Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dry mouth, Dyspnoea, Epilepsy, Feeling abnormal
Clinical narrative: couldnt even move arm; mouth was all dry; felt very bad/ felt like she lost the sugar of her body; arm started hurting; had shortage of breath; Lost her consciousness; received the first dose had epilepsy attacks, epilepsy episodes/had epilepsy all her life; wet all her clothes; felt very bad/ felt like she lost the sugar of her body; Forearm totaly inflammed/arm is still hot/ arm had temperature/ shoulder to the elbow, it was like " inflamed inflamed inflamed"; like a weird discomfort; felt a lot of pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Lost her consciousness) and EPILEPSY (received the first dose had epilepsy attacks, epilepsy episodes/had epilepsy all her life) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaccination site reaction ("she had a similar episode with a vaccine, it infected and it was like a fistula, with a vaccine which had timerosal") and Unspecified disorder of esophagus (Cannot take many medications because of her esophagus surgeries since 11 years, she has had 3 esophagus surgeries). Concurrent medical conditions included Epilepsy (had epilepsy all her life) and Drug allergy (Allergic to thimerosal). Concomitant products included ENALAPRIL and PANTOPRAZOL [PANTOPRAZOLE] for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced INFLAMMATION (Forearm totaly inflammed/arm is still hot/ arm had temperature/ shoulder to the elbow, it was like " inflamed inflamed inflamed"), DISCOMFORT (like a weird discomfort) and MYALGIA (felt a lot of pain in the body). On 16-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Lost her consciousness) (seriousness criterion medically significant), EPILEPSY (received the first dose had epilepsy attacks, epilepsy episodes/had epilepsy all her life) (seriousness criterion medically significant), HYPERHIDROSIS (wet all her clothes), VACCINATION COMPLICATION (felt very bad/ felt like she lost the sugar of her body) and DYSPNOEA (had shortage of breath). On an unknown date, the patient experienced LIMB DISCOMFORT (couldnt even move arm), DRY MOUTH (mouth was all dry), FEELING ABNORMAL (felt very bad/ felt like she lost the sugar of her body) and VACCINATION SITE PAIN (arm started hurting). The patient was treated with FENOBARBITAL ongoing since an unknown date for Epileptic seizure, at a dose of 1 dosage form. At the time of the report, LOSS OF CONSCIOUSNESS (Lost her consciousness), EPILEPSY (received the last dose had epilepsy attacks, epilepsy episodes/had epilepsy all her life), HYPERHIDROSIS (wet all her clothes), INFLAMMATION (Forearm totaly inflammed/arm is still hot/ arm had temperature/ shoulder to the elbow, it was like " inflamed inflamed inflamed"), LIMB DISCOMFORT (couldnt even move arm), DISCOMFORT (like a weird discomfort), DRY MOUTH (mouth was all dry), DYSPNOEA (had shortage of breath), FEELING ABNORMAL (felt very bad/ felt like she lost the sugar of her body), VACCINATION SITE PAIN (arm started hurting) and MYALGIA (felt a lot of pain in the body) outcome was unknown and VACCINATION COMPLICATION (felt very bad/ felt like she lost the sugar of her body) had not resolved.            No history of myocarditis/pericarditis provided by the reporter.  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. Concomitant Epilepsy could be potentially confounder  for the serious events epilepsy and loss of consciousness.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Non-Significant information received On 08-Sep-2021: Non-Significant Follow up received; 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. Concomitant Epilepsy could be potentially confounder  for the serious events epilepsy and loss of consciousness.