Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Hypotension, Inappropriate schedule of product administration
Clinical narrative: he fainted and he was out for a few seconds/was standing his vision was affected; low blood pressure; spike of fever of 101°F; headache; 1st booster probably at the beginning of January 2022 and 2nd booster dose April 8 2022; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (he fainted and he was out for a few seconds/was standing his vision was affected) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002m21a, 026b21a and 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Passed out (two occasions 5 to 10 years ago and there was no explication to what caused it.). Concurrent medical conditions included Drug allergy (ACE inhibitors allergy), Food allergy (Food allergy with sunflower seeds), Hypertension and Cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster probably at the beginning of January 2022 and 2nd booster dose April 8 2022). On 09-Apr-2022, the patient experienced PYREXIA (spike of fever of 101°F) and HEADACHE (headache). On 10-Apr-2022, the patient experienced SYNCOPE (he fainted and he was out for a few seconds/was standing his vision was affected) (seriousness criterion medically significant) and HYPOTENSION (low blood pressure). On 09-Apr-2022, PYREXIA (spike of fever of 101°F) and HEADACHE (headache) had resolved. On 10-Apr-2022, SYNCOPE (he fainted and he was out for a few seconds/was standing his vision was affected) had resolved. In April 2022, HYPOTENSION (low blood pressure) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster probably at the beginning of January 2022 and 2nd booster dose April 8 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2022, Body temperature: 101 101 degree fahrenheit. On 10-Apr-2022, Blood pressure measurement: low (Low) Low. In April 2022, Blood pressure measurement: normal (normal) normal.         Company Comment: This spontaneous case concerns a 75-year-old, male patient, with relevant concurrent condition of Hypertension and medical history of Loss of consciousness who experienced the unexpected, serious (medically significant) event of Syncope which occurred two days after receiving the fourth dose of mRNA-1273 COVID-19 vaccine. Inappropriate schedule of product administration is noted in this case as the second booster dose was administered less than 4 months after the first booster dose. Patient developed fever and headache a day after vaccine administration which spontaneously resolved on the same day of onset. Two days after vaccination, he experienced sudden onset of loss of consciousness. He was able to regain consciousness but noted by the EMT to have low blood pressure. He was not hospitalized but was advised by his physician to temporarily discontinue his anti-hypertensive medication. His blood pressure stabilized after a week of observation. Advanced age, medical history of loss of consciousness and concomitant use of anti-hypertensive medication remain as confounders for the event syncope. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient, with relevant concurrent condition of Hypertension and medical history of Loss of consciousness who experienced the unexpected, serious (medically significant) event of Syncope which occurred two days after receiving the fourth dose of mRNA-1273 COVID-19 vaccine. Inappropriate schedule of product administration is noted in this case as the second booster dose was administered less than 4 months after the first booster dose. Patient developed fever and headache a day after vaccine administration which spontaneously resolved on the same day of onset. Two days after vaccination, he experienced sudden onset of loss of consciousness. He was able to regain consciousness but noted by the EMT to have low blood pressure. He was not hospitalized but was advised by his physician to temporarily discontinue his anti-hypertensive medication. His blood pressure stabilized after a week of observation. Advanced age, medical history of loss of consciousness and concomitant use of anti-hypertensive medication remain as confounders for the event syncope. The benefit-risk relationship of mRNA-1273 is not affected by this report.