Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
The patient received her second dose of the Gardasil-9 series and experienced injection site pain. In addition, she also had severe elbow and forearm pain, which she did not experience with the first dose of the series.; This spontaneous report was received from a Physician Assistant and refers to a 12-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), Injection (dose, administration route, lot # and expiration date were not reported) as prophylaxis. On an unknown date, when the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) she experienced injection site pain (vaccination site pain) that included severe elbow and forearm pain. On an unknown date, the patient recovered from the event. se of the series. on an unspecified date. The causal relationship between the event vaccination site pain and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02908445-02908440 , CLIC number : , ESTAR number : , IRMS number : 500TP00000aDWISYA4|19112025200028|0980 , Central date : 2025-11-20 , Classification : , Attachment description : Call , Safety case number : , MNSC case number : 02908445 , MNSC interaction number : 02908440 , Integration log UniqueID : 500TP00000aDWISYA4|19112025200028|0980 , Service cloud CaseID : 500TP00000aDWISYA4