Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
CAPVAXIVE Provider treated patient for cellulitis; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; This spontaneous report was received from a 60s female patient via company representative referred to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route, anatomical site, dose form, lot # and expiration date were not reported) for cellulitis (product use in unapproved indication). On 12-Mar-2025, the patient experienced side effect with arm that was swollen, doubled in size, and was red, hot, and tender (peripheral swelling, erythema, feeling hot, pain in extremity). It was reported that treatment was given for the events. The outcome of all events was not reported. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. The reporter considered the events of peripheral swelling, erythema, feeling hot and pain in extremity to be medically significant. Lot # is being requested and will be submitted if received.
Cellulitis