hospital for. The physician stated he feels that hypercoaguable state and DVT are life threatening, he was unsure if GARDASIL caused the experience. The patient is still recovering. Additional information has been requested.",,,Y,Y,Y,0,,,N,09/16/2008,11/04/2008,49,"diagnostic laboratory, 11/15/08, unspecified lab tests",OTH,OTH,Zyrtec; Allegra,Allergic respiratory symptom,,,WAES0902USA02661

340337,02/23/2009,,,,,F,02/20/2009,"Information has been received from a consumer via the Internet concerning her daughter who in August 2007, was vaccinated with GARDASIL.  Subsequently the patient had been sick ever since.  The patient had several hospital stays, saw a neurologist on a reg basis, and had been diagnosed with dysautonomia with orthostatic intolerance.  The patient experienced blackouts, chronic dizziness and took massive anxiety medicines.  She also experienced loose clumps of her hair, blurred vision, migraine headaches, nausea and panic attacks.  The patient's immune system had been so compromised that she had gotten MRSA (resistant staff) two times and was hospitalized for that.  The patient was also an honor student (straight A's) with a very bright future.  Her grades had dramatically dropped.  The reporter stated that they had to put her on a plan at school so that her attendance can not be held against her, and her teachers had to reduce her work load because she did not know from one day to the next whether she would be able to get out of bed.  At the time of reporting, the outcome was unknown.  Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available.",,,,Y,Y,0,,,U,08/01/2007,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA02698

340356,02/23/2009,MN,10.0,,,F,02/17/2009,My daughter started to get restless in the legs and had many headaches. She was twitching and couldn't stop from jerking movements in head and legs. We thought maybe she got a hold of some kind of drug. The doctors said she has rheumatic fever. This is triggered by strep throat. The only problem she tested negative for that. Now she can't even walk. She has no hunger and is very depressed. 10 years old and making drugs that take healthy kids and turn them into this. I didn't like the idea of my child taking this drug and my wife only did because the doctor said he highly recommended it. Well now that this has happened I have found out that they have had 21 deaths in 2 years. Thanks for telling us that in the side effects. I don't see anything mentioned about this. My daughter got only one dose and was set to get her second when this happened. This drug needs to be taking off the market. I don't want to see another family go through what we are going through. She has missed 3 weeks of school and I don't see her recovering anytime soon. 1 death is too many and I know that there are many out there that will be permanently disabled over this drug. PLEASE TAKE THIS DRUG OFF THE MARKET. I will continue to spread the word out to Family & Friends in hope that they won't put their child in the hands of this drug maker. GARDASIL needs to be stopped.,,,,,Y,,,,N,,01/25/2009,,,UNK,UNK,,,,,

340359,02/23/2009,,20.0,,,F,02/19/2009,"I was given the GARDASIL shot. A week after being injected I had a serious allergic reaction and broke out in a very itchy rash all over my fingers and between fingers, and also spots on my face. The rash consisted of little bumps, and was spreadable.",,,,,,,,,,,01/27/2009,,,UNK,UNK,,,I've never had an allergic reaction to any medicine in previous situations.,,

340376,02/23/2009,AL,16.0,16,,F,02/16/2009,Pt received varicella vaccine RA SQ on 2-4-09 and returned to office 2-16-09 with red/swollen (15 mm) in area around injection site and reported area itches instructions given per VIS and to return if area worsens or gets larger.,,,,Y,,,,,Y,02/04/2009,02/05/2009,1,,PUB,PUB,,,,,
340377,02/23/2009,AZ,14.0,14,,F,02/06/2009,Pt learned she was pregnant 2 months after receiving GARDASIL vaccine. Pt miscarried at 2 1/2- 3 mos pregnant.,,,,,,,,,Y,10/21/2008,,,,MIL,MIL,BC (OCP),,,,

340503,02/24/2009,,14.0,,,F,02/23/2009,"Information was viewed on the internet concerning a 14-year-old female patient, who on an unspecified date was vaccinated with a dose (s) of GARDASIL. It was reported that the patient has been ""suffering since September 2008, she is now in her third hospital"". It was also reported that she ""has nearly died from this vaccine. She can not eat anything, her digestive system and intestines have shut down, she had the numbness in her legs and the horrible pain. She has nearly lost her entire freshman year of high school, her mother has not been able to work since September"". No further information is expected.",,,Y,Y,Y,0,,Y,N,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA02699

340700,02/25/2009,NM,11.0,11,,F,02/25/2009,"About 1 wk after 1st GARDASIL, my daughter began having headaches, nausea and began passing out. Began having trouble breathing. Pediatrician referred her to cardiologist. Tilt table test were done. BP problems were noted. She has been on medications since. 3/3/09-records received presented with C/O fainting spells 2-3 times per day no LOC. Assessment:chronic fainting spells, chronic dizziness. 7/16/08 C/O abdominal pain watery diarrhea. Positive ill contact. 8/22/08-C/O SOB. History of episodic SOB at school day of visit. C/O body aches. Bronchial asthma. 10/17/08 chest pain with tenderness center or chest. Assessment costochondritis. 1/22/09-persistent headache. 3/9/09-consultant records received for DOS 5/14/08-seen for C/O dizziness and fainting for one month. All occur with position changes. C/O fatigue. Heart rate mildy accelerated prior to fainting and feels dizzy and wobbly.  Impression:mostly likely secondary to neurocardigenic syndrome. Office visit 6/4/08-Continues to faint on daily basis and having difficulty breathing when running. Impression strong vasodilatory component. Neurocardiogenic syncope. Recommend volume loading and salt in diet. Office visit 8/27/08-continues to have dyspnea mostly during PE at school, feels like she cannot breathe, loses breath,loses balance and nearly faints. C/O shortness of breath rather than syncope.",,,,Y,,,,,N,08/03/2007,08/10/2007,7,3/9/09-records received-Electrocardiogram normal. 2D echo with color flow and Doppler normal with trace tricuspid insufficiency with low estimated RV pressure. Holter examination normal. Title table exam multiple episodes of fainting.Pulmon,PUB,PUB,None at time of vaccine,None,None 3/9/09-records received-PMH:bronchitis and whooping cough.

340834,02/27/2009,,26.0,,,F,02/26/2009,"Information has been received from a nurse concerning her 26 year old daughter who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL several months ago. Subsequently the patient developed flu-like symptoms after administration of the first and second dose  of GARDASIL. She also experienced vomiting and muscle aches both times. She missed work because of the severity of her symptoms. Her symptoms were worse after the second dose of GARDASIL as compared to the first dose. She would not be administered a third dose of GARDASIL. The patient recovered on unspecified dates. Flu-like symptoms, vomiting and muscle aches (both occurrences) were considered to be disabling because the patient ""was very, very ill"". The patient sought unspecified medical attention. No further information is available.",,,,,,,,Y,Y,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA03764

340840,02/27/2009,IL,21.0,,,F,02/26/2009,"Information has been received from a physician concerning a 21 year old female who on 05-SEP-2008 was vaccinated with a first dose of GARDASIL and on 14-NOV-2008 was vaccinated with a second dose of GARDASIL. Then the patient was diagnosed with transverse myelitis, which the physician stated it mimics multiple sclerosis. The patient saw a neurologist. At the time of reporting, the outcome was unknown. Upon internal review, transverse myelitis was determined to be an other important medical event. Additional information has been requested.",,,,Y,,,,,U,11/14/2008,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA04035

340882,02/28/2009,NV,17.0,17,,F,02/28/2009,"AFTER FIRST GARDASIL VACCINE (administered 9/13/06): experienced dizziness, light-headed, nauseous, headaches, leg cramps, and shooting leg pain.  AFTER SECOND GARDASIL VACCINE (administered 11/13/06): experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. AFTER THIRD GARDASIL VACCINE (administered 3/13/07): experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive problems, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.). TREATMENT: had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for me.  Recently have been referred to a clinic. (scheduled appt. for 3/30/09). 3/18/09-records received for DOS 5/18-5/20/08-DC DX: Chronic constipation. Exercise induced asthma. Cyanosis. Pancytopenia. Presented to ED with increased generalized weakness and constipation since 2/08.Taking a Chinese herbal formula for chronic fatigue astra lsatis.

340900,03/02/2009,,16.0,16,,F,02/27/2009,"Information has been received from a physician via an email from a consumer concerning the consumer's 16 year old daughter who on 20-MAY-2008 was vaccinated with the third dose of GARDASIL (lot no. and route not reported). The consumer reported that in the summer of 2008, the patient started to complain of constant fatigue, had fainting spells and random bouts of aches and pains. On 11-SEP-2008, she was sent home from school with complaints of headache, spine pain, confusion and symptoms of bladder infection. She was given antibiotics by the gynecologist and was sent home. The consumer reported that the next day (12-SEP-2008) the patient woke up screaming for help as she couldn't feel her arms and legs, was gasping for air, vomiting, had severe back pain and fever. The mother reported that at the emergency room (ER) the patient was given antibiotics and sent home as she was told she ""may have passed a kidney stone"". It was reported that over the next two weeks her health was deteriorating and after her fourth visit to the ER she was finally hospitalized for the next ten days. Over the course of her stay the patient was seen by teams of doctors from Neurology, Rheumatology, Infectious disease, Endocrinology, Adolescent medicine, Urology, and Cardiology. The consumer reported that the patient endured two spinal taps, many MRI, CAT scan, sonograms, ultrasound and blood workups until ""her body could no longer emit any blood"". The patient was on morphine drip for severe headaches, liquids for rehydration, PERCOCET for allover pain and two and nausea medication for severe vomiting and acid reflux. The patient was checked for Lyme disease, meningitis, lupus, fibromyalgia chronic fatigue Hoshimoto's disease kidney disease and multiple sclerosis and everything showed up negative. The patient became so sleep deprived because her heart rate was in the 30 range that a monitor constantly kept her awake. The patient started hallucinate and was developing blood clot in her legs from lack of use. The mother stated that since the",,,Y,Y,Y,10,,Y,Y,05/20/2008,,,"cardiac monitoring, heart rate is in the 30 range",OTH,OTH,Unknown,,Unknown,,WAES0902USA03436

340901,03/02/2009,,,,,F,02/27/2009,"Information has been received from a physician via an email concerning a female who was vaccinated with a dose of GARDASIL. The consumer reported that a ER nurse stated that the patient was admitted to the hospital with the same symptoms as the consumer's daughter down to constant fatigue, inability to walk, severe back pain, spine pain, symptoms of bladder infection, fainting spells, gasping for air, acid reflux, hallucination, headache, sleep deprivation, not feeling of her arms and legs, bouts of aches and pain, fever, blood clots in her legs, vomiting, dehydration and all over pain. It was reported by the nurse that this patient was finally diagnosed with a severe reaction to GARDASIL. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information will be provided if available. This is one of two reports from the same source. Additional information has been requested.",,,,Y,Y,0,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA03722

340952,03/02/2009,,16.0,,,F,02/15/2009,"My daughter received her 3rd injection of GARDASIL vaccine on Feb. 9th 2009.  She had severe headaches ever since.  We took her to the emergency room on Feb 13th.  They ran a series of tests which included a brain scan.  Nothing abnormal showed but she never got rid of her headache.  To this day she is fatigued, dizzy, has headaches, blurry vision and arm pain.  These side effects were never mentioned yet when I looked on the web many people said they had the same side effects after the vaccine.  I am taking her to her pediatrician tomorrow to have him evaluate her again and we will go from there."

340954,03/02/2009,,13.0,13,,U,02/26/2009,"My daughter received GARDASIL vaccine from her doctor on 02/23/2009. Since having the injection she has had a severe headache, body aches, upset stomach, dizziness and tingling in her hands and feet.",,,,,,,,,U,02/23/2009,02/23/2009,0,,UNK,UNK,,,None,,
340955,03/02/2009,NY,0.4,0,.4,F,02/08/2009,"Daughter started throwing up, couldn't get her to respond afterwards for about 10 min, just starred into space (wasn't her normal self for another 3 days).",,,,,,,,,U,01/22/2009,01/23/2009,1,EEG and saw neurologist,PVT,OTH,,,,,

340965,03/03/2009,,15.0,,,F,03/02/2009,"Information has been received from a nurse practitioner, who was told by one of her own patients, concerning a 15 year old female patient who is not a patient in her office, in late June 2008 was vaccinated with the first dose of GARDASIL at a pediatrician office. In mid July 2008, the patient experienced severe headaches, muscle weakness, neurological disorders and autoimmune issues. The reporter stated that the patient had out patient neurological tests done and she was currently experienced seizures. The HPV vaccine was discontinued. As of 23-FEB-2008, the patient had not recovered. The patient sought medical attention with a physician. Upon internal review seizures was considered to be an other important medical event. Additional information has been requested.",,,,Y,,,,,N,06/30/2008,07/15/2008,15,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA04059

340967,03/03/2009,,,,,F,03/02/2009,"Information has been received from a teenage female athlete (runner) via a news report who in May 2008, was vaccinated with GARDASIL. In May 2008, within days of getting the vaccine, the patient became mysteriously ill and was hospitalized. The patient said she couldn't breathe and was really fatigued. Her chest was beginning to hurt like she was having an allergy or asthma attack. In July 2008, doctors diagnosed the patient with mononucelosis. As of 19-FEB-2009, the patient had not recovered and was still too weak to run. The patient's family thinks GARDASIL was responsible, but the patient's physician's did not know if her condition was related to the vaccine or if it was a coincidence. Additional information is not expected.",,,,Y,Y,0,,,N,05/01/2008,05/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA04441

