Age: 12.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Lump 3cm. hard and swollen/hard lump at the site of the injection; Lump 3cm. hard and swollen; area was red/hand area red; Information has been received on request by the Company from FDA (VAERS No. 825876) under the freedom of information act on 14-JUL-2020.  This spontaneous report was received from a certificated medical assistant and refers to a 12-year-old non-pregnant female patient. Concomitant therapies included cetirizine hydrochloride (ZYRTEC ALLERGY). Allergies, other illness at the time of vaccination and chronic or long-standing health condition were reported as none. Her medical history was not provided. She had no adverse events following any previous vaccines.  On 22-JUL-2019 at 13:39, 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) via intramuscular (IM) route, in the left arm, lot # 1602281 has been verified to be a valid lot number, expiration date not reported, but upon internal validation it was established as 21-JUL-2021, (exact dose and frequency were not reported) for prophylaxis. On 26-JUL-2019, the patient came for a visit and reported that on 23-JUL-2019 at 10:00, she experienced in left deltoid area, lump 3 cm size, hard and swollen for 4 days. The patient reported area was red but at the time of this report (reported as now) it was looking better. The patient received treatment which was warm compresses and kept taking cetirizine hydrochloride (ZYRTEC). On an unknown date in July 2019, she recovered from the events (reported as the area was resolved).  The causality assessment was not provided.  Follow-up information has been received from a certified medical assistant on 10-AUG-2020. She requested patient's demographics in order to fill out the Vaccine-Device form. The reporter also provided the correct facility address. On 11-AUG-2020, a questionnaire was sent by the certified medical assistant. The patient had none adverse events following a prior vaccination. She was seen 4 days after vaccine was given. Injection site was updated to left deltoid (previously reported as left arm). She presented a hard lump at the site of the injection. Grandmother (guardian) had noticed it was already looking better. No tests were performed and not medications were prescribed, however support care was recommended. It was confirmed that the vaccine was used according to the instruction leaflet; temperature excursion did not occur as a result of a reading from digital data logger. The causality was uptaded to be related to the suspect vaccine (reported as vaccine reaction). 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: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; 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