Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV9, IPV, MMR, TD
Symptoms: Disorientation, Loss of consciousness, Muscle contracture, Myoclonus, Opisthotonus
Clinical narrative: loss of consciousness/the patient was describing what he felt which was a sensation of black from his eyes and fainting and then waking up; muscle contracture/ his biceps contracted and he kept them close to his chest; myoclonus/ the episodes would be best described as LOC with myoclonus of lower extremities; opisthotonus/ the patient specifically started arching his back and leaned towards his left; posture abnormal/the patient specifically started arching his back and leaned towards his left; seizure; syncope/ patient started to faint and she had to catch him; tonic clonic movements; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (HA #726619) from a  Registered Nurse (RN) referring to a 17 year old male patient. The patient's concurrent conditions included scabies.  On 14-NOV-2017, the patient was vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) (Lot # N019924) dose unknown, intramuscular in the right arm for prophylaxis. On the same date, the patient also received the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA (Lot #N009172) dose unknown subcutaneously in the right arm and the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot #N020352) dose unknown, intramuscularly in the right arm for prophylaxis. Other suspect therapies included influenza virus split virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 3V VACCINE INACTIVATED)), hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B), poliovirus vaccine inactivated (vero)(IPOL) and diphtheria toxoid, tetanus toxoid (TENIVAC). After receiving the patient's last vaccine, the nurse reported that the patient started to faint and she had to catch him. It was unclear if he had a seizure or a vasovagal episode for us. The patient became awake alert and oriented after about 10-15 secs. While, the patient was describing what he felt which was a sensation of black from his eyes and fainting and then waking up. The patient had a second episode that was directly witnessed. The patient specifically started arching his back and leaned toward his left. His biceps contracted and he kept them close to his chest. His legs started having more classic tonic clonic movements. The patient was laid down.This episode lasted approximately 15 seconds and then patient was awake and alert afterwards. AAOx3. The timing between the episodes was approximately 5 minutes. Decision was made to transfer the patient to ER downstairs. Unclear if first episode was a seizure or a vasovagal episode but second episode was more classic convulsion. Probably vasovagal as he has no prior history of seizures. Of note, two episodes is atypical. The episodes would be best described as LOC with myoclonus of lower extremities.The outcome of the adverse events was unknown. The causal relationship between the adverse events and the suspect therapies was unknown.  It has been determined that case # {MARRS CASE NUMBER  1802USA011264} is a duplicate of case # {MARRS CASE NUMBER  1802USA011095} Therefore, case # {MARRS CASE NUMBER  1802USA011264} is being deleted from our files and the cases are consolidated into case # {MARRS CASE NUMBER  1802USA011095}.  Follow up information was received form a physician on 20-JUN-2019. The patient was 17 years old at the time of vaccination. The patient was not taking any prescription, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient did not have any known drug of food allergies. The patient did not have chronic or long-standing health conditions. No medical tests and laboratory results related to the adverse events were performed. The patient visited doctor or other healthcare professional for the adverse events. It was unknown whether the patient was recovered from the adverse events.  This is an amended report. The aware date need to corrected as 19-JUN-2019 (previously was 20-JUN-2019).  As of 25-SEP-2019, all telephone attempts trying to obtain additional information has been unsuccessful. The phone call was answered by the receptionist because the physician was not available. The phone call was transferred to the Nurse Triage line. The phone call was answered by a Registered Nurse. There were no patient identifiers. The Register Nurse was unable to locate the patient. No message for the physician was permitted to be left.