340968,03/03/2009,IL,15.0,,,F,03/02/2009,"Information has been received from a medical assistant concerning a 15 year old female with no previous medical history or drug allergies reported who on 17-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X), 0.5 mL, I.M. On around 05-JAN-2009, the patient became really sick, had a fever of 104 F, a sore throat, and was dehydrated. The patient was awakened in the middle if the night but was not fully alert. Her mother, who spoke with her that night, said that she did not know where she was. On 05-JAN-2009, the patient was taken to the emergency room. She was given MOTRIN and IV fluids. The emergency room could not find a cause for her illness. On 17-FEB-2009, the symptoms were resolved. The patient was followed up on 21-FEB-2009 by her primary care. The symptoms were considered to be an other important medical events by the medical assistant. Additional information has been requested.",,,,Y,,,,,Y,12/17/2008,01/05/2009,19,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA04580

340969,03/03/2009,OR,26.0,,,F,03/02/2009,"Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first and second 0.5mL doses of GARDASIL on 29-JUN-2007 and 29-SEP-2007. The physician reported that they believed the patient was pregnant on 10-DEC-2007. On 29-DEC-2007, the patient was vaccinated with the dose of GARDASIL. On 24-JAN-2008 the patient experienced miscarriage. Lab test performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review miscarriage has been considered an other important medical event. Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage (WAES #0902USA04455). Additional information has been requested.",,,,,,,,,Y,12/29/2007,01/24/2008,26,Unknown,OTH,OTH,Unknown,Pregnancy NOS (LMP = Unknown),,,WAES0902USA04384

341035,03/04/2009,,17.0,17,,F,03/03/2009,"Information has been received from a physician assistant concerning a female patient who on an unknown date was vaccinated with the second dose of GARDASIL (Lot number was not available). Subsequently, the patient experienced a day long seizures and severe headaches after receiving her second dose of GARDASIL. The patient was currently seeing a neurologist but was not yet recovered. On an unspecified date, a magnetic resonance imaging (MRI) was performed (results was not provided). Additional information has been requested.  04/14/2009  Neurology records received for eval of dysphasia, dizziness, H/A from 11/14/08-3/23/09. Pt had recently presented to ER on 11/10/08 with c/o chest pain upon inspiration.  Initially thought to be asthma by parent and tx with nebs. Pt developed tachycardia and became frightened. Dx with anxiety and tx with Ativan in ER and D/c. The next day pt was difficult to arouse and was feeling dizzy. Parent noted pt was having problems with speech, halting and with problems expressing self which continued throughout the day in addition pt very sleepy.  On 11/12/08 pt developed H/A which has continued on/off until 11/14/08 appt.  PE (+) for halting speech with stuttering quality. DTRs 1-2 in UEs and 3+ in LEs. DX: Dysphasia-etiology unclear.  Sent for MRI. Started on Topamax 1/12/09. Pt presented again 1/6/09 with several episodes of fogginess, cognitive sluggishness, falling asleep and H/A. Reports increased menstrual cramps. DX:  H/A and altered mental status. ? migraine variant.  Started on Topamax 1/12/09. Parent reports pt falling during skating practice with H/A and later H/A, neck pain, back pain, muscle and joint pain.

341143,03/05/2009,,22.0,22,,F,03/03/2009,"I had the 1st GARDASIL vaccination in Oct 2008 and ever since then I have been having high fevers, between to 102-103.0.",,,,,Y,,,,N,10/01/2008,10/13/2008,12,"The first GARDASIL injection was in OCT 2008, the 2nd was in Dec. 2008. I have not received the third vaccination because I believe GARDASIL is the cause for my persistent fevers."

341208,03/06/2009,MO,26.0,26,,F,03/05/2009,"Information has been received from a licensed practical nurse concerning a 26 year old female with no known medical history and drug allergies, who on 12-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X) on 12-FEB-2009.  The patient received a 0.5 mL second dose of GARDASIL (lot # 661764/0650X), intramuscularly.  There was no concomitant medication.  It was reported that the patient was pregnant.  It was noted that the patient had experienced vaginal spot bleeding that was bright red.  It was also reported that the patient miscarried.  She was in her first trimester and probably only a couple weeks pregnant.  Beta levels were negative and she will not require a dilation and curettage procedure.  The patient sought medical attention through a phone call to the practice.  Upon internal review, miscarried was determined to be an other important medical event.  Additional information has been requested.",,,,Y,,,,,Y,12/12/2008,01/01/2009,20,"Serum beta-human, negative",OTH,OTH,None,Pregnancy NOS (LMP = 1/18/2009),,,WAES0902USA03994

341212,03/06/2009,NC,14.0,14,,F,03/05/2009,"Information has been received from a office manager concerning a 14 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot number 660387/1967U). On 27-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (Lot number 660553/0070X) and on 24-NOV-2008 with the third dose of GARDASIL (Lot number 661764/0650X). In September 2008, the patient complained of tiredness. The patient was cultured and was positive for mononucleosis. In January 2009, the patient began to felt awful and really bad. The patient had some laboratories taken and her blood work came back as: WBC-2, platelet-150, and no leukemia. The patient was hospitalized for one week. She had since been released from the hospital. Additional information has been requested.",,,,Y,Y,0,,,U,06/27/2008,09/01/2008,66,"Diagnostic laboratory, 01/??/09, blood work: no leukemia; Diagnostic laboratory, 09/??/08, positive for mononucleosis; WBC count, 01/??/09, 2; Platelet count, 01/??/09, 150",OTH,OTH,Unknown,,Unknown,,WAES0903USA00062

341318,03/09/2009,AZ,15.0,,,F,03/06/2009,"Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female who on 18-SEP-2008 was vaccinated IM with the first dose of GARDASIL 0.5 ml (Lot# 660557/0072X). There was no concomitant medication. After receiving the first dose of GARDASIL, the patient became pregnant and experienced a miscarriage. It was noted that the pregnancy was lost at 16-18 weeks gestation. Upon examination the fetus was found to have spinal bifida. The outcome of miscarriage was unknown. It was reported that the patient sought medical attention: seen by the practice. Upon internal review, the patient's miscarriage was considered an other important medical event. Spina Bifida is considered a congenital anomaly. Additional information has been requested.",,,,Y,,,,,Y,09/18/2008,,,"diagnostic laboratory, fetus had spinal bifida",OTH,OTH,None,Pregnancy NOS (LMP = Unknown),,,WAES0903USA00423

341433,03/10/2009,,13.0,13,,F,03/05/2009,"Around February of this year my daughter came up with a few ringworm's on her stomach and thigh. I bought the over-the-counter medication and was applying it 3 times a day to no avail then approximately three weeks after the initial outbreak she started getting more all over her stomach back and legs the other areas originally infected were not healing at all. I took her to our doctor and he diagnosed her with pityriasis rosea and has since put her on a steroid dose pack.. when I learned what it was I started doing some research to try and figure out how she had contracted the virus...then I read that it is possibly caused by a papilloma virus and that got me wondering if this also could be a side effect to the GARDASIL shot...my daughter got the 3rd GARDASIL shot 1/29/09 and the first hearld patch appeared less that a week later however I did not attribute it to the shot until I started doing some research... Could someone please let me know if this is a possible side effect that has just not been listed yet... I find it odd that she gets this virus, one I have never heard of before shortly after the injection...thank you",,,,,,,,,U,01/29/2009,03/03/2009,33,,UNK,UNK,,,,,

341462,03/10/2009,PA,16.0,16,,F,03/10/2009,"After getting the gardasil vaccine three weeks ago, my daughter has severe back pain, general muscle aches, fatigue and terrible headaches. She also had swelling of her mouth and lips. I am very concerned about her back problem because it is very unusual and the doctor really doesn't know what is wrong. These symptoms didn't occur until after her first dose of gardasil. SHE WILL NOT BE RECEIVING THE LAST TWO DOSES OF THE DRUG! 4/1/09-records received-office visit 2/2/09-C/O hives rash on body since 2/7/09, itchy and red-seen in ED started on prednisone. assessment:dermatitis secondary to PCN. 2/17/09 office visit C/O bad headaches every couple of days. Not eating for one week but drinking soda and caffeine. Fatigue. Assessment possible eating diorder possible cause of headaches suspect underlying mood disorder. Received Gardasil/Adacel Menactra. Referred to eating disorder clinic. Office visit 3/2/09-C/O inflammation in upper back with pain began day before and is a recurrent porblem however first time seen for the problem. Assessment muscle sprain likely secondary to month of coughing.

341478,03/10/2009,CA,26.0,26,,F,03/10/2009,"I received my first and only dose of Gardasil in late September, I beleive it was the 20th.  I found out in October that I was pregnant.  My due date based on ultrasound was June 25, 2009 making the date of conception around October 2, 2008- after I received the vaccine.  In January, the baby was diagnosed with Trisomy 18.  He did not survive

341749,03/15/2009,TN,26.0,26,,F,03/15/2009,"After recieving first round of Gardasil shot- three weeks later noted small red spoches on chest area( Sat AM), Sun day felt weak, back cramps, and nausea.  Mon AM and continuing- red spots darken and increased in number.  Doctor diagnosed as pityriasis.  Have found other forums where pityriasis is connected with the vaccine.  Within one week of three spots- the rash has spread throughout entire chest, back, neck and now starting to form on arms and legs. Doctor claims unknown cause or cure.",,,,Y,,,,,N,02/02/2009,03/07/2009,33,pityriasis,PVT,PVT,genertic yaz (birth control pills),none,none,,
341750,03/15/2009,PA,70.0,70,,F,03/15/2009,Severe red burning rash on arm 4in in diameter.  Experiencing chest pains and joint pains.As well as cold sweats.,,,,,,,,,U,03/12/2009,03/13/2009,1,,UNK,PVT,unsure,None,"inactive rhuematoid arthritis, hblood pressure",,

342130,03/16/2009,,,,,F,03/13/2009,"Information has been received from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL (dose, route and lot number not reported).  The consumer reported that her daughter had experienced HPV infections after she had received a dose of GARDSIL.  It was not specified if the patient sought medical attention.  This is one of two reports from the same source.  Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0903USA00033

342147,03/16/2009,TN,22.0,,,F,03/13/2009,"Information has been received from a consumer concerning her 22 year old daughter, with no known drug reaction/allergies and no pertinent medical history, who on 26-AUG-2008, was vaccinated with the first of GARDASIL and on unspecified dates, was vaccinated with the second dose and third dose of GARDASIL.  There was no concomitant medication.  The reporter stated that her daughter started having side effects after getting the second dose of the GARDASIL vaccine.  On 19-FEB-2009, the patient experienced nausea, rash at the injection site, abdominal pain, vomiting, muscle pain, weakness and complained of she felt sick all the time.  The consumer stated that ""she did seek medical attention and they keep telling it is a stomach virus"".  At the time of the report, the patient had not recovered.  Additional information has been requested.

342152,03/16/2009,,,,,F,03/13/2009,"Information has been received from a consumer concerning a female who was vaccinated with GARDASIL (Lot # not provided).  After receiving GARDASIL, the patient got sick and was hospitalized.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  This was one of several reports from the same source.  Additional information has been requested.",,,,,Y,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA04518

342227,03/16/2009,CA,16.0,,,F,03/13/2009,"Information has been received from a consumer concerning her daughter (a 16 year old female) who in March 2008, was vaccinated with her first dose of GARDASIL.  About 24 hours after receiving the vaccine (March 2008), the patient felt like there was stakes going through her arms and legs for about 2 weeks after receiving the vaccine.  Caller stated it was intense pain and she had difficulty moving.  At the time of the report (23-FEB-2009) patient had not received the second or third dose.  It was reported that therapy with GARDASIL was discontinued in March 2008.  The patient was recovered about 2 weeks after receiving the vaccine.   The patient sought unspecified medical attention.  No further information is available.",,,,,,,,,

342233,03/16/2009,IL,38.0,38,,F,03/13/2009,"Information has been received from a physician concerning a 38 year old female with no medical history or drug allergies who was intramuscularly vaccinated with the first, second and third 0.5 ml doses of GARDASIL (1st and 2nd lots #""0770X"", 3rd lot #0573X) on 07-AUG-2008, 11-SEP-2008 and 03-FEB-2009, respectively.  The patient developed reactivation of genital warts a few days after receiving her third dose of GARDASIL.  She had negative culture for herpes.  Subsequently, the patient recovered from reactivation of genital warts on an unspecified date.  The patient visited family physician for medical attention.  Additional information has been requested.",,,,Y,,,,,Y,08/07/2008,08/07/2008,0,"Herpes simplex virus, negative",OTH,OTH,Unknown,,None,,WAES0902USA04004

342356,03/16/2009,,,,,F,03/13/2009,"Information has been received from a female consumer who on an unknown date, was vaccinated with GARDASIL (lot # not reported).  Subsequently the patient experienced severe side effects.  The patient was told that the reason she had the side effects was because she sat down for 15 minutes after administration.  It was unspecified if the patient sought medical attention.  No further information is available.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA03536

342363,03/16/2009,,38.0,,,M,03/13/2009,"Information has been received from a physician concerning a 38 year old male with hypertension who on 13-FEB-2009 was vaccinated with a dose of GARDASIL.  On 15-FEB-2009, the patient noticed ""foaminess"" to his urine.  The patient was evaluated in the office on 16-FEB-2009 and a dipstick check of the urine revealed the presence of protein.  Complete blood count, comprehensive metabolic panel, urinalysis, serum and urine protein electrophoresis, sed rate, ANA, urine microalbumin, and protein/creatinine ratio have been ordered but at the time of report, the results was pending.  At the time of the report the patient was not recovered.  The patient sought unspecified medical attention in the office.  Additional information has been requested.

342405,03/16/2009,,,,,F,03/13/2009,"Information has been received from a consumer via internet concerning a female who on an unspecified date was vaccinated with GARDASIL (lot number, injection site and route not reported).  It was reported that the patient was offered a college scholarship for her athletic skills in track and field, and ""now can barely run 50 yards without resorting to use an inhaler.""  The patient used a nebulizer every couple of hours as she could barely breathe.  It was unknown if the patient sought any medical attention.  The outcome of the patient's experience was unknown.   Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available."

