Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Blood test, Haemoglobin, Off label use, Product use issue
Clinical narrative: off label use; Product use for unapproved combination; Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pre Diabetic Blood Sugar Levels" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose: Date: 11Mar2021 Time: Not Provided Anatomical Site of injection: Not Provided Route of Administration: Not Provided, Batch/Lot number: EN6204), administration date: 11Mar2021, when the patient was 59-year-old, for COVID-19 immunization; BNT162b2 (2nd dose: Date: 06Apr2021 Time: Not Provided Anatomical Site of injection: Not Provided Route of Administration: Not Provided, Batch/Lot number: LW0151 or BW0151 or KW0151. States he can not make out the writing on the card of the first letter.), administration date: 06Apr2021, when the patient was 59-year-old, for covid-19 immunization. The following information was reported: ANAEMIA (non-serious) with onset 22Dec2022, outcome "recovering", described as "Anemia"; OFF LABEL USE (non-serious), outcome "unknown"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Product use for unapproved combination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anaemia.  Additional information: Agent stated she had a patient on the line calling because he received the Covid Bivalent on 14Oct2022. On 19Dec2022, he went for a routine annual physical and discovered he was anemic. He said he was a regular blood donor and could demonstrate he had high hemoglobin up until the time he received his vaccination. He wanted to report it. Caller stated he became aware of the anemia on 22Dec2022. He reported he had subsequent labs drawn 2 weeks later and he has been taking iron and his levels have marginally improved but they are still in the sub therapeutic range. Caller stated he has observed findings on public forums that concur with this occurrence happening so this was not unique to him. Caller was offered to speak with Medical Information. He stated not if it is just education material about the events that transpired. Caller states unless they have documented studies that offer alternative treatments than he is currently doing, he declines transfer. Call handler advises caller she doesn't have the information on what type of information they have. Patient received prior vaccinations (within 4 weeks):Flu Shot and Shingles Vaccine. Family Medical History Relevant to Adverse Events (AEs) was None. Specific Relevant Test for Thromboembolic events with Thrombocytopenia were none or unknown. The event require the initiation of new medication/other treatment.