Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hip fracture
Clinical narrative: Fractured hip; Felt very tired; Recurring Diarrhea; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Fractured hip) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06SF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Transient ischemic attack in 2015. Previously administered products included for Drug use for unknown indication: Keflex, CODEINE, DOXYCYCLINE, Flagyl, CORTISONE, CALCORT, Prednisone and AMOXICLAV. Past adverse reactions to the above products included Dyspepsia with Flagyl; Formication with Prednisone; and Urticaria with AMOXICLAV, CALCORT, CODEINE, CORTISONE, DOXYCYCLINE and Keflex. Concurrent medical conditions included Ulcerative colitis, Tobacco user since 2012, Allergic urticaria and Sulfonamide allergy. Concomitant products included COLECALCIFEROL for Supplementation therapy, PARACETAMOL (TYLENOL) for an unknown indication.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced DIARRHOEA (Diarrhea). On 08-Aug-2022, the patient experienced DIARRHOEA (Recurring Diarrhea). On an unknown date, the patient experienced HIP FRACTURE (Fractured hip) (seriousness criterion medically significant) and FATIGUE (Felt very tired). On 03-Dec-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, HIP FRACTURE (Fractured hip) had resolved and FATIGUE (Felt very tired) and DIARRHOEA (Recurring Diarrhea) outcome was unknown.            Patient stated that Humira was working for her initially but now medication was not working. From 08-Aug-2022 she started having diarrhea continuously. She felt very tired very easily. She had fractured hip that had since healed.  Company Comment: This is a spontaneous case concerning an 88 year-old, female patient with no relevant medical history and concomitant use of adalimumab, who experienced the serious (due to medically important condition) unexpected, event of Hip fracture. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event. The outcome was reported as recovered. The mentioned concomitant medication was reported as co-suspect drug. Patient´s advanced age remains as a risk factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-658033 (Patient Link).; Sender's Comments: Company Comment: This is a spontaneous case concerning an 88 year-old, female patient with no relevant medical history and concomitant use of adalimumab, who experienced the serious (due to medically important condition) unexpected, event of Hip fracture. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event. The outcome was reported as recovered. The mentioned concomitant medication was reported as co-suspect drug. Patient´s advanced age remains as a risk factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.