342426,03/16/2009,,15.0,,,F,03/13/2009,Information has been received from a physician concerning a 15 year old female who was vaccinated with a 0.5 ml dose of GARDASIL about a year ago.  The patient has been chronically ill for a year since receiving GARDASIL and was hospitalized 4 times.  The patient's outcome was unknown at time of reporting.  The patient sought unspecified medical attention.  Additional information has been requested.,,,,Y,Y,0,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA02388

342447,03/16/2009,,,,,F,03/13/2009,"Information has been received from a case in litigation for WAES # 0902USA01678 from a consumer who reported ""her daughter's anemia became worse after received a dose of GARDASIL.""  Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,Anaemia,,,WAES0902USA01775

342451,03/16/2009,,15.0,15,,F,03/13/2009,Information has been received from a Nurse practitioner (N.P.) concerning a 15 year old female who on 01-OCT-2008 was vaccinated with a 0.5 ml dose of GARDASIL (lot # 0947X).  01-OCT-2008 the patient experienced uncontrollable bladder symptoms and wet the bed overnight after receiving the vaccine.  The patient recovered 24 hours after receiving the vaccine.  It was reported that therapy with GARDASIL was discontinued on 01-OCT-2008.  The patient sought unspecified medical attention.  Additional information has been requested.,,,,,,,,,Y,10/01/2008,10/01/2008,0,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA01871

342609,03/16/2009,PA,15.0,15,,U,03/13/2009,Information has been received from a physician concerning a 15 year old patient who on 14-JAN-2009 was vaccinated with the first dose of GARDASIL.  Subsequently the patient experienced significant swelling of the upper arm.  Approximately a six inch region of the upper arm swelled to double the normal size following the administration of the vaccine.  The patient was tested and the physician found significantly elevated level of immunoglobulin E (IGE).  Additional information has been requested.,,,,Y,,,,,U,01/14/2009,01/14/2009,0,serum immunoglobulin E - significant elevated level of IGE,OTH,OTH,Unknown,,Unknown,,WAES0902USA01435

342612,03/16/2009,GA,28.0,28,,F,03/13/2009,"Information has been received from a 29 year old female consumer who in April 2008, was vaccinated with the first dose of GARDASIL.  On June 2008, the patient received the second dose of GARDASIL.  After receiving the second dose the patient began to experience abnormal vaginal bleeding, abnormal pap smears and the feeling of ""bugs crawling on her skin"".  The symptoms had persisted since the second dose was administered.  The patient called her physician office, but had not spoken with them yet.  Additional information has been requested.",,,,,,,,,N,06/01/2008,,,None,OTH,OTH,Unknown,,Unknown,,WAES0902USA01481

342622,03/16/2009,OH,,,,F,03/13/2009,"Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 ml dose of GARDASIL (lot # was not provided, dose of series was unknown.  Before getting vaccine the patient took a HPV test with negative results.  After getting vaccine, the patient got a HPV test with positive result.  At the time of this report, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested."

342624,03/16/2009,,19.0,19,,F,03/13/2009,"Information has been received from a Nurse Practitioner concerning a 19 year old female who was vaccinated intramuscularly with her first, second and third dose of GARDASIL on 16-JAN-2007, 15-MAY-2007 and 23-NOV-2007 respectively. The patient experienced severe hair loss after receiving her second dose of GARDASIL (MAY 2007). She was sent to an endocrinologist for medical attention after the adverse experience occurred. Lot numbers were not available. Additional information has been requested.",,,,Y,,,,,U,05/15/2007,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA00931

342634,03/16/2009,GA,29.0,,,F,03/13/2009,"Information has been received from a 29 year old female consumer who was vaccinated on an unspecified date with the second dose of GARDASIL 0.5 ml intramuscularly. The patient reported that the vaccine ""really tore [her] whole body up"" as it ""ruptured in her vagina"", she had an abnormal pap smear and it stopped her hair from growing. The patient sought unspecified medical attention. Additional information has been requested.",,,,Y,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0902USA01104

342637,03/16/2009,,15.0,,,F,03/13/2009,"Information has been received from a nurse practitioner concerning a 15 year old female patient with a history of appendectomy conducted in December 2007 and a gall bladder removed in April 2008 who was vaccinated with the first dose of GARDASIL.  Four weeks later the patient experienced gastrointestinal and pelvic pain.  The patient was diagnosed as having high aluminum content and lost approximately 10 pounds.  At the time of this report, the patient recovered and was still undergoing nutrition therapy.  It is unknown if the patient sought medical attention.  Additional information has been requested.",,,,,,,,,Y,,,,Unknown,OTH,OTH,Unknown,,Appendicectomy;  Cholecystectomy,,WAES0902USA00924

342640,03/16/2009,,15.0,15,,F,03/13/2009,"Information has been received from a healthcare worker concerning her daughter, a 15 year old female with no pertinent medical history and no known drug allergies who on 26-NOV-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 05-JAN-2009 the patient began a 15 days menstrual cycle. She experienced irregular menstrual and cramping after vaccination. On 26-JAN-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL. On 02-FEB-2009 the patient experienced pain with her menstrual cycle. The patient took MIDOL tablets but the cramping did not subside. The patient never had cramping and irregular cycles prior to the first dose of GARDASIL. The patient's symptoms persisted. The patient sought medical attention by consultation with nurse practitioner. Additional information has been requested.",,,,Y,,,,,N,11/26/2008,01/05/2009,40,None,OTH,OTH,None,,None,,WAES0902USA00488

342767,03/16/2009,,,,,U,03/13/2009,"Information has been received from a nurse practitioner concerning many patients that complain of pain after receiving GARDASIL. The nurse practitioner also reported that it ""appears to be the most painful vaccination."" Follow up information was received on 02-FEB-2009 from a nurse practitioner who stated that all the patients she has given GARDASIL too have complained that it was very painful, their arms went numb and felt heavy. The nurse practitioner felt this was why a lot of patients faint with the vaccine. The actual number of patients was not reported. This is one of several cases from the same source. Additional information is not expected.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0901USA03966

341994,03/18/2009,PA,14.0,14,,F,03/17/2009,"Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 16-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. On 11-OCT-2007, the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL. There was no concomitant medication. On 10-JAN-2008 the patient was diagnosed with gastroparesis and was having abdominal pain. The patient had been hospitalized (dates of admission were not known by the reporter). On 11-FEB-2008, the patient was vaccinated intramuscularly with the third 0.5 mL dose of GARDASIL. The patient had had a nasogastric tube placed since the spring to Summer of 2008 for nutritional support. The reporter stated that the physicians were unable to determine the etiology of the diagnosis. At the time of the reporting, the patient had not recovered. Additional information has been requested. 3/27/09-records received for DOS 4/30-5/4/08-DC DX: Crohns Disease. Presented with 2 month history of abdominal cramping, bloody diarrhea and 28  pound weight loss. 3 month history of diarrhea, weight loss and intermittant abdominal pain. Records-DC DX for 7/28-7/30/08 gastroparesis. DC DX: 8/7-8/15/08-Chronic gastroparesis.

341995,03/18/2009,,14.0,14,,F,03/17/2009,"Information has been received from a consumer concerning his 14 year old granddaughter with a history of migraine who in September 2008, was vaccinated with a dose of GARDASIL. In October 2008 (on an unspecified time after vaccination), the patient experienced abdominal pain and headaches. Her symptoms had been getting more pronounced and more frequent. Since December 2008, the patient had spent more time out of school than in school. On approximately 18-FEB-2009 (""three weeks ago"") the patient was doing homework and was feeling well. Then she began to look unwell and laid down on the couch. As her grandparents watched, the patient's body started to ""draw up"", her hands became claws, and she developed numbness in her legs and hands. Then she developed extreme shortness of breath and coughing. Her head rolled back, her eyes crossed, she passed out and stopped breathing. Paramedics were called and she was taken to a hospital. This was about the seventh time the patient had gone to the ER in the last two months. Oxygen was given in the ambulance. By the time she reached the hospital the patient was responding. After this episode the patient lost her memory for a week and only recognized a few people. The patient was later released from the ER. In the last 2.5 months the patient had spent two nights in the hospital. While at a children's hospital for testing, the patient fainted and was admitted for testing for one week. The patient had had migraines lasting as long as a month. Numerous MRIs and CAT scans were performed. On 10-MAR-2009 ("" Last night"") the patient went to the ER. All tests had come up with no diagnosis. Unknown medications had not worked. At the time of reporting, the adverse events persisted. Additional information has been requested."

341998,03/18/2009,,14.0,,,F,03/17/2009,"Information has been received from a registered nurse concerning an adolescent female between 14 and 17 who was vaccinated with GARDASIL. The patient had an AE to GARDASIL that required the nurse to be trached. The patient was basically ""brain dead"". It was not reported whether the patients sought medical attention. Upon internal review brain dead and required to be trached were determined to be other important medical events. Additional information has been requested.",,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0903USA01470

342365,03/23/2009,,,,,F,03/20/2009,Information has been received from a registered nurse who reported what read an article. In the article was reported that a female patient died because of the serious adverse event due to GARDASIL. The patient was not the reporting nurse's patient and she did not have a copy of the article. This is a unconfirmed report. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.,Y,,,,,,,,N,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0903USA01874

342378,03/23/2009,VA,15.0,15,,F,03/20/2009,"Information has been received from a consumer concerning her 15 year old daughter with no past medical history and no drug reactions or allergies who in August 2008, was vaccinated with the first dose of GARDASIL. In October 2008, the patient received the second dose of GARDASIL. There was no concomitant medication. The consumer reported that the patient developed a low grade fever and felt ""sick"" the day after receiving her second dose of GARDASIL. During October and November of 2008, the patient experienced intermittent ""stomaches"", nausea and vomiting. Starting December of 2008 until the time of this report, she had experienced persistent extreme stomach pains and vomiting. The patient had been examined by three gastroenteriologists who were not able to determine the cause of her symptoms. She had missed 60 days of school. Lab diagnostics studies included a stomach empty test, CAT scan and blood tests with no results available. At time of this report, the patient had not recovered. The patient sought medical attention by an office visit. Upon internal review, low grade fever, felt ""sick"", intermittent ""stomaches"", nausea, vomiting and persistent extreme stomach pains were considered to be disabling. Additional information has been requested. 

342493,03/24/2009,,21.0,,,F,03/23/2009,"Information has been received from a physician concerning a 21 year old female (""who is a family friend of the physicians"") who was vaccinated with her second dose of GARDASIL at another physician's office. Two weeks later the patient experienced seizure and brain swelling and was hospitalized for two or three weeks. Therapy with GARDASIL was discontinued. On unspecified date, the patient recovered. The physician also reported the patient has now returned to college. Attempts to verify the existence of a patient have been unsuccessful. No further information is available.",,,,,Y,21,,,Y,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0903USA02949

342496,03/24/2009,CA,,,,U,03/23/2009,"Information has been received from a physician concerning a patient was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient developed lupus after getting GARDASIL. The patient went to a rheumatologist who thought this was related to the vaccine. No information was known after how many doses this occurred. Upon internal review, lupus was determined to be an other important medical event. Additional information has been requested.",,,,Y,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0903USA03341

342553,03/24/2009,,23.0,23,,F,03/20/2009,"My primary care physician informed me on the use of GARDASIL and how it prevents cervical cancer.  After reading a small pamphlet on the drug I agreed to be administered my first dose sometime in October 2008.  One month after the first initial injection I got a golf ball size knot on my left shoulder exactly where the injection was given.  I had such terrible deep within the muscle so I opted not to have another injection, but I wonder to this day what would have happened if I had, since my arm has never been the same.  I still have some muscle weakness in that arm at the times along with pain where the injection was given.  As well as less of strength in that arm.  Now I told my MD my thoughts and concerns and he just said that maybe it was a good idea I didn't have another.  But like I said what if I had.  I am concerned with this drug.  After my incident I have researched and found that I am not alone, GARDASIL has also been reported to cause moderate to severe migraines.  I really think that more studies should be done on this drug.  And until those studies have been done neither of my daughters will ever have that vaccine!",,,,,,,,,N,10/01/2008,10/01/2008,0,"My MD opted not to test me for any adverse reactions since she says ""It's been a month, I just don't see it.""",UNK,UNK,,,"I falsely tested positive for HPV two years prior to receiving GARDASIL, that's why my MD wanted to administer the vaccine."

342701,03/26/2009,,16.0,,,F,03/25/2009,"Information has been received from a physician assistant concerning a 16 year old female with no allergies who on 12-NOV-2008 was vaccinated with the first dose of GARDASIL.  On 12-MAR-2009 the patient was vaccinated with the second dose of GARDASIL .  Concomitant therapy included MENACTRA on 12-MAR-2009 into opposite arm, LEXAPRO and RECLIPSEN.  On 13-MAR-2009, almost exactly 24 hours after administration, she experienced blacking out, legs feeling like ""dead weight"", her lips turned blue, she had an ashen color to her skin, and she could not see or hear.  She visited the physician assistant who admitted her to the hospital.  She was given saline and was monitored on telemetry for cardiac function.  She also had a CT scan (results not reported).  She was discharged after 24 hours.  Her blood pressure was 94/54.  The patient recovered on an unspecified date.  The patient's mother also told the physician assistant that after the first dose similar symptoms occurred but no black-outs.  The symptoms occurred 24 hours after receiving first dose but the patient did not seek medical attention and had recovered.  The events occurring 13-MAR-2009 were considered to be disabling.  Additional information has been requested.",,,,

342775,03/26/2009,,19.0,19,,F,03/26/2009,"She came in for labs and for a Gardasil vaccination. She was vaccinated, and then while having labs drawn, she became lightheaded and fainted. Mother reports that she was having seizure like shaking while she was out. She did not hit her head, it was a very short period before she responded, was slightly pale, but otherwise herself. No postictal changes. BP low in the 70's initially. She had some ginger ale and cornbread and responded well. After about half an hour she had an excellent BP of 110/70. BP remained stable free standing and walking out.",,,,,,,,,Y,12/31/2008,12/31/2008,0,,PVT,PVT,"methylphenidate,",Excessive daytime sleepiness,none,,
342776,03/26/2009,LA,5.0,5,,F,03/26/2009,SEIZURE LASTING APPROX. 3 MINUTES TRANSPORTED BY EMS TO ER.

