Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z005469 | OT / LA |
Hospitalization for psychosis; HCP states patient was hospitalized for substance use intoxication and acute kidney injury; HCP states patient was hospitalized for substance use intoxication and acute kidney injury; This spontaneous report was received from a Physician on 01-Oct-2025 and refers to a patient of unknown age and gender. The reporter stated that the patient was a Clinical Study participant enrolled in (withheld) clinical trial (however, no information regarding the study was reported). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Aug-2025, the patient was vaccinated with an unspecified dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z005469, expiration date: 27-Feb-2026) dose: 0.5 mL, route of administration intramuscular for Prophylaxis. On 27-Sep-2025, the patient experienced acute kidney injury and substance use intoxication (Toxicity to various agents). The patient was hospitalized on the same date for 9 days. It was reported that the patient sought unspecified medical attention, and the patient received an unspecified treatment. The patient would be discharged from the hospital on 06-Oct-2025. At the reporting time, the outcome of acute kidney injury and substance use intoxication was unknown. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. Follow-up information has been received from a physician on 03-OCT-2025. This report concerns a 32-years old male patient. Patient's demographics was added. Vaccine was administered via IM in the left arm. Concomitant medications included Olanzapine, Thamin, Folic Acid. It was reported that patient's Hospitalization for psychosis induced by substance use and acute kidney injury. Hospitalization dates from 27-SEP-2025 to 30-SEP-2025. The patient was recovered from the events.
Olanzapine; Thamin; Folic acid