Age: 12.0
Sex: M
Vaccine: HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Limb discomfort, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: arm swelling; Deltoid region swollen, warm to the touch, itching with some discomfort; Deltoid region swollen, warm to the touch, itching with some discomfort; Deltoid region swollen, warm to the touch, itching with some discomfort; Information was obtained on request by the Company from the FDA under the Freedom of Information Act via the Agency (VAERS # 826887).  This spontaneous report was received from a licensed vocational nurse and refers to a 12-year-old White male patient. He had no known drug allergies or concomitant therapies. There was no information about the patient's concurrent conditions or medical history provided. The case concerns 1 patient and 1 combination product. On 01-AUG-2019 at 17:00, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe injection, via intramuscular route in the left arm, lot # R011628 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 11-DEC-2020 (exact dose was not reported) for prophylaxis. Other suspect therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) second dose in the right arm via subcutaneous route, lot# R014354, has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 18-NOV-2019, (exact dose was not reported), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) first dose in the right arm via intramuscular route, lot# 2774D, (exact dose and expiration date were not reported), poliovirus vaccine inactivated (vero)(IPOL) fourth dose in the left arm via subcutaneous route, lot# P1A171M, (exact dose and expiration date were not reported) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) first dose in the left arm via intramuscular route, lot# U6015AA (exact dose and expiration date were not reported), all for prophylaxis. On 02-AUG-2019 at 15:00, the patient experienced deltoid region swollen, itching with some discomfort and warm to the touch. No hives were noted, no difficulty swallowing or other swelling noted. No elevated body temperature. It was given to the patient 2 tablets of diphenhydramine hydrochloride (BENADRYL). The outcome of peripheral swelling, limb discomfort, pruritus and skin warm was unknown. There was no causality assessment provided by the reporter.  Follow-up information has been received from the licensed vocational nurse on 21-SEP-2020.  The reporter had no additional information on the patient like name or date of birth and was unable to complete the requested report. The provided date of vaccination was helpful and he would see what he can do. The reporter provided contact details. 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: R011628; expirationdate: 11-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent