Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Poor quality product administered, Product administration error
Clinical narrative: Caller states the Vaccine vial was Punctured and left on the counter at room temperature yesterday, 03May2023, at 8:52am and was administered today, 04May2023, at 9:40am; Caller states the Vaccine vial was Punctured and left on the counter at room temperature yesterday, 03May2023, at 8:52am and was administered today, 04May2023, at 9:40am; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 at 09:34 as dose number unknown (booster), single (Lot number: GJ3268, Expiration Date: 06May2023) intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Coronary Artery Disease", start date: 26Aug2011 (ongoing); "Depression Disorder", start date: 02Feb2012 (ongoing); "Sleep Apnea", start date: 10Oct2014 (ongoing); "Chronic Atrial Fibrillation", start date: 31Jul2017 (ongoing); "Congestive Heart Failure" (unspecified if ongoing); "Urinary Frequency" (unspecified if ongoing). Concomitant medication(s) included: DEMADEX [TORASEMIDE] oral taken for cardiac failure congestive, start date: 04May2023; PROSCAR oral taken for pollakiuria, start date: 01May2023, stop date: 01Jun2023; CELEXA [CITALOPRAM HYDROBROMIDE] oral taken for depression, start date: 01May2023. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 04May2023 at 09:34, outcome "unknown" and all described as "Caller states the Vaccine vial was Punctured and left on the counter at room temperature yesterday, 03May2023, at 8:52am and was administered today, 04May2023, at 9:40am"; DYSPNOEA (non-serious) with onset 2023, outcome "unknown", described as "Shortness of breath". The event "shortness of breath" required physician office visit.  Additional information: The reporter stated that vaccine vial was punctured and left on the counter at room temperature on 03May2023, at 8:52am and was administered on 04May2023, at 9:40am. Clinic Manager called because they have a medical assistant who gave an Adult Pfizer Covid-19 Vaccine Bivalent that has been sitting out from last night so it was 12 hours and they wondered the patient was with them for over half hour and reaction seem fine and they wondered what is the efficacy of the product or if they should tell the patient about potentially having to repeat the dose. Prior Vaccinations was none. Family Medical History Relevant to Adverse Events (Aes) was none. Relevant Tests and Specific Relevant for Thromboembolic Events with Thrombocytopeniast was none. Patient was seen in clinic for shortness of breath. Due to multiple medical conditions provider ordered booster Pfizer bivalent vaccine. Vaccine had been sitting out all night and was not viable but was given believing it was taken out that morning. No adverse reaction was noted. Contacted patient, spoke to draught and gave information about vaccine and told to repeat. Daughter noted no adverse reaction since injection and understanding of next steps.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (13Jun2023): This is a spontaneous follow-up report received from a contactable consumer. This consumer re-ported in response to non-HCP letter sent which included that: Updated information included: Patient full name, Relevant med history, vaccine information updated, vaccine facility information, Concomitant drugs added. Event onset time updated, new event added.