Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Injection site swelling, Interchange of vaccine products, Malaise, Pyrexia
Clinical narrative: COVID vaccine reaction/blood clots; Felt sick; Patient took MODERNA COVID-19 VACCINE primery series/Took PFIZER BIONTECH COVID-19 VACCINE booster dose; Patient took MODERNA COVID-19 VACCINE primery series/Took PFIZER BIONTECH COVID-19 VACCINE booster dose; Welts at injection site; Fever; Rectal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) and VACCINATION SITE THROMBOSIS (COVID vaccine reaction/blood clots) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In June 2022, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE THROMBOSIS (COVID vaccine reaction/blood clots) (seriousness criterion medically significant), MALAISE (Felt sick), INTERCHANGE OF VACCINE PRODUCTS (Patient took MODERNA COVID-19 VACCINE primery series/Took PFIZER BIONTECH COVID-19 VACCINE booster dose), COVID-19 IMMUNISATION (Patient took MODERNA COVID-19 VACCINE primery series/Took PFIZER BIONTECH COVID-19 VACCINE booster dose) and INJECTION SITE SWELLING (Welts at injection site). In 2022, RECTAL HAEMORRHAGE (Rectal bleeding) and PYREXIA (Fever) had resolved, INTERCHANGE OF VACCINE PRODUCTS (Patient took MODERNA COVID-19 VACCINE primery series/Took PFIZER BIONTECH COVID-19 VACCINE booster dose) and COVID-19 IMMUNISATION (Patient took MODERNA COVID-19 VACCINE primery series/Took PFIZER BIONTECH COVID-19 VACCINE booster dose) outcome was unknown. At the time of the report, VACCINATION SITE THROMBOSIS (COVID vaccine reaction/blood clots) and MALAISE (Felt sick) had resolved and INJECTION SITE SWELLING (Welts at injection site) had resolved with sequelae.            No treatment and concomitant medication was reported. Patient underwent Cholecystectomy. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE  020343  CC: This spontaneous case concerns a 58-year-old, male patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant events of an AESI Vaccination site thrombosis and Rectal haemorrhage in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with unknown events' onset dates and vaccination dates. Patient underwent cholecystectomy within the preceding month from the onset of rectal bleeding and fever. Outcome of the events Vaccination site thrombosis and Rectal haemorrhage was reported as resolved. Patient's underlying condition of Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 58-year-old, male patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant events of an AESI Vaccination site thrombosis and Rectal haemorrhage in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with unknown events' onset dates and vaccination dates. Patient underwent cholecystectomy within the preceding month from the onset of rectal bleeding and fever. Outcome of the events Vaccination site thrombosis and Rectal haemorrhage was reported as resolved. Patient's underlying condition of Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.