Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Diarrhoea, Fall, Femur fracture, Fracture pain
Clinical narrative: SHINGLES BROKE OUT DUE TO STRESS; DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE; DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE; DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE; FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN; FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN; FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN; SHINGLES BROKE OUT DUE TO STRESS; SOME ACHINESS; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN) in an 86-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) solution for injection for Crohn's disease.    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 05-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 an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to citrate free. In May 2021, the patient experienced FEMUR FRACTURE (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN) (seriousness criterion medically significant), FALL (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN) and FRACTURE PAIN (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN). In 2021, the patient experienced HERPES ZOSTER (SHINGLES BROKE OUT DUE TO STRESS) and PAIN (SOME ACHINESS). In January 2022, the patient experienced DIARRHOEA (DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE), GASTRIC DISORDER (DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE) and ADVERSE FOOD REACTION (DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE). On an unknown date, the patient experienced STRESS (SHINGLES BROKE OUT DUE TO STRESS). In 2021, PAIN (SOME ACHINESS) had resolved. At the time of the report, FEMUR FRACTURE (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN), FALL (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN), FRACTURE PAIN (FELL AND BROKE FEMUR AND IN QUITE A BIT OF PAIN), HERPES ZOSTER (SHINGLES BROKE OUT DUE TO STRESS), STRESS (SHINGLES BROKE OUT DUE TO STRESS), DIARRHOEA (DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE), GASTRIC DISORDER (DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE) and ADVERSE FOOD REACTION (DIARRHEA/STOMACH ISSUES PROBABLY SOMETHING PATIENT ATE) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided. On unknown dates, the patient experienced still had crohn's disease flare ups while taking humira and bleed when injected on the leg. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  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. A 86-year-old female patient, treated with Adalimumab for Crohn's disease, received an appropriate schedule of 3 doses of mRNA-1273 vaccine and, approximately 1 month after second dose, she fell and experienced medically significant event of femur fracture. She experienced non serious event of shingles break out after femur fracture due to stress. In addition, patient had some achiness after second COVID-19 vaccine for a few days. Approximately 2 months after third dose, she experienced non serious events of diarrhea and stomach issues for one day, probably due to something she ate. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Patient's age and gender represent risk factors for fracture. Older people can also have problems with vision and balance, which can increase the risk of falling. Conditions such as Crohn's disease, that reduce absorption of vitamin D and calcium, also can cause low bone density. Regarding diarrhea and stomach issues, they are common symptoms of Crohn's disease and Adalimumab could be a contributory factor for this events too. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up received, updated new events On 12-Apr-2022: Follow-up received, updated new events; Sender's Comments: This is a spontaneous case reported by a consumer. A 86-year-old female patient, treated with Adalimumab for Crohn's disease, received an appropriate schedule of 3 doses of mRNA-1273 vaccine and, approximately 1 month after second dose, she fell and experienced medically significant event of femur fracture. She experienced non serious event of shingles break out after femur fracture due to stress. In addition, patient had some achiness after second COVID-19 vaccine for a few days. Approximately 2 months after third dose, she experienced non serious events of diarrhea and stomach issues for one day, probably due to something she ate. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Patient's age and gender represent risk factors for fracture. Older people can also have problems with vision and balance, which can increase the risk of falling. Conditions such as Crohn's disease, that reduce absorption of vitamin D and calcium, also can cause low bone density. Regarding diarrhea and stomach issues, they are common symptoms of Crohn's disease and Adalimumab could be a contributory factor for this events too. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.