Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered, Influenza like illness
Clinical narrative: flu-like symptoms; vaccine was given past expiration date of 10Apr2022, pt vaccinated on 14Jun2022; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 14Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FM0698, Expiration Date: 10Apr2022) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Corona virus", start date: 18Mar2020, stop date: 07Apr2020, notes: Corona virus. There were no concomitant medications. Vaccination history included: moderna (Dose 1), administration date: 07Jan2021, for Covid-19 Immunization; moderna (Dose 2), administration date: 04Feb2021, for Covid-19 Immunization; moderna (Dose 3), administration date: 20Sep2021, for Covid-19 Immunization.  The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 14Jun2022, outcome "unknown", described as "vaccine was given past expiration date of 10Apr2022, pt vaccinated on 14Jun2022"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Jun2022 at 15:00, outcome "recovered" (16Jul2022), described as "flu-like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: I am wondering if we need to revaccinate the patient or if the dose given on 14Jun2022 is good. Patient was vaccinated with adult gray top Pfizer for a booster dose. The vaccine expired on 10Apr2022 and was kept in fridge within the temperature threshold of 36F to 46F. Covid-19 vaccine temperature related enquiry by a customer. Product and customer information: Product description: Pfizer gray top vaccine. Batch/Lot number: FM0698. Expiry date: 10Apr2022  Date shipment arrived at customer & OBD reference number of shipment (if applicable): 18Jan2022. Number of product units impacted: 3. Customer type: Pharmacy (hospital or retail) Is the product diluted or undiluted: Undiluted. Where was the product stored when excursion occurred: Fridge (2-8 degree C) Maximum and minimum temperature reported/measured during excursion: Max: 46, Min: 36F. Duration of excursion: Days: 0,Hours: 0,Minutes: 0. If Pfizer has not delivered product to the customer location where excursion has occurred, provide the temperature data for the transport to this location to confirm this stock has not experienced any other/ previous excursions: Pfizer delivered to this location.  Follow-Up (06Jul2022): Follow-up attempts are completed. No further information is expected.  Follow-up (18Jul2022): This is a spontaneous follow-up report from a contactable other HCP. This other HCP (patient) reported in response to HCP letter via follow-up letter which included that: Updated information included: Added middle name for the reporter in slide#2 and updated this reporter as true reporter. Added full name for the patient. Age at vaccination added. Updated historical vaccines as Moderna as Dose 1, 2 and 3. Relevant medical history added. Suspect product time, dose number, route and anatomical location added, dose description updated. Vaccine Facility Information updated. Primary reporter (pharmacist) updated as Best doctor. Added new AE "Flu-like symptoms" with start and stop date, treatment received and Outcome. Concomitant Therapy captured as None added as per narrative.  Additional information: Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire: Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? No. The above vaccinations resulted in Flu - like symptoms for approximately 36 hours.