Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
a knot at injection site; nausea that lasted 48 hours; patient experienced painful, red, swollen rash that grew; the redness went down her arm; as of today it was still red; she was diagnosed with an unspecified autoimmune arthritis; This spontaneous report was received from a medical assistant, reporting on herself, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. She had no allergies and no previous history of vaccine reaction. On 04-Nov-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. That same day (04-Nov-2025) in the evening, the symptoms started. The patient experienced painful, red, swollen rash that grew. The redness went down her arm. She also developed nausea that lasted 48 hours (till 06-Nov-2025). On an unknown day in November 2025, the patient was diagnosed with an unspecified autoimmune arthritis, however her rheumatoid labs were negative. On 11-Nov-2025 (reported as "as of today"), the rash was still red and there was a knot at the injection site. The patient reported no itching, no fever. It was unknown if she sought medical attention or if any treatment was given for adverse events. The outcome of rash and knot at injection site was not resolved. The outcome of autoimmune arthritis was not provided and the outcome of nausea was resolved. The action taken with the suspect vaccine regarding all events was assessed as not applicable. The causality assessment between all events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of autoimmune arthritis was determined to be medically significant. Lot# is being requested and will be submitted if received.
Test Date: 202511; Test Name: rheumatoid labs; Test Result: Negative