Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Acute haemorrhagic ulcerative colitis, Arterial occlusive disease, Blood test, Dehydration, Diarrhoea
Clinical narrative: Heart attack; Arterial occlusion/artery was blocked; Fluid loss; Acute haemorrhagic ulcerative colitis; Diarrhea; Bowel obstruction; Hemorrhoids; Postoperative pain; Groin hernia; Lower extremity mass/big lump on her groin; This is a solicited report based on the information received by Pfizer from manufacturer control number: 21K-163-3910536-00). A contactable consumer (patient) reported that an 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Feb2021 (Batch/Lot number was not reported), at the age of 82-year-old, as single dose for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from 2011 (Batch/Lot number was not reported) and ongoing, at 40 mg (1 in 2 wk) (40MG/0.4ML) for rheumatoid arthritis and ulcerative colitis. Medical history included ulcerative colitis, control unspecified blood condition and heart issues. Concomitant medications included sulfasalazine taken for colitis ulcerative, start and stop date were not reported; prednisone taken for colitis ulcerative, start and stop date were not reported; folic acid taken for control unspecified blood condition, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for heart issues, start and stop date were not reported; isosorbide taken for heart issues, start and stop date were not reported; losartan potassium (COZAAR) taken for heart issues, start and stop date were not reported; metoprolol taken for heart issues, start and stop date were not reported. The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old, in Jan2021 for covid-19 immunization. The patient experienced heart attack on 19Apr2021, groin hernia in Mar2021, lower extremity mass in Mar2021, acute haemorrhagic ulcerative colitis on 13Apr2021, diarrhea on 13Apr2021, bowel obstruction on Apr2021, fluid loss on 13Apr2021, arterial occlusion on 19Apr2021, hemorrhoids in Apr2021, postoperative pain in Apr2021. The patient hospitalized from 18Apr2021 to 25Apr2021 due to these events. It was reported that the patient with events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids and artery was blocked and non-serious possible hemorrhoids and postoperative pain with Humira  40mg/0.4ml (Adalimumab). In Mar2021, the patient experienced groin hernia and big lump on groin. In Apr2021, the patient experienced blockage in bowels, possible hemorrhoids and postoperative pain. On 13Apr2021, the patient experienced bleeding a lot as a complication of ulcerative colitis, diarrhea and loss of fluids. On 19Apr2021, the patient experienced heart attack and artery was blocked. On 19Apr2021, the heart attack and artery was blocked resolved. On 20Apr2021, the diarrhea resolved. On 25Apr2021, the bleeding a lot as a complication of ulcerative colitis resolved. In Apr2021, the groin hernia, big lump on groin, blockage in bowels, loss of fluids, possible hemorrhoids and postoperative pain resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. Unknown stool softener also considered as suspect. In Mar2021, patient felt a big lump on her groin that was determined by physician as a hernia through physical examination and not an imaging test. On 09Apr2021 she had an outpatient surgery due to hernia in her groin. When she took acetaminophen as prescribed she had a blockage in her bowels and took unspecified stool softener which caused terrible diarrhea. On 16Apr2021 she went to the emergency room due to the diarrhea and had loss of fluids and just went home even when advised not to go home. On 18Apr2021 she was continued having diarrhea, she went back to the emergency room and had unspecified blood test that confirmed she was having a heart attack while on emergency room due to not taking her medications for the heart because was told not to take any medication while having diarrhea which she also temporarily interrupted her Humira while having diarrhea. Physician advised to admit patient to the hospital as she was told she was having a heart attack. On 19Apr2021, she had another stent because the artery was blocked from her previous stent. On 25Apr2021 she was discharged. She believed that her hospitalization was prolonged to nine days (as reported) due to she was bleeding a lot as a complication of ulcerative Colitis. She had a shot of covid 19 vaccine before at least one symptom happened therefore covid 19 vaccine was considered as co suspect product. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On Jan2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Feb2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with acetaminophen. The patient underwent other lab tests and procedures which included blood test: heart attack on 18Apr2021, laboratory test with unknown results in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events heart attack, Arterial occlusion/artery was blocked, Postoperative pain was recovered on 19Apr2021. The outcome of the event groin hernia, Lower extremity mass/big lump on her groin, Bowel obstruction, Fluid loss, Hemorrhoids was recovered in Apr2021; of the event Acute haemorrhagic ulcerative colitis was recovered on 25Apr2021; of the event Diarrhea was recovered on 20Apr2021.  The reporter's causality for the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain with humira 40mg/0.4ml (adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events 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.  Manufacturer opinion is that there is no reasonable possibility that the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain are related to humira 40mg/0.4ml(adalimumab).   No follow-up attempts are possible, information about lot/batch number cannot be obtained.