Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | 2006889 | — |
Received from the AE Self-Service Portal: Report submitted by Merck Employee Headache, sore arm, and fatigue following shot administration. Arm pain led to sleep interruption. Case assigned/processed by agent on 8/27/2025. No additional AE/ N; sore arm; fatigue; Arm pain led to sleep interruption; This spontaneous report was received from 54-year-old male patient referring to himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (invalid lot #2006889, expiration date: 26-Sep-2026), dose reported as 1 shot for prophylaxis. On 26-Aug-2025, the patient experienced headache, sore arm (pain in extremity), and fatigue following shot administration. Arm pain led to sleep interruption (sleep disorder). At the reporting time, the outcome of the events was not reported The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) regarding the events was not applicable. The causal relationship between the events and the suspect vaccine was not reported.