Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z002626 | — |
No additional adverse event; A HCP called to report a TE for CAPVAXIVE. The HCP stated that sometime during 06/27/2025 through 07/09/2025 the CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C, but the HCP was unable to confirm when the excursions occurred; Information has been received from Business Partner/CRO on 09-Jul-2025. This spontaneous report was received from an Other health professional and refers to a 36-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-Jun-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Z002626, expiration date: 04-Sep-2026) 0.5 mL for an unknown indication. This vaccine was exposed to a minimum temperature of 0 degree Celsius and a maximum of 9 degree Celsius (Improper storage of product in use). No additional adverse event was reported.; Reporter's Comments: