Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Blood test, Drug specific antibody, Loss of consciousness
Clinical narrative: 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): 21K-163-4186256-00 (AbbVie). A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Dec2020 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single, intramuscular, administration date 19Jan2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single and intramuscular, administration date 10Sep2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "not recovered", described as "Passed out"; ABDOMINAL PAIN (medically significant) with onset Dec2021, outcome "not recovered", described as "Severe Abdominal Pain"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Stomach Cramping". The events "passed out" and "severe abdominal pain" were evaluated at the emergency room visit. The patient had episodes of passing out and non-serious blood test showed high levels of antibody to Humira and abdominal pain with Humira (adalimumab). The patient was in emergency room with episodes of passing out. In Dec2021, she was in emergency room due to severe abdominal pain. The patient underwent the following laboratory tests and procedures: blood test: antibody levels were high; drug specific antibody: present. The action taken for adalimumab was dosage not changed.  The reporter's assessment of causality for the events of stomach cramping, episodes of passing out, blood test showed high levels of antibody to HUMIRA and abdominal pain with the suspect HUMIRA was not provided.  Abbvie's opinion was that the event of episodes of passing out was not assessable; there was a reasonable possibility that the event of blood test showed high levels of antibody to humira is related to adalimumab; there was no reasonable possibility that the event of abdominal pain is related to adalimumab.   The reporter's assessment of causality for the event of stomach cramping with the suspect BNT162B2 was reported as Probable; episodes of passing out, blood test showed high levels of antibody to HUMIRA and abdominal pain with the suspect BNT162B2 was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (10Jan2022): This is a solicited follow up report based on the information received by pfizer from abbvie (Mfr. Control No. 22K-163-4222881-00). Updated information: Upgraded to serious, new events (passing out, blood test showed high levels of antibody to HUMIRA, abdominal pain), vaccination details (start dates, third dose), lab data.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information the event Abdominal pain upper, abdominal pain, loss of consciousness are assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association. 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.