Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malabsorption, Pain, Weight
Clinical narrative: Weight loss; Body was not absorbing nutrients; Headache; Achy all over; Tired; 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 (AbbVie).  A 66-year-old female patient received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years 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. Vaccination history included: BNT162b2 (dose 3 (booster), single; intramuscular), administration date: 21Oct2021, for covid-19 immunisation; BNT162b2 (dose 2, single; intramuscular), administration date: 03Apr2021, for covid-19 immunisation; BNT162b2 (dose 1, single; intramuscular), administration date: 11Mar2021, for covid-19 immunisation. The following information was reported: PAIN (medically significant) with onset 29May2022, outcome "recovering", described as "Achy all over"; HEADACHE (medically significant) with onset 29May2022, outcome "recovering"; FATIGUE (medically significant) with onset 29May2022, outcome "recovering", described as "Tired"; MALABSORPTION (medically significant) with onset 31May2022, outcome "unknown", described as "Body was not absorbing nutrients"; WEIGHT DECREASED (medically significant) with onset 31May2022, outcome "not recovered", described as "Weight loss". The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) Unknown results; (31May2022) Losing weight. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "weight loss", "tired" and "body was not absorbing nutrients" with the suspect product(s) 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 reporter considered "headache" and "achy all over" related to BNT162b2.  Clinical course: On 29May2022, The Patient Experienced Tired, Headache and Achy All Over. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) Was Also Considered Suspect. On 29May2022 She Had A Reaction Of A Headache, Achy All Over And Tired After Her Second Booster. As Of 31May2022 She Was Losing Weight And Her Body Was Not Absorbing Nutrients. It Was Unknown If Patient Was Enrolled In A Covid-19 Vaccine Trial.   Reporter causality with BNT162b2 for events weight Loss, malabsorptio as per Reporter (Drug/Vaccine) it was not Reported. Causality for event Fatigue, headache, generalized Aching as per Reporter (Drug/Vaccine) it was possible.  Causality For Humira (Adalimumab): The Reporter's Causality For The Event(S) Of Weight Loss/Losing Weight, Tired, Headache And Achy All Over With Humira(Adalimumab) Was No Reasonable Possibility. The Reporter's Causality For The Event(S) Of Body Was Not Absorbing Nutrients Was Not Provided Abbvie's Opinion Is That Body Was Not Absorbing Nutrients is Not Assessable. Abbvie's Opinion Is That There Is No Reasonable Possibility That The Events Of Weight Loss/Losing Weight, Tired, Headache And Achy All Over Are Related To Humira(Adalimumab).  Causality for Humira with Malabsorption as Per Reporter (Drug/Vaccine) was not Reported while for as per Mfr.(Drug/Vaccine) was not assessable. Causality for weight Loss (Weight Decreased), tiredness (Fatigue), Headache, generalized Aching as per Reporter (Drug/Vaccine) was not Related. While for as per Mfr.(Drug/Vaccine) was No Reasonable Possibility  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 weight loss, tired, body was not absorbing nutrients, headache, achy all over 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.