Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Name of Drug as Reported: Janssen/Name of Drug as Reported:Pfizer / BioNTech; Name of Drug as Reported: Janssen/Name of Drug as Reported:Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 2, single (Batch/Lot number: unknown) and on 10May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left ventricle dysfunction" (unspecified if ongoing); "tricuspid regurgitation" (unspecified if ongoing); "mitral regurgitation" (unspecified if ongoing); "aortic regurgitation" (unspecified if ongoing); "hyperparathyroidism" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "thyroid nodule" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing); "colon polyps" (unspecified if ongoing); "seizure disorder" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depressive disorder" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Iodinated agents" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]; COENZYME Q10 [UBIDECARENONE]; ESCITALOPRAM; GABAPENTIN; IBUPROFEN; LACTOBACILLUS RHAMNOSUS; MAGNESIUM CITRATE; MELATONIN; METOPROLOL TARTRATE; ROSUVASTATIN, stop date: 20May2022; VITAMIN B COMPLEX; ASCORBIC ACID. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Name of Drug as Reported: Janssen/Name of Drug as Reported:Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive; (01Jun2022) Positive; (28May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient developed symptoms of Covid-19 on 17May22, tested positive at home on 19May2022. Prescribed Paxlovid 20May22 and recovered. Reports she tested negative on rapid antigen test on 28May2022. Developed fatigue, headache and increased congestion on 31May2022. Tested positive for COVID-19 on home test on 01Jun2022. other medical history included left ventricle dysfunction, tricuspid regurgitation, mitral regurgitation, aortic regurgitation, hyperparathyroidism, hypercholesterolemia, thyroid nodule, obstructive sleep apnea, colon polyps, seizure disorder, PTSD, depressive disorder, osteopenia.  Additional information: Patient was not received other medication in 2weeks. She received Anti viral product-COVID 19 Treatment, brand-PaxlovidTreatment start date-20May2022 and stop date-24May2022. The information on the batch/lot number for BNT162b2 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 events Drug ineffective and covid 19 with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.