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Conversion disorder from HPV (GARDASIL) 2008

Vaccine Manufacturer:MERCK & CO. INC.
Vaccine Code:HPV4
Vaccine Type:HUMAN PAPILLOVAVIRUS QUADRIVALENT
Vaccine Name:HPV (GARDASIL)
Year Reported:2008
Symptom Reported:Conversion disorder

HPV (GARDASIL) Side Effects Report #304663
HPV (GARDASIL) vaccine side effect was reported on 02/08/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no known allergies who in February 2007, was vaccinated with Gardasil. In May 2007, she received the second dose and on 29-JAN-2008, she received the third dose. There was no concomitant medication. There were no adverse events following the first and second doses. On 29-JAN-2008, four hours after the third dose, the patient experienced numbness in her legs, severe headaches, Dizziness, nausea, fever, muscle weakness and her body would not stop shaking. The patient sought medical attention and has been in and out of the hospital since 29-JAN-2008. The reporter was unsure of the exact amount of time she was hospitalized. As of 04-FEB-2008, the patient had not recovered. Additional information has been requested. 03/13/2008 MR received for DOS 1/31-2/5/2008 with D/C DX: Anxiety NOS with hysterical gait disorder. Pt presented for admission with 2 day hx of shaking episodes which began within hours of HPV vax #3 on 1/29/08. Also c/o photophobia, nausea, and dizziness. Pt has episodic multi-amplitude shivering/shaking type movements of the upper and lower extremities, trunk, and head somewhat decreased when distracted on PE. Neuro and psych consults. Neuro exam (+) for psychogenic wide-based gait with pseudotremor and ataxia. D/C for outpt f/u." None. One episode of shaking with anxiety 1 yr ago.diagnostic laboratory - tests and results not provided. Labs and Diagnostics: CT brain scan WNL. EEG normal. MRI brain normal. CXR WNL. CBC with WBC 3.95. ASO titre 416. . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #310953
HPV (GARDASIL) vaccine side effect was reported . Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Lt facial numbness, tremors to lt hand, arm, hard. Pain to left side of head. Stutters. Mother evidenced sxs with HPV and MCV4. Has been seen in hospital, neuro clinic. Unknown Dx - possible complex partial seizure/? Psychogenic component. 5/9/08 Reviewed neuro clinic records of 1/29-2/21/08. FINAL DX: stress induced conversion reaction Records reveal patient experienced left sided numbness, left hand twitching which included face & leg intermittently w/periodic vertigo & HA. Exam found very blunted affect, poor eye contact, slow speech, mild decreased sensation of LUE w/normal strength, tone & reflexes. By 2/21, tremors had increased & now included stuttering. Referred for counseling." N/AN/A"All done at hospital. LABS: EEG abnormal w/mild encephalopathy & abnormalities suggesting a risk for focal seizures. CBC, chemistry, UA, urine c/s, monospot all WNL. MRI of brain & c-spine WNL." . Patient recovered.

HPV (GARDASIL) Side Effects Report #311851
HPV (GARDASIL) vaccine side effect was reported on 04/30/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Initial report received on 28 April 2008 from another manufacturer, report# WAES 0804USA04043. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: ~Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of Gardasil (Lot# 659653/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reaction and/or exercise induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and ~choleretic pain.~ The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck the pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to" The patient had an allergy to Naproxen."15/Feb/2008, Chest x-ray, (no change); 12/Mar/2008, Pulmonary Function Test, (normal); 04/Mar/2008, CBC, (normal), serum Mycoplasma pneumoniae antibody, (convalescent mycoplasma), erythrocyte sedimentation rate, (11)" . Patient recovered.

