Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Poor quality product administered, Product administration error, Rotator cuff syndrome
Clinical narrative: The product was opened for 24 hours and expired due to being opened x 24 hours and then was administered to 3 patients; The product was opened for 24 hours and expired due to being opened x 24 hours and then was administered to 3 patients; acute pain of right knee; tear of left rotator cuff; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 14:26 as dose 3 (booster), 0.3 ml single (Lot number: GH9693, Expiration Date: 29Nov2022) at the age of 57 years intramuscular, in right deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 21Oct2022 as dose 1, single (Lot number: UT7759JA) intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Nontraumatic incomplete tear of left rotator cuff", start date: 02Feb2021 (ongoing), notes: Noted: 02Feb2021, Resolved: present; "Osteoarthritis of left glenohumeral joint", start date: 02Feb2021 (ongoing), notes: Noted: 02Feb2021, Resolved: present; "Diabetes mellitus", start date: 03Sep2020 (ongoing), notes: Diabetes mellitus (HCC) (Chronic), Noted: 03Sep2020, Resolved: present; "Hypertension", start date: 03Sep2020 (ongoing), notes: Noted: 03Sep2020, Resolved: present; "Mixed hyperlipidemia", start date: 03Sep2020 (ongoing), notes: Noted: 03Sep2020, Resolved: present; "Hyperlipidemia" (unspecified if ongoing); "Urinary Symptoms" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "type 2 diabetes mellitus/Diabetes mellitus type 2 insulin dependent" (unspecified if ongoing); "Essential hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hyperglycemia" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Allergy to Sulfa" (unspecified if ongoing); "Rotator cuff impingement syndrome of left shoulder", start date: 25Feb2022 (ongoing), notes: Noted: 25Feb2022, Resolved: present; "Tendonitis of upper biceps tendon of left shoulder", start date: 25Feb2022 (ongoing), notes: Noted: 25Feb2022, Resolved: present; "Chronic pain in right shoulder/Left shoulder pain", start date: 13Sep2021 (ongoing), notes: Chronic pain in right shoulder, Noted: 13Sep2021, Resolved: present. Concomitant medication(s) included: NORVASC oral taken for essential hypertension, start date: 22Sep2020 (ongoing); LIPITOR oral taken for hyperlipidaemia, start date: 01Jun2021 (ongoing); CALCIUM CARBONATE AND VITAMIN D3 oral; CATAPRES [CLONIDINE] oral taken for essential hypertension, sleep disorder, anxiety, start date: 26Aug2021 (ongoing); FARXIGA oral taken for type 2 diabetes mellitus, start date: 27Jul2021 (ongoing); VOLTAREN EMULGEL topical; SENOKOT S oral taken for constipation, start date: 21Jul2022 (ongoing); BASAGLAR KWIKPEN taken for type 2 diabetes mellitus, hyperglycaemia, start date: 21Oct2022 (ongoing); COZAAR oral taken for hypertension, essential hypertension, start date: 24Sep2020 (ongoing); MOBIC oral; GLUPHAGE oral taken for type 2 diabetes mellitus, hyperglycaemia, start date: 19Apr2022 (ongoing); REGLAN [METOCLOPRAMIDE HYDROCHLORIDE] oral, start date: 16Sep2021 (ongoing); MACROBID [NITROFURANTOIN] oral taken for urinary tract disorder, start date: 08Feb2022 (ongoing); POLYETHYLENE GLYCOL 3350 oral taken for constipation, start date: 21Jul2021 (ongoing); VITAMIN C [ASCORBIC ACID] oral. Past drug history included: Losartan for Drug hypersensitivity. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: ER2613, Right Deltoid, Intramuscular), administration date: 31Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot number: EW0164, Right Deltoid, Intramuscular), administration date: 26Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "rotator cuff impingement syndrome of left shoulder", "tendonitis of upper biceps tendon of left shoulder", "left shoulder pain/ Chronic pain in right shoulder". The following information was reported: ARTHRALGIA (non-serious) with onset 21Oct2022, outcome "not recovered", described as "acute pain of right knee"; ROTATOR CUFF SYNDROME (non-serious) with onset 21Oct2022, outcome "not recovered", described as "tear of left rotator cuff"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 21Oct2022 at 14:26, outcome "unknown" and all described as "The product was opened for 24 hours and expired due to being opened x 24 hours and then was administered to 3 patients". Additional information: The caller reported that an expired Pfizer COVID-19 bivalent vaccine gray cap was administered to patient, vaccine was opened 24 hours then administered to patient. The product was opened for 24 hours and expired due to being opened x 24 hours and then was administered to 3 patients. The caller wanted to know what to do for the patients that received the vaccine. The caller noted that the product was punctured and stored in the refrigerator within the vial. 20Oct2022 vial was punctured at 08:20 and the 1st dose was given at 08:40 - 20 min outside of the 24 hours caller stated. This was the patient's 3rd dose total. First 2 doses patient received were the Pfizer COVID-19 vaccine purple cap, 12 and older. The caller clarified that the vaccine was administered to multiple patients. As far as expiration dates, on the bottle the expiration date was Jul2022. The expiration date caller was given was 29Nov2022, so had 3 expiration dates total, information caller was given was once the vial was opened, discard vial at end of day because vial was good for 10-12 hours, so this vial would have expired at 20:00 pm on 20Oct2022. No investigations were done. There was a Product complaint. The case was reported as non-serious. On 09Nov2022, it was reported that the patient did not provide information regarding the reported adverse events with the use of the product. Comments: 1. Lack of awareness to expiration date. 2. Dispensing. 3. Vaccine vial & remaining doses not wasted at the end of the previous shift. That gave vaccine did not ensure it was a new vial opened, just assumed at was. Not paying close enough attention when dispensing & preparing vaccine. 4. No adverse reactions have been reported.  Follow-up attempts are completed. No further information is expected.  Follow-up (24Oct2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported for a patient that: Updated information: Reporter details.  Follow-up attempts are completed. No further information is expected.  Follow up (09Nov2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported in response to HCP letter sent. Updated information included: reporter information updated, patient details (relevant medical history, past drug history, vaccination history), concomitant drug information, co-suspect drug added, suspect product information (vaccination time, anatomical location), event details (event onset time of Product administration error and Poor quality vaccine administered, new events Arthralgia and Rotator cuff syndrome) and clinical course.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201249461 same reporter/drug/event, different patients;US-PFIZER INC-202201250304 Same reporter/drug/event, different patient;