Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope, Wrong product administered
Clinical narrative: Syncope/the patient fainted; This report was identified from a line listing obtained on request by the Company from the FDA (HA# 703937) under the Freedom of Information Act, concerning a 12-year-old male patient. The patient did not have any concurrent illnesses, medical history and other medications. The patient's drugs reaction/allergies were not reported.  On 14-JUL-2017, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly in the right arm, lot# M009378, expiration date: 23-APR-2018 (dose was not reported) and the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), injection, subcutaneously in the left arm, lot # M047660 (dose and expiration date were not reported) for prophylaxis. Other suspect therapies included: diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL), first dose, injection, intramuscularly in the left arm, lot # reported as U5458BA (dose and expiration date were not reported); hepatitis a virus vaccine inactivated (HAVRIX), first dose, injection, intramuscularly, in the right arm, lot # reported as 9n33z (dose and expiration date were not reported); and meningococcal acyw conj vaccine (crm197) (MENVEO), first dose, injection, intramuscularly, in the left arm, lot# reported as M16075 (dose and expiration date were not reported).  On 14-JUL-2017, immediately following the final immunization, the patient fainted. The patient was monitored for 20 minutes by register nurse (RN). A cool compress was applied around his neck, and he was given a glass of water. The patient's mother declined for onsite pediatrician to assess the patient. On the same day, after 20 minutes, the patient stated he felt fine. He left the clinic with his mother, with normal gait and being stable. On that day, he recovered from the event.   No laboratory tests were performed.  The relatedness between the event and suspect therapies was not reported.  Follow up information was received from the FDA (HA# 703937) under the Freedom of Information Act on 15-APR-2019.   The reporter was registered nurse (RN), Bachelor of Science in Nursing (BSN). The patient was Hispanic. He had no allergies to medications, food or other products. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and no other illnesses at the time of vaccination and up to one month prior. He had no chronic or long-standing health conditions. The patient had not had an adverse event following any previous vaccine.  The patient was vaccinated on 14-JUL-2017 at 11:10. The adverse event started on 14-JUL-2017 at 11:10. The information about the facility where vaccines were given was updated.  Follow up information was received from a vaccine provider on 22-MAY-2019.  It was reported that the patient was vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) injection, intramuscularly in the left arm, lot # M16075 (dose and expiration date were not reported) for prophylaxis, instead of meningococcal acyw conj vaccine (crm197) (MENVEO), as it was reported previously.