Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Vision blurred, Vitreous floaters
Clinical narrative: exacerbation of Celiac disease; Bubble floating in eye/eyes had a bubble floating there for a week; Difficulty focusing eye; Elevation of blood pressure; Stomach Pain/severe stomach pain for about 3 weeks; Lying in bed for 3 days; Difficult to breathe; Extremely scary heartbeat at night while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (exacerbation of Celiac disease) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Celiac disease (worsening symptoms) since 1995.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (Extremely scary heartbeat at night while sleeping). On an unknown date, the patient experienced COELIAC DISEASE (exacerbation of Celiac disease) (seriousness criterion medically significant), VITREOUS FLOATERS (Bubble floating in eye/eyes had a bubble floating there for a week), VISION BLURRED (Difficulty focusing eye), BLOOD PRESSURE INCREASED (Elevation of blood pressure), ABDOMINAL PAIN UPPER (Stomach Pain/severe stomach pain for about 3 weeks), BED REST (Lying in bed for 3 days) and DYSPNOEA (Difficult to breathe). On 20-Feb-2021, VITREOUS FLOATERS (Bubble floating in eye/eyes had a bubble floating there for a week), VISION BLURRED (Difficulty focusing eye) and HEART RATE INCREASED (Extremely scary heartbeat at night while sleeping) had resolved. At the time of the report, COELIAC DISEASE (exacerbation of Celiac disease) and BLOOD PRESSURE INCREASED (Elevation of blood pressure) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach Pain/severe stomach pain for about 3 weeks), BED REST (Lying in bed for 3 days) and DYSPNOEA (Difficult to breathe) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: rapid (High) rapid. On 19-Feb-2021, Heart rate: rapid (High) rapid. In 2021, Blood pressure measurement: elevated (High) elevated.         Concomitant product use was not provided by the reporter.  The patient had severe stomach pain for about 3 weeks after the vaccine, extremely scary heartbeat at night while sleeping. It woke her up because it was difficult to breathe. It settled within a few minutes both times but was very disturbing. One of the eyes had a bubble floating there for a week and she had difficulty focusing it. The patient went to see doctors for all of these. Eventually they resolved themselves, but the fear of breathing issues at night remained.  No treatment information was provided.  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 16-Jun-2021: Follow up received on 16-jun-2021. No new information. On 23-Jul-2021: Significant Follow up received on 23Jul2021 contains events updated breathing difficult and Difficulty focusing eyes and fear of breathing issues at night relevant history celiac as current condition and suspect dose date detail.; 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.