Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dx acute Covid Jan2024/acute Covid Positive/rebounded after Paxlovid Jan2024; Dx acute Covid Jan2024/acute Covid Positive/rebounded after Paxlovid Jan2024; This is a spontaneous report received from a Physician and a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Lot number: HH7595) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "depression", start date: 1985 (ongoing); "anxiety", start date: 1985 (ongoing); "Hashimoto's Disease" (ongoing); "Thyroiditis" (ongoing), notes: Illness/AE: Hashimoto's thyroiditis, Stop Date: ongoing; "Rheumatoid arthritis" (ongoing); "1st COVID infection/diagnosed with acute COVID", start date: Jul2022 (unspecified if ongoing), notes: developed RLL Pneumonia; "developed RLL Pneumonia", start date: Jul2022 (not ongoing); "2nd COVID infection", start date: Jan2023 (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); METHIMAZOLE oral taken for graves' disease, autoimmune thyroiditis (ongoing); ROPINIROLE oral taken for depression (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, lot number: 011J20A, intramuscular in the arm), administration date: 23Dec2020, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, lot number: EW0177, intramuscular in the arm), administration date: 04Aug2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, lot number: FL3198, intramuscular in the arm), administration date: 11Jan2022, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "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", "Psoriasis"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Lot number: GJ6739 (Pfizer bivalent)), administration date: 25Oct2022, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "Graves' disease". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Dx acute Covid Jan2024/acute Covid Positive/rebounded after Paxlovid Jan2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Normal High; (Jan2024) positive, notes: Rebound acute Covid Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  Clinical course: Dose 5 was given on 08Sep2024 (as reported, pending clarification). Paxlovid acute unapproved symptoms but symptoms Dx acute Covid Jan2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-PV202400099201 Same reporter/patient/vaccine; different dose/event;