Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia, Muscle spasms
Clinical narrative: Blood in stool; Diarrhea; Cramps; This is a solicited report from a contactable consumer (patient) from the marketing program, based on information received by Pfizer from AbbVie (manufacturer control number 21K-163-4093350-00).   A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on 10Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization, age at vaccination was 12-year-old; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced blood in stool on Sep2021, cramps on Sep2021, diarrhea on Sep2021. Clinical details: Solicited report by a consumer of a 12 years old male with events of non-serious blood in stool, cramping and diarrhea with HUMIRA (adalimumab). There was no reported medical history. On unknown dates, the patient experienced blood in stool and cramping. In Sep2021, the patient experienced diarrhea. In Sep2021, the diarrhea resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 10Sep2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was not applicable. The outcome of events blood in stool, cramps was unknown, outcome of event diarrhea was recovered on an unspecified date in Sep2021.  Causality for HUMIRA (adalimumab): The reporter's causality for the events of blood in stool and cramping was not provided. The reporter's causality for the event of diarrhea with HUMIRA (adalimumab) was no reasonable possibility.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the events of blood in stool and cramping was not provided. The reporter's causality for the event of diarrhea was Possible.  The reporter's assessment of the causal relationship of the events blood in stool and cramping with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug 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