Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
Caller noted that her 14 year old son had received his 2nd shot for GARDASIL-9 around 23 months after receiving the first dose; AE was filed as caller noted that her son had become depressed and sluggish, however, has since balance back out.; This spontaneous report was received from a consumer or other non health professional and refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9 (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. On an unknown date, around 23 months after receiving the first dose, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9 (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis (inappropriate schedule of product administration) On 19-May-2025, the reporter's son had become depressed and sluggish. The outcome of the event was considered to be recovered since the reporter noted, that he had "since balance back out". No additional information was provided. No additional adverse event (AE) and no product quality complain (PQC) was noted. Lot # is being requested and will be submitted if received.