Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Product COVID 19 Treatment, brand Paxlovid/vaccine brand Pfizer / BioNTech; Product COVID 19 Treatment, brand Paxlovid/vaccine brand Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1 , single (Lot number: EH9899), in right arm, on 07Jan2021 as dose 2, single (Lot number: EL3246), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies; Sulfa" (unspecified if ongoing); "Thyroid cancer on thyroid replacement" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Mild Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: 18Apr2022, stop date: 25Apr2022; FLONASE; ALBUTEROL [SALBUTAMOL SULFATE]; LEVOTHYROXINE; FEXOFENADINE; CALCIUM; VITAMIN D [COLECALCIFEROL]; FLUTICASONE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "Product COVID 19 Treatment, brand Paxlovid/vaccine brand Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Negative; (09May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course:  Report about covid treatment: Yes Reporter type:  Patient is pregnant Not Pregnant If vaccine received: Yes Other medications in two weeks: Yes Anti-viral details Product= Covid-19 treatment Brand=Paxlovid Treatment start date= 26Apr2022 Treatment stop date= 01May2022 Indication= Treatment of Covid-19    Covid vaccine details Vaccine brand= Pfizer / BioNTech Vaccine brand unknown= False Vaccine administration date= 29Sep2021 Vaccine lot number= EW0191 Vaccine lot unknown= False Vaccine dose Number= 3 Vaccine dose number unknown= False    Vaccine Location= Right arm         Vaccine brand= Pfizer / BioNTech Vaccine brand unknown= False Vaccine administration date= 07Jan2021 Vaccine lot number= EL3246 Vaccine lot unknown= False Vaccine dose Number= 2 Vaccine dose number unknown= False    Vaccine Location= Left arm    Vaccine brand= Pfizer / BioNTech Vaccine brand unknown= False Vaccine administration date= 17Dec2020 Vaccine lot number= EH9899 Vaccine lot unknown= False Vaccine dose Number= 1 Vaccine dose Number Unknown= False Other medication details Other medication in 2 weeks product= Fluticasone Other medication in 2 weeks brand= Flovent Other medication in 2 weeks start date= 18Apr201 Other medication in 2 weeks lot No= 25Apr2022            Other medication in 2 weeks product= Fluticasone Other medication in 2 weeks product=  Flonase    Other medication in 2 weeks product= Albuterol  Other medication in 2 weeks product= Levothyroxine Other medication in 2 weeks product= Fexofenadine   Other medication in 2 weeks product= Calcium Other medication in 2 weeks product= Vitamin D   Adverse event: I believe I experienced rebound COVID infection after Paxlovid. I completed the course on 5/1, tested neg on 5/2, and then started having sx again on 5/8 (sinus congestion); tested positive w/a home antigen test on 5/9 and went on to experience sinus congestion/pain for the next 4 days. I had to go into quarantine for the 2nd time in 2 weeks; I couldn't go to work, but was able to work from home. adverse event Adverse event start date: 08May2022   Ae resulted in: None of the above If patient recovered: Recovering If treatment ae: No    Known allergies: Sulfa Other medical history:  Asthma/hx thyroid cancer on thyroid replacement/Allergic rhinitis/mild hyperlipidemia, no meds; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the vaccination failure , covid-19 cannot be completely excluded.