Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Haematemesis, Herpes zoster, Immunisation, Pancreatitis
Clinical narrative: pancreatitis; Vomiting blood; Rectal bleeding; Booster; Shingles; Arthritic pains; Vaccination adverse reaction; This is a solicited report from a non-Pfizer sponsored program (FACILITATED COLLECT) from a contactable reporter(s) (Consumer or other non HCP) based on information received by Pfizer from AbbVie (manufacturer control number 21K-131-4195241-00).  Solicited report from by a consumer of a 70 year old male with events of pancreatitis, vomiting blood and rectal bleeding and non-serious reaction to covid 19 vaccine and the administration process, shingles and arthritis pain with Humira 40mg/0.4ml (adalimumab). In 2021, the patient experienced reaction to Covid 19 vaccine and the administration process and Arthritis Pain. In Nov2021, the patient experienced Vomiting Blood and Rectal Bleeding. On 15Nov2021, the patient experienced Pancreatitis. On 28Nov2021, the patient experienced Shingles. BNT162B2 (TOZINAMERAN) was also considered suspect.  Patient had three blood transfusion and unspecified antibiotic was used to treat pancreatitis. He referred he was in the intensive area in the hospital due to pancreatitis, blood vomiting and rectal bleeding approximately on 15Nov2021. On 24Nov2021, he was discharged from the hospital. He indicates that an unspecified event may be related to the COVID-19 vaccine and the administration process. He reports the use of arthritis pain as medication patient administers arthritis pain, as concomitant medication this medication was not found. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 5 Mar 2021, he received first dose COVID-19 Vaccine manufactured by Pfizer (BNT162b2). On 25Mar2021, he received second dose COVID-19 Vaccine manufactured by Pfizer (BNT162b2). On 8Sep2021, he received third dose COVID-19 Vaccine manufactured by Pfizer (BNT162b2). Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with Zovirax and Neurontin.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of pancreatitis and shingles with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of reaction to covid 19 vaccine and the administration process, vomiting blood, rectal bleeding and arthritis pain was not provided. Abbvie's opinion is that there is a reasonable possibility that the events of pancreatitis, vomiting blood, rectal bleeding and shingles are related to humira 40mg/0.4ml(adalimumab). Abbvie's opinion is that the event of reaction to covid 19 vaccine and the administration process is not assessable. Abbvie's opinion is that there is no reasonable possibility that the event of arthritis pain is related to humira 40mg/0.4ml(adalimumab).  Change History: On 05Jan2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, treatment drug information and narrative description. The event of "ARTHRITIS PAIN" was added.  The reporter's assessment of the causal relationship of the events 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: Based on the information provided in the narrative, a causal association between the suspect drug and the 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.