Age: 4.0
Sex: U
Vaccine: COVID19, DTAP, IPV, MMR, VARZOS
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product administration error
Clinical narrative: obesity; they gave to patients that were used beyond use date; they gave to patients that were used beyond use date; Dose: 1st, Date: 07Oct2022 / Dose: 2nd, Date: 01Mar2023; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 4-year-old patient received BNT162b2 (BNT162B2), on 01Mar2023 as dose 2 (maroon cap), single (Lot number: FX5095) at the age of 4 years intramuscular, in left thigh for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL), on 01Mar2023 as dose 5, single (Lot number: C5969AD) intramuscular, in right thigh for immunisation; polio vaccine (POLIO), on 01Mar2023 as dose 4, single (Lot number: V18891M) intramuscular, in left thigh for immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 01Mar2023 as dose 2, single (Lot number: W007041) subcutaneous, in right thigh for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 01Mar2023 as dose 2, single (Lot number: W022294) subcutaneous, in left thigh for immunisation. The patient's relevant medical history included: "Atopic Dermatitis", start date: 29Apr2019 (unspecified if ongoing); "Asthma", start date: 05Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of Injection: Left Thigh, Route of Administration: Intramuscular, Batch/Lot number: FT9142), administration date: 07Oct2022, for COVID-19 immunization; Daptacel (Dose 1, Manufacturer: Sanofi), for Immunization; Daptacel (Dose 2, Manufacturer: Sanofi), for Immunization; Daptacel (Dose 3, Manufacturer: Sanofi), for Immunization; Daptacel (Dose 4, Manufacturer: Sanofi), for Immunization; Polio (Dose 1, Manufacturer: Sanofi), for Immunization; Polio (Dose 2, Manufacturer: Sanofi), for Immunization; Polio (Dose 3, Manufacturer: Sanofi), for Immunization; Mmr (Dose 1, Manufacturer: Merck), for Immunization; Varicella zoster vaccine (Dose 1, Manufacturer: Merck), for Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Mar2023, outcome "unknown", described as "Dose: 1st, Date: 07Oct2022 / Dose: 2nd, Date: 01Mar2023"; OBESITY (non-serious) with onset 01Mar2023, outcome "unknown"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 01Mar2023, outcome "unknown" and all described as "they gave to patients that were used beyond use date".  Additional information: 1 patient was involved. Upon follow up 03May2023, it was reported that the caller stated she called before regarding 49 doses of the Pfizer Covid-19 vaccine that were given patients past the beyond-use-date. It was 49 doses but 47 patients, because two patients received 2 doses with the products that were past the beyond use date. She stated they received 3 packets that were required to be filled out, but it looked like it was one packet per patient. She wanted to know if she should copy these forms for all 47 patients or if they only needed information on 3 patients? The form was from Drug Safety. She did not have any medical questions and just wanted information on how to fill out this form she received. This involved all formulations: The gray cap bivalent and monovalent, orange cap bivalent and monovalent, and maroon cap bivalent and monovalent. On FU 03May2023 there were 6 patients who received LOT# FX5095 and 6 patients received LOT# GK1667. patients were given the vaccines after the beyond use date. Basically what happened is 47 patients received the vaccine after the beyond use date. And their practice they got 3 package from drug safety to fill out paper work regarding those what they had reported. And she has 47 patients but they were only given 3 packets of 47 patients. Upon follow up on 22Jun2023, it was reported that the Covid 19 vaccine was given after the beyond use date. The medication error occurred when the product was administered to / taken by the patient. The error was not noticed and intercepted before the product was supplied to the patient. The factor considered to be responsible for the medication error was inadvertent Human error.  Follow up (03May2023): This is a spontaneous follow-up report received from a contactable other-HCP. This other-HCP reported for a patient that: Updated information included: Additional information.  Follow-up (03May2023): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported for a patient that: Additional information updated (6 patient involved in given LOT FX5095).  Follow-up attempts are completed. No further information is expected.  Follow-up (22Jun2023): This is a spontaneous follow-up report from a contactable Other HCP. Updated Information included: Reporter information, Patient details (Age and Age at vaccination), medical history, historical vaccine, suspect vaccine details, co-suspect, event onset date, new events (inappropriate schedule of vaccine administered and obesity) and additional information.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151565 same reporter, drug, and event; different patient;