Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | MA2505 | OT |
feeling febrile; chills; swelling; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 12Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, 0.5 ml single (Lot number: MA2505, Expiration Date: 30Sep2026) intramuscular for immunisation, Device Lot Number: MA2505, Device Expiration Date: 30Sep2026. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (medically significant) with onset 16Sep2025, outcome "recovering"; PYREXIA (medically significant) with onset 16Sep2025, outcome "recovering", described as "feeling febrile"; SWELLING (medically significant) with onset 16Sep2025, outcome "recovering". The events "feeling febrile", "chills" and "swelling" required emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, swelling. Clinical course: the patient experienced an adverse event after taking a Pfizer product. The patient was not taking any other medications within 2 weeks prior to the event onset. No other diagnosed illnesses/medical history/chronic health conditions. On16Sep2025, feeling febrile and had chills, swelling, progressively worsened. The patient went to ER on 19Sep2025. The event was reported as non-serious. The patient underwent the treatment for the adverse events which included IV fluids and antibiotics. Causality for "feeling febrile", "chills" and "swelling" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None