Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
redness, and swelling at the injection site; redness, and swelling at the injection site; inflammation/redness, and swelling at the injection site; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in May 2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 ml (reported as 0.5 m) intramuscularly (anatomical location, lot # and expiration date were not provided) for prophylaxis. Since an unknown date in May 2025, post the suspect vaccination ,the patient suffered from redness, and swelling at the injection site. The area of redness and swelling stretched about 3 inches across and about 4-5 inches wide. The reporter noted inflammation but stated it did not appear to be infected. The patient sought medical attention. At the time of the report, the patient suffered from the events for at least 6 days. The outcome of the events was reported as not recovered. Causality assessment was not provided. Lot # is being requested and will be submitted if received. This is an invalid report due to lack of the patient's identifiers.
Test Date: 202505; Test Name: investigation; Result Unstructured Data: the area of redness and swelling stretched about 3 inches across and about 4-5 inches wide