Received Apr 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LX4483 | OT / LA |
Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; This is a spontaneous report received from a Nurse. A 56-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2025 as dose number unknown (0.5 ml), single (Lot number: LX4483, Expiration Date: Feb2026) 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), VACCINATION SITE PAIN (non-serious), VACCINATION SITE OEDEMA (non-serious) all with onset 17Apr2025, outcome "recovering" and all described as "Erythema, pain at the injection site, and edema.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site oedema. Additional information: Patient did not received any other vaccines on the same date as the vaccine and not received any other vaccines within 4 weeks prior to the vaccine. Patient taking other medications within 2 weeks of the event starting. Reported events included erythema, pain at the injection site, and edema. On 22Apr2025, received additional context in which stated report 1 of 4 on patient. She reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physican stated a patient recently reported a side effect that came from one batch, the same lot number. Stated the physician is not comfortable using that lot. 1st patient reported erythema, pain and edema at injection site site left deltoid. Prevnar 20 given on 16Apr2025 and noted erythema, pain and edema at injection site left deltoid on 17Apr2025. Outcome was recovering. Patient has an appointment with her provider today. Seriousness criteria reported as it was mild so she doesn't think significant. It is definitely inconvenient but not life threatening.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086599 same reporter/product/event, different patient.;US-PFIZER INC-202500086566 same reporter/product/event, different patient;