Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | OT |
A patient experienced a nodule at the injection site after receiving their second dose of GARDASIL 9 that lasted approximately a week.; After the nodule went away, the patient has still been experiencing arm pain; This spontaneous report was received from a Physician regarding a 45-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date in November 2024 (reported as at the end of November), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, 0.5 mL, administered Intramuscularly for vaccination (lot number, expiration date and anatomical site of injection were not reported). After receiving the mentioned dose, the patient experienced a nodule at the injection site (Vaccination site nodule) that lasted approximately a week. After the patient recovered from the vaccination site nodule on an unknown date in November 2024 (reported as after the nodule went away), the patient has still been experiencing arm pain (Pain in extremity). The reporter stated that due to the event of Vaccination site nodule, they decided not to administer the third dose of the vaccine. At the time of the report, the patient was recovered from the event of Vaccination site nodule and was not recovered from the event of Pain in extremity. The action taken with the suspect vaccine regarding the events was reported as drug withdrawn. Dechallenge and rechallenge were not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.