Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
fatigue; headache; This spontaneous report was received from a patient refers to herself (64-year-old female patient). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Sep-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 0.5 ml, administered by intravenous route (lot # and expiration date were not reported) as pneumococcal vaccination On 08-Sep-2025, the patient experienced headache and fatigue. Consumer did not report any additional side effects. Consumer stated that the side effects went away the following day. The patient recovered from the events of headache and fatigue on 09-Sep-2025. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the event of headache and fatigue and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received.