Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
I still have inflammation around the injection site, as well as being warm to the touch, itchy, and red.; I still have inflammation around the injection site, as well as being warm to the touch, itchy, and red.; I still have inflammation around the injection site, as well as being warm to the touch, itchy, and red.; I still have inflammation around the injection site; This spontaneous report was received from a patient (the Company employee) and refers to herself, a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 16-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (exact dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) administsred for prophylaxis. On an unspecified date in July 2025, the patient experienced inflammation around the injection site, as well as being warm to the touch, itchy, and red (vaccination site inflammation, vaccination site warmth, vaccination site pruritus, vaccination site erythema). It was reported that even after 6 days, the patient still had inflammation around the injection site, as well as being warm to the touch, itchy, and red. On 22-JUL-2025 (reported as of yesterday), she had been going to the site for monitoring. At the reporting time, the patient had not recovered from the events of inflammation around the injection site, as well as being warm to the touch, itchy, and red. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was assessed as not applicable. The reporter considered the events of inflammation around the injection site, as well as being warm to the touch, itchy, and red to be related to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as an adverse reaction to the suspect vaccine). Lot # is being requested and will be submitted if received.