Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Gastric bypass, Nausea, Product odour abnormal, Retching
Clinical narrative: Shoulder issue with arthritis; Dry heaves; Nauseous; Gastric bypass Surgery; Product smell abnormal; 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-163-4430992-00.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, daily dose: citrate free, subcutaneous for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC BYPASS (medically significant) with onset 2020, outcome "unknown", described as "Gastric bypass Surgery"; PRODUCT ODOUR ABNORMAL (non-serious) with onset 2020, outcome "unknown", described as "Product smell abnormal"; ARTHRITIS (non-serious), outcome "unknown", described as "Shoulder issue with arthritis"; RETCHING (non-serious), outcome "not recovered", described as "Dry heaves"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "gastric bypass surgery", "product smell abnormal", "shoulder issue with arthritis" and "nauseous" 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 "dry heaves" related to BNT162b2.  Additional information:  The patient experienced dry heaves and nauseous from the smell of the medicine since having covid shot. She could not give the shot in her belly. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of gastro bypass surgery, shoulder issue with arthritis, dry heaves and nauseous from the smell of the HUMIRA unknown onset and dry heaves and nauseous from the smell of the HUMIRA unknown onset was not provided. The reporter's causality for the event(s) of dry heaves and nauseous from the smell of the HUMIRA unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility.  AbbVie's opinion is that there is no reasonable possibility that the events of gastro bypass surgery, shoulder issue with arthritis, dry heaves and nauseous from the smell of THE HUMIRA unknown onset, dry heaves and nauseous from the smell of the Humira unknown onset and dry heaves and nauseous from the smell of the HUMIRA unknown onset are related to HUMIRA(ADALIMUMAB).  Causality for Drug: Humira(solution for injection)(Adalimumab)  1) Gastric bypass (Gastric bypass ) Causality as per reporter (drug/vaccine): Not reported Causality as per mfr.(drug/vaccine):  no reasonable possibility  2) Shoulder arthritis (arthritis) Causality as per reporter (drug/vaccine):  Not reported Causality as per mfr.(drug/vaccine) :  no reasonable possibility  3) Dry heaves (Retching) Causality as per reporter (drug/vaccine):  Possible Causality as per mfr.(drug/vaccine):  no reasonable possibility  4) Nauseous (Nauseous) Causality as per reporter (drug/vaccine):  not reported Causality as per mfr.(drug/vaccine):  no reasonable possibility  5) Product smell abnormal (Product odour abnormal) Causality as per mfr.(drug/vaccine): no reasonable possibility  Causality for Drug: pfizer biontech covid-19 Vaccine(tozinameran)(tozinameran)  1) Gastric bypass (Gastric bypass ) Causality as per reporter (drug/vaccine):  Not reported  2) Shoulder arthritis (arthritis) Causality as per reporter (drug/vaccine):  Not reported  3) Dry heaves (Retching) Causality as per reporter (drug/vaccine):  Possible  4) Nauseous (Nauseous) Causality as per reporter (drug/vaccine):  Possible  5) Product smell abnormal (Product odour abnormal) Causality as per reporter (drug/vaccine):  Possible  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 association between the events 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.