Received Dec 17, 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 WARMTH; INJECTION SITE REACTION; Information has been received from Foods and Drug Administration (FDA) (2853963) on 10-DEC-2025. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 27-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE )(lot # Y013009 has been verified to be a valid lot number, expiration date reported was not provided, but upon internal validation established as 17-Nov-2025 (Dose 1), administered by Intramuscular route in right arm for prophylaxis. On 28-Jun-2025, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site reaction. The patient recovered from all the events on an unknown day. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : [withheld]@merck.com , Index date : 2025-12-11 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2853963-1 , Central date : 2025-12-11 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :