Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013099 | — |
Reported called on behalf of HCP who reported a 58-year-old female patient experienced tingling below her neck down to her breast (side of body unknown by reporter) after being administered CAPVAXIVE. Patient administered vaccine on 2/4/2025 and reported; This spontaneous report was received from a physician referring to a 58-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On 04-FEB-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution (CAPVAXIVE) injection, 0.5 ml administered intramuscularly (vaccination scheme frequency, and anatomical location were not provided; invalid lot number Y013099, with expiration date on 17-NOV-2028). On an unknown date, after being vaccinated, the patient experienced tingling below her neck down to her breast of body. On 17-FEB-2025, the patient reported the adverse event to the physician, and the physician stated he feels symptoms are due to transverse myelitis. It was not reported if the patient received any treatment for this adverse event. The physician reported the patient was sent and admitted to the hospital for a neurological workup. At the time of the reporting, the outcome of the event was unknown. The causal relationship between the event and the suspect vaccine was not reported.