Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased, Intestinal resection
Clinical narrative: Magnesium low; Potassium low; Bowel resection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4417628-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159928) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTESTINAL RESECTION (medically significant) with onset 22Jan2022, outcome "unknown", described as "Bowel resection"; BLOOD MAGNESIUM DECREASED (medically significant), outcome "unknown", described as "Magnesium low"; BLOOD POTASSIUM DECREASED (medically significant), outcome "unknown", described as "Potassium low". The patient underwent the following laboratory tests and procedures: Blood magnesium: (07May2022) Low; Blood potassium: (07May2022) Low; Weight: (unspecified date) Losing. The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced weight loss/losing weight, low on magnesium, body was not absorbing nutrients and low on potassium. on 22Jan2022, the patient experienced bowel resection surgery. On 07May2022 the patient ended up in the emergency room, she was low on potassium and magnesium.  Causality For Humira (Adalimumab): The reporter's causality for the event(s) of bowel resection surgery, was no reasonable possibility. The reporter's causality for the event(s) of low on magnesium and low on potassium was not provided Agency opinion is that the events of bowel resection surgery, low on magnesium and low on potassium are not assessable.  The reporter's assessment of the causal relationship of "bowel resection", "magnesium low" and "potassium low" with the suspect product(s) BNT162b2 was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 available information in the case, the causal association between the event bowel resection, magnesium low, potassium low and the 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.