Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested Covid-19 Positive; Tested Covid-19 Positive; Asthma; Cough; Fever; Feeling bad; 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-163-4247179-00.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154440) at unk (citrate free) for hidradenitis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "not recovered" and all described as "Tested Covid-19 Positive"; COUGH (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Cough"; PYREXIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Fever"; FEELING ABNORMAL (non-serious) with onset 30Dec2021, outcome "unknown", described as "Feeling bad"; ASTHMA (non-serious) with onset Jan2022, outcome "unknown", described as "Asthma". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive. The action taken for adalimumab was unknown. Clinical course: It reported the patient with events of non-serious tested covid-19 positive, cough, fever, feeling bad the same day after the covid-19 booster dose and asthma with Humira (Adalimumab). On 30Dec2021, the patient experienced cough, fever and feeling bad the same day after the covid-19 booster dose. In Jan2022, the patient experienced asthma. On 20Jan2022, the patient experienced tested covid-19 positive. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Unknown date, patient received a first and second dose of COVID-19 Vaccine manufactured by Pfizer/BioNtech. On 30Dec2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer/BioNtech.   Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the events of tested covid-19 positive, cough, fever, feeling bad the same day after the covid-19 booster dose and asthma was Possible.   Causality for Humira (Adalimumab): The reporter's causality for the events of tested covid-19 positive, cough and fever with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of feeling bad the same day after the covid-19 booster dose and asthma was not provided.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE, covid-19, COUGH, PYREXIA, FEELING ABNORMAL, and ASTHMA and BNT162B2.