Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Colitis ulcerative, Condition aggravated, Diarrhoea, Haematochezia
Clinical narrative: upset stomach; headache; Fever; Flair ups diarrhea; Ulcerative colitis aggravated; Blood in stool; Flare ups increased to once a week; got sick; nauseous; diarrhea; sore arm on covid vaccine shot; This is a solicited report from a non-interventional based on the information received by Pfizer from AbbVie manufacture number (21K-163-4097881-00). This is a non-interventional study report from the marketing program marketing program received from a contactable consumer or other non-health care professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number/ Lot number: not reported) via intramuscularly on 01Mar2021 (at the age of 41 years) as DOSE 1, SINGLE for covid-19 immunization and also received adalimumab (HUMIRA) (Lot number: 1143997) via subcutaneously on an unspecified date at weekly, at unspecified dose for moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe ulcerative colitis and non infectious intermediate posterior and panuveitis. Relevant medical history included: Moderate to Severe Rheumatoid arthritis, Moderate to Severe chronic plaque psoriasis, Moderate to Severe ulcerative colitis, non infectious intermediate posterior and panuveitis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. On an unspecified date in 2021, the patient experienced flare ups increased to once a week, got sick with diarrhea and nauseous, sore arm on covid vaccine shot, flair ups diarrhea and blood in stool. In Mar2021, the patient experienced first vaccine caused upset stomach, headache and fever. The action taken with adalimumab was unknown. Outcome of events blood in stools, flair up diarrhea and ulcerative colitis was not recovered, flare ups increased to once a week was recovering and outcome of rest of the events was recovered on an unspecified date in 2021.  Causality as per reporter HUMIRA: The reporters assessment of the causal relationship of flare ups increased to once a week, sore arm on covid vaccine shot, got sick with diarrhea and nauseous onset in 2021, flair ups diarrhea and blood in stool unknown onset, got sick with diarrhea and nauseous onset in 2021, first vaccine caused upset stomach, headache and fever onset in Mar2021, first vaccine caused upset stomach, headache and fever onset in Mar2021, first vaccine caused upset stomach, headache and fever onset in Mar2021 was not provided. Since no determination has been received, the case is managed based on the company causality assessment.  Causality as per reporter PFIZER BIONTECH COVID-19 VACCINE: The reporters assessment of the causal relationship of flare ups increased to once a week, Blood in stool and Diarrhea aggravated with the bnt162b2 was not reported and the reporters assessment of the causal relationship of got sick with the 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 reporters assessment of the causal relationship of Vaccination site pain, Nauseous, Diarrhea, Upset stomach, Headache and Fever was possible with the bnt162b2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Feb2022): This is a solicited follow-up report based on the information received by Pfizer from AbbVie (Mfr Control No.: 21K-163-4097881-00).  Updated Information Included: Suspect coding (dose number and dose description), Biological Product, Dosage Regimens, Co-suspect product information (frequency, lot number, Include in vaers block), Event information (new events: Blood in stools, upset stomach, headache, fever, flair up diarrhea, Ulcerative colitis aggravated) (onset date, stop date, outcome), Reporter causality and clinical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Colitis ulcerative, Haematochezia, Condition aggravated, illness, nausea, Diarrhoea, Vaccination site pain, Abdominal discomfort, head ache, pyrexia. and suspect drug 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.