Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Blood pressure measurement, Hypertensive urgency
Clinical narrative: Blood pressure 200/100; Lost taste; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSIVE URGENCY (Blood pressure 200/100) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder, Arthritis and Hypercholesterolaemia.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSIVE URGENCY (Blood pressure 200/100) (seriousness criterion medically significant) and AGEUSIA (Lost taste). The patient was treated with AMLODIPINE BESILATE (NORVASC) for Adverse event, at an unspecified dose and frequency and LISINOPRIL for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSIVE URGENCY (Blood pressure 200/100) had resolved and AGEUSIA (Lost taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: 200/100 (High) 200/100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is on medications for thyroid, cholesterol and arthritis.  It was reported that the patient got blood pressure on control about a month ago.  Company Comment: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Hypertensive urgency and the non serious event/AESI of Ageusia after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The onset of the events occurred approximately 2 weeks after the second dose of mRNA- 1273 vaccine. Blood pressure was reported as 200/100mmHg without associated symptoms, two antihypertensive drugs were prescribed and blood pressure was controlled after approximately 4 to 6 months. At the time of the report, ageusia was ongoing. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Hypertensive urgency and the non serious event/AESI of Ageusia after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The onset of the events occurred approximately 2 weeks after the second dose of mRNA- 1273 vaccine. Blood pressure was reported as 200/100mmHg without associated symptoms, two antihypertensive drugs were prescribed and blood pressure was controlled after approximately 4 to 6 months. At the time of the report, ageusia was ongoing. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report