Received Jul 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y019157 | OT |
The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful.; The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful.; The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful./However, pain and redness spread up to her elbow; However, pain and redness spread up to her elbow; This spontaneous report was received from a pharmacist and refers to a 85-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported. On 12-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) solution for injection, 1 dose, lot #Y019157, expiration date: 23-MAY-2026, administered by intramuscular route as routine vaccination (anatomical site was not reported). For first 4 days after the vaccination the patient complained that her arm was "sore" and on the 5th day the injection site got red and swollen and her arm was painful. She went to an urgent care and received a prescription for Doxycycline 100mg twice a day for 7 days. However, pain and redness spread up to her elbow, so she went to an unspecified hospital and received unspecified IV antibiotic. Confirmed with pharmacist that the patient was not hospitalized. At the reporting time, the patient had not recovered from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported but established as not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.