Reporte zur Charge UT77445A

Symptomtext

arm sore; received an expired shot; Fluzone was given on same day as BNT162B2; Fluzone was given on same day as BNT162B2; This is a spontaneous report received from contactable reporter(s) (Pharmacist). An 11-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2022 at 18:00 as dose 1 (orange cap), single (Lot number: FL2757, Expiration Date: 11Oct2022) at the age of 11 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 20Oct2022 as dose number unknown, single (Lot number: UT77445A) intramuscular, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 20Oct2022 at 18:00, outcome "unknown" and all described as "Fluzone was given on same day as BNT162B2"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 18:00, outcome "unknown", described as "received an expired shot"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2022, outcome "recovered", described as "arm sore". Therapeutic measures were not taken as a result of expired product administered, product use issue, off label use, pain in extremity. Additional information: caller stated he is calling about the Pediatric Vaccine, verified Pfizer Pediatric Covid Monovalent Vaccine. Caller states he is calling from (name) because they gave an expired shot to someone last week, later clarified to two patients, and corporate told him he needed to reach out to Pfizer to get the stability information to fill out the VAERS form. Caller states he is wondering if there may be extended stability?. The patient provided information regarding the reported adverse event(s) with the use of the product. Pfizer product had no causal effect to the adverse event. Follow-Up (27Oct2022): Follow-up attempts are completed. No further information is expected. Follow-up (09Nov2022): This is a spontaneous follow-up report from the same contactable Pharmacist. This Pharmacist reported in response to HCP letter sent included that: Updated Information Included: Reporter information updated, suspect product details (Dose start/stop time. Dose description. Anatomical Location, Vaccine Facility Information. Co-suspect product updated), event details (Event onset time. Event onset date. Event outcome. Treatment received updated) and additional information updated. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253324 same reporter/product/AE, different patient; Report 1 of 2;