Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
shortness of breath; hives; This spontaneous report was received from a consumer via Company representative, concerning their child as a currently 15-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On approximately 2023 (reported as "at age 13"), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1, 0.5 mL administered by intramuscular (IM) route (lot #, expiration date and anatomical location were not reported); and on the same date with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL (dosage regimen, lot #, expiration date, anatomical location and route of administration were not reported) which was diluted with sterile diluent, 0.5 mL (expiration date, and lot # were not reported). Both vaccines were administered as prophylaxis. On an unknown date, after receiving his first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), shortness of breath (dyspnoea) and hives (urticaria.) The patient recovered from the events on an unspecified date. The causal relationship between dyspnoea, urticaria and the suspect vaccines/sterile diluent was not provided. Lot # is being requested and will be submitted if received.