Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
This morning, she is pretty miserable; With chilling; and burning in her neck and body; Generalized body ache and pain, similar to the flu; Generalized body ache and pain, similar to the flu; It was administered in her high upper right arm, and her arm has been sore ever since/Her arm pain has gotten progressively worse; she felt the medicine travelling thru her arm down to her elbow, the worst that she has ever felt it during a vaccination; This spontaneous report was received from a consumer or other non-health professional referring to herself a 54-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 30-Sep-2025, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) administered as prophylaxis (Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On the same date (30-Sep-2025), the patient experienced the medicine travelling thru her arm down to her elbow, the worst that she has ever felt it during a vaccination (sensory disturbance) and it was stated that the vaccine was administered in her high upper right arm, and her arm has been sore ever since and her arm pain has gotten progressively worse (vaccination site pain). On 01-Oct-2025 (reported as this morning), it was reported that she was pretty miserable (feeling abnormal) and her arm pain was with chilling (chills) and burning in her neck and body (burning sensation); also, the patient experienced generalized body ache and pain, similar to the flu (pain) (influenza like illness). At the reporting time, the patient had not recovered from the event of vaccination site pain (reported as arm pain has gotten progressively worse). The outcome of the events of sensory disturbance, feeling abnormal, chills, burning sensation, pain and influenza like illness was unknown. The causal relationship between all the events with the suspect vaccine was not provided.