Reporte zur Charge 017F21AFM9992

Symptomtext

COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 23-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: 017F21AFM9992) at the age of 23 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Hydronephrosis" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "dairy" (unspecified if ongoing), notes: Reaction: Allergy: dairy. Concomitant medication(s) included: ALLEGRA, start date: 01Jan2015; LEXAPRO, start date: 01Aug2020; PRILOSEC [OMEPRAZOLE], start date: 01Jan2021; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, start date: 03May2022; TIVICAY, start date: 03May2022; also reported as patient received other medications in two weeks of starting COVID-19 treatment. Past drug history included: Nsaids, reaction(s): "NSAIDs: Drug Allergy"; Amoxicillin, reaction(s): "amoxicillin: Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative for 8 days; Positive, notes: positive on Day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 treatment started on 17May2022 and stopped on 22May2022. Clinical course was reported as, Paxlovid rebound. Tested positive on Day 9 after negative for 8 days, on 26May2022. No treatment received for symptoms and patient was recovering from symptoms. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.