Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure increased, Electrocardiogram, Pain in extremity, Peripheral swelling
Clinical narrative: "blood pressure went nuts"; "soreness only when you touched it"; "arrhythmia skipping beats 1234 skip 1234 skip"; "a bump like the muscle was puffy"; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ("blood pressure went nuts") and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NADOLOL, CLONIDINE and FINASTERIDE (PROSCAR) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING ("a bump like the muscle was puffy"). On 23-May-2021, the patient experienced BLOOD PRESSURE INCREASED ("blood pressure went nuts") (seriousness criteria hospitalization and intervention required) and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY ("soreness only when you touched it"). On 24-May-2021, PERIPHERAL SWELLING ("a bump like the muscle was puffy") had resolved. On 12-Jun-2021, ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") had resolved. At the time of the report, BLOOD PRESSURE INCREASED ("blood pressure went nuts") outcome was unknown and PAIN IN EXTREMITY ("soreness only when you touched it") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: skipping beats 1234 skip. (Inconclusive) skipping beats 1234 skip..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient  had call  on 14Jun2021, with symptoms following his first dose of the Moderna COVID-19 Vaccine, which he received on 19May2021 in his left arm, lot#027C21A,  expiration 10Oct21. He states that he had  felt really good for a day or so and then he developed soreness on his arm only to the touch, "a bump like the muscle was puffy," and "blood pressure went nuts." He  had states the puffy  muscles and soreness on his arm lasted about 2-3 days. He also states he was hospitalized for his blood pressure and was told by the doctors in the hospital that he had "arrhythmia skipping beats 1234 skip 1234 skip" that was seen on an EKG they performed.  At the hospital, doctor  "loaded he up with meds and sent he home" and his arrhythmia went away around 12Jun2021 but he is still dealing with the blood pressure. He states he has been dealing with blood pressure issues since before his vaccine and has seen his cardiologist and primary care since hospitalization. Consents to follow up with Safety.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.