Received Jul 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4930 | OT / LA |
Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; This is a spontaneous report received from a Nurse. A 74-year-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: 24Jul2026) at the age of 74 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis in the elbow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Severe pain upon administration of Prevnar 20". The events "cellulitis in the elbow" and "severe pain upon administration of prevnar 20" required physician office visit. Additional information: The reporting nurse stated, "I am calling because we have had 3 patients complaint of severe pain upon administration of Prevnar 20. Two of which have seen the doctor for cellulitis and cellulitis in the elbow. They both have been assessed by the doctor." Causality was reported as "Yes". Causality for "cellulitis in the elbow" and "severe pain upon administration of prevnar 20" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (malfunction).
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None