Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory viral panel, SARS-CoV-2 test
Clinical narrative: subject tested positive for COVID-19; subject tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 1, 30 ug single (Batch/Lot number: unknown) and on 17Nov2021 as dose 2, 30 ug single (Batch/Lot number: unknown) at the age of 23 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Vitamin D deficiency" (ongoing); "Allergic rhinitis" (ongoing); "Transient visual loss", start date: 01Aug2018, stop date: 25Mar2019; "Cardiac murmur", start date: 14Jun2012 (ongoing); "Priapism" (unspecified if ongoing); "Cholelithiasis", start date: Dec2015, stop date: 18Jan2016; "Port insertion", start date: 12Nov2012 (unspecified if ongoing); "Sickle cell nephropathy", start date: 09Mar2017 (ongoing); "Retinal thinning", start date: 05Sep2018 (ongoing); "Arterial stenosis", start date: 28Sep2018 (unspecified if ongoing), notes: Moderate stenosis of A1 segment of RACS and supraclinoid segment of LICA; "Intermittent headache" (ongoing); "Sickle cell disease", start date: 06Mar2020 (unspecified if ongoing); "DVT prophylaxis" (unspecified if ongoing); "Stenosis", start date: 28Sep2018 (unspecified if ongoing); "Hypokalemia" (unspecified if ongoing); "Intermittent abdominal pain", start date: 06Jan2020, stop date: 06Feb2020; "Intermittent hypoxia while on narcotics" (ongoing); "PE" (unspecified if ongoing); "Sickle cell disease/Pre-oxbryta VOC" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID oral taken for sickle cell disease (ongoing); GLUTAMINE [LEVOGLUTAMIDE] oral taken for sickle cell disease, start date: 03Jun2019 (ongoing); HYDROXYUREA oral taken for sickle cell disease, start date: 26Sep2016 (ongoing); ERGOCALCIFEROL D2 oral taken for vitamin d deficiency (ongoing); ELIQUIS oral taken for pulmonary embolism, thrombosis prophylaxis, sickle cell disease, start date: 17Mar2021, stop date: 15Nov2021; MORPHINE oral taken for sickle cell disease, start date: 13Dec2019, stop date: 20May2022; OXYCODONE oral taken for sickle cell disease, start date: 06Nov2020, stop date: 20Dec2021. Past drug history included: Morphine, start date: 31Aug2018, stop date: 13Dec2019, for Sickle cell disease, notes: Indication (select all that apply): SCD(Sickle cell disease), Dose: 15, Dose Unit: mg, Frequency: BID (twice a day), Route: Oral; Crizanlizumab-tmca, start date: 30Apr2020, stop date: 18Jun2020, for Sickle cell disease, notes: Indication (select all that apply): SCD(Sickle cell disease), Dose: 300, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: q4w (every 4 weeks ), Route: Intravenous; Terbutaline (brethine), start date: 01Jun2017, stop date: 15Aug2019, for Sickle cell disease, notes: Indication (select all that apply): SCD (Sickle cell disease)/Other (Specify), Indication Specify: Priapism, Dose: 2.5, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: QD(once a day) and as needed, Route: Oral; Terbutaline (brethine), start date: 01Jun2017, stop date: 15Aug2019, for Priapism, notes: Indication (select all that apply): SCD/Other (Specify), Indication Specify: Priapism, Dose: 2.5, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: QD(once a day) and as needed, Route: Oral; Oxycodone ir, start date: 26Sep2016, stop date: 06Nov2020, for Sickle cell disease, notes: Dose: 10, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: q4h(every 4 hours)  PRN (as needed), Route: Oral; Cyclobenzaprine (flexeril), start date: 07May2021, stop date: 06Jun2021, for Sickle cell disease, notes: Indication (select all that apply): SCD/Adverse Event, Dose: 5, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: BID(twice a day) PRN (as needed), Route: Oral; Ibuprofen, start date: 11Nov2015, stop date: 08Apr2021, for Sickle cell disease, notes: Indication (select all that apply): SCD (Sickle cell disease), Dose: 400, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: Q6H (every 6 hours)  PRN (as needed), Route: Oral; Acetaminophen, start date: 15Aug2019, stop date: 10Sep2019, for Sickle cell disease, notes: Indication (select all that apply): SCD (Sickle cell disease0, Dose: 325, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: Q4H (every 4 hours)  PRN (as needed), Route: Oral; Morphine, start date: 10May2019, stop date: 11May2019, for Sickle cell disease/ Pre-oxbryta VOC, notes: Indication (select all that apply): SCD (Sickle cell disease), Dose: 15, Dose Unit: mg, Frequency: BID (twice a day), Route: Oral; Hydromorphone, start date: 17Oct2019, stop date: 17Oct2019, for Sickle cell disease/Pre-oxbryta VOC, notes: Indication (select all that apply): , SCD (Sickle cell disease), Other (Specify, Indication Specify: Pre-oxbryta VOC, Dose: 2, Dose Unit: mg, Frequency: TID (three times a day), Route: Intravenous; Morphine, start date: 26Sep2019, stop date: 26Sep2019, for Sickle cell disease, notes: Indication (select all that apply): , SCD (Sickle cell disease), Indication Specify: Pre-oxbryta VOC, Dose: 10, Dose Unit: mg, Frequency: Once, Route: Intravenous; Morphine, start date: 27Jul2021, stop date: 27Jul2021, for Sickle cell disease, notes: Indication (select all that apply): , SCD (Sickle cell disease), Dose: 10, Dose Unit: mg, Frequency: Once, Route: Intravenous; Morphine, start date: 30Jul2021, stop date: 30Jul2021, for Sickle cell disease, notes: Indication (select all that apply): , SCD (Sickle cell disease), Dose: 10, Dose Unit: mg, Frequency: Once, Route: Intravenous; Eliquis, start date: 10May2019, stop date: 11May2019, for Sickle cell disease/Pre-oxbryta VOC, notes: Indication (select all that apply): , SCD (Sickle cell disease), Other (Specify, Indication Specify: Pre-oxbryta VOC, Dose: 10, Dose Unit: mg, Frequency: Other (Specify), Other Frequency Specify: 2 doses given, Route: Subcutaneous. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "subject tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Respiratory viral panel: (23Jun2020) Negative; SARS-CoV-2 test: (unspecified date) Negative, notes: Rapid covid test negative; (09Jan2022) Positive, notes: rapid test COVID+/presented again and tested positive for COVID.  Clinical course: On 03May2022, patient received another dose of Pfizer Covid-19 Vaccine (30 mcg, Single) via intramascular route for Covid-19 Prophylaxis. Patient tested positive for COVID-19 on a rapid test at on 09Jan2022, but had no complaints of URI symptoms at time of admission. COVID-19 tests on 22Jun and 26Jun were both negative, and a full respiratory viral panel on 23Jun2020 was also negative. On 09Jan2022, patient presented again and tested positive for COVID. While patient was COVID-19 positive, patient had no complaints of URI symptoms at time of admission. Patient was also started on Enoxaparin prophylaxis given COVID infection and h/o DVT/PE. Patient had a negative rapid COVID-19 test.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events drug ineffective, COVID-19 and BNT162B2 is considered possible.,Linked Report(s) : US-PFIZER INC-202300194718 Same patient/vaccine, different event and dose;