Age: 12.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Abdominal pain upper, Anaphylactic reaction, Anxiety, Arthralgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 25-MAY-2010, a 12 year old female was intramuscularly vaccinated with second dose of GARDASIL (lot # 661954/0075Y). Secondary suspect therapy included VARIVAX (lot # 665810/1412Y). Concomitant therapy included HAVRIX (lot # AHAV3349BA), BOOSTRIX (lot # AC52B046DA) and MENACTRA (lot # U3018AA). The reporter stated that on the same day patient broke out in rash with headaches and dizzy spells. A couple of month later she started having seizures, severe headaches, stomach pains, anaphylaxis and several other problems. The following information was obtained through follow-up and /or provided by the government. On 10-JAN-2011 ER record was received for date of service (DOS) 21-AUG-2010. The impression was as bellow: syncope, dehydration, headache and early rhabdomyolysis. Patient presented with complaint of (c/o) clonic tonic type movement, eyes rolled back in head and foaming at the mouth. Episode lasted 20 seconds. Patient had been playing in softball tournament all day in the heat. Patient reported having a headache since last night. The patient received IV fluids and was discharged home. On 05-JAN-2011 vaccine report was received for DOS 25-MAR-2010 and primary care physician (PCP) office records received for DOS from 23-AUG-2010 to 28-DEC-2010. Assessment was as below: dehydration, seizure. Patient had seen on 23-AUG-2010 for ER follow-up. Patient reported to have played 4 ball games back to back on Saturday. Patient passed out, had seizure, in & out of consciousness and went to ER, dehydrated. Patient had seen the next day for c/o fever at school, bad headache and hard time urinating. Patient noted to have abdominal pain. Patient's temperature was 97.7 F and urine analysis (U/A) was normal. Assessment was as bellow: abdominal pain, left side. Patient was seen 01-OCT-2010 for c/o sore throat, cough and chest pains. Assessment was upper respiratory tract infection (URI) early pharyngitis. Patient had seen on 21-OCT-2010 for c/o right wrist hurt during soft ball game. X-ray revealed non-displaced fracture of wrist. Plan was splint. Patient had seen for ER follow-up. Patient reported that on Saturday she nauseated and felt unwell. Patient passed out and checked blood sugar "40". Assessment was as bellow: syncopal episode, hypoglycemia. Patient has seen on 01-DEC-2010 for right wrist. Redness noted at the base of old fracture (FX). Assessment was cellulitis. Patient had seen on 28-DEC-2010. Patient reported passing out eating nuts and also passed out again the next day. Also lip swelled up. Patient noted having problems since receiving GARDASIL in May. Assessment was anaphylaxis reaction nuts. On 10-JAN-2011 ER records were received for DOS 30-OCT-2010 and 06-NOV-2010. Assessment was as bellow: near fainting episode, hypoglycemia. Patient presented to ER with c/o feeling weak, lightheaded   [Due to memory limitations, the remainder of this text could not be compared.]  htheaded and nauseated while on a hayride. Patient reported told friend that she thought she was going to have a seizure. Patient was witnessed to go limp, then shaking. Friend's mother reported that patient seemed anxious, apprehensive and was hyperventilating. Patient was given a couple of coles. Blood sugar was reported to be the 40s. Upon ER presentation, patient alerted without sensory or motor deficits. Patient was discharged home. Patient presented to ER on 06-NOV-2010 for c/o seizure-like event. Patient was in car with parents and started jerking and kicking. The parents did not visualize the movement directly. Upon presentation, patient alerted and smiled. Patient discharged home and to follow up (F/U) with pediatrician. On 10-JAN-2011 patient's hospital records, progress notes and diagnostics were received for DOS from 10-NOV-2010 to 12-NOV-2010. Diagnosis (DX) was pseudoseizure. Patient received her transfer with c/o fainting spells which had intensified over past 10 days. First episode was reported on 31-OCT-2010 while on hayride. Patient noted to have episodes with tonic clonic movement of arms and legs with eyelids blinking rapidly and a headache since 31-OCT-2010. Patient reported to have complete vision loss yesterday and today vision is blurry. Patient's parents noted patient had lost 21 lbs. and had nonbloody diarrhea 3 xs per day. Record noted patient anxiety and patient was suspended from school due to fights with softball teammates. Patient neurology and general physical exam were normal. Assessment was as bellow: headache and abnormal involuntary movement NEC. Plan was taking patient off TRILEPTAL and beside ling-term electroencephalography (EEG). During night patient had 2 episodes of seizure-like activity and patient's EEG did not show epileptiform activity. Patient discharged home and to follow up with psychology. On 14-JAN-2011 ER notes were received. At the time of reporting, the outcome of the patient was unknown. A check has been initiated. The events were considered to be life threatening and serious. The original reporting source was not provided. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question, 661954/0075Y for GARDASIL, were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question, 665810/1412Y for VARIVAX (Merck) (MSD), were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.