Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: problems with rheumatoid arthritis during bad weather; tired; Inflammation; Itching all over; pain in joints at times; body aches/ pain; diarrhea; cold symptoms; Sinus infection; Vaccination site pain; Pain stomach; This is a non-interventional study report from the marketing program received from a non-contactable consumer and a physician based on information received by Pfizer (manufacturer control number: 21K-163-3847510-00) that: A 55-year-old female consumer (patient) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), dose 1 intramuscular on 01May2021 (Batch/Lot number was not reported) at the age of 55-year-old as DOSE 1, SINGLE, dose 2 intramuscular on 07Jun2021 (also reported as on 07Jul2021, pending clarification) (Batch/Lot number was not reported) at the age of 55-year-old as DOSE 2, SINGLE for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from 30Jul2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg, weekly for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On an unknown date she was tired, had inflammation, itchy all over, after taking covid-19 vaccine, pain in joints at times, during cold weather, body aches/pain, diarrhea, cold symptoms and sinus infection. Upon follow up (09Jul2021) & (06Aug2021) the patient experienced Vaccination site pain and pain in stomach on an unknown date. The patient was treated with Vitamin C. Solicited report from the USA by a consumer of an adult female with events of non-serious leaking HUMIRA pen in Mar2021 and problems with rheumatoid arthritis during bad weather with HUMIRA (adalimumab). There was no reported medical history. On unknown dates, the patient experienced leaking HUMIRA pen and problems with rheumatoid arthritis during bad weather. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01May2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On 07Jun2021, she received second dose COVID-19 Vaccine manufactured by Pfizer. The action taken for adalimumab was unknown. The outcome of inflammation was recovering and other events it was unknown.  The reporter causality between bnt162b2 and events for tiredness, Itching all over, General body pain, Diarrhea, Cold symptoms, Sinus infection were not reported, for Inflammation, Painful joints as no reasonable possibility, for Rheumatoid arthritis was possible.  No follow-up attempts are possible. No further information is expected.  Follow up(09Jul2021 and 06Aug2021): New information received from the same consumer (Patient) includes: Suspect (BNT162B2) dosage regime was added, New events added (Vaccination site pain and pain in stomach), Event outcome for Inflammation was updated to recovering from unknown, causality and clinical course was updated.'  The reporter causality between bnt162b2 and events for tiredness, Itching all over, General body pain, Diarrhea, Cold symptoms, Sinus infection were not reported, for Inflammation, Painful joints as no reasonable possibility.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Sep2021): New information received from a contactable consumer based on the information received by Pfizer (Manufacturer Control No: 21K-163-4051133-00) included: Vaccine information, new events (rheumatoid arthritis) and event details, reporter's causality assessment for event rheumatoid arthritis.  Causality as per reporter (Drug/Vaccine) of Adalimumab for device leakage was not reported, for Rheumatoid arthritis was no Reasonable possibility. Causality as per reporter (Drug/Vaccine) of Pfizer Biontech Covid-19 Vaccine for device leakage not reported, for Rheumatoid arthritis was possible.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between events  rheumatoid arthritis, fatigue,inflammation,pruritus,arthralgia,pain,diarrhoea,nasopharyngitis,sinusitis, vaccination site pain, and upper abdominal pain and suspect product BNT162B2 cannot be 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.