Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Blood test abnormal, Haematochezia, Pain in extremity, Vaccination site pain
Clinical narrative: Some bleeding in bowels/blood showing up in stool; Blood test abnormal/blood level for prostate was over four point zero; Vaccination site pain; Sore arm when took covid vaccine;   This is a solicited report received from contactable consumer for a Pfizer sponsored program (Not provided). The reporter is the patient. Other Case identifier(s): 21K-163-4087414-00 (Company).  A 63 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 12May2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,  (1 in 1 once), via Intramuscular route), administration date: Apr2021, when the patient was 63 years old, for COVID-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Medical history was reported as no. The patient's other relevant history and concomitant medications were not provided. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via intramuscular route on Apr2021 (at the age of 63-year-old) as dose 1, single (reported as 1 in 1 once) for covid-19 immunization. On an unspecified date, the patient experienced blood level abnormal, blood level for prostate was over four point zero. In May2021, the patient experienced sore arm when took covid vaccine and vaccination site pain. The reporter considered the events as non-serious. Events abate after stopping drug was reported as not applicable. The action taken in response to the events for adalimumab was unknown. The patient underwent lab tests and procedures which included blood level for prostate resulted as over four point zero, on an unspecified date. Upon follow up on 24Nov2021, it was reported that the patient experienced non-serious sore arm when took second COVID Vaccine, some bleeding in bowels/blood showing up in stool and blood level for prostate was over four point zero with HUMIRA (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event (s) sore arm when took second covid vaccine with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event (s) of Some bleeding in bowels/blood showing up in stool and blood level for prostate was over four point zero was not provided. Relevant Laboratory & Other Diagnostic Tests: Unknown date blood level for prostate: Over Four Point Zero. The outcome of blood showing up in stool was not recovered, the outcome of  blood test abnormal was unknown and the outcome of the rest of events was recovered in 2021.   The reporter's causality for the events of blood level for prostate was over four point zero and sore arm when took covid vaccine with BNT162B2 was not reported. The reporter's causality for the event vaccination site pain with BNT162B2 was reported as probable.  The reporter's causality for the events of blood level for prostate was over four point zero and sore arm when took covid vaccine with Humira was not reported. The reporter's causality for the event vaccination site pain with Humira was no reasonable possibility.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24Nov2021): New information received from a Non-Interventional Study based on information received by Pfizer from a company, manufacturer control number: 21K-163-4087414-00 which includes: adverse event details (new event blood in stool and event causality added) and course information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of haematochezia, vaccination site pain, pain in arm and blood test abnormal are related to the suspect product of BNT162B2 based on plausible temporal relationship. 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.