Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Lip injury, Syncope, X-ray
Clinical narrative: Collapsed; large hematoma on the back of head; feeling very weak; Woozy and Headachy; flat on my back on the bathroom floor; quite disoriented; memory of what happened next is a little hazy; attempted to get up once and was unsuccessful; Low Blood Pressure; gash open my front lip in the fall; Woozy and headachy; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dust allergy, Pollen allergy, Grass allergy, Ragweed allergy and Seasonal allergy since 1960. Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM WITH VITAMIN D3 [CALCIUM;COLECALCIFEROL]) for Osteoporosis.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criteria hospitalization and medically significant), DIZZINESS (Woozy and Headachy), FALL (flat on my back on the bathroom floor), DISORIENTATION (quite disoriented), AMNESIA (memory of what happened next is a little hazy), DYSSTASIA (attempted to get up once and was unsuccessful), HYPOTENSION (Low Blood Pressure), LIP INJURY (gash open my front lip in the fall) and HEADACHE (Woozy and headachy). On 19-Mar-2021, the patient experienced ASTHENIA (feeling very weak). On an unknown date, the patient experienced HAEMATOMA (large hematoma on the back of head). At the time of the report, SYNCOPE (Collapsed), DIZZINESS (Woozy and Headachy), FALL (flat on my back on the bathroom floor), DISORIENTATION (quite disoriented), AMNESIA (memory of what happened next is a little hazy), DYSSTASIA (attempted to get up once and was unsuccessful), HYPOTENSION (Low Blood Pressure) and HEADACHE (Woozy and headachy) had resolved and ASTHENIA (feeling very weak), HAEMATOMA (large hematoma on the back of head) and LIP INJURY (gash open my front lip in the fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) 85/45. On an unknown date, Computerised tomogram: negative (Negative) brain bleed (negative). On an unknown date, X-ray: negative (Negative) negative.         Treatment for the events included aspirin and intravenous saline.  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.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: updated concomitant medications, treatment information, and medical history.; Sender's Comments: 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.