Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Small intestinal haemorrhage
Clinical narrative: Bleed in small intestine; anemia; low iron; On 27 Aug 2021, booster COVID-19 Vaccine manufactured by Pfizer; Fatigue from vaccination; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from, manufacturer control number: 21K-163-4025134-00.   A contactable consumer (patient) reported that a 67-year-old male patient received the dose 3 (booster) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on 27Aug2021 (at age of 67 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunisation; adalimumab (HUMIRA), via Subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriatic arthritis, moderate to severe chronic plaque psoriasis, moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 12Feb2021 (at age of 66 years old) for COVID-19 immunization; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 13Mar2021 (at age of 66 years old) for COVID-19 immunization and experienced fatigue. The reporter reported with events of bleed in small intestine and non-serious anemia, fatigue from vaccination and low iron with Humira (Adalimumab). On unknown dates, the patient experienced bleed in small intestine, anemia and low iron. In 2021, the patient experienced fatigue from vaccination. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. In 2021, patient had fatigue from second vaccination and third vaccination. Also had bleed in small intestine and low iron. He had iron infusions for anemia. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 12Feb2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. On 13Mar2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. On 27Aug2021, booster covid-19 vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events "Small intestinal bleeding, anemia" was not recovered. The outcome of other events was unknown. The causality for Fatigue with BNT162B2 was provided as not related.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of bleed in small intestine, anemia and low iron with Humira(Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of fatigue from vaccination was not provided.   opinion is that the event of bleed in small intestine is not assessable.  opinion is that there is no reasonable possibility that the events of anemia, fatigue from vaccination and low iron are related to Humira (Adalimumab).   The reporter's assessment of the causal relationship of the events (except event fatigue) with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect vaccine, the company cannot completely exclude a reasonable possibility that BNT162B2 may have contributed to the onset of fatigue;  other events bleed in small intestine,  anemia and  low iron are considered unrelated to the vaccine use but more likely associated to the 67-year-old patient underlying contributory factors.  More information including medical history and concomitant medications are needed for meanfully medical assessment.