Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dizziness, Headache
Clinical narrative: to receive the second is to far out from his first dose since he got it on 03Mar2021; chills; Fever; headache; Light headed; Collapsed; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID -19 in December of 2020 but was not hospitalized.) in December 2020. Concomitant products included VALSARTAN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced DIZZINESS (Light headed) and HEADACHE (headache). On 05-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (to receive the second is to far out from his first dose since he got it on 03Mar2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SYNCOPE (Collapsed), DIZZINESS (Light headed), PRODUCT DOSE OMISSION ISSUE (to receive the second is to far out from his first dose since he got it on 03Mar2021), HEADACHE (headache), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102-103 (High) fever around 102-103 degrees. In 2021, Blood pressure measurement: low (Low) Low. In 2021, Heart rate: low (Low) Low.     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.   It was reported that the patient collapsed in a restaurant booth around 6:50pm and had to go to ER and it was found that his pulse and Blodd pressure was low. But the ER could not come to a conclusion of what caused him to collapsed. His primary care doctor referred him to a cardiologist to make sure everything was okay but he determined that his medication needed to be changed.   On 04Mar2021 he felt light headed  and on 05Mar2021 her had a fever around 102-103 degrees, chills and used Tylenol to break the fever. The patient could only work half a day both days. On Saturday the patient felt fine and the next week would have spells of lightheadedness that would cause him to have to sit down.  Company Comment: This report refers to a case of Product dose omission issue with adverse events of syncope, dizziness, pyrexia, headache and chills in a 45-year-old male patient. Reportedly, the patient experienced syncope, dizziness, pyrexia, headache and chills after the administration of the first dose of Moderna COVID-19 Vaccine, and based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The causality for the product dose omssion issue is not applicable.; Sender's Comments: This report refers to a case of Product dose omission issue with adverse events of syncope, dizziness, pyrexia, headache and chills in a 45-year-old male patient. Reportedly, the patient experienced syncope, dizziness, pyrexia, headache and chills after the administration of the first dose of Moderna COVID-19 Vaccine, and based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The causality for the product dose omssion issue is not applicable.