Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Cough, Diabetes mellitus, Laboratory test, Pain
Clinical narrative: Diabetic; Colitis ulcerative aggravated; Streptococcal sore throat; Dry cough; Ache; Mucus discharge; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetic), COLITIS ULCERATIVE (Colitis ulcerative aggravated), SECRETION DISCHARGE (Mucus discharge), PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat) and COUGH (Dry cough) in a 55-year-old male 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.    No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced SECRETION DISCHARGE (Mucus discharge), COUGH (Dry cough) and PAIN (Ache). On 24-Nov-2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetic) and COLITIS ULCERATIVE (Colitis ulcerative aggravated). In December 2021, PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat) had resolved. At the time of the report, DIABETES MELLITUS (Diabetic) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) had not resolved and SECRETION DISCHARGE (Mucus discharge), COUGH (Dry cough) and PAIN (Ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: abnormal (abnormal) Abnormal, elevated level.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter causality of Humira (adalimumab) for all events was reported as not related and the event of elevated levels was a reasonable possibility (probable).  On an unknown date, laboratory test was performed and result found to be elevated levels.  Treatment medication was not provided by reporter.  Company Comment: This spontaneous case concerns a 55-year-old male patient, with relevant medical history of Colitis Ulcerative and intake of Adalimumab, who experienced the unexpected events of Secretion discharge, Cough, Pain, Diabetes mellitus, Colitis ulcerative aggravated and Pharyngitis streptococcal. The event Pharyngitis streptococcal on the same day after receiving the third dose of mRNA-1273 Vaccine. The other events occurred on an unknown date. The outcome of the events was reported as resolved for Pharyngitis, not resolved for diabetes mellitus and Colitis ulcerative, and unknown for secretion discharge, cough and pain. Treatment information was not provided. The patient's medical history of  Colitis Ulcerative and intake of Adalimumab remain as confounders for the occurrence of Colitis ulcerative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Live follow up received significant information included updated event start date, updated suspect product Moderna start date, causality updated, updated. Sender's Comments: This spontaneous case concerns a 55-year-old male patient, with relevant medical history of Colitis Ulcerative and intake of Adalimumab, who experienced the unexpected events of Secretion discharge, Cough, Pain, Diabetes mellitus, Colitis ulcerative aggravated and Pharyngitis streptococcal. The event Pharyngitis streptococcal on the same day after receiving the third dose of mRNA-1273 Vaccine. The other events occurred on an unknown date. The outcome of the events was reported as resolved for Pharyngitis, not resolved for Diabetes mellitus and Colitis ulcerative, and unknown for Secretion discharge, Cough and Pain. Treatment information was not provided. The patient's medical history of  Colitis Ulcerative and intake of Adalimumab remain as confounders for the occurrence of Colitis ulcerative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.