Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Blood pressure decreased, Feeling abnormal, Injection site pain, Loss of consciousness
Clinical narrative: The patient threw up while in the clinic; tremor; loss of consciousness; syncope; blood glucose normal; feeling abnormal; hypotension; pallor; Complains of pain on injection site; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 11-APR-2018, a 11-year-old female client at clinic accompanied by parent (mother) for 11-year-old Immunizations. Client properly identified by name and date of birth. Client properly screened for allergies (food/medication) and medical conditions. As per mother statement client had no allergies and no medical conditions. Client and parent explained vaccines about to received. Parent provided VIS. Questions/concerns parent were answered by nurse. Nurse started administering influenza virus split virion 4v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 4V VACCINE INACTIVATED)) intramuscular (lot # UT5936JA, expiration date was not provided) and the first dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) intramuscular (lot # U5752AB, expiration date was not provided) vaccines at 14:00 on left arm without any problems/reactions. Nurse continued to administer first dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) intramuscular (lot # U5748AA, expiration date was not provided) and first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular (lot # N021475, expiration date: 31-JAN-2020) vaccines to right arm. Around 14:01, when nurse just finished giving client hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine client fainted and started shaking legs and arms for less than 5 seconds. Client quickly regained consciousness but looked "spaced-out" and pale. 14:05, vital signs were checked, and blood pressure was low, and pulse was normal. Ambulance was called. In the meantime, vital signs were monitored, blood pressure stabilized by 14:12, the client remained conscious but continued to be looked "spaced-out". At 14:30, the ambulance and paramedics arrived. Vital signs checked and normal. Random blood sugar (RBS) checked and normal. At 14:40 the client threw up. At 14:46 client left clinic in ambulance going to Hospital and accompanied by mother. The outcome of the events was reported as recovered on an unknown date in 2018.  The relatedness between the events and suspect vaccines was not reported.  Follow-up information has been received from a Licensed Practical Nurse on 05-DEC-2019. The patient's age was updated to 12-year-old (also reported as 11-year-old). Expiration date for the administered vaccines were provided: influenza virus split virion 4v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 4V VACCINE INACTIVATED)) (expiration date: 30-JUN-2018), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (expiration date: 16-NOV-2018), and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (expiration date: 23-AUG-2019). At 14:05, the patient's blood pressure was low at 72/52 (units not provided) and pulse was normal at 69 (units not provided). By 14:12, the patient's blood pressure was stabilized at 87/65 (units not provided). At 14:40, the patient threw up while in the clinic. The nurse contacted the parent (mother) for follow-up of the patient's status on 12-APR-2018. As per the mother statement, the patient was doing "okay" and had only complaints of pain on injection sites (vaccination site pain). The nurse informed the mother that this reaction was normal and advised to give patient over the counter (OTC) pain medication such as (acetaminophen (TYLENOL) / ibuprofen (MOTRIN)). As per the mother's statement patient was only monitored and assessed by the emergency room doctor. No labs or other studies were performed. As per mother, the doctor stated that the patient could receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in 6 months. The relatedness between the events of vaccination site pain and vomiting with the suspect vaccines was not reported.