Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Scab, Shoulder operation, Sinus disorder
Clinical narrative: Right knee fractured leg / She fell and had fractured right knee; Affecting lower back / She had 3 back surgeries; SHOULDER SURGERY; Deviated septum; Sinus issues; Pain in stomach; Postnasal drip; Pain; Colon polyps; Had cyst in thoracic region; Emphysema; Tissue adhesion/Scar tissue; Urinary tract infection; Scabs in nose; A mishaps with Crohn's; Diarrhoea/Watery bowels; Sore arm with booster shot; Sore arm with booster shot; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (A mishaps with Crohn's), LOWER LIMB FRACTURE (Right knee fractured leg / She fell and had fractured right knee), BACK DISORDER (Affecting lower back / She had 3 back surgeries) and SHOULDER OPERATION (SHOULDER SURGERY) in a 70-year-old 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 Crohn's disease.    The patient's past medical history included Meniscus tear (She Fell three times her right knee went out, right knee had pain in front and back.) in 2020. Concurrent medical conditions included Crohn's disease.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-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) at an unspecified dose. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arm with booster shot) and VACCINATION SITE PAIN (Sore arm with booster shot). On 15-Nov-2021, the patient experienced DIARRHOEA (Diarrhoea/Watery bowels). On an unknown date, the patient experienced CROHN'S DISEASE (A mishaps with Crohn's) (seriousness criterion medically significant), LOWER LIMB FRACTURE (Right knee fractured leg / She fell and had fractured right knee) (seriousness criterion hospitalization), BACK DISORDER (Affecting lower back / She had 3 back surgeries) (seriousness criterion hospitalization), SHOULDER OPERATION (SHOULDER SURGERY) (seriousness criterion medically significant), NASAL SEPTUM DEVIATION (Deviated septum), SINUS DISORDER (Sinus issues), ABDOMINAL PAIN UPPER (Pain in stomach), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), PAIN (Pain), LARGE INTESTINE POLYP (Colon polyps), CYST (Had cyst in thoracic region), EMPHYSEMA (Emphysema), ADHESION (Tissue adhesion/Scar tissue), URINARY TRACT INFECTION (Urinary tract infection) and SCAB (Scabs in nose). The patient was treated with CYANOCOBALAMIN (B12-VITAMIIN) at an unspecified dose and frequency; Surgery (Knee operation) for Lower limb fracture and Surgery (Back operation) for Back disorder. On 04-Nov-2021, PAIN IN EXTREMITY (Sore arm with booster shot) and VACCINATION SITE PAIN (Sore arm with booster shot) had resolved. At the time of the report, CROHN'S DISEASE (A mishaps with Crohn's), LOWER LIMB FRACTURE (Right knee fractured leg / She fell and had fractured right knee), BACK DISORDER (Affecting lower back / She had 3 back surgeries), SHOULDER OPERATION (SHOULDER SURGERY), NASAL SEPTUM DEVIATION (Deviated septum), SINUS DISORDER (Sinus issues), ABDOMINAL PAIN UPPER (Pain in stomach), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), LARGE INTESTINE POLYP (Colon polyps), CYST (Had cyst in thoracic region), EMPHYSEMA (Emphysema), ADHESION (Tissue adhesion/Scar tissue), URINARY TRACT INFECTION (Urinary tract infection), SCAB (Scabs in nose) and DIARRHOEA (Diarrhoea/Watery bowels) outcome was unknown and PAIN (Pain) had resolved.            No concomitant medication provided.  HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB),1157583,1161756 administered.  Patient reported that she fell three times her right knee went out, right knee had pain in front and back. Had cyst in thoracic region had emphysema. She took B12. She had sore arm with first and second dose and the booster shot of the COVID-19 only lasted for one day. Had scar tissue. Her right leg was fractured. She had postnasal drip, deviated septum and sinus issues. Over a year ago doubled because of pain in stomach. She had three back surgeries, shoulder surgery and knee surgeries. She had pain on left side. She had right knee fractured leg, choked on walnut while in hospital. She fell and had fractured right knee, it was getting worse and started to affect lower back. She had sinus problem, scabs in nose, a mishaps with Crohn's stilled and had watery bowels. She had a urinary tract infection and a little pain in stomach.  CC: This is a Spontaneous case concerning a 70-year-old female patient, with concurrent condition of Crohn's disease treated with Adalimumab, who experienced the serious unexpected adverse events of Crohn's disease and Shoulder operation (Serious criteria Medically Significant) and Lower limb fracture and Back disorder that led to hospitalization; additionally other non-serious adverse events were reported in this case. The events occurred in an unknown date in the context of the administration of the 3rd dose of the of the mRNA-1273 vaccine. The concurrent condition of remains as a contributor for the event Crohn's disease. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-583422, MOD-2022-583418.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2022: Significant Live follow up appended  : Event added , narrative description updated. On 15-Feb-2022: Significant Live follow up appended  : Patient demographics, event and narrative description updated. On 11-Mar-2022: Significant Live follow up appended  : Co-suspect indication added, events and narrative updated. On 08-Apr-2022: Significant Live follow up appended  : Events added and causality updated. On 03-Jun-2022: Significant Live follow up appended  : New events added. Outcome for an event provided along with narrative update. Seriousness criteria updated for certain events.; Sender's Comments: This is a Spontaneous case concerning a 70-year-old female patient, with concurrent condition of Crohn's disease treated with Adalimumab, who experienced the serious unexpected adverse events of Crohn's disease and Shoulder operation (Serious criteria Medically Significant) and Lower limb fracture and Back disorder that led to hospitalization; additionally other non-serious adverse events were reported in this case. The events occurred in an unknown date in the context of the administration of the 3rd dose of the of the mRNA-1273 vaccine. The concurrent condition of remains as a contributor for the event Crohn's disease. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.