Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z002626 | OT |
the patient did not report any adverse issues or side effects from the administered dose; CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C / The HCP also stated the CAPVAXIVE was administered to a patient; This spontaneous report was received from a medical assistant and refers to a) 45-year-old female patient. The patient's medical, concurrent conditions and concomitant therapies were not reported. The reporter stated that sometime during 27-Jun-2025 through 09-Jul-2025 the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was exposed to a minimum temperature of 0C and a maximum of 9C, but the reporter was unable to confirm when the excursions occurred, and it was unknown if the vaccine had any prior excursions. On 01-Jul-2025, the patient was vaccinated with the improper storage vaccine Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 168 mcg/ml, lot #Z002626, expiration date: 04-Sep-2026, 0.5 mL once administered by Unknown route as prophylaxis. The reporter confirmed the patient did not report any adverse issues or side effects from the administered dose. This is one of several cases from the same source.