Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Device loosening, Fatigue, Gastrointestinal fistula, Muscle spasms
Clinical narrative: HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE; Device loosening; FORTEO TO STRENGTHEN BONES; ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA/Abdominal pain/Nausea; Cold; Pain in hand; OCASSIONAL CRAMPING; Condition aggravated; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL FUSION SURGERY (HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE), DEVICE LOOSENING (Device loosening), OSTEOPOROSIS (FORTEO TO STRENGTHEN BONES), GASTROINTESTINAL FISTULA (ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA/Abdominal pain/Nausea), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Pain in hand), MUSCLE SPASMS (OCASSIONAL CRAMPING), CONDITION AGGRAVATED (Condition aggravated) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Crohn's disease.    The patient had no known allergies.  Concurrent medical conditions included Crohn's disease and Arthritis (Moderate to severe).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-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) 40MG/0.4ML, Solution for injection in pre-filled pen. In August 2021, the patient experienced FATIGUE (Fatigue) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SPINAL FUSION SURGERY (HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE) (seriousness criteria hospitalization and medically significant), DEVICE LOOSENING (Device loosening) (seriousness criteria hospitalization and medically significant), OSTEOPOROSIS (FORTEO TO STRENGTHEN BONES) (seriousness criteria hospitalization and medically significant), GASTROINTESTINAL FISTULA (ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA/Abdominal pain/Nausea) (seriousness criteria hospitalization and medically significant), NASOPHARYNGITIS (Cold) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in hand) (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS (OCASSIONAL CRAMPING) (seriousness criteria hospitalization and medically significant) and CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and medically significant). The patient was treated with TERIPARATIDE (FORTEO) at an unspecified dose and frequency. In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, SPINAL FUSION SURGERY (HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE), DEVICE LOOSENING (Device loosening), OSTEOPOROSIS (FORTEO TO STRENGTHEN BONES), GASTROINTESTINAL FISTULA (ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA/Abdominal pain/Nausea) and NASOPHARYNGITIS (Cold) outcome was unknown and PAIN IN EXTREMITY (Pain in hand), MUSCLE SPASMS (OCASSIONAL CRAMPING) and CONDITION AGGRAVATED (Condition aggravated) had not resolved.            No concomitant medications were provided by the reporter.   The reporter's causality for the event(s) of HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE unknown onset, ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA unknown onset, COLD, ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA unknown onset and LACK OF EFFECT was not provided. The reporter's causality for the event(s) of FLU, HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE unknown onset, FORTEO TO STRENGTHEN BONES and RECEIVED BOOSTER VACCINE AND WAS LITTLE FATIGUE with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FLARE UP, OCASSIONAL CRAMPING, OCASSIONAL NAUSEA and PAIN IN HANDS with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility.  possibility that the events of HAD THREE FUSIONS ON SPINE AND  BOTTOM ONE SCREW IN SPINE CAME LOOSE unknown onset, HAD THREE FUSIONS ON SPINE AND BOTTOM ONE SCREW IN SPINE CAME LOOSE unknown onset, TO STRENGTHEN BONES, RECEIVED BOOSTER VACCINE AND WAS LITTLE FATIGUE, ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA unknown onset, FLARE UP, OCASSIONAL CRAMPING, OCASSIONAL NAUSEA, PAIN IN HANDS, ABDOMINAL PAIN AND RUBBER BAND CONNECTED TO FISTULA unknown onset and LACK OF EFFECT are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).    there was a reasonable possibility that the event of COLD is related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  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.  Company comment:This is a Spontaneous case reported by a consumer, concerning a 66-year-old female patient, with relevant medical conditions of rheumatoid arthritis and Crohn´s disease, who experienced the unexpected and serious (due to hospitalization and medically significant) events of Spinal fusion surgery, Device loosening, Osteoporosis, Gastrointestinal fistula, Nasopharyngitis, Pain in extremity, Muscle spasms, Condition aggravated and Fatigue, which occurred related to the third dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for Rheumatoid arthritis and Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. Underlying conditions of Rheumatoid arthritis and Crohn´s disease remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 66-year-old female patient, with relevant medical conditions of rheumatoid arthritis and Crohn´s disease, who experienced the unexpected and serious (due to hospitalization and medically significant) events of Spinal fusion surgery, Device loosening, Osteoporosis, Gastrointestinal fistula, Nasopharyngitis, Pain in extremity, Muscle spasms, Condition aggravated and Fatigue, which occurred related to the third dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for Rheumatoid arthritis and Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. Underlying conditions of Rheumatoid arthritis and Crohn´s disease remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.