Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
faint; fainting; This spontaneous report was received from a pharmacist and referring a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) for prophylaxis (dose, expiration date, and lot # were not reported). And the patient was fainting after the vaccination (syncope). On approximately December 2024 (reported as about 2 months ago), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) for prophylaxis (dose, expiration date, and lot # were not reported). And patient fainted (syncope). At the reporting time, the outcome of both events was not reported. The causal relationship between both events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown/not reported/not provided. Upon internal review, the events of faint and fainting were determined to be medically significant.
Comments: unknown