Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y019158 | OT / LA |
Arthralgia; rash macular; injection site pain; pain; Influenza like illness; rash; Information has been received from the Food Drug Administration (FDA) (agency number 2844372-1) on 20-Aug-2025. This spontaneous report refers to a 65-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (lot #Y019158, expiration date: 20-May-2026), dose number 1, administered by Intramuscular route in Left Arm for prophylaxis. On 01-Jun-2025, the patient experienced rash macular, injection site pain, arthralgia, pain, influenza like illness, and rash. At the reporting time, the patient had not recovered from rash macular, injection site pain, Arthralgia, pain, Influenza like illness and rash. The causal relationship between the events of rash macular, injection site pain, arthralgia, pain, influenza like illness, rash and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (withheld)@merck.com , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2844372 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :