Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agitation, Discomfort, Gait disturbance
Clinical narrative: Patient felt agitated; Patient could not walk; Began to feel discomfort; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Patient felt agitated), GAIT DISTURBANCE (Patient could not walk) and DISCOMFORT (Began to feel discomfort) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure abnormal. Concomitant products included AMLODIPINE and METOPROLOL for Blood pressure abnormal, SIMVASTATIN for Cholesterol.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced AGITATION (Patient felt agitated) (seriousness criterion hospitalization), GAIT DISTURBANCE (Patient could not walk) (seriousness criterion hospitalization) and DISCOMFORT (Began to feel discomfort) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 01-Apr-2021 due to AGITATION, DISCOMFORT and GAIT DISTURBANCE. The patient was treated with HEPARIN for Heart attack, at an unspecified dose and frequency. At the time of the report, AGITATION (Patient felt agitated), GAIT DISTURBANCE (Patient could not walk) and DISCOMFORT (Began to feel discomfort) outcome was unknown.            They did the laboratory exam with doctor that includes stress test but patient cant complete it. On 27-MAR-2021 he began to feel discomfort, felt agitated and could not walk. On 30-MAR-2021 he went to the emergency room and was hospitalized for two days. It was released by 1-APR-2021, without any complications. On the 25-APR-2021 he was hospitalized again with the same increased symptoms palpitations and chest pain. They gave him a catheterization and tell him that he had angina. He begins to suspect that it was a symptom of myocarditis or pericarditis, for which he wants to know if he should put on the booster since he did not want to suffer the same symptoms again. The patient received heparin - in the hospital to treat a possible heart attack. Company comment: This case concerns a 71-year-old, male patient with medical history of blood pressure abnormal and cholesterol, who experienced the unexpected events of agitation, gait disturbance and discomfort, which required hospitalization. The events occurred approximately 9 days after the first dose of mRNA-1273. As reported the patient received heparin - in the hospital to treat a possible heart attack. The rechallenge was not applicable as outcome of events was unknown. The patient was hospitalized for one day. However, after second dose the patient had similar symptoms and reported chest pain and palpitations and was diagnosed with angina. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2021-399937 (Patient Link).; Sender's Comments: This case concerns a 71-year-old, male patient with medical history of blood pressure abnormal and cholesterol, who experienced the unexpected events of agitation, gait disturbance and discomfort, which required hospitalization. The events occurred approximately 9 days after the first dose of mRNA-1273. As reported the patient received heparin - in the hospital to treat a possible heart attack. The rechallenge was not applicable as outcome of events was unknown. The patient was hospitalized for one day. However, after second dose the patient had similar symptoms and reported chest pain and palpitations and was diagnosed with angina. The benefit-risk relationship of mRNA-1273 is not affected by this report.