Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z002626 | — |
No additional AE; the CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C. Capvaxive was administered to a patient on 07/03/2025; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a 28-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. From 27-JUN-2025 through 09-JUN-2025, a temperature excursion occurred for Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). On 03-JUL-2025, the patient was vaccinated with an improperly stored dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection, prefilled syringe, strength: 168 mcg/ml, 0.5 ml, once, administered as prophylaxis (lot number Z002626 has been verified to be valid for Pneumococcal 21-valent Conjugate Vaccine [CAPVAXIVE], expiration date not reported but upon internal validation was established as 04-SEP-2026; anatomical site of injection, route of administration and vaccination scheme frequency were not provided). The reporter stated that the administered vaccine was exposed to a minimum temperature of 0 degree Celsius (C) and a maximum of 9 degree C (Product storage error), but was unable to confirm the exact dates of the excursions and indicated that is unknown if there were any previous excursions. The reporter confirmed the patient did not report any adverse issues or side effects from the administrated dose (No adverse event). This is one of three reports from the same reporter.