Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Poor quality product administered, Product administration error
Clinical narrative: A dose of the vaccine was given to the patient after being stored at room temperature in a syringe for more than 12hrs. Additional to the allowable 12hrs, vaccine was left for an additional 16hrs.; A dose of the vaccine was given to the patient after being stored at room temperature in a syringe for more than 12hrs. Additional to the allowable 12hrs, vaccine was left for an additional 16hrs.; very tired; body aches; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 76-year-old male patient received BNT162b2 (COMIRNATY), on 18Mar2022 at 13:30 as dose 2, 30 ug single (Lot number: FJ5683) at the age of 76 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL TARTRATE ACCORD oral taken for heart rate decreased, start date: 16Dec2021 (ongoing); FERROUS SULFATE oral taken for mineral supplementation, start date: 29Dec2021 (ongoing). Vaccination history included: comirnaty (as dose 1, single, Time: 13.31, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: FJ5683), administration date: 25Feb2021, for COVID-19 immunisation. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 18Mar2022 at 13:30, outcome "unknown" and all described as "A dose of the vaccine was given to the patient after being stored at room temperature in a syringe for more than 12hrs. Additional to the allowable 12hrs, vaccine was left for an additional 16hrs."; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "very tired".  Additional information: The pharmacist wanted to report an administration error for Pfizer-BioNTech COVID-19 vaccine (gray cap). Reporter stated that a dose of the vaccine was given to the patient after being stored at room temperature in a syringe for more than 12 hours. Additional to the allowable 12 hours of storage, they left the vaccine for an additional 16 hours. The pharmacist then asked for stability information on the vaccine, what to do if they have to repeat a dose, and revaccination guidelines after having a patient receive the second dose 16 hours after the use-by-date. The reporter assessed the events as serious, medically significant and reported the relatedness of the drug to the events as unrelated. The pharmacist felt it was significant as it was past its expiration time. Stated they mistakenly kept it in the "fridge" (as reported) longer than they should have. Upon follow-up 12Apr2022 it was reported that the patient did not provided information regarding the reported adverse event(s) with the use of the product. Vaccination Facility Type: Public health clinic / Facility. No Prior Vaccinations (within 4 weeks). No relevant tests. The type of Medication error was patient received correct drug and dosage but covid vaccine was out of date range in refrigerator by 28 and ½ hours. Stability is the issue here. The type of error is the preparation of the covid 19 vaccine , as stated above vaccine was drawn up in syringe kept in the refrigerator but the date was expired for the vaccine. Again, it is all about stability of the product that was given to the patient, it was 28and ½ hours. The medication error happened because the syringe with vaccine in it was not removed at the end of day nor removed first thing in the morning and destroyed. Since this happened we have change our process and the person who fills out the covid tracker daily now destroyed the unused Vaccine at night. The patient was not affected physically. The patient did received an unstable vaccine but when I spoke to patient he said he got very tried and body ache for 2days after covid injection. patient was taking that as good news as the injection of covid 19 was doing its job. At this time his Provider does not want to give him a second shot of vaccine due to patient had signs that the vaccine worked. We have decided to just let him received his booster shot when due and patient is fine with his. No clinical consequence on the patients part.  The lot number for BNT162B2 was not provided and will be requested during follow up.  Follow-up (12Apr2022): This is a spontaneous follow-up report received from a contactable Pharmacist This Pharmacist reported for a 76-year-old male patient. Updated information included: New reporter information in slider#02, patient information (AGE), (Vaccination information in chart), new event, concomitants drug.  No follow-up attempts are possible. No further information is expected.