342821,03/27/2009,,16.0,,,F,03/26/2009,"Information has been received from a nurse practitioner concerning a 16 year old female with history of mild reaction (itching) to orange who on 23-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot# not reported), on 5-MAR-2009 11:00 AM was vaccinated IM with the second dose of GARDASIL (Lot# 655604/0052X) in the upper deltoid. On 05-MAR-2009 the patient had an anaphylactic reaction. The patient left the office at 11:45 AM with no reactions. The patient went back to school, had basketball practice and around 4 PM ate an orange and took a shower. The patient's lips at an unspecified time started to swell. The mother of the patient called the office and the patient went back to the office. The patient arrived at the office at 4:30 PM and the patient went into respiratory distress. The patient was treated with Epipen, Benadryl and a breathing treatment while waiting for the ambulance. The patient's ""pulse ox"" was 78 when she 1st arrived at the office. The patient's ""pulse ox"" was 92 or 93 after treatment and when the ambulance arrived. The patient was taken to medical center. The nurse practitioner checked on the patient at 7 PM and the patient had fully recovered and was released that same night. The mother of the patient mentioned that the patient had shown a mild reaction (itching) to an orange before. The nurse practitioner mentioned there had been reports of people having reactions after eating oranges in her center. The nurse practitioner would not giving the 3rd dose of GARDASIL. The patient did not have any problems with the 1st dose of GARDASIL. It was reported that the patient sought medical attention: in the office. Respiratory distress, lip swelling and anaphylactic reaction were determined to be other important medical events, and life threatening. Additional information has been requested."

343026,03/31/2009,,,,,F,03/30/2009,Information has been received from a consumer concerning his granddaughter (a female patient of unknown age) who experienced paralysis after getting the first 0.5 ml dose of GARDASIL. Lot# was not provided. The patient was hospitalized and at the time of reporting she was still in hospital. No further information is available

343027,03/31/2009,,15.0,15,,F,03/30/2009,"Information has been received from a physician concerning a 15 year old female patient with atypical seizure disorder (started following an episode of head trauma) characterized by lip smacking and dysarthria (not tonic clonic movements). She was on treatment for this. On 10-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (Lot # 661841/0653X) in the right buttock and had only minor localized tenderness. Subsequently, in March 2009 the patient developed paralysis, dysarthria, pain in legs and ""stroke-like symptoms"". In follow-up, the physician reported that on 13-MAR-2009, 3 days after the dose, the patient developed a rash in the distribution of her quadriceps on both legs which lasted 3 days before resolving. ON 17-MAR-2009, 1 week after the dose, the patient developed dysarthria without other seizure symptoms. There were no new medications or change in medications. The patient was admitted to the hospital for evaluation: EEG, CT, CBC, blood chemistries all came back normal. She was discharged without any specific treatment. On 24-MAR-2009, the patient saw her neurologist for the dysarthria. An MRI with gadolinium was negative. That evening at home she stood up and lost consciousness. The patient complained of numbness in her right arm and leg. On 25-MAR-2009, the patient had been complaining of burning pain in the right leg (front and back) without focality. There were no objective physical findings. At the time of reporting, the patient's dysarthria persisted. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. Additional information has been requested.

343257,04/01/2009,TX,16.0,16,,F,04/01/2009,"Gardasil shot was given.  Pain starting in arm of injection site, quickly moved to shoulders and neck. Within two days it included the entire back and hips. Now, nearly a week later it is painful for her to walk and she is complaining that her entire body feels as if it is bruised. 4/8/09-records received-offcie visit 3/26/09-chlamydia positive. First gardasil vaccine received. Oral contraception.  5/1/09-records received for telephone call from parent, C/O headaches, pain and weakness for several days after injection."

343265,04/01/2009,AZ,18.0,18,,F,03/27/2009,"Pt was given GARDASIL vaccine was informed would have to wait 20 minutes to be observed, pt was sitting on exam table after injection passed out -  falling forward hitting cabinet broke tooth & cut to head.  Pt observed stabilized.  8/5/09 Medical records received DOS 3/27/09. Assessment: Syncopal episode with scalp laceration and tooth fracture. Fell forward off of exam table from seated position, lost consciousness 10-15 seconds. R parietal upper scalp laceration. R front tooth chipped. Upper lip contusion.  8/17/09 Hospital records received DOS 6/14/09 to 6/15/09. Assessment: Right facial cellulitis, fever, broken tooth causing abcess, hyperglycemia, hyponatremia. Patient fell forward and damaged right upper teeth. Root canal performed. Developed increased swelling and redness in right upper part of face. Oral surgeon performed I&D. Pain and swelling increased. 2 cm X 1 cm area of swelling redness and fluctuance posterior to right central incisor on the hard palate.  ICD-9 Codes: 682.0 Cellulitis of Face, 276.1 Hyposmolality, 522.4 AC Apical Periodontitis, 790.29 Other Abnormal Glucose, V45.89 Postsurgical States NEC, 521.81 Cracked Tooth.",,,,,,,,,Y,03/27/2009,03/27/2009,0,8/5/09 Medical records received DOS 3/27/09. LABS and DIAGNOSTICS: CT Brain w/o Contrast - Moderate ethmoid sinusitis. 8/17/09 Hospital records received DOS 6/14/09 to 6/15/09.  LABS and DIAGNOSTICS: CT Scan - periapical abcess right max,PVT,PVT,,None,"8/5/09 Medical records received DOS 3/27/09. Asthma, exercise induced."

343415,04/03/2009,CA,15.0,15,,F,04/02/2009,"Information has been received from a medical assistant concerning her 16 year old daughter who on 11-FEB-2008 was vaccinated the third dose of with GARDASIL. During the last week of February 2009, the patient experienced anal bleeding and approximately 3 lesions around the anus. She was treated by a physician assistant in the office. The lesions were at that time ""burned off"". One week later the bleeding returned and the daughter had more than 30 lesions around her anus. Follow-up information was received from the physician's assistant concerning the 16 year old female patient with no known allergies and no illness at time of vaccination who on 04-APR-2007 was vaccinated IM with the first dose of GARDASIL (lot #: 655503/0012U) into the left thigh, on 21-AUG-2007 was vaccinated IM with the second dose (lot #: 658556/1060U) into the right thigh and on 12-FEB-2008 was vaccinated IM with the third dose (lot #: 657736/0389U) into the right thigh. In approximately January 2009, the patient developed multiple warts on rectum. On 05-MAR-2009, rectum biopsy was performed. The tissue of genital wart (rectum) was tested. It was reported the specimen consisted of a single tan, irregularly shaped tissue fragment measuring 0.3x0.3x0.2 cm. The surface was regular. The margin was inked black. The physician's diagnose by the rectum biopsy was condyloma. There was viral cytopathic effect characteristic of HPV infection. No high-grade dysplasia was seen. The patient was treated with podophyllin and ""hyphinkater"". Multiple warts on rectum/condyloma and characteristic of HPV infection were considered to be other important medical events.

343419,04/03/2009,NY,12.0,12,,F,04/02/2009,"Information has been received from a physician concerning a 12 year old female with allergies to Augmentin who on 10-OCT-2007, 17-JAN-2008 and 17-SEP-2008 was vaccinated IM 0.5 mL with the first (lot# 658554/0928U), second (lot# 658488/1264U) and third (lot# 660391/0063X) doses of GARDASIL. There was no concomitant medication. After the third vaccination, the patient developed muscle aches and ""went berserk at home"" on an unspecified date. The patient's mother called the physician on 30-MAR-2009 to report that the patient ""went berserk"" and was hospitalized in the ""psych ward"". The patient's symptoms persisted. Additional information has been requested. 4/20/09-records received-for DOS 3/27-4/3/09-DC DX:anxiety disorder NOS. Admitted for a period of explosive outburst earlier. Punished for not oing to school. Punched wall. Refuses to go to school, did not sleep at night verbally abusive, few epsiodes of physical aggression towards property. Screaming. Parent felt threatened."

343499,04/03/2009,OK,16.0,16,,F,04/03/2009,"Within 5-10 minutes of patient receiving TdaP and gardasil, pt had a 30 second episode of stiffening and blank staring.  Since that time she has had a headache and blurry vision.  Had some flushing as well."

343673,04/07/2009,KY,12.0,12,,F,04/07/2009,Received 3rd dose of Gardasil on 3/31/09 On 4/2/09 she had an episode where she became very angry and agitated and had behavior not like her normal behavior. Mom said better after that day but concerned behavior related to vaccine.

343700,04/08/2009,,,,,F,04/07/2009,"Information has been received via an internet blog from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL. In the middle of the patient's series she ""had a bout of Bell's palsy that paralyzed the right side of her face"". Two months later, patient was diagnosed with Grave's disease. The doctor says an immune reaction to something he can't determine is most likely responsible. Upon internal review, a bout of Bell's palsy and Grave's disease were considered to be other important medical events. No further information is available."

343701,04/08/2009,MA,16.0,16,,F,04/07/2009,"Information has been received from via the physician of a patient whose mother found the current case online. The current case concerns a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The mother of the other patient stated that the current patient had the ""exact same problem"" as her daughter: minor localized tenderness, developed a rash, dysarthria without other seizure symptoms, had loss of consciousness, complained of numbness and tingling, pain in side, burning pain, paralysis and stroke-like symptoms. The patient sought a specialist. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. This is one of several cases from the same source. Additional information has been requested. 

343704,04/08/2009,,17.0,,,F,04/07/2009,"Information has been received from a physician concerning a 17 year old female who was vaccinated with her second dose of GARDASIL, 0.5 mL, IM. The physician stated that the patient's mother had contacted him and questioned him about the vaccine. It was reported that the patient had been having seizures ""almost every day"" since getting the second dose. She had been ""to a lot of specialists"" who had not been able to make a diagnosis. The reporter was not the patient's physician. It was unknown if there were any seizures after the first shot or if they only appeared after it was reintroduced. The patient would not be completing the series. The patient had not been able to go to school because of this experience.

343777,04/09/2009,VA,11.0,,,U,04/08/2009,"Information has been received from a physician concerning an 11 year old patient who was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient died. Additional information has been requested." (See next one in blue and bold below.)

343791,04/09/2009,NE,16.0,16,,F,04/06/2009,"Patient is a 16-year-old female who presents today with mother. The patient states she was with her mom earlier getting her prom dress fitted when she blacked out. Her mom states her face when pale and her lips turned blue in color. The patient was out for about 2 minutes. She did not fall to the floor, because her mom was able to hold her up. The patient did stated that she had her knees locked while she was standing. She did say everything went black. When she woke up she did remember where she was at. She was very tired upon waking up and is still very lethargic. She did receive a GARDASIL shot in her right shoulder yesterday and meningitis shot in her left shoulder yesterday. Patient did have a similar episode back in November, the day after her first GARDASIL shot was given. The patient denies any vision changes, headache, nausea, chest pain, shortness of breath, bladder or bowel changes. She states she is still very tired and her legs feel very heavy.

343795,04/09/2009,NH,15.0,15,,F,,"Developed bilateral pulmonary embolisms and moderate to severe right ventrical heart dysfunction. Misdiagnosed originally as ""walking pneumonia"", and blood being coughed up as bronchial inflammation from bad cough. Began having trouble breathing about one week after GARDASIL injection.  4/17/09 Received hospital medical records of 2/26-3/1/2009. FINAL DX: bilateral pulmonary emboli; SOB Records reveal patient experienced worsening dyspnea & chest pain x 2 days.  Fatigue had increased since 11/08 & around 12/25 began to have bouts of coughing which had continued & now w/dyspnea & hemoptysis.  Seen by PCP multiple times & had been on several courses of antibiotics for pneumonia.  Had developed dull pain in both LEs & chest pressure when lying down.  Now difficult to walk even across a room.

(The following looks like the same as that above in bold and blue)
344160,04/15/2009,GA,11.0,11,,F,04/14/2009,"Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested.  4/24/09 ER record received for DOS 4/1/09 with dx: Fever.  Pediatric Viral syndrome.  Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx:  Post-vaccination reaction. Pt presented again to ER with fever of 102'F, body aches, inability to walk 2' to leg pain, nausea, vomiting, rash and polymyagias.  PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX:  Necrotizing fasciitis (gram (+) cocci with septic shock).  Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis.  Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability.  Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD:  Necrotizing Fasciitis (Gram (+)) with septic shock.",Y,04/03/2009,,Y,,,,,N,03/31/2009,03/31/2009,0,"diagnostic laboratory, a group A strep in the blood was found. Labs 4/1/09:  CBC with WBCs 11.1 73% segs, 13.1% lymphs, 12.6% monos. UA WNL Labs 4/3/09:  CK 116.  LDH 389. Na+ 131. K 3.1. Cl 94. CO2 18.6. Anion gap 21.5. Glucose 170. Albu",OTH,OTH,,"sore throat 4/24/09 PCP records received which reveal 11yr WCC 3/31/09 with no medical c/o.  Vax given- Hep A, Gardasil, TDaP a",PMH:  foot swelling.  Sickle-cell trait.,,WAES0904USA01011

344155,04/14/2009,,,,,F,04/09/2009,"My daughter is 13 yrs old and has received the gardasil vaccine during which before receiving the 3rd vaccine I was notified that there would be some information broadcasted.  I did decide not to give her the third vaccine due to her having some of the symptoms which included headaches, abdominal pain, nausea, fatigue, shortness of breath, chest pain or tightness, I have taken her to the emergency room twice this month for those symptoms and the physicians are not sure what is happening and say it could be asthma but I am concerned that it is more than that.  Please let me know what else we need to do.  Thank you."

