Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y013565 | IM / LA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y013565 | OT |
the patient has been experiencing soreness and pain in her arm after the administration; the patient has been experiencing soreness and pain in her arm after the administration; This spontaneous report was received from a nurse referring to a 12-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. The patient had no known allergies (NKA). On 30-Jun-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y013565, expiration date: 01-Feb-2027), dose number 1, administered by Intramuscular route (IM) as prophylaxis (dose was not reported). On 30-Jun-2025 (after the administration), the patient experienced soreness and pain in her arm (pain in extremity, myalgia). The patient had sought medical attention, and she initially started on Naproxen (ALEVE) and then on a methylprednisolone (MEDROL) pack as treatment. At the tine of this report, the patient was still experiencing pain and soreness associated with the vaccination administration. At the reporting time, the patient had not recovered from the events. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown.
Comments: unknown