Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Flushing, Hypertension, Loss of consciousness, Pericarditis
Clinical narrative: Verge of passing out; Flushing; Dry heaving; High blood pressure; Pericarditis has gotten worse (inflammation around the sac); This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Verge of passing out), FLUSHING (Flushing), RETCHING (Dry heaving), HYPERTENSION (High blood pressure) and PERICARDITIS (Pericarditis has gotten worse (inflammation around the sac)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Verge of passing out) (seriousness criteria hospitalization and medically significant), FLUSHING (Flushing) (seriousness criterion hospitalization), RETCHING (Dry heaving) (seriousness criterion hospitalization), HYPERTENSION (High blood pressure) (seriousness criterion hospitalization) and PERICARDITIS (Pericarditis has gotten worse (inflammation around the sac)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in December 2021 due to FLUSHING, HYPERTENSION, LOSS OF CONSCIOUSNESS, PERICARDITIS and RETCHING. At the time of the report, LOSS OF CONSCIOUSNESS (Verge of passing out), FLUSHING (Flushing), RETCHING (Dry heaving), HYPERTENSION (High blood pressure) and PERICARDITIS (Pericarditis has gotten worse (inflammation around the sac)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         Patient is on concomitant medications, did not specify which ones. On Dec 2021, patient experienced nausea. Treatment includes medicine for nausea name was unspecified.  Company comment: This is a spontaneous case concerns a 52-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Hospitalization) events of hot flush, loss of consciousness, high blood pressure and expected, serious and AESI of Pericarditis. The patient experienced after her 2nd dose and booster dose of mRNA-1273 vaccine, adverse effects which caused hospitalized. After the second dose was administered, within 5-10 minutes, she felt flushing, was on the verge of passing out, chest pain, pericarditis that has gotten worse (inflammation around the sac) and dry heaving. She reported her blood pressure is usually was 177/100. Within 5-10 minutes after her booster dose was administered, she experienced the same reactions, which caused her to go to the emergency room, hence the rechallenge is positive. It was reported that she is on several concomitant medication, however, the patient did not specified them. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-409826 (Patient Link).; Sender's Comments: This is a spontaneous case concerns a 52-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Hospitalization) events of hot flush, loss of consciousness, high blood pressure and expected, serious and AESI of Pericarditis. The patient experienced after her 2nd dose and booster dose of mRNA-1273 vaccine, adverse effects which caused hospitalized. After the second dose was administered, within 5-10 minutes, she felt flushing, was on the verge of passing out, chest pain, pericarditis that has gotten worse (inflammation around the sac) and dry heaving. She reported her blood pressure is usually was 177/100. Within 5-10 minutes after her booster dose was administered, she experienced the same reactions, which caused her to go to the emergency room, hence the rechallenge is positive. It was reported that she is on several concomitant medication, however, the patient did not specified them. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.