Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Vaccination site reaction, Vaccination site swelling
Clinical narrative: blood pressure was very high; patient started with headaches described as a band around head; It bubbled up, like a hard not; injection site reaction immediately; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was very high) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included CODEINE and METOPROLOL for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction immediately) and VACCINATION SITE SWELLING (It bubbled up, like a hard not). In June 2021, the patient experienced HYPERTENSION (blood pressure was very high) (seriousness criterion hospitalization). On 17-Jun-2021, the patient experienced HEADACHE (patient started with headaches described as a band around head). The patient was hospitalized for 1 day due to HYPERTENSION. The patient was treated with NIFEDIPINE (PROCARDIA [NIFEDIPINE]) for Adverse event, at an unspecified dose and frequency and CLONIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (blood pressure was very high), VACCINATION SITE REACTION (injection site reaction immediately) and HEADACHE (patient started with headaches described as a band around head) outcome was unknown and VACCINATION SITE SWELLING (It bubbled up, like a hard not) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Blood pressure measurement: 180/133 (High) 180/133.         Patient used cold compress as treatment.  Reported that in pre-surgery tests, in which blood pressure appeared to be very high. Patient went to ER once. And was hospitalized for 1 day after surgery because of high blood pressure. Particularly since July blood pressure was impossible to control.  Company Comment : This case concerns a 56-year-old, male patient with previous relevant medical history of blood pressure high, who experienced the unexpected serious event of hypertension. The date of onset was not reported. The event occurred after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as the outcome of the events is unknown. The medical history of blood pressure high could be confounder for the event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 56-year-old, male patient with previous relevant medical history of blood pressure high, who experienced the unexpected serious event of hypertension. The date of onset was not reported. The event occurred after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as the outcome of the events is unknown. The medical history of blood pressure high could be confounder for the event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.