Sex: M
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Memory impairment, Oesophageal stenosis, Rotator cuff syndrome, SARS-CoV-2 test
Clinical narrative: Esophageal stricture/ ESOPHAGUS CLOSING UP; Stress; Depression; Forgetful; Hiatal hernia; Herniated disc in back; Insomnia; Rotator cuff tear/TORN ROTATOR CUFF; Fall/ FELL DOWN THE STAIRS; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL STENOSIS (Esophageal stricture/ ESOPHAGUS CLOSING UP) in an adult 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) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OESOPHAGEAL STENOSIS (Esophageal stricture/ ESOPHAGUS CLOSING UP) (seriousness criterion medically significant), STRESS (Stress), DEPRESSION (Depression), MEMORY IMPAIRMENT (Forgetful), HIATUS HERNIA (Hiatal hernia), INTERVERTEBRAL DISC PROTRUSION (Herniated disc in back), INSOMNIA (Insomnia), ROTATOR CUFF SYNDROME (Rotator cuff tear/TORN ROTATOR CUFF), FALL (Fall/ FELL DOWN THE STAIRS) and COVID-19 (COVID-19). At the time of the report, OESOPHAGEAL STENOSIS (Esophageal stricture/ ESOPHAGUS CLOSING UP), STRESS (Stress), DEPRESSION (Depression), MEMORY IMPAIRMENT (Forgetful), HIATUS HERNIA (Hiatal hernia), INTERVERTEBRAL DISC PROTRUSION (Herniated disc in back), INSOMNIA (Insomnia), ROTATOR CUFF SYNDROME (Rotator cuff tear/TORN ROTATOR CUFF), FALL (Fall/ FELL DOWN THE STAIRS) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive and (Positive) Positive.         Company comment: This is a spontaneous case concerning an adult male patient with Ankylosing spondylitis on treatment with Adalimumab, who experienced the unexpected serious (medically significant) event esophageal stenosis and non-serious AESI COVID-19. The events occurred on an unknown date after an unspecified dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Stress, Depression, Memory impairment, Hiatus hernia, Intervertebral disc protrusion, Insomnia, Rotator cuff syndrome and Fall were also reported as non-serious events. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Co suspect drug HUMIRA Dose description was reported as Solution for injection in pre-filled pen, Citrate free.  The reporter's causality for the events of stress, depression, forgetful, hiatal hernia, herniated discs in back, COVID 19, insomnia, esophagus closing up, torn rotator cuff and fell down the stairs was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in; Sender's Comments: Company comment: This is a spontaneous case concerning an adult male patient with Ankylosing spondylitis on treatment with Adalimumab, who experienced the unexpected serious (medically significant) event esophageal stenosis and non-serious AESI COVID-19. The events occurred on an unknown date after an unspecified dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Stress, Depression, Memory impairment, Hiatus hernia, Intervertebral disc protrusion, Insomnia, Rotator cuff syndrome and Fall were also reported as non-serious events. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.