Received Jul 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z004301 | OT |
been admitted to the hospital; This spontaneous report was received from a pharmacist and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unknown date in June 2025 (reported as 22-Jun-2025 or 24-Jun-2025 but unable to confirm), the patient was vaccinated with pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), 0.5 mL, lot number Z004301, expiration date was not reported but was established as 07-Sep-2026 upon internal validation, administered by intramuscular route for immunization and prevention of pneumonia (strength and anatomical location were not reported). Unknown if product was available for retrieval. On unknown date in June 2025, the patient was admitted to the hospital (hospitalization). Hospital name and address unknown. At the reporting time, the outcome of event hospitalization was unknown. The reporter considered the event of hospitalization to be related to pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reporter felt the AE was related to the specific lot # as he also reported a second patient adverse event related to this lot). This is one of two reports received from the same reporter. This is a non-valid case due to lack of patient identifiers. Follow-up information has been received from pharmacist, on 10-JUL-2025. The patient's information and contact information has been updated, it refers to a 96-years-old female patient.; Sender's Comments: Priority : 2 , Is case serious : Yes , MNSC number : 02829466-02829461 , CLIC number : , ESTAR number : , IRMS number : 500UW00000eSGu1YAG|10072025230029|6503 , Central date : 2025-07-11 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2301181 , MNSC case number : 02829466 , MNSC interaction number : 02829461 , Integration log UniqueID : 500UW00000eSGu1YAG|10072025230029|6503 , Service cloud CaseID : 500UW00000eSGu1YAG