Received May 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | OT |
Consumer advised after she received the first dose (date unknown) she was sore after the first shot; with the second dose she had burning while the vaccine was being injected but it went away; This spontaneous report was received from a consumer or other non health professional and refers to herself, a 34-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccines included flu shot. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. On an unknown date, after she received the first dose, she was sore after the first shot (pain). On an unknown date, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. On an unknown date, with the second dose she had burning while the vaccine was being injected but it went away, and she similar to when she got a flu shot (injection site pain). No additional details were provided. No additional adverse event (AE) was reported. No product quality complaint (PQC) was reported. At the time of reporting, the patient had recovered from the reported adverse events. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not applicable. The causal relationship between the reported adverse events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Lot # is being requested and will be submitted if received.