Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
his "arm swelled really bad after" receiving his first dose of GARDASIL 9 and that "they were concerned about nerve damage"; This spontaneous report was received from pharmacist tech referring to himself as male patient of unknown age. The patient's medical history, current conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (exact dose, strength, anatomical route of administration, lot # and expiration date were not reported) as vaccine (prophylaxis). The reporter stated that, his arm "swelled really bad" after receiving first dose of vaccine Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) and they were concerned about nerve damage. It was reported that, this occurred a couple of days after the shot and went away about a week later" and he is apprehensive about getting the second shot. No missed dose and it was unknown if any treatment was provided or when this occurred (Vaccination site swelling). The outcome of the event Vaccination site swelling was assessed as recovered on an unspecified date. The causal relationship between the event Vaccination site swelling and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided. Lot number is being requested and will be submitted if received.