Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z004302 | OT |
she now has blistering at the site covering an area about 2-3 inches wide by 3-4 inches long.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; This spontaneous report was received from a Medical Assistant and refers to a 57-year-old female patient. The patient's medical history included pneumonia. The patient's concurrent conditions and concomitant therapies were not reported. On 17-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered intramuscularly; lot # Z004302 has been verified to be valid, expiration date: 04-Sep-2026; given as vaccination. On the same day, the patient experienced redness (Vaccination site erythema), inflammation (Vaccination site inflammation) and became painful (Vaccination site pain) and hot to touch (Vaccination site warmth). On 21-Jul-2025 (Also reported as this morning), patient called HCP and stated reaction had gotten progressively worse over the past few days and she now had blistering at the site (Vaccination site vesicles) covering an area with about 2-3 inches wide by 3-4 inches long. The patient sent pictures, and prednisone was given as treatment. It was also reported that she sought medial attention. At the reporting time, the outcome of all the events was unknown. The causal relationship between all the events with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
Medical History/Concurrent Conditions: Pneumonia