Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y011819 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y011819 | OT |
the vaccine stung a little bit; a patient was administered an expired dose of CAPVAXIVE; This spontaneous report has been received from a pharmacist referring to a 67-year-old female patient. The patient's historical drug included sulfa drugs. Concurrent condition included drug reaction/allergies to sulfa drugs. The patient's other pertinent medical history was unknown. Concomitant therapies included atorvastatin calcium (LIPITOR) and estradiol (ESTRACE) cream. On 24-Oct-2025 (reported as today), the patient was administered an expired dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # Y011819, expiration date 01-Oct-2025), 0.5 ml once administered via intramuscular route by a health professional as pneumonia vaccination for prophylaxis (strength and anatomical site were not reported) (Expired product administered). On the same day (24-Oct-2025) after being administered the dose, the patient stated the vaccine "stung a little bit" (Vaccination site pain). No additional adverse event (AE) or product quality complaint (PQC) reported. At the reporting time, the outcome of vaccination site pain was unknown. The action taken with suspect vaccine was not applicable. The causal relationship between the event of vaccination site pain and suspect vaccine was not reported.
Sulfonamide allergy
LIPITOR; ESTRACE