Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site mass, Vaccination site pain
Clinical narrative: INJECTION SITE BLEEDING; INJECTION SITE BRUISE; Flare up; Constipation; Inflammation; Dizziness; INJECTION SITE LUMP; second dose of Moderna vaccine caused sore arm; Swelling after injection; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (INJECTION SITE BLEEDING), VACCINATION SITE BRUISING (INJECTION SITE BRUISE), CONDITION AGGRAVATED (Flare up), CONSTIPATION (Constipation) and INFLAMMATION (Inflammation) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Ulcerative colitis (Moderate to Severe) and Crohn's disease (Moderate to Severe).   On 23-Apr-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate Free. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (INJECTION SITE BLEEDING), VACCINATION SITE BRUISING (INJECTION SITE BRUISE), CONDITION AGGRAVATED (Flare up), CONSTIPATION (Constipation), INFLAMMATION (Inflammation), DIZZINESS (Dizziness), VACCINATION SITE MASS (INJECTION SITE LUMP), VACCINATION SITE PAIN (second dose of Moderna vaccine caused sore arm), VACCINATION SITE SWELLING (Swelling after injection), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE HAEMORRHAGE (INJECTION SITE BLEEDING), VACCINATION SITE BRUISING (INJECTION SITE BRUISE), VACCINATION SITE MASS (INJECTION SITE LUMP) and VACCINATION SITE SWELLING (Swelling after injection) had resolved and CONDITION AGGRAVATED (Flare up), CONSTIPATION (Constipation), INFLAMMATION (Inflammation), DIZZINESS (Dizziness), VACCINATION SITE PAIN (second dose of Moderna vaccine caused sore arm), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            Moderna COVID-19 Vaccine.  Second dose of Moderna vaccine caused sore arm, dizziness, chills, fever, constipation, injection site bruise, flare up, injection site bleeding and injection site lump.  On 01Jul 2022, patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) as 3rd booster dose, one in once for COVID-19 Vaccination.   The reporter's causality for the event(s) of swelling after injection, injection site lump, inflammation, constipation, injection site bleeding, injection site bruise and flare up with Adalimumab solution for injection was reasonable possibility. The reporter's causality for the event(s) of chills, dizziness, fever and second dose of Moderna vaccine caused sore arm with Adalimumab solution for injection was not provided.   Agency's opinion was that the causality for the event(s) of swelling after injection, chills, dizziness, injection site lump, inflammation, fever, constipation, second dose of Moderna vaccine caused sore arm, injection site bleeding, injection site bruise and flare up with Adalimumab solution for injection was not provided.  Agency's opinion was that the causality for the event(s) of chills, swelling after injection, dizziness, injection site lump, fever, inflammation, constipation, injection site bleeding, second dose of Moderna vaccine caused sore arm, injection site bruise and flare up with Moderna COVID-19 vaccine (Elasomeran) was not provided.  Treatment information was not provided.