Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | OT / LA |
HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; Patient also complained of flu like symptoms; This spontaneous report has been received from a pharmacist regarding a 78-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 07-MAR-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), as a single dose, administered intramuscularly in the left deltoid as immunization (lot number reported as Y013009, which has been verified as valid, expiration date reported and validated as 17-NOV-2025) (strength, dose, and vaccination scheme were not reported). On 08-MAR-2025, the patient developed a large area of redness and warmth around the injection site (Vaccination site erythema, Vaccination site warmth). The reporter stated there was minimal swelling and mild tenderness (Vaccination site swelling, Vaccination site pain). On an unknown date in March 2025, patient also complained of flu like symptoms (Influenza-like illness). The outcome of all events was not reported. The causal relationship between the aforementioned events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.