Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Frequent bowel movements, Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Back disorder; Injury at work; Gas in stomach; Fall; Joint range of motion decreased; Limbs stiffness; Vaccination site pain; Tooth ache; Painful arm; Swollen arm; Could not move arm; Vaccination site swelling; Increased stool frequency; Tooth cavity; Adverse food reaction; This spontaneous case was reported by a physician and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), BACK DISORDER (Back disorder), DENTAL CARIES (Tooth cavity), ADVERSE FOOD REACTION (Adverse food reaction) and ACCIDENT AT WORK (Injury at work) in a 46-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) injection for Ulcerative colitis.    The patient's past medical history included Tobacco user (Tobacco user a pack of cigarette a day (stopped 2009)) in 2009 and Fall (Fell from the stairs and was injured at work). Concurrent medical conditions included Allergy to antibiotic (Amoxicillin allergies manifested by frequent visit to the bathroom), Drug allergy (Ibuprofen allergies manifested by stomach pain), Diabetes since 2000, Emphysema since 2009, Chronic pain, Heartburn, Ulcerative colitis, Mental disorder and Alcohol use (Alcohol user: a bottle of beer once a month). Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Back pain, LISINOPRIL and ATENOLOL for Blood pressure management, PRAVASTATIN for Cholesterol, METFORMIN for Diabetes, SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) for Emphysema, RANITIDINE for Heartburn, IRON for Iron supplementation, RISPERIDONE (RISPERDAL) for Mental disorder, GABAPENTIN for Pain, PANTOPRAZOLE for Ulcerative colitis, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D supplementation.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form every two weeks. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DENTAL CARIES (Tooth cavity), ADVERSE FOOD REACTION (Adverse food reaction), FREQUENT BOWEL MOVEMENTS (Increased stool frequency), TOOTHACHE (Tooth ache), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), JOINT RANGE OF MOTION DECREASED (Could not move arm) and VACCINATION SITE SWELLING (Vaccination site swelling). On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 23-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and MUSCULOSKELETAL STIFFNESS (Limbs stiffness). On an unknown date, the patient experienced BACK DISORDER (Back disorder), ACCIDENT AT WORK (Injury at work), FLATULENCE (Gas in stomach) and FALL (Fall). The patient was treated with IBUPROFEN for Tooth ache, at an unspecified dose and frequency; AMOXICILLIN for Tooth ache, at an unspecified dose and frequency; CELECOXIB (DEBROX [CELECOXIB]) at an unspecified dose and frequency and Physical therapy for Back disorder. In March 2021, DENTAL CARIES (Tooth cavity), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm) and JOINT RANGE OF MOTION DECREASED (Could not move arm) had resolved. In April 2021, TOOTHACHE (Tooth ache) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 24-Apr-2021, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) had resolved. At the time of the report, BACK DISORDER (Back disorder) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved, ADVERSE FOOD REACTION (Adverse food reaction) and FREQUENT BOWEL MOVEMENTS (Increased stool frequency) had not resolved and ACCIDENT AT WORK (Injury at work), MUSCULOSKELETAL STIFFNESS (Limbs stiffness), FLATULENCE (Gas in stomach) and FALL (Fall) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), JOINT RANGE OF MOTION DECREASED (Could not move arm), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) to be probably related, MUSCULOSKELETAL STIFFNESS (Limbs stiffness) to be possibly related and DENTAL CARIES (Tooth cavity), FLATULENCE (Gas in stomach) and TOOTHACHE (Tooth ache) to be not related. No further causality assessments were provided for BACK DISORDER (Back disorder), ADVERSE FOOD REACTION (Adverse food reaction), ACCIDENT AT WORK (Injury at work), FREQUENT BOWEL MOVEMENTS (Increased stool frequency) and FALL (Fall).    The event of dental caries takes time to develop and flatulence and increased bowel movement are inherent to the nature of the underlying ulcerative colitis and thus, these events are assessed as unlikely related to mRna-1273 use. There is limited information regarding  event of fell at work  and thus causality  with product use cannot be confirmed. The remaining events are temporarily associated withy the administration of the product and causal association cannot be excluded.   This case was linked to MOD-2021-169427 (Patient Link).; Sender's Comments: The event of dental caries takes time to develop and flatulence and increased bowel movement are inherent to the nature of the underlying ulcerative colitis and thus, these events are assessed as unlikely related to mRna-1273 use. There is limited information regarding  event of fell at work  and thus causality  with product use cannot be confirmed. T he remaining events are temporarily associated withy the administration of the product and causal association cannot be excluded.