Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Vaccination site bruising
Clinical narrative: Bruising at the injection site; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired/date on the paper was 15Jun2022; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired/date on the paper was 15Jun2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2022 at 14:20 as dose 4 (booster), 0.3 ml single (Lot number: FK9894) at the age of 62 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis C/ Chronic Hepatitis C" (ongoing); "Immunocompromised" (unspecified if ongoing). The patient's family history included: "family history of cancer" (unspecified if ongoing); "family history of heart disease" (unspecified if ongoing); "family history of diabetes" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE oral; ONDANSETRON oral; FAMOTIDINE oral; TRAZODONE oral; BACLOFEN oral; LIDOCAINE; FUROSEMIDE oral; KCL oral; SPIRONOLACTONE oral; ALBUTEROL [SALBUTAMOL] oral. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE, Lot number: FA6780, Given in ER , Route: Intramuscular, If other, please specify: Given elsewhere), administration date: 02Sep2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, 0.3 ML SINGLE, Lot number: FF8839, Expiration date: 31Dec202, Time: 17:36, Route: Intramuscular, Anatomical location: Left deltoid), administration date: 12Oct2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "hepatic cirrhosis", "hepatocellular carcinoma"; BNT162b2 (DOSE 3 (BOOSTER), 0.3 ML SINGLE, Lot number: FF8839, Expiration 31Mar2022, Time: 15:25, Route of administration: Intramuscular, Anatomical location: Right deltoid), administration date: 17Mar2022, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Aug2022 at 14:20, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired/date on the paper was 15Jun2022"; VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "Bruising at the injection site". Therapeutic measures were not taken as a result of poor quality product administered, product administration error.  Additional information: The report was related to a study or programme. Covid-19 gray cap vaccine that was administered to 5 patients while the vaccine was expired. The reporter said the patient was given in an afternoon clinic and not when seen by provider. The reporter confirmed that the patient received 4 Pfizer vaccines. The reporter reported that they got the vaccines from the Health Department and took out of the freezer and had a shorter amount of time and should have expired. The date on the paper was 15Jun2022 and she said she should have marked the box. She said the vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. No treatment was received, no problem and the reporter had not contacted him yet. The first dose was not given by them and given in the Emergency Room. The reporter said that she called to know what to do for the patients and if she needed to call them back. The reported declined to complete report on the 4 other patients. The reporter had not called the patients yet and wanted to find out what to do next. It was reported that no adverse event resulted. It was reported that chronic hepatitis C was ongoing. On 26Jan2022, Hepatic Cirrhosis and Hepatocellular carcinoma were diagnosed and were ongoing. The patient was administered with the booster dose due to a weakened immune system and current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas). They removed the Pfizer vaccine from their freezer and gave them a shortened shelf life, which was waxed on paperwork given to reporter, but not on the vial or box in which the Pfizer vaccine was stored-. Reporter did not note the corrected expiration date on the vaccine log they kept and ended up giving the expired vaccine - unknowing at the time that it was in fact expired. No testing was done specific to the administration of expired vaccine. No problem was noted by patient as result of administration of the expired vaccine. Upon follow-up on 26Sep2022, vaccination facility type was reported as Workplace Clinic. Vaccine was not administered at Military Facility. Vaccination facility address was (address withheld). Prior vaccination (within 4 weeks) included none. Patient's medical history stated as extensive history. Patient taken multiple meds (concomitant drugs) for quite some time. Reporter got some Pfizer gray top from Health Dept. and did not document sooner expiration date (10 weeks withdrawn) at time Pfizer was removed from freezer and placed into refrigerator. No problems were noted by patient, except some bruising at the injection site. Reporter was other, medical assistant.  Follow-Up (02Sep2022): Follow-up attempts are completed. No further information is expected.  Follow-up (08Sep2022): This is a spontaneous follow-up report received from the same contactable other HCP. This other HCP reported for the patient in response to HCP letter: Updated information: Reporter information updated. Medical history and family medical history added. Route of administration, anatomical location of suspect and vaccination facility details were added, Concomitant medications were added. Historical vaccine reactions added for dose 2. Clinical information updated.  Follow-up attempts are completed. No further information is expected.  Follow-up (26Sep2022): This is a spontaneous follow-up report received from the same contactable other HCP updated information included: Suspect vaccine onset time (14:20); vaccination facility information; new event (Bruising at the injection site); historical vaccines notes, and additional information was updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201070271 Same reporter/drug/event, different patient;US-PFIZER INC-202201099578 Same reporter/drug/event, different patient;