Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Blood pressure measurement, Hypertension, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: high blood pressure; covid 19/ Caller is asymptomatic; The patient received 1st dose on 11May2021 and 2nd dose on 16Jun2021; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERTENSION (high blood pressure) and ASYMPTOMATIC COVID-19 (covid 19/ Caller is asymptomatic) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 050C21 and 016C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was not on any medications before previously and had no known allergies. There was no parental vaccine exposure.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 11May2021 and 2nd dose on 16Jun2021). In December 2022, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization) and ASYMPTOMATIC COVID-19 (covid 19/ Caller is asymptomatic) (seriousness criterion hospitalization). The patient was treated with AMIODARONE for Blood pressure high, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (high blood pressure), ASYMPTOMATIC COVID-19 (covid 19/ Caller is asymptomatic) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 11May2021 and 2nd dose on 16Jun2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had three Moderna vaccines and was in the hospital testing positive for covid about a week ago. Patient was asymptomatic. Patient was on amiodarone for high blood pressure, but they stopped giving that to patient.  Company comment: This spontaneous case concerns a 71-year-old female patient with no medical history reported, who experienced serious (hospitalization) unexpected events of COVID-19 and hypertension, that occurred approximately 1 year and 6 months after the 3rd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administration since interval between the 1st and the 2nd dose was 36 days and thus, the report does not meet the criteria for vaccination failure. Reportedly, the patient tested positive for COVID-19 at the hospital and was treated with amiodarone for hypertension. It was not clear whether the patient was hospitalized due to both events or only had COVID-19 test at the hospital.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The patient's advanced age and concomitant COVID-19 disease are a possible confounder for hypertension. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old female patient with no medical history reported, who experienced serious (hospitalization) unexpected events of COVID-19 and hypertension, that occurred approximately 1 year and 6 months after the 3rd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administration since interval between the 1st and the 2nd dose was 36 days and thus, the report does not meet the criteria for vaccination failure. Reportedly, the patient tested positive for COVID-19 at the hospital and was treated with amiodarone for hypertension. It was not clear whether the patient was hospitalized due to both events or only had COVID-19 test at the hospital.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination.The patient's advanced age and concomitant COVID-19 disease are a possible confounder for hypertension. The benefit-risk relationship of mRNA-1273 is not affected by this report.