Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Hypertension
Clinical narrative: COVID-19; Blood pressure high; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and COVID-19 (COVID-19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for Rheumatoid arthritis.    No Medical History information was reported.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (Subcutaneous) ADALIMUMAB Solution for injection. In November 2021, the patient experienced HYPERTENSION (Blood pressure high) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (Blood pressure high) and COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: Extremely High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  Patient had the booster dose and got covid right after the injection. In Nov 2021, he was in the emergency room in the hospital with extremely high blood pressure.  It was unknown if patient was enrolled in covid-19 vaccination trial. No treatment medication was provided.  CC- This spontaneous case concerns a 71-year-old, male patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect drug adalimumab, who experienced the unexpected, serious (medically significant) events of hypertension and COVID-19 (AESI). The event hypertension occurred unknown number of days after receiving adalimumab and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the administration date of adalimumab was not reported while the event onset date was reported as unspecified date in Nov2021, hence, the onset latency could not be assessed. The event COVID-19 occurred unknown number of days after receiving adalimumab and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19 'right after the injection'. No symptoms were reported and treatment information was not provided. A week after the patient received the booster dose, it was reported that the patient was in the Emergency room with extremely high blood pressure (blood pressure measurement was not provided). No further details were provided. The events had not resolved at the time of the report. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: This spontaneous case concerns a 71-year-old, male patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect drug adalimumab, who experienced the unexpected, serious (medically significant) events of hypertension and COVID-19 (AESI). The event hypertension occurred unknown number of days after receiving adalimumab and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the administration date of adalimumab was not reported while the event onset date was reported as unspecified date in Nov2021, hence, the onset latency could not be assessed. The event COVID-19 occurred unknown number of days after receiving adalimumab and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19 'right after the injection'. No symptoms were reported and treatment information was not provided. A week after the patient received the booster dose, it was reported that the patient was in the Emergency room with extremely high blood pressure (blood pressure measurement was not provided). No further details were provided. The events had not resolved at the time of the report. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.