Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z004302 | — |
No additional AE; Nurse calling to report administering a dose of CAPVAXIVE after experiencing a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-Sep-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 168 mcg/ml (lot #Z004302 with expiration date reported as and confirmed to be 04-Sep-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was administered after experiencing a temperature excursion (TE) (temperature: 50.3F; time frame: 154 hours 0 minutes 0 seconds; previous temperature excursion: no) (product storage error). The TE assessment was not supported. No additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event).