Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
Consumer to report their child experienced vomiting; Consumer to report their child experienced hot flashes; Consumer to report their child experienced syncope; Consumer to report their child experienced shortness of breath; Consumer to report their child experienced hives; This spontaneous report was received from a consumer or other non health professional and refers to a 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (also reported as when the patient was 14-years-old), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL, intramuscularly, for the treatment of routine vaccination. (scheme, strength, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient hot flashes, syncope, vomiting, shortness of breath and hives. At the reporting time, the outcome of the events was unknown. The causal relationship between the events and the suspect vaccine was unknown. Upon internal review, the event of syncope was determined to be medically significant.