Received Feb 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Z011090 | IM / RA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Z011090 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
HCP reported that the patient reported a fever on 23-JAN-2026; HCP reported that patient reported itchy rash on 23-JAN-2026; Patient received first dose on 26-JUL-2024 and second dose on 22-JAN-2026; the patient's initial fever and rash resolved but the patient developed upper respiratory symptoms of runny nose; the patient's initial fever and rash resolved but the patient developed upper respiratory symptoms of nasal congestion; HCP reported that a newer fever started after the initial fever subsided; This spontaneous report was received from a physician and refers to a(n) 12-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 26-Jul-2024, the patient was vaccianted with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (strength, exact dose, anatomical route of administration, lot # and expiration date were not reported), for prophylaxis (HPV prevention) On 22-JAN-2026, (inappropriate schedule of product administration) the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection in pre-filled syringe (GARDASIL 9) (lot #Z011090, who had been verified to be a valid lot #, expiration date assessed and validated as 07-Aug-2027), dose number 2, (0.5 mL/second dose) for prophylaxis (HPV prevention). On 23-JAN-2026, the patient experienced fever (pyrexia) and itchy rash (Rash pruritic). Pyrexia and Rash pruritic was recovered on 25-JAN-2026 but the patient developed upper respiratory symptoms of runny nose (Rhinorrhoea) and nasal congestion on an unspecified date in January 2026 (reported as 48-60 hours after receiving second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). In addition, a newer fever (pyrexia) started after the initial fever subsided. Antihistamine over the counter, Tylenol and Motrin for addressing the fever was administered to patient as treatment. The outcome of the events Rhinorrhoea, nasal congestion and second episode of pyrexia was not reported. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.
Medical History/Concurrent Conditions: Eczema