Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Chest pain, Dizziness, Hypotension
Clinical narrative: Tightness in the chest; Chest hurt really bad; Very dizzy; blood pressure was extremely low at 95/57; Almost past out 2 times; flu like symptoms; Arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost past out 2 times), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST DISCOMFORT (Tightness in the chest), CHEST PAIN (Chest hurt really bad) and DIZZINESS (Very dizzy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (Arm was very sore). On 03-Sep-2021, the patient experienced PRESYNCOPE (Almost past out 2 times), CHEST DISCOMFORT (Tightness in the chest), CHEST PAIN (Chest hurt really bad), DIZZINESS (Very dizzy) and HYPOTENSION (blood pressure was extremely low at 95/57). On 04-Sep-2021, PRESYNCOPE (Almost past out 2 times), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST DISCOMFORT (Tightness in the chest), CHEST PAIN (Chest hurt really bad), DIZZINESS (Very dizzy) and HYPOTENSION (blood pressure was extremely low at 95/57) had resolved. On 06-Sep-2021, MYALGIA (Arm was very sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Blood pressure measurement: 95/57 (Low) 95/57.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The same day after vaccination, patient felt flu like symptoms that lasted till 04-Sep-2021 and their arm was very sore till 05 or 06Sep2021. Around 8pm on 03-Sep2-021 patient felt tightness in the chest, their chest hurt bad, patient was very dizzy and almost passed out 2 times, all these till 04Sep2021. Patient blood pressure was extremely low at 95/57 till 04-Sep-2021. Patient has no previous or current myocarditis or pericarditis diagnose. Patient had covid-19 back in March 2021, and tested positive on 29Mar2021, about 5 days after the symptoms started. Patient was not hospitalized for this and the treatment received was antibiotic and a z-pack. Caller state the covid-19 infection symptoms were mainly upper respiratory.  Company comment: This case concerns a 59-year-old male patient with no relevant medical history, who experienced the unexpected non-serious event of Presyncope. The event occurred 1 day after first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Case seriousness downgraded due to lack of evidence of seriousness from a regulatory or clinical standpoint according to source document.; Sender's Comments: This case concerns a 59-year-old male patient with no relevant medical history, who experienced the unexpected non-serious event of Presyncope. The event occurred 1 day after first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Case seriousness downgraded due to lack of evidence of seriousness from a regulatory or clinical standpoint according to source document.