Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Haematochezia, Middle insomnia, Mucous stools, Rectal haemorrhage
Clinical narrative: Blood in stool; Mucus stools; Wakless night; Abdominal pain; bleeding after bowel movement; Abdominal cramping; Wearing off effect; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4171851-00 (AbbVie).  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RECTAL HAEMORRHAGE (medically significant) with onset Jun2021, outcome "not recovered", described as "bleeding after bowel movement"; HAEMATOCHEZIA (medically significant), outcome "unknown", described as "Blood in stool"; MUCOUS STOOLS (non-serious), outcome "unknown", described as "Mucus stools"; ABDOMINAL PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "Abdominal cramping"; THERAPEUTIC RESPONSE SHORTENED (non-serious) with onset Jun2021, outcome "not recovered", described as "Wearing off effect"; MIDDLE INSOMNIA (non-serious), outcome "recovered", described as "Wakless night"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "Abdominal pain". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received second dose COVID-19 Vaccine manufactured by Pfizer. Patient experienced events of non-serious three to four day before administering the humira, using the bathroom five to six times a day that had mucus and blood in the stools after covid vaccination with HUMIRA (ADALIMUMAB).    Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of three to four day before administering the humira experiences abdominal cramping and bleeding after bowel movement onset in June 2021 and Wearing off effect with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of using the bathroom five to six times a day that had mucus and blood in the stools unknown onset was not provided. The reporter's causality for the event(s) of weakness night of frequent bathroom usage after covid vaccination and abdominal pain after covid vaccination with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) Rectal bleeding, Mucus stools, Abdominal cramp, Wearing off effect, Blood in stool was not Reported and Nocturnal awakening, Abdominal pain was reported as 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 provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.