Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Constipation, Expired product administered, Gastrooesophageal reflux disease, Poor quality product administered
Clinical narrative: anemia; constipation; They gave to patients that were used beyond use date; They gave to patients that were used beyond use date; Dose administration date: 20Jan2023/Expiration date: 28Dec2022; suspect gastro-esophageal reflux disease; The initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 11Apr2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 7-month-old male patient received BNT162b2 (BNT162B2), on 20Jan2023 at 09:34 as dose 2 (maroon cap), single (Lot number: FT9142, Expiration Date: 28Dec2022) at the age of 7 months intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1st, Time: 09:59, Anatomical site of injection: Left thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 21Dec2022, when the patient was 6-month-old, for COVID-19 immunization; fluzone quadrivalent (Manufacturer: Sanofi, Batch/Lot# UT7695JA, Route: IM, Anatomical Site of Injection: Left thigh, No. of Previous Doses: 1), administration date: 21Dec2022, when the patient was 6-month-old, for Immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 20Jan2023, outcome "recovered" (21Mar2023), described as "suspect gastro-esophageal reflux disease"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 20Jan2023 at 09:34, outcome "unknown", described as "Dose administration date: 20Jan2023/Expiration date: 28Dec2022"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 20Jan2023 at 09:34, outcome "unknown" and all described as "They gave to patients that were used beyond use date"; ANAEMIA (non-serious) with onset 21Mar2023, outcome "not recovered", described as "anemia"; CONSTIPATION (non-serious) with onset 21Mar2023, outcome "not recovered".  Additional information: Reporter confirmed that vials were unpunctured prior to the administration of the vaccines. 5 Patients received Lot# FT9142, none received FX5095 as the 1st dose. Covid-19 monovalent vaccine dose#02 given beyond use date.  Follow-up (09May2023): Follow-up attempts are completed. No further information is expected.  Follow-up (23May2023): This is a spontaneous follow-up report from the same contactable Other HCP. This Other HCP reported for a 07 Moths old male patient in response to HCP letter sent which included that: Updated Information Included: Patient Information (Initials. DOB. Age. Height. Weight), Historical vaccine, Vaccine information [Dose administration date/time. Route of administration. Expiration date. Drug taken beyond expiry date. Anatomical location], Vaccine Facility Information, Event onset date, New AEs (Expired vaccine used, Gastrooesophageal reflux disease, Anemia and Constipation) added and narrative updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151563 same reporter/drug/event, different patient;US-PFIZER INC-202300151563 same reporter/drug/event, different patient;