Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
flushng on her face; warmth in her hole arm; nausea; Headache; This spontaneous report has been received from a consumer regarding a 10-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 02-APR-2025, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, scheme, route of administration, anatomical site, lot number and expiration date not reported). On an unspecified day in April, 2025, the patient's mom has called stating that the patient has developed flushing on her face (flushing of face) , nausea, warmth in her whole arm (skin warm) and a headache. She states she is aware of all of the adverse events with the exception of flushing. At the time of the reporting, the outcome of the events is unknown. Causal relationship between the suspect vaccine and the events was unknown.