Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4932 | OT / LA |
Redness at the injection site; Warm and tenderness at the injection site; Warm and tenderness at the injection site; Chilled fever; Itchiness at at the injection site; This is a spontaneous report received from a Nurse. A 56-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Aug2025 at 12:09 as dose number unknown, 0.5ml single (Lot number: LN4932, Expiration Date: 30Aug2026) at the age of 56 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness at the injection site"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Warm and tenderness at the injection site"; PYREXIA (non-serious), outcome "unknown", described as "Chilled fever"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itchiness at at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site warmth, pyrexia, vaccination site pruritus. Causality for "redness at the injection site", "warm and tenderness at the injection site", "chilled fever" and "itchiness at at the injection site" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Doctor prescribed Doxycycline, Prednisone, Triamcinolone Cream and Pepcid. NDC number of Prevnar 20: 0005200001; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500157347 Same reporter and suspect product different patient/AE;US-PFIZER INC-202500157363 Same reporter and suspect product different patient/AE;