Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injury, Loss of consciousness, Mobility decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out and woke up on the floor, passed out on the toilet and woke up on the floor, passed out again) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 011L20A, 012M20A and 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Runny nose. Concurrent medical conditions included Sulfonamide allergy, Drug allergy and Chronic back pain. Concomitant products included OMEPRAZOLE, MINERALS NOS, VITAMINS NOS, XANTOFYL (KIRKLAND SIGNATURE ADULT MULTIVITAMIN) and CALCIUM CITRATE, COLECALCIFEROL (EQUATE CALCIUM CITRATE + D3) for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN ABRASION (cuts and scrapes). On 23-Apr-2022, the patient experienced VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling). On 24-Apr-2022, the patient experienced LOSS OF CONSCIOUSNESS (passed out and woke up on the floor, passed out on the toilet and woke up on the floor, passed out again) (seriousness criterion medically significant), ASTHENIA (weak), INJURY (damage done to myself), DYSSTASIA (She was afraid to stand up so she scooted along the floor), CONTUSION (bruising, cuts and scrapes) and DIZZINESS (lightheaded, careful during the day but still light headed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Bruising, at an unspecified dose and frequency. On 25-Apr-2022, DIZZINESS (lightheaded, careful during the day but still light headed) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out and woke up on the floor, passed out on the toilet and woke up on the floor, passed out again), INJURY (damage done to myself), DYSSTASIA (She was afraid to stand up so she scooted along the floor), CONTUSION (bruising, cuts and scrapes), SKIN ABRASION (cuts and scrapes), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling) outcome was unknown and ASTHENIA (weak) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2022, Blood glucose: normal (normal) normal. On 24-Apr-2022, Blood pressure measurement: normal (normal) normal. On 24-Apr-2022, Electrocardiogram: normal (normal) normal. On 24-Apr-2022, Oxygen saturation: normal (normal) normal. Patient's EKG, blood sugar glucose, oxygen, and blood pressure were checked by EMT's, but there was nothing wrong and they all agreed there was no reason for her to go to the hospital. Patient was never tested positive for COVID-19. Patient was given fiber well gummies. It was reported that patient gets swelling and soreness with flu shots as well and she never passed out before. COMPANY COMMENT: This is an Spontaneous case concerning a 75-years-old female patient with clinical history of Runny nose, Sulfonamide allergy, Drug allergy and Chronic back pain who experienced the unexpected events of LOSS OF CONSCIOUSNESS (1st episode), LOSS OF CONSCIOUSNESS (2nd episode), LOSS OF CONSCIOUSNESS (3rd episode), SKIN ABRASION, ASTHENIA, INJURY, DYSSTASIA, CONTUSION and other expected events 1 days after 4th dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME. Sender's Comments: COMPANY COMMENT: This is an Spontaneous case concerning a 75-years-old female patient with clinical history of Runny nose,  Sulfonamide allergy, Drug allergy and Chronic back pain who experienced the unexpected events of LOSS OF CONSCIOUSNESS (1st episode), LOSS OF CONSCIOUSNESS (2nd episode), LOSS OF CONSCIOUSNESS (3rd episode), SKIN ABRASION, ASTHENIA, INJURY, DYSSTASIA, CONTUSION and other expected events 1 days after 4th  dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME.