Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LX4482 | LA |
cellulitis; Caller thinks the technician administered it too low, a couple of inches above the elbow; This is a spontaneous report received from a Pharmacist from medical information team. A 76-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Aug2025 as dose number unknown, single (Lot number: LX4482, Expiration Date: Feb2026) at the age of 76 years, in left arm for immunisation, Device Lot Number: LX4482, Device Expiration Date: Feb2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (medically significant) with onset 19Aug2025, outcome "unknown", described as "Caller thinks the technician administered it too low, a couple of inches above the elbow"; CELLULITIS (medically significant) with onset 29Aug2025, outcome "unknown". The event "cellulitis" required physician office visit. Therapeutic measures were taken as a result of cellulitis. Clinical course: The patient didn't receive any other vaccines on the same date as the Pfizer vaccine. The patient didn't receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient didn't previously receive the Pfizer suspect vaccine. No allergic to any previous vaccination, medications, food or other products. NDC number of Prevnar 20: 0005-2000-10. Caller mentioned a patient (female, 76 years) developed cellulitis after getting Prevnar 20. Caller thought the technician administered it too low, a couple of inches above the elbow. Caller would like to get more information about the re-vaccination. Reporter later clarified given too low as right above the elbow, it was the left elbow. She does not know if it being given too low went hand and hand with the development of cellulitis. No AE require a visit to the Emergency Room. She went to her primary physician, but does not know specifically what she. Was prescribed an antibiotic that they are dispensing. Causality for "caller thinks the technician administered it too low, a couple of inches above the elbow" and "cellulitis" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).