Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fatigue, Feeling abnormal, Headache, Loss of consciousness, Loss of personal independence in daily activities
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 (VAERS # 720967), on 31-JAN-2018, referring to a 12 year old male patient with no concurrent illnesses and a medical history of asthma. On 09-OCT-2017, the patient was vaccinated with GARDASIL 9 (lot/batch number 70003014800, expiration date not provided), dose 2, intramuscularly, in the left arm for prophylaxis. There were no other concomitant medications. On 09-OCT-2017, the patient experienced a short syncopal episode - on table, as laying down, passed out but came to almost immediately. Later on the same date, the patient experienced vomiting, 100.8 oral fever (units not provided), headache, achy. On the next day, 10-OCT-2017, the patient experienced fatigue. The patient was out of school for 3 days (loss of personal independence in daily activities) and felt "out of it". The patient recovered from syncope and loss of consciousness, on 09-OCT-2017, and from loss of personal independence on 12-OCT-2017. The outcome of the events of pain, feeling abnormal, vomiting, fatigue, headache and pyrexia was reported as recovered, on an unspecified date. The agency considered this case as non-serious. The agency did not give the causality assessment between the events and the suspect vaccine. Lot number 70003014800 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information has been received from a physician via a line listing obtained on request by the Company from the FDA under the Freedom of Information Act on 25-FEB-2019 concerning the 13 year old (previously reported as 12 year old) not Hispanic white patient with asthma and no allergies. The patient was not taking any medication at the time of vaccination. Historical vaccination included influenza. The physician reported that on 09-OCT-2017 at 10:00, the patient was vaccinated with GARDASIL 9. The physician stated that the patient recovered from the adverse events and returned to school the following Thursday. Follow-up information was received from physician on 05-APR-2019: The reporter stated that they were unable to locate the patient without name or date of vaccination. Later the details were provided to a physician and he stated that they will attempt to locate patient information. The patient was a 14 years old male patient (also reported as 15 years old and previously reported as 13 years old). On 09-OCT-2017, other suspected vaccines included influenza vaccine (dose and frequency unknown) lot# U1829AC, dose number 9, intramuscularly given for prophylaxis. The event syncope occurred 21 minutes post vaccination and it was a brief episode for a duration of less than 1 minute. The onset date of events pain, vomiting, pyrexia and headache was reported as 10-OCT-2017 (previously reported as 09-OCT-2017). The patient received no prescription drug as treatment for the events. There were no temperature excursions and no digital data logger involved.