Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Facial bones fracture, Fall
Clinical narrative: fell down broke his nose had the be hospitalized; fell down broke his nose had the be hospitalized; vertigo; lower back pain; dizziness; knee pain/ the knee pain can be kind of serious. It impairs him from being able to stand up; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell down broke his nose had the be hospitalized) and FACIAL BONES FRACTURE (fell down broke his nose had the be hospitalized) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypothyroidism (hypothyroid that they take medications) and Hypertensive (hypertensive that they take medications). Concomitant products included COLLAGEN for an unknown indication.    In April 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell down broke his nose had the be hospitalized) (seriousness criterion hospitalization), FACIAL BONES FRACTURE (fell down broke his nose had the be hospitalized) (seriousness criteria hospitalization and medically significant), VERTIGO (vertigo), BACK PAIN (lower back pain), DIZZINESS (dizziness) and ARTHRALGIA (knee pain/ the knee pain can be kind of serious. It impairs him from being able to stand up). At the time of the report, FALL (fell down broke his nose had the be hospitalized), FACIAL BONES FRACTURE (fell down broke his nose had the be hospitalized), VERTIGO (vertigo), BACK PAIN (lower back pain), DIZZINESS (dizziness) and ARTHRALGIA (knee pain/ the knee pain can be kind of serious. It impairs him from being able to stand up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was unknown hether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was stated that patient was taking a supplement called Collagen and it seems to be helping them. Patient had a slight amount of vertigo, the knee pain can be kind of serious. It impaired him from being able to stand up. Patient received most recent Moderna booster on 01Feb2023. Patient had 6 of the Moderna vaccines. Patient did not have their vaccination card with the dates and lot number at the time. Patient stated that they did not remember details regarding when the side effects started or other details at this time.  Company comment: This spontaneous case concerns a 69- year-old, male patient with relevant medical history of Type 2 diabetes mellitus and Hypertension (on medication) , who experienced the unexpected serious (hospitalization) events of Fall and Facial bones fracture(also medically significant) that occurred in the context of mRNA-1273 vaccine in the Covid-19 vaccination series. Latency cannot be assessed since event onset date and exact date of vaccination was not available.Also, Dizziness and Vertigo were reported among other non-serious events. No further information regarding detailed clinical course, investigations, treatment received were provided. The outcome of the events was unknown. Non- serious events of vertigo and dizziness along with patients' medical history of Type 2 diabetes mellitus and hypertension , for which she was on medication remains as a confounder for the event fall. The benefit-risk relationship of mRNA-1273 is not affected by this report.