344256,04/16/2009,,17.0,,,F,04/15/2009,"Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine (manufacturer unknown). It was reported that ""2 hours after getting the vaccine"" the patient started having trouble breathing and feeling chest pains. The patient was taken to the emergency room but was not admitted overnight. ""A full work up was performed at the emergency room (results not provided), also a computed axial tomography scan, electroencephalography and magnetic resonance imaging were performed (results not provided). It was reported that she had couple more breathing episodes since. The patient also experienced seizure like activity starting on 11-MAR-2009. It was reported that the first seizure was pretty severe and the patient did not calm down until she was given ATIVAN. It was reported that the patient overall was experiencing tiredness, weakness, chest pains, dizziness and nausea. The patient was seen at the practice. It was reported that the patient had not recovered at the time of the report. Upon internal review, seizure-like activity was determined to be other important medical event. Additional information has been requested."

344321,04/17/2009,,18.0,18,,F,04/16/2009,"Information has been received from an 18 year old female with migraine and no allergies for GARDASIL, a Pregnancy Registry product, who in February 2007, was vaccinated with the first dose of GARDASIL (lot# not reported). Concomitant therapy included vitamins (unspecified). In April 2007, the the patient received her second dose of GARDASIL (lot# not reported) 0.5 mL when she was 2 weeks pregnant. The patient requested a pregnancy test before receiving the shot of second dose however it was never given to her. On 13-FEB-2008, the patient delivered a baby. It was reported that the baby experienced unexplained fever almost every other day as well as seizures. The baby was also congested all the time and was diagnosed with asthma. The reporter felt that the baby's unexplained fever, seizures and asthma were related to therapy with GARDASIL. Unspecified medical attention was sought. Upon internal review, seizure was considered to be an other important medical event. No further information is available."


345222,04/17/2009,VA,21.0,21,,F,04/14/2009,"Information has been received from an office nurse concerning a female who on an unknown date, was vaccinated with the third dose of GARDASIL (lot# not reported). Subsequently the patient was diagnosed with Guillain Barre by a neurologist. Upon internal review, Guillain Barre was considered to be an other important medical event. In follow-up, the nurse revealed that the approximately 22 year old patient received two doses of GARDASIL on 18-JUL-2007 (lot# 658100/0525U) and 20-DEC-2007 (lot# 659439/1267U). Additional information has been requested.  8/26/09  MR rec'd for DOS  5/6-12/2008 with D/C DX:  Guillain-Barre Syndome, s/p 5 days of IVIG.  ADHD.  Pt initially presented to ER with 9 day hx of ascending numbness and weakness to the level of the abdomen. 2 prior ER visits, but presented again with chest pressure, decreased strength, difficulty walking, and worry re: condition. PE (+) for decreased strength and sensation. DTRs trace or absent. Admitted for IVIG.  Pt had autonomic instability with tachycardia and HTN, insomnia, H/A and constipation, somewhat improved by d/c.  Transferred for rehab 5/12/08 ICD9-357.0, 787.20, 349.0,314.01,  9/4/09 Hospital records received DOS 5/23/08 to 6/9/08. Assessment: Guillain-Barre' Syndrome Previous hospital stay complicated by respiratory distress / insufficiency. Transferred and placed on respiratory support (BiPAP). 7 days of plasmapheresis. Dysphagia, PEG tube. Difficulty activating facial muscles. Decreased muscle strength. Deep tendon reflexes absent lower extremities, trace in upper extremities. Anemia. Headache. Discharge to rehabilitation."

345224,04/17/2009,,,,,F,04/14/2009,"Information has been received from a Registered Nurse concerning a female patient who was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml.  Patient had a ""severe allergic reaction"" after received the vaccine and was hospitalized.  The reporter did not know what the ""severe allergic reaction"" consisted of.  Additional information has been requested.",,,,Y,Y,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0903USA03984
345225,04/17/2009,AZ,16.0,,,F,04/14/2009,"Information has been received from a physician concerning a 16 year old female who was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. It was reported that sometime after she got the vaccine the patient had been having ""fainting spells."" The patient sought unspecified medical attention and went to an emergency room but was not admitted. The doctor reported that since the patient was continuing to faint then it was a significant disability/incapacity. At the time of reporting the patient was not recovered.

345235,04/17/2009,,16.0,16,,F,04/14/2009,"Information has been received from a nurse practitioner concerning a 16 year old female with not sexually active and a history of meningitis as a baby who in August 2008, was vaccinated with the first dose of GARDASIL (Lot# not reported), on 20-OCT-2008, was vaccinated with the second dose of GARDASIL (Lot# not reported). There was no concomitant medication. And the patient had had an unspecified number of urinary tract infections, frequent lower back pain, abdominal pain and got the flu for the first time. The first dose and second dose were given by another unspecified provider's office. Prior to receiving GARDASIL, the patient had ""always been healthy all her life"" (as reported by the patient's mother). The patient went to emergency room in January 2009 for the flu. The nurse practitioner assumed urine culture and sensitivity test done by another unspecified provider's office. The reporter nurse mentioned although she did not feel the patient's symptoms were related to the GARDASIL, the third dose of GARDASIL would not be given. Subsequently, the patient recovered from unspecified number of urinary tract infections, frequent lower back pain, abdominal pain and flu on unknown date.

345241,04/17/2009,,49.0,49,,F,04/14/2009,"Information has been received from a nurse practitioner (N.P.) concerning a 49 year old female with hypothyroidism and gastroesophageal reflux disease who on 2-MAR-2009 was inadvertently vaccinated IM with a 0.5 ml first dose of GARDASIL (lot # not reported) due to human error. It was reported that the patient was supposed to received a tetanus toxoid vaccination. There was no product confusion involved. Concomitant therapy included omeprazole (MSD), SYNTHROID and vitamins (unspecified). On 3-MAR-2009 the patient experienced pain and swelling in armpit after the vaccination. The patient sought medical attention at the practice. No lab test performed. As of 9-MAR-2009 the patient was recovering.

345269,04/17/2009,,,,,F,04/14/2009,"Information has been received from a nurse practitioner concerning a female patient who on unspecified dates in 2007 was vaccinated with the first two doses of GARDASIL, 0.5ml, intramuscularly in the buttocks and in December, 2007 was vaccinated with the third dose of GARDASIL, 0.5ml, intramuscularly in the left arm. The nurse practitioner reported that when the patient was seen in December, 2007, there was an indentation in her buttocks about the size of half dollar and the skin was ""caved in"". There was no inflammation. The patient was seen again that week. The area on her buttock has increased in severity. The indentation remained. The area was blue-purple in color and tender to touch. At the reporting time, the patient had not recovered.

344385,04/20/2009,CA,16.0,,,F,04/17/2009,Information has been received from an office manager that the physician heard from the physician's colleague that a 16 year old female colleague's patient was given an unspecified dose of GARDASIL (Lot not reported) on a Friday and on Monday the patient passed away (specific dates were unknown).  The reporter considered the event as disabling and life threatening.  Additional information has been requested.

344583,04/22/2009,MN,15.0,15,,F,,"Immediately after vaccination, eyes rolled back, color became gray/green, leaned to left; mother supported her - nurse attempted to assist her to put head between knees and her back jerked and stiffened twice and her fingers were extended and hands shaky; she didn't recall what happened; described self as feeling ""daze-y"" Records received 05/01/2009 - DOS 04/21/2009. Seizure and R hand weakness post-adminstration of Gardasil and varicella.   Review of systems unremarkable other than Hx of ADHD and depression.  RX Prozac and Dexedrine.  Headaches past 2 weeks. Discharge Dx: Seizure.",,,,Y,,,,,U,04/21/2009,04/21/2009,0,"mother took to urgent care and was referred to hospital ED; had MRI which was ""clear""; was told that it was seizure not due to immunization; referred for further neuro work up  Records received 05/01/2009

344918,04/22/2009,,17.0,,,F,04/07/2009,"Information has been received from a physician assistant concerning a female under 18 year old who on unspecified date was vaccinated with her third dose of GARDASIL (lot number, route and site not reported) About 6 weeks after the third dose of GARDASIL the patient broke out in a rash all over her body. The patient had gone to a dermatologist who diagnosed the patient with lichen nitidus. The physician assistant was not sure if it was from the GARDASIL since the patient had no reaction with the first and second dose of GARDASIL, but the dermatologist believed it was from GARDASIL. Subsequently, the patient recovered from lichen nitidus. Additional information has been requested.",,,,

344767,04/24/2009,WA,15.0,15,,F,04/23/2009,"Initial information has been received from a physician and follow up information has been received from a registered nurse concerning a 15 year old female with no medical history, who on 14-APR-2009 was vaccinated with a first dose of GARDASIL (lot # 661846/1312X). There was no concomitant medication. The patient had blood work drawn a few minutes after receiving the vaccination. After the blood work was drawn. The patient fainted for approximately 15 seconds and may have had a minor seizure. The patient's eyes rolled to the back of her head and she became unresponsive for about 15 seconds. It was reported that her pupils were dilated and she was out for about 15 seconds. The patient regained consciousness and was given juice to drink. No medications or treatment were given to the patient. The patient stated that she did not have much to drink prior to the physician's visit. The patient was not hospitalized. The patient was observed for a little while and then was sent home with her mother. It was reported that the patient stayed home from school the next day and reported she was tired and had some muscle aches. On 15-APR-2009 the patient's mother was instructed to call the physician back if the patient continued with any problems. The physician advised the patient not to receive the remaining doses of GARDASIL. The patient did not receive any other vaccinations other than GARDASIL on 14-APR-2009. The patient had an appointment to see the physician on 07-MAY-2009. Upon internal review seizure was determined to be an other important medical event.

344820,04/24/2009,NJ,11.0,11,,F,04/22/2009,"My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.",,,,Y,,,,,U,04/21/2009,04/21/2009,0,A neurologist had received her results today I have to go see him in the office to find out where we go from here.  We left the er after 5 hours and were exhausted so they said I didn't have to wait for the results she was negative the neur,UNK,UNK,,,"She is learning disabled, she has apraxia, sensory integration dysfunction, and had a run of myoclonic seizures 5 years ago.",,
344822,04/24/2009,CA,91.0,91,,F,04/25/2009,"4/23/09 - reviewed PROTCOL questions with patient, denied steroid use  4/24/09 - patient came to pharmacy and showed pharmacist shingles-like rash.  MD notified & gave pt VALTREX and appt scheduled 4/27/09 Called pt 4/25/09 & she's feeling better on medicine.  MD said she had steroid epidural recently"

345105,04/28/2009,,14.0,14,,F,04/26/2009,Excessive rapid hair loss a month after administration of GARDASIL.

345435,05/01/2009,,21.0,,,F,04/30/2009,Information has been received via the internet concerning a 21 year old female who was vaccinated with GARDASIL.  The patient died 4 days after vaccination.  The cause of death was unknown.  No further information is available.,Y,,,,,,,,N,,,,Unknown,OTH,OTH,Unknown,,None,,WAES0904USA03499

345528,05/04/2009,,16.0,,,F,05/01/2009,"Information has been received from a TV news report and the patient's father concerning his 16 year old daughter who in March 2008, was vaccinated with GARDASIL. The patient's father reported that in March 2008 just after the vaccination, he received a phone call in which he was informed that his daughter had a seizure and was on her way to the ER. The patient's father stated that although the doctors were not connecting seizures with the vaccine, he thought it was too much of a coincidence that the vaccination was involved at the same time, closely related with the only seizure his daughter has had in her life. The patient's father felt that the GARDASIL had absolutely something to do with the seizure. It as reported that the patient survived and is healthy today. Upon internal review, seizure was considered an important medical event. This is one of two reports received from the same source.

345789,05/06/2009,,13.0,13,,F,05/05/2009,"Information has been received from a nurse concerning a her great-niece 13 year old female with no known allergies or medical history reported, who on 28-APR-2009 was vaccinated with her first dose of GARDASIL (dose, route of administration and lot number not reported). There was no concomitant medication. The nurse reported, the patient two seizures soon after receiving her first dose of the vaccine. The first seizure was described as violent jerking, stiffness, frothing at the mouth, tongue deviated to the right and eyes rolled back lasting five minutes. The patient experienced a second seizure within the hour as she was being escorted from the office. The patient was transported home by her mother and was recovering, although still ""weak and pale"". The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested."

345790,05/06/2009,,24.0,,,F,05/05/2009,"Information has been received from a physician who reported that a patient's mother told him that her 24 year old daughter, on an unspecified date was vaccinated with the third dose of GARDASIL (Lot not reported) and ""shortly after vaccination"" the patient complained of sore body and pain in joints and she was diagnosed with macrophagic myofascitis. It was reported that the patient could not get out of bed. She also developed skin lesions. The patient's muscle biopsy showed that the muscle contain aluminum. The physician also reported that she is no longer his patient. Additional information has been received from the physician, who stated that he ""run into the patient's mother and she told him that her daughter was diagnosed with macrophagic myofascitis"" at another medical center. The patient's mother stated that aluminum hydroxide was found in the patient's muscle. The physician also stated that the patient did not receive GARDASIL in his office. The physician felt that Macrophagic myofascitis and skin lesions were considered to be disabling. No additional information is expected."

