Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LJ5283 | LA |
Celulitis in the left arm; This is a spontaneous report received from a Pharmacist from a sales representative. An 82-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jan2025 as dose number unknown, single (Lot number: LJ5283) at the age of 82 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (hospitalization) with onset 26Jan2025, outcome "recovering", described as "Celulitis in the left arm". The patient was hospitalized for vaccination site cellulitis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of vaccination site cellulitis. Causality for "celulitis in the left arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Based on the given information, the Company confirms that the event vaccination site cellulitis is unrelated to the suspected drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) and most likely to the device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).