Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
patient complained of enlarged lymph node after receiving GARDASIL 9.; This spontaneous report was received from a/an Consumer or other non health professional (Field-Based Employee [FBE]) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection (exact dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified day in January 2025 (reported as about 3 months ago), the patient experienced enlarged lymph node after receiving suspect vaccine. At the reporting time, the outcome of enlarged lymph node was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) regarding the event was assessed as not applicable. The causal relationship between the event of enlarged lymph node and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received.