HPV (GARDASIL) Side Effects Report #313116
HPV (GARDASIL) vaccine side effect was reported on 05/14/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Information has been received from a physician concerning a 17 year old female who was vaccinated on an unspecified date with GARDASIL (lot# not provided). Concomitant therapy included MENACTRA and poliovirus vaccine. Subsequently the patient fainted after receiving the vaccines. When she came to she had a ~conversion reaction~ where she was anxious, shaky and hyperactive. The patient was taken to the ER, but was not admitted. Subsequently, the patient recovered from fainting, being anxious, shaky and hyperactive. Additional information has been requested." UnknownUnknown . Patient recovered.

HPV (GARDASIL) Side Effects Report #315138
HPV (GARDASIL) vaccine side effect was reported on 06/04/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Information has been received from a physician concerning a 17 year old female with no specified pertinent medical history, who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL, lot # 654510/0962F, and she was reported as fine. Subsequently, sometime later on an unspecified date, the patient experienced seizures. On 17-NOV-2007, the client received her second dose of GARDASIL, lot # 657006/01884, and she is still experiencing some sporadic seizures/epilepsy activity. The patient is recovering and is being seen by a neurologist for follow-up. Upon internal review, seizures were considered to be an other important medical event. Additional information has been requested. 7/4/08 Vaccination record reveals patient received HPV #1, lot #0962F, on 5/29/2007; and HPV #2, lot #0188U, on 9/7/2007. 7/15/08 Reviewed hospital medical records of 11/17-11/20/2007. FINAL DX: Conversion disorder Records reveal patient experienced syncope, right arm shaking, postictal confusion. Seen by PCP w/o treatment. Presented to ER w/right arm/leg weakness & unable to get OOB. On exam, c/o right temporal HA, RUE & RLE slightly weak w/decreased sensory. Gait was normal. Neuro & psych consults done." Unknown PMH: asthma. Anxiety. On BCP."LABS: CT & CTA of head, EEG WNL. Blood work WNL." . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #320133
HPV (GARDASIL) vaccine side effect was reported on 07/22/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Patient received Gardasil vaccine on 7/16/2008 and subsequently was noted to have jerking movements; patient also complained of tingling and pain with her extremities. Patient was subsequently hospitalized where she was evaluated and monitored. 8/21/08-ED records received for DOS 7/22/08-Presented with C/O burning sensation in chest, headache and feeling funny. facial swelling and hand swelling began yesterday. Pain in both legs with headache. Movement disorder twitching movements. Neuro consult observed episodes of shoulder shrugging. Impression: conversion disorder." None"Allergies to eggs and tomatoes, and environmental allergens. Medical history includes asthma, hypertension, obesity, sinus disease, and granulosis cell tumor of the right ovary status post salpingo-oophorectomy. 8/21/08-records received- PMH: morbidly obese, asthma granulosis cell tumor of the right ovary status post salpingo-oophorectomy."CT head negative for acute events. . During the same period patient was treated with Albuteral prn. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #321425
HPV (GARDASIL) vaccine side effect was reported on 07/28/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "15 yo GO WF LMP October 2005 presents with her mother to discuss her infrequent menstrual cycles. The pt had her first menstrual cycle in August of 2005. She then had a cycle in September and then October 2005. She has not had a menstrual cycle since that time. She has never been sexually active. She has severe cramping with her menstrual cycles. She denies any weight changes, temperature instability or breast discharge. D/w pt and her mother issues regarding menarche and cycle irregularity. Also d/w the potential for PCOS. Explained to them the reason that cycle regulation is important long term. They agree to OBCP for cycle regulation. Plan to do some lab evaluation and induce menstrual flow w/ course of progestin. D/w pt information regarding HPV and hepatitis B vaccine. Entire patient history reviewed by MD. 9/23/08 Reviewed neuro 2nd opinion of 3/1/07 & subsequent visits. FINAL DX: periodic paralysis Records reveal patient experienced episodic limpness, constant HA. Tx w/meds. Developed numbness/tingling in fingers/toes & depression, severe heartburn, pinched nerve, leg/muscle pain & cramping on meds. 10/7/08 Reviewed hospital medical records of 2/14-2/15/2007. FINAL DX: conversion disorder Records reveal patient experienced 4 episodes of sudden unexplained paralysis within a 2 week period starting around 12/25/06 w/migraine HA. Then developed a cough & sore throat & dx w/mono. Had decreased energy & increased sleep. Divides time between parent's homes. Outpatient CT of head & EEG WNL. Had been transferred from outlying ER to PICU. Work up completely WNL. Parent refused psychiatric eval & referred instead for second neuro opinion at outpatient clinic where was seen 3/1/07. 8/26/08 Reviewed OB/GYN medical records for 10/3/2006-2/19/2007. FINAL DX: Records reveal patient experienced good health on 10/3/2006 date of 2nd vaccinations. Returned to clinic 2/5/2007 for f/u after d/cing contraception which she had been on for cycle regulation. Stopped due to severe HAs. HAs did not improve" NoneNone PMH: migraines. Family hx epilepsy"LABS: SGOT 88(H), SGPT 178(H), CPK 53(N). MRI WNL. CBC w/Hct 36.5(L), segs 31%(L), lymphs 47%(H), Mono test neg. Globulin 3.8(H), ALT 68(H). CBC WNL. ALT 73(H), AGR 1.1(L). CXR WNL. EKG abnormal. Flu A&B neg." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #326068
HPV (GARDASIL) vaccine side effect was reported on 08/14/2008. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, Information has been received from a physician concerning her daughter who was vaccinated with a dose of GARDASIL vaccine (yeast) and manifested pseudoseizures. At the time of the report the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #326284
HPV (GARDASIL) vaccine side effect was reported . Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "High fever 102 degrees up and down for 5 days. Stomach pains, muscle aches, emotional stress, and hysteria, (complained of ribs aching - breathing difficult at times)" NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #327557
HPV (GARDASIL) vaccine side effect was reported on 10/08/2008. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Within a day or two after the first shot on 03/25/08 she developed severe back pain. On 04/27/08 she had a seizure and went to the ER. She had the second shot on 05/06/08 and had another seizure. She had two more seizures between then and 06/20/08 when she had three seizures at work and was admitted to the hospital. She had daily seizures throughout the summer, was diagnosed with epilepsy and put on anti-seizure meds. After a cluster of 4 seizures when she turned blue and stopped breathing she was admitted to the hospital and a Video EEG done. Epilepsy was ruled out and psuedoseizures diagnosed and meds stopped. She continued to have seizures and saw a psychiatrist as suggested. The psychiatrist said the seizures were not psychological and were medical. Put back on anti-seizure meds until she became toxic from the meds and was admitted to the hospital through the ER where she was given charcoal. After discharge she began to start feeling better and has been seizure free now for 30 days. Also from March until now she suffered from severe stomach aches, eye problems, headaches, one kidney infection and one urinary infection (never had any in her life before this), severe fatigue (this is a very hyper kid)and body aches. She is not currently on seizure meds and is slowly gaining her strength and getting back to her independent life as before the shot. She lost the ability to drive, to be left alone, was injured repeatedly from the drop seizures, lost her job and her confidence with the way the medical community threw her back and forth between treatments and diagnosis and labeled her as emotionally disturbed. This was a very happy, Dean's list, independent college kid before this shot. Thankfully, she appears to be coming back to us but still has fatigue and stomach issues which we are treating with diet and vitamins. 10/27/08-records received for DOS 6/20-6/21/08-DC DX: Generalized tonic clonic seizures. First seizure 4/26/08 a partial seizure and two additional ones. Did not begin her anti-seizure medication unt" None"Allergies: penicillin, sulfa, percocet, milk; Asthma 10/27/08-records received-PMH: two concussions. Motor vehicle accident with head injury and broken nose. Mononucleosis, asthma, cervical dysplasia. Four knee surgeries, 3 ACL and one meniscus surgery.""EEG, MRI, blood work, Cat Scan 10/28/08-records received-MRI normal." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #330587
