Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
HCP noted that there was a patient that had pain, soreness on the injection side; redness on the injection site; with a nodule measuring 4x2cm in size, which has lasted for a month; This spontaneous report was received from a Physician and refers to a 32-year-old female patient (also reported as gender queer, biologically female). The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On 10-JUN-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered as Prophylaxis (dose, vaccination scheme frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported). On that same date (10-JUN-2025) the patient experienced pain, soreness and redness on the injection site with a nodule measuring 4x2cm in size, which has lasted for a month (Vaccination site pain, Vaccination site erythema, Vaccination site nodule). The reporter inquired about additional data regarding extended side effects with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). At the reporting time, the patient had not recovered from Vaccination site nodule, while the outcome for Vaccination site pain and Vaccination site erythema was not provided. The causal relationship between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the events was not reported.
Test Date: 20250610; Test Name: Nodule size; Result Unstructured Data: 4x2cm in size