345848,05/07/2009,TX,13.0,13,,F,05/06/2009,"Information has been received from a physician and a nurse concerning her 13 year old daughter with asthma and no known allergies who on 06-AUG-2008 was vaccinated with the first dose of GARDASIL (lot no. 660620/0571X). Second dose of GARDASIL (lot no. 659184/0843X) was given on 07-OCT-2008 and on 22-APR-2009 was given third dose of GARDASIL 0.5 ml, IM into the left arm (lot no. 661846/1312X). The patient did not have any other vaccines administered that day. The nurse was reporting that her daughter was having ongoing symptoms after getting the third dose of GARDASIL. There was immediate burning and pain during vaccination followed by a tingling and numbness within five minutes (also reported as 10 minutes) to the vaccinated arm (left). The injection site was red, raised, erythemous, warm to touch and the size of a ping pong ball. The nurse reported that, that night the patient's left arm felt numb from the fingers to the shoulder. The swelling at the injection site was the size of a golf ball. There was intense pain with the application of ice to the injection site. She was given ALEVE for pain. The next morning (on 23-APR-2009) she did not feel good. Both hands were puffy. On 23-APR-2009, around 10:00, she was shaking (chills), can't move having joint pain throughout, abdominal tenderness. and fever. She saw her pediatrician around 11:30 for the fever (100.6F), numbness, nausea and abdominal discomfort. The patient was prescribed ZANTAC and ANSAID or TYLENOL. At 19:00 the same day, the patient went to the emergency room (ER). She had a temperature of 103F. All labs came back negative. Lab test performed included C reactive protein (""RCP"" for appendicitis), kidney profile, abdominal pelvis exam, contrast CT scan and Liver Function Test (LFT). She was given IV morphine (no relief) IV TORADOL (positive relief) and IV ZOFRAN. The nurse reported that the patient was diagnosed with acute inflammatory response to GARDASIL. Last evening the patient had a temperature of 101.6F, horrible abdominal pain (right sided from",,,,Y,,,,Y,N,04/22/2009,04/22/2009,0,"diagnostic laboratory, 04/24/09, kidney profile normal; diagnostic laboratory, 04/24/09, liver function test normal; diagnostic procedure, 04/24/09, pelvic examination normal; computed axial, 04/24/09, normal; diagnostic laboratory, 04/24/0",OTH,OTH,ADVAIR; PATANASE,Asthma,PMH: EIA.,,WAES0904USA03995

346054,05/11/2009,,15.0,,,F,05/08/2009,"Information has been received from a physician's wife concerning her daughter, an 15 year old female who was on unspecified dates vaccinated with two 0.5ml doses of GARDASIL (lot number not reported). Subsequently the patient experienced blue color around mouth, dizziness, headache and bleeding problems. The patient had sought unspecified medical attention. At time of reporting, the patient was not recovered. The patient's blue color around mouth, dizziness, headache and bleeding problems were considered to be immediately life-threatening. The patient's sister also experienced blue color around mouth, dizziness, headache and bleeding problems after vaccination with GARDASIL (MSD WAES 0905USA00188). Additional information has been requested."

346055,05/11/2009,,11.0,,,F,05/08/2009,"Information has been received from a physician's wife concerning her daughter, an 11 year old female who was on unspecified dates vaccinated with two 0.5ml doses of GARDASIL (lot number not reported). Subsequently the patient experienced blue color around mouth, dizziness, headache and bleeding problems. The patient had sought unspecified medical attention. At time of reporting, the patient was not recovered. The patient's blue color around mouth, dizziness, headache and bleeding problems were considered to be immediately life-threatening. The patient's sister also experienced blue color around mouth, dizziness, headache and bleeding problems after vaccination with GARDASIL (MSD WAES0905USA00344). Additional information has been requested.",,,

346102,05/11/2009,IA,15.0,15,,F,05/08/2009,"3-4 Months after 3rd dose of GARDASIL, Pt developed, headaches, dizziness, abdominal discomfort, various aches / pain, dairy sensitivity, elevated discomfort with menstruation, elevated susceptibility to infections, headaches are daily + progressively worse.  5/20/09 medical records (consultation) received DOS 9/9/08 FINAL DIAGNOSIS: gastritis and irritable bowel. Presents with abdominal pain and back pain. Nausea, sore throat and cough.   5/21/09 medical records received DOS 8/6/08. FINAL DIAGNOSIS: Cephalgia etiology unknown, neck pain musculoskeletal. Presents with abdominal, flank, and back pain. Diarrhea. Sinusitis with headache. Fuzzy vision, difficulty focusing. Generalized joint pain.",,,,,,,,,

346337,05/14/2009,VA,16.0,16,,F,05/14/2009,"During the series of 3 injections and after the patient developed utis, uris, strep throat 3 times, joint pains, muscle weakness, numbness, insomnia, mental status changes, POTS, clinical lyme disease, rheumatoid arthritis, gastrointestinal disturbances following vaccination of gardasil. Two years later still has not recovered. Recently developed presepal cellulitis and was hospitalized.  7/21/09 Medical records received DOS 1/24/08 to 4/9/09. Assessment: Chronic pain in neck, back, and mid spine region. Patient presents with missing school, severe joint pain neck and back - hurt all the time. Reports eyes dilated. Constantly tired. Pain also shoulders, wrists, hands, ankles, feet. Difficulty walking. Hypersensitive. emotional. Acute tracheitis, sore throat. Myalgias, myositis. Fibromyalgia. Feels sad. Depression, difficulty sleeping. Parent says patient ""talking crazy things"" and wanted to kill herself. Crying hysterically. Therapeutic abortion. Cafe-au-lait spots noted. Limitation of cervical range of motion.  7/24/09 Cardial consultant records received DOS 4/22/09. Assessment: Chronic fatigue, chronic Lyme disease, autonomic disfunction, postural orthostatic tachycardia syndrome. Patient presents with dizziness, 'declining cognitive' and poor memory. Frequent headaches and insomnia. Generalized body aches. Nausea. Hand and feet are cold. Head felt foggy, lightheaded. 'Marijuana intake'  7/27/09 Hospital records received DOS 5/9/09 to 5/11/09. Discharge Diagnosis: Severe Periorbital Cellulitis, Chronic Lyme Disease, Seronegative Rheumatoid Arthritis, Post reactive Streptococcal Arthritis, and POTS, Chronic pain/chronic opiates, Polyarthralgia, Euthyroid Sick Syndrome.  Patient was extracting blackheads and plucking ingrown eyebrow hairs, presents with red swollen right eyelid and face with prurulent areas, tenderness, scaling. Marked facial erythema and edema on the right, left side much less red and swollen. Honey-crusted papules. Difficulty opening right eye. Poor eye contact, flat affect. Drowsy

346500,05/18/2009,WI,15.0,15,,F,05/18/2009,"Shortly after her first shot patient started having episods of what we thought were panic attacks. She had a hard time breathing, her heart would race and she could not catch her breath. After the second shot this so called panic attacks seemed to get worse and she was having them more freqently. She was tired all the time and a bit withdrawn. She had her third shot on June 9th of 2008 and on June 12th I saw one of these episods for the first time. I was stunned. This was no panic attack. She knows it going to happen she get a real intense pain on the top right side of her head. Usually within 30 to 60 seconds of the pain she becomes completly catatonic like. She is unable to comunicate at all. Then she goes into seizure like activity. But, during these seizures she goes into a breathing pattern, she will seizure like activity for about 45 seconds and then she will stop breathing for anywhere from 30 to 40 seconds and this will continue for anywhere from 2 mins to 50 mins. This has been going on for almost a year. She will have these episodes anywhere from 2 to 4 a week.  6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. Assessment: Paroxysmal disturbance, etiology indeterminate. Patient presents with stereotypical episodes consisting of sharp stabbing incapacitating discomfort in right parietal or temporal area. Hyperventilation, irregular breathing, unresponsive, dissociated, amnestic. Gardasil Dose #1 (0211U) LA 8/13/07 Gardasil Dose #2 (1266O) RA 1/21/08",,,,Y,,,,,N,06/11/2008,06/12/2008,1,6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. LABS and DIAGNOSTICS: Total Protein 8.4 (H) Globulin 4.1 (H). Video EEG Monitoring - Normal. Pulmonary function test - Mildly increased residual volume otherwise WNL.,UNK,UNK,,none,none. 6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. Migraine,seizures~HPV (Gardasil)~~15~Patient,

346559,05/18/2009,,17.0,,,F,05/12/2009,"Daughter received first GARDASIL shot in June 2008. She passed out and hit her head getting a concussion -the Dr believed-. She had to stay in bed for over a week. She had severe headaches and neck pain. After the second shot, in September she also went to bed for about a week and a half. She had achiness all over especially in legs and stomach. The doctor ran CBC and xrays but could only find a slightly elevated protein level in the urine at this time. Because of these, she did not receive third vaccine. Over the winter, her toes started turning blue. She is now being tested for lupus. I will know the results in about one week, but if she has it I am sure it is from GARDASIL. This is a very dangerous vaccine and I wish I would have researched it more before forcing my daughter to receive it. I will never forgive myself for making her take this vaccine against her will. I was trying to help her by giving her a guaranteed cancer free future but may have ended up shortening her life or making her have a chronically ill life and she is only 17. I am so furious with the makers of this drug. If she tests positive for lupus, I plan on hiring a lawyer.",,,,,,,,,N,06/01/2008,,,I will report back in one week once we receive test results.,UNK,UNK,,,NONE. Perfectly healthy before this!

346664,05/18/2009,,26.0,26,,F,05/14/2009,"Information has been received from a registered nurse and a 26 year old female with no pertinent medical history and no history of known drug reactions/allergies who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (therapy site unknown, lot # not reported).  On 17-OCT-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 mL IM (therapy site unknown;  lot # not reported).  On 17-FEB-2009 the patient received the third dose of GARDASIL 0.5 ml IM (therapy site unknown) (Lot# 661044/0548X).  There was no concomitant medication.  On 01-APR-2009, a nurse reported that after the third dose, the patient developed varicose vein on her legs, headaches, chest pain and shortness of breath.  The patient was seen by her primary care physician.  The nurse reported the patient was recovering.  On 02-APR-2009, the patient reported that ""a few days before receiving the third dose:, she started to experience leg pain, chest pain, headaches.  After receiving the third dose, the patient still had the same symptoms.  The patient reported she had a Magnetic resonance imaging (MRI) done and had seen a knee doctor, a spine doctor and her primary care physician.  The doctors were still unsure what was causing her symptoms and she will soon find out the results of the MRI.  At the time of this report, the patient had not recovered.  Additional information has been requested.",,,,Y,,,,,N,02/17/2009,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0904USA00178

346665,05/18/2009,,20.0,20,,F,05/14/2009,"Information has been received from a 20 year old female patient with no relative medical history, drug reactions or allergies who was vaccinated with third doses of GARDASIL (lot number 661044/0648X), site and route not reported).  Concomitant therapy included OCELLA.  She didn't know the dates of the vaccination, but she finished the series about one month ago, in approx March 2009.  After the second dose, she developed joint pain at the wrists and ankles and this got worse after the third dose.  The pain affected all of her joints and muscles after the third dose.  She was seen on 24-MAR-2009 by the doctor and was prescribed NAPROXEN but it didn't help.  She saw the physician again on 30-MAR-2009 for the condition described above.  The events persisted at this report time.  Follow-up information was received from a registered nurse who reported that the patient was seen by the physician on 08-APR-2009 and still had ""aches"" and the doctor referred patient to a rheumatologist.  It was confirmed that the patient was not hospitalized.   Additional information has been requested."

346667,05/18/2009,,29.0,29,,F,05/14/2009,"Information has been received from a 28 year old female patient with irregular heartbeat and no allergies who in June 2007, was vaccinated with the first dose of GARDASIL. In September 2007 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. In October 2007, the patient developed two ovarian cysts, vaginal discharge and vaginal bleeding after receiving GARDASIL. The patient's two ovarian cysts and vaginal discharge and vaginal bleeding persisted. She has not yet received the third dose. The patient sought unspecified medical attention and saw a physician. No further information is available.",,,,Y,,,,,N,09/01/2007,10/01/2007,30,None,OTH,OTH,None,Heart rate irregular,,,WAES0904USA00234

346896,05/18/2009,FL,16.0,16,,F,05/14/2009,"Information has been received from consumer concerning  her 17 year old daughter who""2 or 3 months ago"" was vaccinated with the first dose of GARDASIL and on 13-Apr-2009 received the second dose of HPV vaccine. On 13-APR-2009, soon after the second dose of HPV vaccine was given, hives appeared in her mouth and all over her body. The patient's mother reported that her daughter has bumps everywhere including her tongue, gums, roof of her mouth, anywhere there is skin she has bumps.  The bumps are itchy.  It was also reported that the patient's mother had spoken with the physician who believed it is a viral response due to the HPV vaccine.  The physician put the patient on amoxicillin but it does not seem to be helping.  The patient's mother stated that her daughter did not have an experience after the first dose of HPV vaccine was given.  In follow-up the patient's physician reported that she does not believe the HPV vaccine is responsible for the patient's hives.  At the time of reporting, the patient had not recovered.  Follow-up information was received from a physician who reported that the patient, a white 16 years old student with a history of tonsillectomy and adenoidectomy in 1996, was vaccinated in the right arm with the second dose of HPV vaccine (lot # 661531/1311x on 13-APR-2009 at 2:00 pm.  It was reported that the rash onset was on 14-APR-2009 (previously reported per mother as 13-APR-2009) and that it was not hives.  The physician stated that she did not feel this was related to vaccination.  The final outcome was not reported.  Additional information has been requested.