HPV (GARDASIL) vaccine side effect was reported on 10/29/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Patient was seen 10/16/08 for Well Teen Exam, given Gardasil and flu shot. Patient developed tremors, weaknesss, decreased sensation, hysteria on 10/25/08, went to ER had extensive lab, drug screening and CT of head - all WNL. Followed up with PCP on 10/27/08 - inital neuro exam showed decreased sensation bilateral hands and grip strength and abnormal gait. Patients right leg appeared weak with tremors primarily on right side. Patient appeared to be depressed. Patient has follow-up on 10/30/08, MRI of brain and neck pending, neuro consult also pending. 12/11/08-records received-office visit 11/8/07-requested testing for disease, vomited day before C/O breast pain left side times 2 days, C/O bumps in vaginal area times 2 weeks. Denies sexual activity. Assessment:URI. 10/16/08 C/O stuffy nose. 10/27/08C/O tremors shaking onset began Friday. DX hysteria with tremor. Dragging right foot. 10/20/08. Improved denies shaking weakness. Does not remember events of Friday." NoneNone"CT of head, drug screen and lab - all WNL 12/11/08-records received-CT no abnormality. MRI of brain pending." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #334944
HPV (GARDASIL) vaccine side effect was reported . Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "Within one week of immunizations patient developed hip arthralgia, in (R) hip then both, crutches, seen 11/25/08 1st. Referred to Rheumatology at Med. Ctr. 1/21/09 Received Rheumatology clinic records of 12/3/08 FINAL DX: probable conversion reaction Records reveal patient had right hip pain x 3 weeks. Seen by PCP & in ER for pain. X-rays were WNL. Now w/bilateral hip pain & unable to walk w/o crutches. Sleep was disturbed. Morning stiffness. NSAIDS had not helped. tx w/meds & PT" None"X-ray; Ultrasound Hips; WBC; CBC; WMC (WBC 7.2), ESR 7, CK 95; Lyme, neg; RA factor, neg, ANA, neg LABS: hip US WNL. CBC, ESR, CK, ANA, RA, CRP all WNL." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #335795
HPV (GARDASIL) vaccine side effect was reported on 12/12/2008. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Conversion disorder, "A serious, spontaneous report of conversion disorder reaction, facial muscles have not moved and numbness in toes and fingers was received from a consumer concerning a 12 year old female subsequent to FLUMIST. The patient has a history of psychosocial issues. The patient received GARDASIL the same day as FLUMIST. The patient received FLUMIST intranasal for Flu vaccination on 11-Nov-2008. On 11-Nov-2008 the patient was seen in the pediatricians office for chest pains and during the visit received FLUMIST and GARDASIL. Since 24 hours after administration the patients facial muscles have not moved and she has numbness in her toes and fingers. The patient subsequently was seen by a neurologist, cardiologist and the pediatrician for the events and an MRI was taken. Results are not available. The events are on going and the patient is scheduled to begin physical therapy. The responsible physician assessed the events as not related to vaccine administration and instead considered the event a conversion disorder reaction. The event is considered a serious important medical event. 1/2/09 Received PCP, ER & Neuro medical records of 11/24-12/3/08 FINAL DX: none provided; possible conversion reaction Records reveal patient experienced HA, weakness, difficulty walking, pain in all extremities x approx 3 wks. Missed several days of school. Had been seen in Urgent care 11/24 & 11/27 for sore throat, HA & body aches. W/u WNL. Dx w/viral illness & pharyngitis. Flat affect, weight loss. Required follow-up attempts have been performed, requested information unable to be obtained." "Psychosocial issues in school PMH: eczema, constipation, head trauma 1 yr ago, fall, umbilical hernia repair. Family hx: SLE & mental health issues.""LABS: CBC, CRP, CK, CMP all WNL." . During the same period patient was treated with Concomitant Drug(s) Not Reported. Patient recovered.


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