Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Computerised tomogram, Dyspnoea, Heart rate
Clinical narrative: Blood pressure kept rising/BP went up to over 200/100; Blood clot; Very weak/could not lift anything heavy; Heart rate was going up; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and HYPERTENSION (Blood pressure kept rising/BP went up to over 200/100) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). On 28-Sep-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization, medically significant and intervention required). On an unknown date, the patient experienced HYPERTENSION (Blood pressure kept rising/BP went up to over 200/100) (seriousness criteria hospitalization and medically significant), ASTHENIA (Very weak/could not lift anything heavy) and HEART RATE INCREASED (Heart rate was going up). The patient was hospitalized from 28-Sep-2021 to 29-Sep-2021 due to HYPERTENSION and THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of 5 milligram twice a day. At the time of the report, THROMBOSIS (Blood clot), HYPERTENSION (Blood pressure kept rising/BP went up to over 200/100) and HEART RATE INCREASED (Heart rate was going up) outcome was unknown, DYSPNOEA (Shortness of breath) had resolved and ASTHENIA (Very weak/could not lift anything heavy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, Blood pressure measurement: 200/100 (High) BP went up to over 200/100. On 28-Sep-2021, Chest X-ray: abnormal (abnormal) had a blood clot. On 28-Sep-2021, Computerised tomogram: abnormal (abnormal) had a blood clot. On an unknown date, Blood pressure measurement: rising (High) blood pressure kept rising. On an unknown date, Heart rate: high (High) heart rate was going up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The shortness of breath went on for few days. She was checking her blood pressure (BP), pulse and temperature. Her blood pressure kept rising, her heart rate was going up with her blood pressure and she was getting very weak. She called her doctor and she was told to go to the emergency room (ER). She went to the ER on 28-Sep-2021, they ran tests; her BP  went up to over 200/100. They did chest XRAY and CT scan and found that she had a blood clot. She was not on a long ride neither she had stayed in bed for few days. She was up and actively up till the date (while talking to the doctor). The doctor could not tell her what caused it but the only thing she could think of was the shot. She was healthy and had no problems. She was discharged the next day, in the afternoon. She had an appointment with her healthcare provider on Friday 8-Oct-2021. Her walking got better, but she still could not lift anything heavy.  Company comment: This case concerns a 71-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of Thrombosis and hypertension. The events occurred approximately 5 months and 20 days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 71-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of Thrombosis and hypertension. The events occurred approximately 5 months and 20 days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.