Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | z002626 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z002626 | OT / LA |
INJECTION SITE INDURATION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2843026-1) on 17-Jul-2025. This spontaneous report refers to a 62-year-old female patient. The patient's medical history, concomitant therapies and concurrent conditions were not reported. On 13-May-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (valid lot ##Z002626, expiration date was not provided but established as: 04-Sep-2026) administered by Intramuscular route in Left Arm, for prophylaxis at pharmacy. On 15-May-2025, the patient experienced injection site induration, injection site erythema and injection site pain (severity for all the events reported as "medium"). On an unspecified date in May 2025, the patient recovered from the events of injection site induration, injection site erythema and injection site pain The causal relationship between all the event and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-07-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2843026 , Central date : 2025-07-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :