Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Hip fracture, Pneumonia, SARS-CoV-2 test
Clinical narrative: broke his hips; lack of balance; severe COVID 19/positive COVID-19 test; pneumonia/ Breathing Coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (severe COVID 19/positive COVID-19 test), PNEUMONIA (pneumonia/ Breathing Coughing up blood), HIP FRACTURE (broke his hips) and BALANCE DISORDER (lack of balance) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A, 006M20A and 026620A) for COVID-19 prophylaxis.     The patient's past medical history included Heart disorder. Concurrent medical conditions included Allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMONIA (pneumonia/ Breathing Coughing up blood) (seriousness criteria hospitalization and medically significant). On 13-Sep-2022, the patient experienced COVID-19 (severe COVID 19/positive COVID-19 test) (seriousness criterion hospitalization). On an unknown date, the patient experienced HIP FRACTURE (broke his hips) (seriousness criteria hospitalization and medically significant) and BALANCE DISORDER (lack of balance) (seriousness criterion hospitalization). At the time of the report, COVID-19 (severe COVID 19/positive COVID-19 test) and PNEUMONIA (pneumonia/ Breathing Coughing up blood) had not resolved and HIP FRACTURE (broke his hips) and BALANCE DISORDER (lack of balance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2022, SARS-CoV-2 test: (Positive) Hospitalization due to COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are reported. Patient stated they received the primary vaccine and booster around the same time. They had the primary series and booster in 2021. They are looking to get the second booster, and she wanted to know if she had to wait an amount of time. She stated her husband been in the hospital 3 times. Patient was currently in the hospital since 08Nov2022, and he broke his hips due to lack of balance from COVID-19. Patient stated that, she must wait 5 weeks before he could get the booster. Patient wanted to know if that was correct since her husband and her had severe COVID 19 and was hospitalized. She also wanted to know if you were not severely sick with COVID could she still take the vaccine. Patient was taking a lot of medication HCP is aware of patient had COVID. Safety consent to follow up with the patient's wife was received. Patient's wife preferred to be called. After Hospitalization due to COVID-19, Breathing Coughing up blood Ended up with pneumonia and Treatment received in the hospital twice during that 2 month period. Patient had Heart issues. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient received all covid vaccines in dosage form vial.  Company comment: This is a spontaneous case, reported by a consumer, concerning an adult male patient with no relevant medical history reported, who experienced the unexpected serious (hospitalization, medically significant) events of Pneumonia and Hip fracture, and unexpected serious (hospitalization) events of COVID-19 and Balance disorder. The events Hip fracture and Balance disorder occurred on unknown date, the event Pneumonia occurred 46 days after receiving the first booster dose of mRNA-1273 vaccine, and the event COVID-19 occurred 320 days after receiving the first booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 29 days which falls within the recommended vaccine dosing schedule. It was reported that the patient had pneumonia with associated breathing problems and coughing up blood. Patient was hospitalized twice in 2 month period. Patient was again hospitalized due to hip fracture due to lack of balance. Moreover, patient also admitted due to severe COVID-19 confirmed by a positive SARS-CoV-2 test. No further details about the treatments were provided. Outcome of the events Hip fracture and Balance disorder were unknown, while the other events were not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult male patient with no relevant medical history reported, who experienced the unexpected serious (hospitalization, medically significant) events of Pneumonia and Hip fracture, and unexpected serious (hospitalization) events of COVID-19 and Balance disorder. The events Hip fracture and Balance disorder occurred on unknown date, the event Pneumonia occurred 46 days after receiving the first booster dose of mRNA-1273 vaccine, and the event COVID-19 occurred 320 days after receiving the first booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 29 days which falls within the recommended vaccine dosing schedule. It was reported that the patient had pneumonia with associated breathing problems and coughing up blood. Patient was hospitalized twice in 2 month period. Patient was again hospitalized due to hip fracture due to lack of balance. Moreover, patient also admitted due to severe COVID-19 confirmed by a positive SARS-CoV-2 test. No further details about the treatments were provided. Outcome of the events Hip fracture and Balance disorder were unknown, while the other events were not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.