Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Immunisation, Off label use
Clinical narrative: cough after two months it stopped, and started back; had booster shot in 2021; had booster shot in 2021; This is a solicited report based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4085446-00).  A contactable consumer (patient herself) reported a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) (at the age of 64-years-old) as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine via an unspecified route of administration on 2021 (Batch/Lot number was not reported), as single dose for immunization and adalimumab (HUMIRA solution for injection in pre-filled syringe), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, as citrate free for moderate to severe rheumatoid arthritis. Medical history included asthma and rheumatoid arthritis. Concomitant medication included hydrocortisone (CORTIZONE) taken for unknown indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 64-years-old); both intramuscular and for COVID-19 immunisation and experienced bad foot problems lost all functions of toes, nine toe fracture, dietary restrictions, did not felt great with grains, dark veggies, cough, pain in hip, angst in body sounds like body was fighting itself. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had booster shot in 2021 and got flu shot. In 2021, she had cough after two months it stopped and started back. She takes inhaler for life history of asthma. The action taken in response to the events for adalimumab was unknown. Outcome of event was not recovered. The reporter assessed the event as Other medically important condition.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of cough and with Humira (Adalimumab) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Cough" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.