Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse food reaction, Drug ineffective, Hypersensitivity, Stress
Clinical narrative: Stomach aches; Stomach aches few times from eating wrong food and stress; Stomach aches few times from eating wrong food and stress; Allergies; COVID-19/Drug ineffective; COVID-19; 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-163-4352940-00 (Abbvie).  A 17-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 17 years, in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease, crohn's disease. Patient received three doses of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE (TOZINAMERAN) via intramuscular route of administration on unspecified dates in 2021 taken for COVID-19 vaccination. The patient's relevant medical history and concomitant medications were not reported. Other relevant medical history was not reported. No concomitant medications were reported.  The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "COVID-19/Drug ineffective"; HYPERSENSITIVITY (non-serious) with onset 07Apr2022, outcome "unknown", described as "Allergies"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach aches"; ADVERSE FOOD REACTION (non-serious), STRESS (non-serious), outcome "unknown" and all described as "Stomach aches few times from eating wrong food and stress". The action taken for adalimumab was unknown. Reaction onset date was reported as Jan2022. Solicited report from the USA by a consumer of a 17-year-old female with events of non-serious stomach aches few times from eating wrong food and stress, allergies and COVID-19 with Humira (adalimumab). On an unspecified date in Jan2022, the patient experienced stomach aches few times from eating wrong food and stress. In Jan2022, the patient experienced COVID-19. On 07Apr2022, the patient experienced allergies. In 2022, the COVID-19 resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The event start date for Allergy (Hypersensitivity) was reported as 07Apr2022. The event start date for COVID-19 (COVID-19) was reported as Jan2022 while the event stop date was 2022. Causality for HUMIRA (ADALIMUMAB) was reported as the reporter's causality for the event(s) of stomach aches few times from eating wrong food and stress unknown onset and stomach aches few times from eating wrong food and stress unknown onset was not provided. the reporter's causality for the event(s) of allergies, stomach aches few times from eating wrong food and stress unknown onset and COVID-19 with Humira (adalimumab) was no reasonable possibility. The suspect product was HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), Unknown taken via subcutaneous route of administration taken for moderate to Severe pediatric crohns disease and moderate to Severe adult crohns disease with therapy dates was unknown. The causality between Adverse food reaction (Adverse food reaction) with the actions taken with drug being unknown and causality as per reporter Drug/Vaccine was not reported while dechallenge was N/A. Stress (Stress) actions taken with drug was Unknown and causality as per reporter Drug/Vaccine was not reported with dechallenge being N/A. Allergy (Hypersensitivity) with the actions taken with drug was Unknown and causality as per reporter Drug/Vaccine was No reasonable possibility with dechallenge being N/A. Stomach ache (Abdominal pain upper) with the actions taken with drug was  Unknown and causality as per reporter Drug/Vaccine was No reasonable possibility with dechallenge as  N/A. COVID-19 (COVID-19) with the actions taken with drug was Unknown and causality as per reporter Drug/Vaccine: No reasonable possibility and dechallenge was N/A. The causality for Adverse food reaction (Adverse food reaction) with the actions taken with drug as unknown and causality as per reporter Drug/Vaccine as not reported and dechallenge was N/A. Stress (Stress) with the actions taken with drug as unknown and causality as per reporter Drug/Vaccine as not reported and dechallenge N/A. Allergy (Hypersensitivity) with the actions taken with drug was unknown and causality as per reporter Drug/Vaccine was possible and dechallenge was N/A. Stomach ache (Abdominal pain upper) with the actions taken with drug as unknown and causality as per reporter Drug/Vaccine as possible and dechallenge was N/A. COVID-19 (COVID-19) with actions taken with drug as unknown and causality as per reporter Drug/Vaccine as possible with dechallenge as N/A.   The reporter's assessment of the causal relationship of "covid-19/drug ineffective", "covid-19", "stomach aches", "stomach aches few times from eating wrong food and stress" and "allergies" 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 causality of adverse food reaction, stress was not reported for adalimumab (HUMIRA), The causality of allergy, stomach ache, COVID-19 was no reasonable causality for adalimumab (HUMIRA).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Suspected Covid 19, Drug Ineffective, Abdominal pain upper, adverse food reaction, stress, allergy and the suspect drug cannot be excluded. The case will be reassessed once new information is available.