Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastric dilatation, Hypersomnia, Insomnia, Musculoskeletal discomfort
Clinical narrative: Pressure in the chest and the heart; Insomnia; Patient states that was diagnosed with candida after receiving the vaccines; slept all day long; felt a "balloon" in the throat; inflammation in the stomach; lots of itches in the fingers; had a lot of anxiety; felt tension in the neck; Stomach upset; Neck tense and hard, like she had pressure there; Strong pain in the arm; Fatigue; Feel kind of oppression; Anxiety attack; Pressure in the chest and the heart; This spontaneous case was reported by a consumer and describes the occurrence of SENSE OF OPPRESSION (Feel kind of oppression), ANXIETY (Anxiety attack), CHEST DISCOMFORT (Pressure in the chest and the heart), CARDIAC DISCOMFORT (Pressure in the chest and the heart) and ABDOMINAL DISCOMFORT (Stomach upset) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Insomnia. Concurrent medical conditions included Penicillin allergy, Migraine, Hypertension, Hyperlipidemia, Pre-diabetes, Fatty liver and Sulfonamide allergy (allergic to Sulfa drugs). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced SENSE OF OPPRESSION (Feel kind of oppression), ANXIETY (Anxiety attack), CHEST DISCOMFORT (Pressure in the chest and the heart), ABDOMINAL DISCOMFORT (Stomach upset), MUSCULOSKELETAL DISCOMFORT (Neck tense and hard, like she had pressure there), PAIN IN EXTREMITY (Strong pain in the arm) and FATIGUE (Fatigue). On 29-Jun-2021, the patient experienced CANDIDA INFECTION (Patient states that was diagnosed with candida after receiving the vaccines), HYPERSOMNIA (slept all day long), OROPHARYNGEAL DISCOMFORT (felt a "balloon" in the throat), GASTRIC DILATATION (inflammation in the stomach), PRURITUS (lots of itches in the fingers), ANXIETY (had a lot of anxiety) and MUSCULOSKELETAL STIFFNESS (felt tension in the neck). On an unknown date, the patient experienced CARDIAC DISCOMFORT (Pressure in the chest and the heart) and INSOMNIA (Insomnia). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSE OF OPPRESSION (Feel kind of oppression), ANXIETY (Anxiety attack), CHEST DISCOMFORT (Pressure in the chest and the heart), CARDIAC DISCOMFORT (Pressure in the chest and the heart), ABDOMINAL DISCOMFORT (Stomach upset), MUSCULOSKELETAL DISCOMFORT (Neck tense and hard, like she had pressure there), PAIN IN EXTREMITY (Strong pain in the arm), CANDIDA INFECTION (Patient states that was diagnosed with candida after receiving the vaccines), HYPERSOMNIA (slept all day long), OROPHARYNGEAL DISCOMFORT (felt a "balloon" in the throat), GASTRIC DILATATION (inflammation in the stomach), PRURITUS (lots of itches in the fingers), ANXIETY (had a lot of anxiety), MUSCULOSKELETAL STIFFNESS (felt tension in the neck), INSOMNIA (Insomnia) and FATIGUE (Fatigue) outcome was unknown.            Patient stated second dose administration on 10-Mar-2021, Lot number 013A21A. Patient went to the emergency room were HCP administered an anxiolytic. Other treatment included medication for candida.  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 29-Jun-2021: Significant follow up appended to AER; 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.