Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
immobility; Merk Employee calling on behalf of HCP to report an AE for CAPVAXIVE. HCP reported that the their pharmacy administered a dose of CAPVAXIVE, and following the administration, the patient developed a "severe headache and immobility." HCP also reporte; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered intramuscularly (IM) (lot # and expiration date were not reported) for Streptococcus pneumoniae prophylaxis. On an unknown date in May 2025 (reported as sometime last weekend), following the administration, the patient developed a severe headache and immobility. HCP also reported that the patient had to be taken to the emergency room following the administration. No other symptoms or side effects were reported. The outcome of the events was not reported. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of immobility was determined to be medically significant. Lot# is being requested and will be submitted if received.