Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Condition aggravated, Depression, Psoriasis, Rheumatoid arthritis
Clinical narrative: Hashimoto's thyroiditis; Hashimoto's thyroiditis; Rheumatoid arthritis; Psoriasis; Depression; This is a spontaneous report received from a Physician and a Consumer or other non HCP.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Lot number: HH7595) at the age of 55 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "long COVID", start date: Jul2022 (ongoing), notes: Developed after 1st COVID infection; "depression anxiety", start date: 1985 (ongoing); "Hashimoto's thyroiditis" (ongoing); "Graves Disease", start date: Jan2023 (ongoing), notes: developed Graves disease with Second COVID infection Jan2023; "Rheumatoid arthritis" (ongoing); "Psoriasis", start date: 2022 (ongoing); "weakened immune system" (unspecified if ongoing); "COVID-19", start date: Jul2022 (unspecified if ongoing); "COVID-19", start date: Jan2023 (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); ROPINIROLE oral taken for depression (ongoing); METHIMAZOLE oral taken for graves' disease, autoimmune thyroiditis (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Anatomical Site of injection: arm, Route of administration: intramuscular, Batch/Lot number: 011J20A), administration date: 23Dec2020, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2 (INITIAL PFIZER DOSE), SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EW0177), administration date: 04Aug2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "developed RLL Pneumonia", "Long COVID", "cognitive defects in shifting focus, concentration, working memory, immediate memory/inability to do basic math problems", "cognitive defects in shifting focus, concentration, working memory, immediate memory", "cognitive defects in shifting focus, concentration, working memory, immediate memory", "inability to read"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FL3198), administration date: 11Jan2022, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Graves' disease", "Psoriasis"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE , Batch/Lot number: GJ6739), administration date: 25Oct2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: DEPRESSION (non-serious) with onset Sep2023, outcome "unknown"; AUTOIMMUNE THYROIDITIS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Hashimoto's thyroiditis"; PSORIASIS (non-serious) with onset Sep2023, outcome "unknown"; RHEUMATOID ARTHRITIS (medically significant) with onset Sep2023, outcome "unknown".; Sender's Comments: The possible contribution of suspect drug BNT162B2 OMI XBB.1.5 to the serious events cannot be totally excluded. Patient underlying medical history may be a confounder. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400099201 Same reporter/patient/vaccine; different dose/events;