Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product administration error, Product temperature excursion issue
Clinical narrative: Right arm soreness; Caller confirmed that the vaccine was given 12 hours passed the 6 hour window after dilution; Caller states a pharmacist gave a dose to a patient that was expired by about 12 hours. vaccine was given 12 hours passed the 6-hour window after dilution//Received vaccine 12 hours after use by date; Caller confirmed that the vaccine was given 12 hours passed the 6 hour window after dilution/Received vaccine 12 hours after use by date; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 20 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 26Jan2022 11:00 (Lot number: 33036BD, Expiration Date: Jun2022) at the age of 20 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (The first dose was given on 06Apr2021.Lot, expiration and site of administration are unknown.), administration date: 06Apr2021, when the patient was 20 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose was given on 27Apr2021, Lot, expiration and site of administration are unknown), administration date: 27Apr2021, when the patient was 20 years old, for COVID-19 Immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 26Jan2022 11:00, outcome "unknown", described as "Caller confirmed that the vaccine was given 12 hours passed the 6 hour window after dilution"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 26Jan2022 11:00, outcome "unknown", described as "Caller states a pharmacist gave a dose to a patient that was expired by about 12 hours. vaccine was given 12 hours passed the 6-hour window after dilution//Received vaccine 12 hours after use by date"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 26Jan2022 11:00, outcome "unknown", described as "Caller confirmed that the vaccine was given 12 hours passed the 6 hour window after dilution/Received vaccine 12 hours after use by date"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Right arm soreness".  Additional information: Caller was a pharmacist calling regarding the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine. Caller states a pharmacist gave a dose to a patient that was expired by about 12 hours. Caller confirmed that the vaccine was given 12 hours passed the 6-hour window after dilution. Caller states the vaccine was diluted, stored in the vial at room temperature. Caller would like to know what he should do and if the dose should be repeated. He did talk to patient this morning, close to 24 hours after administration, and the only adverse effect was soreness in arm that was typical with immunization and there were no others. This was a booster dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: none. Adverse Event (AE) Details: Provide the time of onset of AE(s): Right arm soreness  Unknown. Received vaccine 12 hours after use by date-recovered. It was unknown- (when he talked to patient there was no indication of that) whether adverse event resulted in Emergency or physician office visit. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and AE(s) following prior vaccinations: Unknown. Patient's Medical History (including any illness at time of vaccination): None or Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity Illness/AE: Unknown. Family Medical History Relevant to AE(s) and Relevant Tests was reported as unknown. Other products: Unknown. Investigation assessment: No.  No follow-up attempts are possible. No further information is expected.