Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z006889 | OT / LA |
"developed a high fever, high enough that the Dr advised that the patient go to the ER." Patient was admitted overnight.; This spontaneous invalid report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) solution for injection, 0.5 ml (dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. On an unspecified date, the patient developed a high fever, high enough that the physician advised that the patient go to the emergency room (ER) and the patient was admitted overnight. The outcome of the event was not provided. The action taken with the suspect vaccine regarding the event was assessed as not applicable. The causal relationship between the event and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Lot# is being requested and will be submitted if received. This is an invalid report due to lack of patients' identifiers. Follow up information has been received from a healthcare professional on 01-Dec-2025. Information regarding patient identifiers was provided; and refers to a 55-year-old male patient. The date of vaccination was reported as 02-Oct-2025, lot number reported as Z006889, which was verified to be a valid lot number for Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), expiration date reported on 09-Sep-2026, administered intramuscularly in the left deltoid. The onset of the event was on an unknown date in October 2025, it was reported that the patient did not receive any treatment for the event, and on an unspecified date in 2025, was recovered. The causal relationship between the event was the suspect vaccine was reported as related.; Sender's Comments: Priority : 2 , Is case serious : Yes , MNSC number : 02885353-02885349 , CLIC number : , ESTAR number : , IRMS number : 500UW00000nd8eIYAQ|01122025230045|4454 , Central date : 2025-12-02 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2337087 , MNSC case number : 02885353 , MNSC interaction number : 02885349 , Integration log UniqueID : 500UW00000nd8eIYAQ|01122025230045|4454 , Service cloud CaseID : 500UW00000nd8eIYAQ