Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Pain, Pain in extremity, Poor quality product administered
Clinical narrative: temperature of 100.4; body aches; sore arm; who received their first dose of the Pfizer BioNTech Covid 19 vaccine that was used past its beyond use time; who received their first dose of the Pfizer BioNTech Covid 19 vaccine that was used past its beyond use time; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP) from medical information team.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 08Sep2021 09:30 (Lot number: EW0217) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 08Sep2021 09:30, outcome "unknown" and all described as "who received their first dose of the Pfizer BioNTech Covid 19 vaccine that was used past its beyond use time"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 09Sep2021, outcome "recovered" (10Sep2021), described as "temperature of 100.4"; PAIN (non-serious) with onset 09Sep2021, outcome "recovered" (10Sep2021), described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 09Sep2021, outcome "recovered" (10Sep2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient came into our office on 08Sep21 at approximately 9:30 am for her first COVID-19 Pfizer vaccination that was used past its beyond use time. She initially believed it expired between 1-3PM yesterday but didn't have the exact data. The vaccine was drawn up yesterday and was sitting in the vaccine refrigerator. Her medical assistant administered a vaccine that had expired the day before. Normally the expired vaccines were removed from the med room at the end of each day by another staff member, however for some unknown reason this did not occur, and the medical assistant unknowingly gave a vaccine that had been at the office approximately 24 hours (20 hours past the recommended time frame per Pfizer and temperature standards). Once the error was recognized, the patient was informed. She handled the situation very well and stated she did not even want to get the vaccine as she did have natural immunity from COVID-19, and she was only getting this as her employer was requiring her to do so. Upon follow-up with the patient, she did have an elevated temperature of 100.4, body aches, and a sore arm approximately 24 hours after the vaccine administration. This lasted pretty much the entire next day and by 10Sep21 (48 hours after vaccine administration), the patient felt back to normal, resolved after 24 hours and denied any symptoms. Patient reported that the expected symptoms related to receiving the vaccine. She does plan to come back for her second dose. Fifteen days post dose 1 administration, the patient was still symptom free and express no concern. The patient stated that she had COVID-19 in May of this year, however we had no record of this as the patient had just moved to (withheld) from (withheld) and contracted the virus during the move. Vaccination Facility Type was Doctor's Office/Urgent Care. Vaccine was not Administered at Military Facility. Prior Vaccinations (within 4 weeks) no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  Follow-up attempts are completed. No further information is expected.