Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product dose omission issue, Ultrasound abdomen, Vaccination site swelling, Vision blurred
Clinical narrative: Chest tightness; Face pain; Blurry eyes; Insomnia; Strange bruising; Going to the bathroom more (described as a laxative effect); When the phlebotomist took my bloos it bled a lot; Diarrhea; Abdominal cramping; Pricking/ tingling sensation; Flushing; Patient missed the second dose of vaccine, and it was past 42 days; Arm ballooning; Headache; Tiredness; Shortness of breath; Heart palpitations; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNEA (Shortness of breath), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Chest tightness), FACIAL PAIN (Face pain) and VISION BLURRED (Blurry eyes) in a 47-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.     The patient's past medical history included Lupus erythematosus (Lupus diagnosis due to high ANA) and Anemia. Concurrent medical conditions included Menopause (entering menopause), Food allergy (Food preservative: small hive on face. Food additives: quick heartbeat, some difficulty breathing from mucus production.) and Allergy to chemicals (Paints: Difficulty breathing). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], MAGNESIUM, COD LIVER OIL [COD-LIVER OIL], ALOE VERA and ZINC for an unknown indication.    On 11-Apr-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021 at 3:00 PM, the patient experienced DYSPNEA (Shortness of breath) and PALPITATIONS (Heart palpitations). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), FACIAL PAIN (Face pain), VISION BLURRED (Blurry eyes), INSOMNIA (Insomnia), CONTUSION (Strange bruising), FREQUENT BOWEL MOVEMENTS (Going to the bathroom more (described as a laxative effect)), INJECTION SITE HAEMORRHAGE (When the phlebotomist took my bloos it bled a lot), DIARRHEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), PARAESTHESIA (Pricking/ tingling sensation), FLUSHING (Flushing), PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose of vaccine, and it was past 42 days), VACCINATION SITE SWELLING (Arm ballooning), HEADACHE (Headache) and FATIGUE (Tiredness). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Symptomatic treatment, at an unspecified dose and frequency. On 30-Jun-2021, DYSPNEA (Shortness of breath) had resolved. At the time of the report, PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Chest tightness), FACIAL PAIN (Face pain), VISION BLURRED (Blurry eyes), INSOMNIA (Insomnia), CONTUSION (Strange bruising), FREQUENT BOWEL MOVEMENTS (Going to the bathroom more (described as a laxative effect)), INJECTION SITE HAEMORRHAGE (When the phlebotomist took my bloos it bled a lot), DIARRHEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), PARAESTHESIA (Pricking/ tingling sensation), FLUSHING (Flushing), VACCINATION SITE SWELLING (Arm ballooning), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose of vaccine, and it was past 42 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antinuclear antibody: negative (Negative) Follow-up lupus testing revealed ANA was negative. In April 2021, Blood test: normal (normal) blood was drawn. all test results were negative for abnormal findings. In April 2021, Cardiac stress test: negative (Negative) Negative for abnormal cardiac findings. In April 2021, Chest X-ray: negative (Negative) Negative for abnormal findings. In April 2021, Echocardiogram: negative (Negative) Negative for abnormal cardiac findings. In April 2021, Electrocardiogram: negative (Negative) Negative for abnormal cardiac findings. In April 2021, Heart rate: 80 (High) Increase in heart rate from 70BPM to 80-100PBM post vaccination and 100 (High) Increase in heart rate from 70BPM to 80-100PBM post vaccination. In April 2021, Ultrasound abdomen: negative (Negative) Negative for abnormal findings.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Consumer stated she felt the vaccine was a catalyst to jump start things in her body.  On unknown date, consumer was seen by a cardiologist.  On unknown date, consumer was seen by a rheumatologist for follow-up lupus testing. Significant arm ballooning and strange bruising when blood was drawn was reported.  Consumer had not received the second dose of the vaccine post 42 days of first dose.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021 included new events, patient's demographics, other relevant history added and outcome of the event updated to recovered.; 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.