Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blepharospasm, Blood pressure measurement, Body temperature, Chest pain
Clinical narrative: slight delirium; racing heart; tachycardia at 120 bpm; not hungry but very thirsty; not hungry but very thirsty; lot of trouble sleeping; low grade fever; EKG at home and she was catching Afib; tinnitus - ears ringing; could'nt talk; could'nt move; TIA with eyes fluttering; TIA with eyes fluttering, couldn't talk or move; chest pain; shortness of breath; extreme hypertension 200/115; forgot name for about 15 minutes; sterile diarrhea; lost 20 pounds; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (EKG at home and she was catching Afib), DELIRIUM (slight delirium) and TRANSIENT ISCHAEMIC ATTACK (TIA with eyes fluttering, couldn't talk or move) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (For about a month.) in March 2020. Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (COPPER IUD) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds). On 09-Apr-2021, the patient experienced DIARRHOEA (sterile diarrhea). On 10-Apr-2021, the patient experienced MEMORY IMPAIRMENT (forgot name for about 15 minutes). On 18-Apr-2021, the patient experienced CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and HYPERTENSION (extreme hypertension 200/115). On 19-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA with eyes fluttering, couldn't talk or move) (seriousness criterion medically significant), BLEPHAROSPASM (TIA with eyes fluttering), SPEECH DISORDER (could'nt talk) and HYPOKINESIA (could'nt move). On 20-Apr-2021, the patient experienced TINNITUS (tinnitus - ears ringing). On 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (EKG at home and she was catching Afib) (seriousness criterion medically significant). On an unknown date, the patient experienced DELIRIUM (slight delirium) (seriousness criterion medically significant), PALPITATIONS (racing heart), TACHYCARDIA (tachycardia at 120 bpm), DECREASED APPETITE (not hungry but very thirsty), THIRST (not hungry but very thirsty), INSOMNIA (lot of trouble sleeping) and PYREXIA (low grade fever). On 10-Apr-2021, MEMORY IMPAIRMENT (forgot name for about 15 minutes) had resolved. On 05-May-2021, PYREXIA (low grade fever) had resolved. At the time of the report, ATRIAL FIBRILLATION (EKG at home and she was catching Afib), DELIRIUM (slight delirium), TRANSIENT ISCHAEMIC ATTACK (TIA with eyes fluttering, couldn't talk or move), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), HYPERTENSION (extreme hypertension 200/115), BLEPHAROSPASM (TIA with eyes fluttering), PALPITATIONS (racing heart), TACHYCARDIA (tachycardia at 120 bpm), WEIGHT DECREASED (lost 20 pounds), DECREASED APPETITE (not hungry but very thirsty), THIRST (not hungry but very thirsty), TINNITUS (tinnitus - ears ringing), DIARRHOEA (sterile diarrhea), INSOMNIA (lot of trouble sleeping), SPEECH DISORDER (could'nt talk) and HYPOKINESIA (could'nt move) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Dehydroepiandrosterone test: increased (High) Elevated. On 18-Apr-2021, Blood pressure measurement: 200/115 (High) Extreme hypertension. On 18-Apr-2021, Urine analysis: increased (High) High leukocytes in urine. On 18-Apr-2021, White blood cell count: increased (High) Elevated.. On 19-Apr-2021, Body temperature: increased (High) Low grade fever. On 19-Apr-2021, Heart rate: 120 (High) 120 beats per minute. On 20-Apr-2021, Neutrophil count: increased (High) high. On 27-Apr-2021, Electrocardiogram: atrial fibrillation catching atrial fibrillation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 09-Apr-2021, the patient reported that she consulted her primary care, followed by an OBGYN consult on On 13-Apr-2021, and unspecified blood work was done. The patient reported that she visited the ER (emergency room) on 18-Apr-2021, 19-Apr-2021 and 20-Apr-2021 with a follow-up visit with her primary care on 19-Apr-2021. The patient also reported that she started consulting her primary care physician since March 2020, for abnormal weight gain and blood tests were done for thyroid levels. It was reported that this whole period the patient lost 20 pounds.  The Treatment medications included Tylenol (acetaminophen), hydroxyzine and propranolol.   The patient reported that she had taken buspirone and quetiapine for insomnia, but stopped the medications on an unspecified date. On an unspecified date, Ativan (lorazepam) was discontinued.  Company Comment:  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Fever is consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Fever is consistent with the product known safety profile.