Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, UNK
Symptoms: Swelling
Clinical narrative: swelling, rash and pain under left arm extending all the way up the neck to the forehead; swelling, rash and pain under left arm extending all the way up the neck to the forehead; pain under left arm extending all the way up the neck to the forehead; pain under left arm extending all the way up the neck to the forehead; fever; This report was identified from a line listing obtained on request by the Company from the Food and Drugs Administration (FDA) under the Freedom of Information Act (VAERS # 849985).  This spontaneous report as received from a health care professional refers to a 16-year-old male patient. The patient had severe reaction at 3 months old after vaccination (unspecified).  On 21-NOV-2019 at 13:30, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621929, expiration date was not reported but upon internal validation established as 06-DEC-2021) intramuscularly in the right arm, th first dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot# ABXA60BA, expiration date was not reported) intramuscularly in the left arm, a dose of influenza virus split virion 4v vaccine inactivated (FLULAVAL) (lot# 97S5T, expiration date was not reported), intramuscularly in the left arm and the second dose of meningococcal acyw conj vaccine (crm197) (MENVEO) (lot# AMVA097A, expiration date was not reported) intramuscularly in the right arm; all for prophylaxis. On the same day at 18:00, the patient experienced fever, swelling, severe rash and pain under left arm extending all the way up the neck to the forehead. He was seen at the physician's office on 22-NOV-2019 (Friday). The physician suggested a reaction to meningococcal acyw conj vaccine (crm197) (MENVEO) and advised not to receive second dose. Rash become more severe and was at it's worst on 23-NOV-2019 (reported as Saturday night). On 25-NOV-2019 (Monday), a follow up was made with the patient's mother. She advised the patient's fever broke late Saturday night and the rash had not gotten any worse and the patient was feeling much better.  The outcome of the events was reported as recovered. The relatedness between the events and the suspect vaccines was not provided.  Follow-up information was received from the health care professional who was a nurse on 11-DEC-2020.  The reporter was not able to give any information about the patient having only the patient's initials and not the patient's name. No further information was available. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent