Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "currently recovering from nasal surgery" (unspecified if ongoing), notes: Other medical history: currently recovering from nasal surgery; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex; "Known allergies: bell pepper" (unspecified if ongoing), notes: Known allergies: bell pepper; "Known allergies: quinoa" (unspecified if ongoing), notes: Known allergies: quinoa; "Known allergies: pineapple" (unspecified if ongoing), notes: Known allergies: pineapple; "Known allergies: cantaloupe" (unspecified if ongoing), notes: Known allergies: cantaloupe. Concomitant medication(s) included: ARMOUR THYROID, start date: Jan2010.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jan2023) Negative, notes: I tested negative; (Jan2023) Positive, notes: the next day tested positive again; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:Paxlovid rebound. After taking my 5 day course symptoms were minimal and I tested negative. About 4 days later I became symptomatic again, with some new symptoms I hadn't had before and the next day tested positive again and remained positive and symptomatic for another 5 days after that. Patient received other medication in 2weeks. Treatment start date was 02Jan2023 and treatment Stop date was 07Jan2023.  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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.