346899,05/18/2009,MS,21.0,21,,F,05/14/2009,"Information has been received from an office assistant and a female patient who on 19-MAR-2009 was vaccinated the first dose of GARDASIL. Concomitant therapy included (LEXAPRO). After received her first dose of GARDASIL (LOT# not reported) she experienced genital irritation and swelling. She saw doctor and had a pap test was performed on 31-MAR-2009, results ""come back as genital herpes"". The event was not disability of life threatening and did not require hospitalization. She also stated that all other tests came back negative before GARDASIL was ever administered. At the time of the report the patient's condition persisted and the patient was treated with LEXAPRO. Additional information will be provided if available.",,,,,,,,,N,03/19/2009,03/26/2009,7,"cervix biopsy, 03/02/09 - clear; pap test, 03/31/09 - genital herpes; pap test, 01/13/09 - Pt. at high risk for HPV",OTH,OTH,LEXAPRO,,Unknown,,WAES0904USA03214

346901,05/18/2009,NJ,,,,F,05/14/2009,Initial and follow-up information has been received from a licensed nurse practitioner concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL and now was complaining of vision problems. It was reported that the patient's mother called the office and told her daughter's physician that she experienced scarring of cornea after the first GARDASIL vaccination. The nurse practitioner stated that the patient was vaccinated with GARDASIL vaccine in her pediatrician office and not in her gynecologist's office. It is unknown if the patient received the second dose of GARDASIL vaccine. The final outcome was not reported. Additional information has been requested

346929,05/18/2009,MI,19.0,,,F,05/14/2009,"Information has been received from a physician concerning a 19-20 year old female who was vaccinated with the first 0.5 ml dose of GARDASIL (no lot number was provided) over a year ago (approximately 2008). Subsequently the patient experienced ""neuropathy"" and ""winging of scapula"". The patient discontinued after the first dose. She partially recovered and had gone to physical therapy. Additional information has been requested.",,,,Y,,,,,N,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0904USA03824

346939,05/18/2009,,,,,F,05/14/2009,Information has been received from a registered nurse concerning that her son's several female friends developed muscle twitches and tingling sensations after receiving GARDASIL.  All drop down fields refer to all patients.  No further information is available at the time of reporting.  It's unspecified that the patients sought any medical attention.  No further information is available.,,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0904USA04012

346945,05/18/2009,NC,,,,F,05/14/2009,"Information has been received from an office manager concerning a female who was vaccinated with the first, the second and the third dose of GARDASIL on 11-MAY-2007, 19-JUL-2007 and 18-JAN-2008 respectively. The patient was requesting records due to GARDASIL and there was a lawyer involved. The patient did not mention any problems or why the medical records were needed for the lawyer. The office manager thought that this may be due to the patient not wanting to pay her bill. The office manager was also not positive if this was about GARDASIL or the patient was mixed up with another shot such as Depo-provera. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.",,,,,,,,,U,05/11/2007,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0904USA04370

346951,05/18/2009,CT,17.0,17,,F,05/14/2009,"Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL. The patient had a negative pap smear test on 22-JUN-2007 and  negative HPV test. Patient then received the first dose of GARDASIL vaccine on 18-DEC-2006 and second dose on 28-FEB-2007 and the third dose on 19-JUN-2007. Patient had a negative pap smear and positive high risk HPV on 19-SEP-2008. On 10-FEB-2009 the patient had a low grade squamous cell HPV high risk positive. Lot #'s were not available. The patient sought medical attention by physician. At the time of the report the patient's status was unknown. Follow-up information has been received from a pediatrician concerning the patient she reported as having negative pap smears/negative HPV tests until after receiving the third dose of GARDASIL. Subsequent to the third dose, the patient had positive results. The pediatrician did not know which HPV strain was detected. The patient received her doses on 18-DEC-2006 (lot # 653938/0954U), 28-FEB-2007 (lot # 654702/0011U) and 19-JUN-2007 (lot # 657868/0523U). No other vaccines were given at the time of the GARDASIL vaccine. The outcome of the patient was unknown. The patient was referred to gynecology. No further information is available. This is one of several reports received from the same source.",,,,Y,,,,,U,06/19/2007,09/19/2008,458,"Diagnostic laboratory, 06/22/07, negative HPV test; Diagnostic laboratory, 09/19/08, positive high risk HPV; Diagnostic laboratory, 02/10/09; had a low grade squamous cell HPV high risk positive; Pap test, 06/22/07, negative; Pap test, 09/1",OTH,OTH,Unknown,,Unknown,,WAES0904USA04435

346959,05/18/2009,,21.0,,,F,05/14/2009,"Information has been received from a consumer concerning her 21 year old daughter who was vaccinated with the first dose of GARDASIL (lot #, route and site of administration not reported). The patient experienced 36 hours of diarrhea after vaccination with GARDASIL. This is one of several reports from the same source. No further information is available.

346674,05/20/2009,,12.0,,,F,05/19/2009,"Information has been received from a Registered Nurse (R.N) who heard that a 12 year old female patient, who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient died on an unspecified date after receiving the vaccine. It was noted that the death occurred over one year ago. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.",Y,,,,,,,,N,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0905USA01825

 346965,05/22/2009,,,,,F,05/20/2009,"Information has been received from a female concerning her daughter, for a pregnancy registry for GARDASIL, who on an unspecified date was vaccinated with the first dose of GARDASIL. The reporter stated that the patient did not know at the time of the vaccination that she was pregnant. The patient had the baby 3 weeks after the vaccination. It was reported the patient sought unspecified medical attention. It was reported that the baby died. The patient was 9 weeks pregnant. Upon internal review, baby died at 9 weeks was determined to be an other important event. No further information is available.",,,,,,,,,Y,,,,Unknown,OTH,OTH,Unknown,Pregnancy NOS (LMP = Unknown),,,WAES0905USA01916

347717,05/28/2009,,,,,F,05/26/2009,"Information has been received from a registered nurse (R.N.) concerning a female patient who received two doses of GARDASIL. The patient had no difficulties after the first dose. After the second dose the patient experienced a high fever, soreness in her arm and temporary paralysis. The patient sought medical attention through an office visit. Upon internal review, temporary paralysis was determined to be an other important medical event. No further information is available.",,,,Y,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0905USA02514

348310,06/02/2009,TX,14.0,14,,F,06/01/2009,"Information has been received from a physician concerning a 24 year old female patient who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot#660557/0072X), 0.5ml. On 27-OCT-2008 the patient was vaccinated with the second dose of GARDASIL (Lot#660557/0072X), 0.5ml, and on 21-MAY-2009 the patient was vaccinated with the third dose of GARDASIL (Lot#661953/1130X), 0.5ml. MENACTRA (Lot#U2877AA) was administered during the same visit. There was no other concomitant medication. On 21-MAY-2009, 5 minutes after receiving her third dose of GARDASIL, the patient fainted and fell on the floor. She was now experiencing severe headache and she also had a ""busted lip"" and her upper tooth was loose. The patient was not recovered now and she had sought medical. Additional information was received from a medical assistant that the patient was admitted to a hospital on 21-May-2009. The admitting diagnoses were reported as syncope, head trauma, severe headache, reaction to vaccine, contusion to mouth, and laceration to lower lip. It was also noted that the patient's two front teeth were loose. When the patient was discharged and the patient's recovery status were both unknown. The patient was not scheduled for a follow-up visit with the physician. Additional information has been requested.   7/8/09 Received PCP & vaccine records.  Patient was seated during injection of vaccines and after 5 min, fell onto the floor sustaining facial injuries.  Observed in office 40 min.  BP prior ro vaccines 110/80; after fall 8/40; then returned to 110/70.  Stable & d/c to home w/parents.  Phone contact w/parent that evening revealed patient c/o HA, toothache & dizziness.  Admitted to hospital for 23 hr observation.  Remained stable & d/c to home.  Seen again in PCP office for cellulitis/abscess left thigh/hip.  No further problems.  6/9/09 Hospital records received DOS 5/21/09. Admitting diagnosis: syncope, head trauma, headache, reaction to immunizations.",,,,,Y,1,,,U,05/21/2009,05/21/2009,0,None.  6/9/09 Hospital records received DOS 5/21/09. LABS and DIAGNOSTICS: CHEM - Sodium 143 mml/L (H) Carbon Dioxide 26 mml/L (H). CBC - Hematocrit 30.7% (L) RBC Morph 1+ Aniso. CT Brain - Normal. Pregnancy Test (-).,UNK,UNK,,,None,,WAES0905USA03247

348400,06/03/2009,AR,,,,F,06/02/2009,"Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female patient who was vaccinated with GARDASIL when she was on her first trimester gave birth to a healthy baby but the baby was born without arms and legs. Lot # is not available. The patient had sought physician for medical attention. No further information provided at the time of reporting. Additional information has been requested.",,,,,,,,,Y,,,,Unknown,OTH,OTH,Unknown,Pregnancy NOS (LMP = Unknown),,,WAES0905USA03655

348418,06/03/2009,,18.0,18,,F,05/29/2009,"The date above is simply the most recent event, one of many throughout the past 9 months. This date reflects the diagnosis given by a neurologist of Parsonage Turner syndrome, a rare neurological syndrome which impairs her left arm and shoulder which she first noticed with chest, arm and shoulder pain in March. It has left her left arm and shoulder weak. Her left scapula is markedly bigger and different than her right. My daughter received her first GARDASIL shot in August, right before she left for college. Within two weeks she began having loose bowel movements, fatigue, and complaining of her ""legs feeling heavy"". She is a runner and was in excellent physical condition. By early October, she had her thyroid levels tested. Normal levels are between 0.5 and 4.5. Her level was 24 leaving extremely fatigued. By the time I got her home and seen by her own physician the levels had dropped dramatically and seemed to have remain now in the normal level. This ""acute thyroiditis"" is caused by a ""virus"". Shortly thereafter, she began have dizzy spells, nausea, near fainting spells, often but not exclusively concurring in the middle of the night while lying down heart racing and dysregulation of blood pressure. Along with nausea she had and continues to have burbing/acid reflux symptoms. She was hospitalized by a cardiologist and they found nothing wrong with her heart. They did try her on a bp regulation medication-FLORINET-which seem to make things worse not better. She was referred to and electro physiologist, who met with her but only recommended that she continue to monitor her bp. She had tingling in her face and arms, toothache, nausea - which she has-, migraine like headaches, and then most recently the diagnosis of Parsonage Turner syndrome. Most of these symptoms came and went...the dizzy spells lasted for about 3 months, the headaches have not occurred since April. The Nausea continues as does the tingling in her left hand and left arm weakness. Her stamina is not what it used to be. She tires easily. 

348425,06/03/2009,NY,14.0,14,,F,05/20/2009,"I took my daughter to a physician she had never been to before. While we were there the nurse suggested my daughter get the GARDASIL injection. I asked her 2 X's what are the side effects of this injection and she said only a slight chance of redness and swelling at the injection site. The Dr came in and AGA IN I asked her about ANY side effect of the GARDASIL, shot and she assured me that there was SIDE EFFECT. I said yes IF you ARE SURE there is NO CHANCE of any side effects.. 3 times I asked her BEFORE the injection. As soon as my daughter got the shot within SECONDS she felt sick. She became hot and clammy. At the check out desk at the Dr's, she felt very weak and dizzy..I asked the receptionists to call back and tell the Dr how my daughter was feeling, the Dr said it would pass. Within 10 minutes after the shot my daughter had extremely bad leg pain on the right side and could not walk. When we got home she felt very SAD and tired. During the night my daughter started throwing up. I called the ER and they said that that was not a normal reaction to an injection. That was Monday night, today is Wednesday and she still is having A LOT of symptoms and problems including muscle weakness, feeling sick, nauseous, chest pain, swollen glands, stomach pain. She went for blood work today and tomorrow a visit to the Dr who gave her the shot. This is CRAZY, she is suffering for what reason???? Because a Dr gave an injection WITHOUT either knowing- ignorantly-what can happen as a side effect on just not TELLING us. THIS MEDICATION SHOULD BE REMOVED..I my daughter should continue to suffer ANYTHING from this injection the makers will be SUED by US.  6/9/09 Medical records received DOS 5/18/09 to 5/20/09. Pt in for 14 yr WCC with 2-3 c/o coughing congestion. Vax given. Returned next day with c/o arm not feeling right since injections.

348435,06/03/2009,MA,34.0,34,,M,05/26/2009,"Close to 9 months after being given the GARDASIL vaccine. I had a ct scan done, which showed that my lymph nodes were enlarged. A little over a year later. I was diagnosed with Hodgkin's Lymphoma -HL-. I am now undergoing chemotherapy treatment for this illness. This vaccine needs to be researched properly. I am convinced there is an increased risk for Lymphoma in women who were vaccinated. How many people have to die or get seriously sick for this vaccine to be investigated? I known of several women who became sick with Lymphoma months following vaccination with GARDASIL. I do not believe this is a mere coincidence. Statistical data would prove a connection, I'm certain. No oncologist or other doctor has ever asked me whether I was vaccinated with GARDASIL.  6/15/09 Oncology records received DOS 12/23/08 to 5/5/09. FINAL DIAGNOSIS: Hodgkin's Disease Lymphocytic Depletion, Unspec Site. Presented with complaints of fever and swollen cervical lymph nodes. Fatigue, pain/discomfort right neck. Night sweats. Decreased appetite. Muscle weakness and soreness in joints. Numbness right hand. Peri-anal itching, diarrhea, rectal fissure pain. Undergoing six cycles of chemotherapy. Has chemotherapy related side effects.  ICD-9 Code: 201.70  6/19/09 PMH records received. PMH:  Appy, ankle fx, ovarian cyst, blocked duct, UTI.  6/24/09 Medical, vaccine records received.

