Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Exposure to SARS-CoV-2, Respiratory tract congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Respiratory tract congestion; COVID-19 virus test positive/Cough; COVID-19 virus test positive/Cough; Exposure to COVID-19; PROGRAM NAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4246336-00.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single and intramuscular, administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient had no relevant medical history. It was unknown if patient was enrolled in a COVID-19 vaccine trial. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "Augmentin allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "not recovered" and all described as "COVID-19 virus test positive/Cough"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Exposure to COVID-19"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "Respiratory tract congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive. The action taken for adalimumab was unknown. Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. The case was assessed as non-serious.  Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of patient was exposed to covid, covid positive, congestion and cough unknown onset and congestion and cough unknown onset was not provided.  Causality HUMIRA (ADALIMUMAB) 1. Exposure to COVID-19 (Exposure to SARS-CoV-2)  Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): not reported Dechallenge: n/a  2. COVID-19 virus test positive (SARS-CoV-2 test positive)  Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): not reported Dechallenge: n/a  3. Respiratory tract congestion (Respiratory tract congestion)  Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): not reported Dechallenge: n/a  4. Cough (Cough)  Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): not reported Dechallenge: n/a  Pfizer biotech COVID-19 vaccine (TOZINAMERAN)  1.Exposure to COVID-19 (Exposure to SARS-CoV-2)  Causality as per reporter (drug/vaccine): Possible Dechallenge: n/a  2. COVID-19 virus test positive (SARS-CoV-2 test positive)  Causality as per reporter (drug/vaccine): Possible Dechallenge: n/a  3.Respiratory tract congestion (Respiratory tract congestion)  Causality as per reporter (drug/vaccine): Possible Dechallenge: n/a  4. Cough (Cough)  Causality as per reporter (drug/vaccine): Possible Dechallenge: n/a  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.