Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: patient is not feeling to well today; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Jul2022 at 16:38 as dose 4 (booster), 0.3 ml single (Batch/Lot number: FP7139, Expiration Date: 31Dec2022) at the age of 60 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: BASAGLAR subcutaneous taken for diabetes mellitus, start date: Jan2021; METFORMIN; ATORVASTATIN; LISINOPRIL; GLIMEPIRIDE; FENOFIBRATE; ESCITALOPRAM. Vaccination history included: influenza quadrivalent (Family Medical History Relevant to AE(s): No, Patient had one prior vaccination listed in (state name) database that caller can see. Only other vaccine was a Influenza quadrivalent on 02Oct2018.), administration date: 02Oct2018; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2 (1st COVID-19 Vaccine booster), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 07Jul2022 at 16:38, outcome "unknown", described as "patient is not feeling to well today".  Addition information: The report was not related to a study or programme. Reaction / Event as Reported by the Primary Source for Translation: given 27 hours after first puncture of the vial. Caller's first fill of this medication was Jan2021. Dosage text: 14 units injection subcutaneous twice daily. Vaccine was given 07Jul2022 at 4:38 pm. Caller has not spoken with the patient since he left and he hasn't called the caller to report anything. This was the patient's 2nd booster dose of the COVID-19 Vaccine. Patient got the other vaccines in a different state. Patient had his card with him and told the caller that he got his 1st COVID-19 Vaccine booster at the hospital. Patient didn't have proof of first booster dose due to the facility not documenting anything on his vaccine card and the caller cant see anything in the (state name) database. Caller does not know the manufacturer for the patient's previous vaccinations. Expiration date: The beyond use date from when the vaccine was put in the refrigerator was 26Aug2022. Concomitant Medications: Caller does not have time to go through and tell Pfizer what the medications are used for or when he started taking the medications. The patient received Prevnar 20 (Manufacturer Unknown, Lot Number / Expiry Date: FJ2602/ 30Jun2023), intramuscular injection right arm/deltoid. The patient received Shingrix (Manufacturer Unknown, Lot Number / Expiry Date: 39YM7/ 01Sep2023), intramuscular injection left deltoid. The patient received Heplisav-B (Manufacturer: unknown, Lot Number / Expiry Date: 937233/ 11Mar2023), Intramuscular injection right deltoid. The patient received Adacel (Manufacturer: unknown, Lot Number / Expiry Date: U6923AA/ 21Jan2023), intramuscular injection left deltoid. Relevant Tests was none. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none, patient had one prior vaccination listed in database that caller can see. Only other vaccine was a Influenza quadrivalent on 02Oct2018. Caller asks if he follow's up and he has any other adverse reaction, can caller call and make a follow up report. He states with getting five vaccinations, he is sure the patient is not feeling to well today. Which is expected. He states being that this was given out of specification he will call the patient and tell the patient to come in and get another dose which is recommend from guidance from the CDC.