Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Gait inability, Magnetic resonance imaging
Clinical narrative: her husband woke up and could not walk,still unable to walk after more than 2 months; very dizzy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (her husband woke up and could not walk,still unable to walk after more than 2 months) and DIZZINESS (very dizzy) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 015M20A) for COVID-19 vaccination.     Concomitant products included INSULIN, CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE BESILATE (NORVASC), ATORVASTATIN CALCIUM (LIPITOR) and FINASTERIDE (PROSCAR) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced GAIT INABILITY (her husband woke up and could not walk,still unable to walk after more than 2 months) (seriousness criteria hospitalization, disability and medically significant) and DIZZINESS (very dizzy) (seriousness criterion hospitalization). The patient was hospitalized from 23-Sep-2021 to 26-Sep-2021 due to DIZZINESS and GAIT INABILITY. The patient was treated with Physical therapy (physical therapy) for Gait inability. At the time of the report, GAIT INABILITY (her husband woke up and could not walk,still unable to walk after more than 2 months) was resolving and DIZZINESS (very dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) MRI, CAT scan, bloodwork all came back normal. On an unknown date, Computerised tomogram: normal (normal) MRI, CAT scan, bloodwork all came back normal. On an unknown date, Magnetic resonance imaging: normal (normal) MRI, CAT scan, bloodwork all came back normal.         No treatment medications were reported.  No Medical History information was reported.  Patient  was sent to the ER for various test (MRI, CAT scan, bloodwork all came back normal). He was discharged from the hospital after 4 days. He had done physical therapy and that had only helped him a little bit, but he was nowhere to where he was before this.  Patients weight was 185.  Company Comment: This case concerns a  86-year-old, male patient with intake of concomitant drugs Insulin, Clopidogrel, Amlodipine, Atorvastatin and Finasteride, who experienced the unexpected serious events of Gait inability and Dizziness. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine which resulted in hospitalization and disability. During admission MRI, CAT scan, bloodwork were done all of which came back normal. At the time of report the outcome of the events was unknown. The patient's medical history of intake of concomitant drugs Insulin, Clopidogrel, Amlodipine, Atorvastatin and Finasteride remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  86-year-old, male patient with intake of concomitant drugs Insulin, Clopidogrel, Amlodipine, Atorvastatin and Finasteride, who experienced the unexpected serious events of Gait inability and Dizziness. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine which resulted in hospitalization and disability. During admission MRI, CAT scan, bloodwork were done all of which came back normal. At the time of report the outcome of the events was unknown. The patient's medical history of intake of concomitant drugs Insulin, Clopidogrel, Amlodipine, Atorvastatin and Finasteride remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.