Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | OT / RA |
INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE PAIN; Information has been received from a Regulatory Authority (agency # 2831941-1) and refers to a 52-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-MAR-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPAXVIVE) Injection, lot #Y013009, expiration date was not reported but upon internal validation was established as 17-NOV-2025 (dose and strength was not reported) administered by Intramuscular route his Right Arm for prophylaxis. On 09-MAR-2025, the patient experienced Injection site swelling, erythema and pain. At the reporting time, the patient had not recovered from the events. The causality assessment between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPAXVIVE) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-05-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2831941 , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :