Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Therapeutic response unexpected, Upper limb fracture
Clinical narrative: her mother fell and broke her right hip and right elbow; her mother who has had squamous cell and basal cell on both arms, face and neck for years and experienced improvement after her Moderna COVID-19 vaccines. Her arms were almost totally clear after the first two doses in 2021; her mother fell and broke her right hip and right elbow; her mother fell and broke her right hip and right elbow; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HIP FRACTURE (her mother fell and broke her right hip and right elbow) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 030M20A, 011F21A and 057M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced FALL (her mother fell and broke her right hip and right elbow) and UPPER LIMB FRACTURE (her mother fell and broke her right hip and right elbow). On an unknown date, the patient experienced HIP FRACTURE (her mother fell and broke her right hip and right elbow) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE UNEXPECTED (her mother who has had squamous cell and basal cell on both arms, face and neck for years and experienced improvement after her Moderna COVID-19 vaccines. Her arms were almost totally clear after the first two doses in 2021). At the time of the report, HIP FRACTURE (her mother fell and broke her right hip and right elbow), FALL (her mother fell and broke her right hip and right elbow), UPPER LIMB FRACTURE (her mother fell and broke her right hip and right elbow) and THERAPEUTIC RESPONSE UNEXPECTED (her mother who has had squamous cell and basal cell on both arms, face and neck for years and experienced improvement after her Moderna COVID-19 vaccines. Her arms were almost totally clear after the first two doses in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took Dose 5 on 28 APR 2023 with lot no A57172B and dose 6 on 30 SEP 2023 with lot number AU3835E.  The patient had squamous cell and basal cell on both arms, face, and neck for years and experienced improvement after her Moderna COVID-19 vaccines. Her arms were almost totally clear after the first two doses in 2021. The boosters helped but not as much as the first two doses had. Prior to the Moderna vaccine she had 23 basal cells. Since the Moderna vaccines, she has only had 1 basal cell. In Apr 2022, she fell and broke her right hip and right elbow. Her dermatologist wanted to report the improvements to Moderna as they believe the vaccine helped her.  Also received RSV vaccine (by Pfizer) on 09 FEB 2023.  Company Comment: This is a spontaneous case concerning a 95-year-old female patient with medical history of squamous cell and basal cell on both arms, face, and neck, who experienced the serious (due to medically significant) unexpected, event of hip fracture, and the non-serious events of fall, upper limb fracture, and therapeutic response unexpected. Event fall occurred which occurred on the same month after a dose of mRNA-1273 vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that patient fell and broke her right hip and right elbow. It was reported that the patient had squamous cell and basal cell on both arms, face, and neck for years and experienced improvement after her Moderna COVID-19 vaccines. Her arms were almost totally clear after the first two doses in 2021. The boosters helped but not as much as the first two doses had. Prior to the Moderna vaccine she had 23 basal cells. Since the Moderna vaccines, she has only had 1 basal cell. Her dermatologist wanted to report the improvements to Moderna as they believe the vaccine helped her. Event fall was assessed as not related, due to lack of biological plausibility. Events hip fracture and upper limb fracture were assessed as not related due to alternative explanation (fall). Age could be a contributing factor for events fall, hip fracture and upper limb fracture. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.