Received May 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z008509 | OT |
enterocolitis; This spontaneous report was received from a physician and refers to a 39-year-old male patient. The patient's Pertinent Medical History included HIV. Concomitant medications included cabotegravir (+) rilpivirine (CABENUVA). On 10-Mar-2026, the patient was vaccinated with 1 dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z008509 with valid expiration date reported as 23-Jul-2027) administered by intramuscular route (exact dose and vaccination site were not reported) for prophylaxis, as part of an independent study (not a Merck Clinical Study). On 30-Apr-2026, the patient experienced enterocolitis and was hospitalized due to the adverse event. The did "a bunch" of lab diagnostics in the hospital (results were not provided). The patient was treated with antibiotics. The product was discarded so it could not be held for possible return. No additional adverse event (AE) and no product quality complaint (PQC) was reported. On 04-May-2026, the patient recovered from enterocolitis and was discharged from the hospital. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not applicable. The causal relationship between the event of enterocolitis and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Upon internal review, the event of enterocolitis was determined to be medically significant.
Medical History/Concurrent Conditions: HIV infection
Cabenuva