Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | Y016291 | — |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | Y016291 | — |
HBP calling to report AE for PNEUMOVAX 23. Patient was administered the vaccine twice within the same month.; Patient experienced swelling and redness at the injection site.; Patient experienced swelling and redness at the injection site.; This spontaneous report was received from a consumer referring to a 54-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On 03-JUN-2025, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for vaccination, (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y016291, with expiration date on 06-DEC-2026). On 19-JUN-2025, she received an extra dose of Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for vaccination, (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y016291, with expiration date on 06-DEC-2026) (Extra dose administered). On an unknown date, the patient experienced swelling and redness at the injection site (Vaccination site swelling) (Injection site erythema). On an unknown date, she recovered from the events of vaccination site swelling and injection site erythema. The causal relationship between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) was not reported.