Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, TDAP, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events were reported; Shingrix is for ages 50 years and older; Information was obtained on request by the Company from the FDA.  This spontaneous report as received from a registered nurse referring to a 13 years old female patient. The patient had no known allergies to medications, food, or other products. The patient had no other illnesses at the time of vaccination and up to one month prior. It was unknown whether the patient had an adverse event following any previous vaccine. The patient had no known chronic or longstanding health conditions at time of vaccination. Concomitant therapies included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), mometasone furoate (NASONEX) and omeprazole.    On 26-AUG-2019 at 08:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose were unknown; lot # 1621934, expiration date not reported, but upon internal validation established as 29-JAN-2022, via intramuscular route in right arm), the first dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) (strength, dose and expiration date were unknown; lot # 53BF4, via intramuscular route in right arm), the second dose of hepatitis a virus vaccine inactivated (HAVRIX) (strength, dose and expiration date were unknown; lot # BE554, via intramuscular route in right arm) and the first dose of zoster rgE vaccine (mammalian) (SHINGRIX) (strength, dose and expiration date were unknown; lot # 2792L, via intramuscular route in left arm) all for prophylaxis.  It was reported that the patient received the zoster rgE vaccine (mammalian) (SHINGRIX) as an extra vaccine (product administered to patient of inappropriate age). Zoster rgE vaccine (mammalian) (SHINGRIX) was for ages 50 years and older. She was to receive her Meningococcal vaccine. No adverse events were reported. The outcome of the events was unknown.  Follow-up information was received via telephone call on 09-OCT-2020. On 09-OCT-2020, a call was received from the nurse. She reported receiving a vaccine adverse experience form and stated she didn't report anything so did not understand why she received this. Explained to her the information came in through a VAERS form. She reported she may not be able to identify the patient, but she would see if she could and fax the form in. No further information 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability