Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Palpitations, Vaccination site pain
Clinical narrative: feeling like her heart was racing and pounding out of her chest; blood pressure was elevated; sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (feeling like her heart was racing and pounding out of her chest) and HYPERTENSION (blood pressure was elevated) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Single functional kidney (She lost a kidney, due to renal cell carcinoma.) and Renal cell carcinoma (She lost a kidney, due to renal cell carcinoma.). Concurrent medical conditions included Blood pressure abnormal.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). On 14-Feb-2021, the patient experienced PALPITATIONS (feeling like her heart was racing and pounding out of her chest) (seriousness criterion medically significant) and HYPERTENSION (blood pressure was elevated) (seriousness criterion medically significant). In February 2021, PALPITATIONS (feeling like her heart was racing and pounding out of her chest) had resolved. At the time of the report, HYPERTENSION (blood pressure was elevated) and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood pressure measurement: high (High) blood pressure was elevated. It was around 210/100. On 14-Feb-2021, Heart rate: high (High) Her heart rate was over 200 beats/min. In February 2021, Blood pressure measurement: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included unspecified blood pressure medicine The patient was taken to the emergency room. Her heart rate was over 200 beats/min. They also noticed that her blood pressure was elevated. It was around 210/100. They were going to give her some medicine to slow her heartrate down. Before giving her the medicine for her racing heart, it went back to normal on it's own. The patient was already taking blood pressure medicine. She saw a cardiologist a week, or so, after the emergency room visit. He changed her blood pressure medicine. She saw her PCP about a month later, just for her regular follow up and some blood work. Her Doctor changed her blood pressure medicine back to the original one. The new blood pressure medication which the cardiologist put her on was not working. She also said she did not have to go back to the cardiologist. Company comment This case concerns a 88-year-old, female patient with medical history of hypertension and renal cell carcinoma, who experienced the serious, unexpected events of hypertension and palpitations. The events occurred 29 days after first dose of the mRNA-1273 Moderna COVID-19 vaccine. The rechallenge was not applicable for the event hypertension, as the outcome is unknown and negative for the event hypertension. The medical history of hypertension and renal cell carcinoma remain as confounders. The benefit-risk relationship of the mRNA-1273 Moderna COVID-19 vaccine is not affected by this report. Case seriousness was reported as disabling and IME, however, based on available information on the regulatory authority, the seriousness criteria was captured as IME.   This case was linked to MOD-2021-370256 (Patient Link).; Sender's Comments: This case concerns a 88-year-old, female patient with medical history of hypertension and renal cell carcinoma, who experienced the serious, unexpected events of hypertension and palpitations. The events occurred 29 days after first dose of the mRNA-1273 Moderna COVID-19 vaccine. The rechallenge was not applicable for the event hypertension, as the outcome is unknown and negative for the event hypertension. The medical history of hypertension and renal cell carcinoma remain as confounders. The benefit-risk relationship of the mRNA-1273 Moderna COVID-19 vaccine is not affected by this report. Case seriousness was reported as disabling and IME, however, based on available information from the regulatory authority, the seriousness criteria was captured as IME.