Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z013320 | — |
No additional AE; the CAPAVAXIVE was inadvertently administered following a TE. Nurse reports the CAPVAXIVE was administered to one patient on 07/02/2026.; This Spontaneous report was received from Nurse and referred to a/an ( Race Unknown ) ( Ethnicity Unknown) patient of unknown age and gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 02-Jul-2026, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 (Batch/Lot Number: Z013320) (Expiration date: 04-Jun-2027) dose form was Solution for injection (Dose Text: 168 mcg/ml). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 for the treatment of Prophylaxis, On 02-Jul-2026, the patient experienced the CAPAVAXIVE was inadvertently administered following a TE. Nurse reports the CAPVAXIVE was administered to one patient on 07/02/2026. (Product storage error). On an unknown date, the patient experienced No additional AE (No adverse event). Site Narrative: Names of vaccines involved: CAPVAXIVE LOT: 2013320, EXP: 06/04/2027 Temperature: (34.7F) Time frame: 0 hours 19 minutes and 0 seconds Previous temperature excursion? NO. The Outcome of Product storage error was not provided. The Outcome of No adverse event was not provided. The action taken with Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Product storage error was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding No adverse event with Not Applicable dechallenge and rechallenge results. The Nurse considered the event No adverse event (,) to be not assessed to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 and the event Product storage error (,) to be not assessed to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 The Nurse considered the event No adverse event to be non-serious and the event Product storage error to be non-serious