348552,06/05/2009,AZ,16.0,16,,F,05/29/2009,Pt was injected with 2nd GARDASIL inj. About 30 seconds later pt fainted fell head first off of bed. Pt hit right forehead on floor and ice was applied. Pt became nausea and vomited. Pt was sent to Hospital for evaluation.,,,,Y,,,,,Y,05/29/2009,05/29/2009,0,"UA; UOS; CT head/brain w/o contrast, Chest",PVT,PUB,Trinessa 28d Birth Control,None,None,,

348576,06/05/2009,IL,15.0,15,,F,05/13/2009,"Patient given dose #2 of GARDASIL, seems to tolerate well. No c/o offered - fainted upon preparing to leave facility, hitting back of head hard on door frame - Loss of consciousness for approx. 1min; with posturing of head and arms, possible seizure no obvious head wound or bleeding. Patient transported to local hospital for evaluation. Had further episode of posturing after regaining consciousness.  7/13/09 Hospital ER records received DOS 5/13/09. Assessment: Vasovagal syncope. Patient present at ER after having a syncopal episode in a clinic waiting room after receiving shot of ""Depo"". Parents report patient was shaking and ""posturing"" - flexed arms and wrists. Dizziness. Mild headache. 

348684,06/08/2009,,17.0,17,,F,06/05/2009,"Information has been received from a 17 year old female with no medical history or drug allergy who was vaccinated with 1st, 2nd and 3rd doses of GARDASIL in April 2007, October 2007 and December 2007, respectively. There was no concomitant therapy. In December 2007, after receiving the third dose of GARDASIL, the patient experienced irregular periods and severe pain during menstruation. She was hospitalized on 01-JAN-2008 and informed that she had cysts in her ovaries and she would no longer be able to conceive. The doctor advised her that GARDASIL had caused these problems. She was not recovered at time of reporting. The patient went to hospital for medical attention. Additional information is not expected.

348918,06/11/2009,TX,23.0,,,F,06/10/2009,"Information has been received from a nurse concerning a 23 year old female who on 29-MAY-2009 was vaccinated with the first dose of GARDASIL, 0.5ml/IM.  After about 20 minutes the patient experienced the feeling of a lump in her throat, tingling of her tongue, achy joints and body tremors.  Follow up information has been received from a physician reporting that when the patient had gone to the emergency room she was given I.V. BENADRYL and Benztropine mesylate (MSD) and released.  The physician stated that he received a call from the patient a few minutes ago and the patient said that she was starting to have body tremors again as well as aching of her jaw.  At the report time the patient was on her way to see the physician and the outcome was unknown.  Upon internal review tingling of her tongue, body tremors and lump in her throat were considered as Other Important Medical Events. 

348974,06/11/2009,CA,14.0,14,,F,06/11/2009,"April 2009: Pt. had conjunctivitis in both eyes and was tx'd with antibiotic gtts x5 days. 8 May 09: Annual physical exam was normal.  Conjunctivitis had cleared.  Gardasil vaccine was offered, but patient and parent refused. 26 May 09: Eye discharge (OU) in a.m., so made MD appt. 29 May 09: Went to physician to have eyes checked again for conjunctivitis return.  MD noticed that Gardasil had not been given at the 8 May 09 annual physical exam.  MD stated that pt. really should have the Gardasil vaccine because ""it will save your life.""  Pt. finally consented.  At 9 a.m., Gardasil was administered in the left deltoid.  Pt. and mother immediately went to front desk to schedule next appt. to receive Gardasil (2nd in a series of 3 Gardasil vaccinations).  At 9:10 am, at the front desk, the nurse who had given the vaccine came out to offer ibuprofen for deltoid pain.  The pt. was pale and tried to hold onto the counter when she lost consciousness.  She hit the back of her head on the floor and sustained a contusion.  The pt's mother, the RN and the MD came to the pt's side.  The pt. was unconscious for about 5 minutes.  During the 5 minutes of unconsciousness, she sustained clonic/tonic seizures with her hands clutching up and down.  Her eyes rolled up and to the right and she was ""twitching.""  The RN rubbed knuckles on the pt's sternum to evaluate consciousness while an oxygen mask (100% oxygen) was applied.  An EMT who happened to be in the waiting room assisted by holding the pt's head to keep it from banging against the floor repeatedly.  After 5 minutes, the pt. spontaneously opened her eyes and was able to accurately say her name, the date and the location.  She complained of neck and head pain.  911 was called and the pt. brought to the ER at 10:30 am.  Pt. kept asking what had happened and had no recollection of any events after holding onto the reception desk in the waiting room.  Neuro status was normal except for the head contusion.  CV status was evaluated by ultrasound which was found to be normal (ER phy",,,,Y,,,,,Y,05/29/2009,05/29/2009,0,29 May 09: cardiac ultrasound was normal.        29 May 09: CBC was normal.,UNK,UNK,last medication pt. had taken was on 24 May 09: 400 mg ibuprofen for menstrual cramps.,"conjunctivitis, otherwise the pt. was in completely normal state of good health.","None:  Pt. has no history of seizures.  She does have a history of seasonal allergies, but does not take any medication for it.  Pt. had a history of allergic reaction to bee stings (swelling and pruritis at sting site) and poison oak (both successfully treated with Benedryl).",,

349005,06/12/2009,OH,16.0,,,F,06/11/2009,"Information has been received from a physician concerning a 16 year old female patient who is a tampon user and who on an unknown date was vaccinated with the first dose of GARDASIL. Three days later, the patient experienced toxic shock syndrome and was admitted to the hospital. It was reported that the patient was menstruating and was using a tampon at that time. The physician stated that the patient survived but she spent one week in the hospital. The patient's final outcome was not reported. Additional information has been requested.",,,,,Y,7,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0906USA01328

349150,06/15/2009,,,,,U,06/12/2009,Information has been received from a physician concerning a patient who on unspecified date was vaccinated with a dose of GARDASIL (LOT# not reported). The reporter said the patient experienced an AE involving GUILLAIN-BARRE Syndrome-like symptoms. Additional information has been requested.,,,,,,,,,U,,,,Unknown,OTH,OTH,Unknown,,Unknown,,WAES0906USA00130

349168,06/15/2009,ME,16.0,16,,F,06/12/2009,"Information has been received from a medical assistant concerning a female who was vaccinate with on unspecified dates (doses and LOT# were not reported). When donating blood after vaccinated with GARDASIL the patient's parasite blood test showed positive for Chagas. Further testing showed the original test was false positive and she did not have Chagas disease. The patient was told that Chagas test showed positive was frequently see in patients that have vaccinated with GARDASIL. Follow-up information has been received via a phone call from the physician concerning a 17 year old female who was vaccinated with GARDASIL on unspecified dates (dose and LOT# were not reported). The patient attempted to donate blood and was told that she had a false positive confirmatory test for Chagas disease. It reported that  the false positive test was related to the GARDASIL vaccination. Follow-up information has been received via a phone call from a medical assistant (M.A.) concerning the 17 year old female who on 06-AUG-2007, 15-NOV-2007 and 03-MAR-2008 was vaccinated with a dose of GARDASIL (LOT# not reported, 659435/1265U, 659182/1757U respectively). No other concomitant vaccines were given at the time of the GARDASIL doses. Additional information has been requested

349287,06/15/2009,NJ,23.0,,,F,06/12/2009,"Information has been received from a consumer concerning her daughter a 23 year old female with a history of eczema and Dairy allergies (cause of the eczema) who completed vaccination series of GARDASIL ""just about a year ago"". Concomitant therapy included omega-3 marine triglycerides, proboitics, and pure essential brand (Dr. Ashes Brand). The patient didn't experience any symptoms after the first or second dose of GARDASIL. Two days after the third dose the patient developed a vaginal rash during her menstruation the rash became worse. The patient also had ""abscesses"" that had developed on the outside of the vagina. She stated that the abscesses were caused from an e-coli bacteria. The patient had been test for sexually transmitted diseases, skin cultures, abscess cultures, and biopsies all of which had been negative. The mother also stated her daughter has not engaged in any sexual activity and could not identify a source for rashes. The patient had been placed on antibiotics that do not provide relief and was last prescribed a cortisone cream that states ""has settled things a little bit this week during her period."" The mother and her daughter believed in ""doing everything natural and only received GARDASIL after it was highly recommended by a physician who is a friend of the family."" The office manager at the gynecologist explained the patient didn't receive her vaccinations at their office and speculated that the vaccines were given either at school or by the patient's father, who is a physician. The patient was now visiting her physician about two times a week due to ""flare ups"" and was going to be seeing an infectious disease physician. The patient was not recovered. Additional information has been requested.",,,,Y,,,,,N,,,,"Biopsy, negative; Diagnostic laboratory, test for sexually transmitted diseases-negative; Skin and/or subcutaneous, negative; Abscess culture, negative",OTH,OTH,Omega-3 marine triglycerides,,Eczema; Food allergy,,WAES0905USA00950

349300,06/15/2009,,,,,F,06/12/2009,Information has been received from a female who in 2006 was vaccinated orally with GARDASIL and just recently had been diagnosed with human papillomavirus. The patient was not sure what type but was upset to find out she now had human papillomavirus. The patient experienced colposcopy but the result was unknown. The patient sought unspecified medical attention and outcome was unknown. The patient refused to provide any demographics. No further information is available

349301,06/15/2009,,16.0,16,,F,06/12/2009,"Information has been received from a consumer concerning her 16 year old daughter with lactose intolerance and not other drug reactions or allergies who was vaccinated with the first two doses of GARDASIL ""sometime in 2007"". After both doses she did not feel well. On approximately 22-APR-2009, ""three weeks ago"", the patient was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On the night of 09-MAY-2009 the patient started to have a headache and stomach aches. In the past three days her stomach issues and headache have gotten worse, that she came home crying on 12-MAY-2009 because of the pain. As of 13-MAY-2009, ""today"", the patient was still experienced these symptoms and now she also felt hot to touch but did not have a fever. It was also reported that the patient just got her menstrual cycle and was going on three days of having that . No lab tests were done. The physician was called and unspecified medical attention was sought. The reporter was not sure the experiences the patient was having was from GARDASIL. Additional information has been requested.

349302,06/15/2009,,15.0,15,,F,06/12/2009,"Information has been received from a physician, a consumer and a secretary concerning a 15 year old female patient with no history of allergies who on 08-MAY-2009 was vaccinated with the first dose of GARDASIL in her right arm.  Almost immediately the patient felt like that she had no circulation and no blood flow.  She experienced numbness, pain all down the arm and hand, and she had the inability to move and her hand became swollen.  The patient's mother reported that the patient could not use her hand.  There was no rash or itching and no systemic symptoms.  On 11-MAY-2009 the patient went back to see her physician.  The physician stated that it was GARDASIL that was causing the experience and she should not get any more doses of GARDASIL.  The physician did not offer any treatment nor did he do any treatment.  On 14-MAY-2009 the patient's hand was still swollen and had pain, but there was no more pain in her arm.  The patient's mother gave the patient ADVIL 200 mg which seemed to help.  The patient's mother reported that she was going to take the patient back to see the physician.  The outcome for other adverse events was unknown.  Follow up information was received from the physician which reported that on 08-MAY-2009, the patient with no pertinent medical history and no known drug allergy received four different vaccines. 

349371,06/15/2009,OH,15.0,15,,F,06/12/2009,"Information has been received from a physician concerning a 15 year old female student with no medical history and no known drug allergy who on 25-FEB-2009 at 13:45 was vaccinated with the first dose of GARDASIL IM into her left deltoid (lot # 660612/0229X). On the same day at 13:45, the patient also received the first dose of ADACEL IM into her right deltoid (lot # C3031AA). There was no illness at the time of vaccination. On 26-FEB-2009 the patient's mother stated that the patient went to bad awake with sore muscles and headache after vaccines. The patient was given ibuprofen and the adverse events had relief. On 30-APR-2009, the patient returned for the second dose and her mother noted that she forgot to mention that the patient had hives on arms and chest after vaccines. The physician advised against the second injection. The patient had had prior ADACEL without reaction. At the time of reporting, the outcome was unknown.

349177,06/16/2009,,16.0,,,F,06/15/2009,"Information has been received from a hospice nurse concerning a 16 years old female with unknown drug allergies and unknown medical history who was vaccinated with the first dose of GARDASIL. Subsequently the patient was diagnosed with Amyotrophic Lateral Sclerosis (ALS) shortly after receiving the first dose of GARDASIL. The nurse learned of the patient's experience when her family called seeking hospice care for her. The family did mention that the first dose of GARDASIL caused that to the patient. Unspecified medical attention was sought. It was unspecified if laboratory studies were performed. At the time of the report, the patient had not recovered. The Amyotrophic Lateral Sclerosis was considered to be disabling. In follow-up with the representative, it was learned that no contact information is available. No further information is available."

349289,06/16/2009,CA,37.0,37,,F,06/12/2009,"Information has been received from a 36 year old female patient who in 2006 was vaccinated with the three doses of GARDASIL. The patient was now HPV positive. The consumer stated that she had only one partner in her life and she was vaccinated with GARDASIL before having sexual relations. The patient had not recovered. The patient contacted her physician. Follow up information has been received from the physician, who reported that the patient on 15-NOV-2006 was vaccinated with first dose of GARDASIL (Lot number 653736/0868F), on 26-JAN-2007 with the second dose of GARDASIL (Lot number 653736/0868F). The physician reported that on concomitant vaccines were given. The patient was last seen in the office in 2007, at which time her PAP smear was negative for HPV. Additional information has been requested.",,,,Y,,,,,N,04/25/2007,,,"Diagnostic laboratory, HPV positive; Diagnostic laboratory, ?/?/07, HPV: negative"

349544,06/19/2009,,,,,U,06/18/2009,"Information has been received from a physician who heard from the mother of one of his patients that she was told by a pediatric rheumatologist that a patient with a genetic predisposition for lupus (family members had lupus) was vaccinated with GARDASIL and actually came down with lupus as well. The treating rheumatologist was reported to have thought that the vaccine triggered the onset of the disease. Upon internal review, lupus was determined to be an other important medical event. The existence of an identifiable patient and reporter could not be confirmed.

349667,06/22/2009,TX,16.0,16,,F,06/19/2009,"Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included ""LOLESTRA"". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL "" The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)."" The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling.



More to come no doubt.