Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pruritus, Rash, Urticaria, Vaccination complication
Clinical narrative: Itching; Urticaria; Irregular heart rate; Heart Rate > 100 beats/ min; Difficulty swallowing; Wheezing; Flushing; Diarrhoea; Unusual taste; Cough; Hoarnesness; Chest tightness; Vertigo; Nausea; cannot se or read; Weak Muscle; Incontinence; Puffy Eyes; Strong Chemical Smell; Severe reaction to Vaccine; Short Of Breath; Foggy Brain; Stomach Pain; Huge muscle; Joint pain; Massive Headache; Rash on the chest, Injection Site, and Hands; Cloud Come Over Her (Fatigue); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to Vaccine), DYSPNOEA (Short Of Breath), FEELING ABNORMAL (Foggy Brain), ABDOMINAL PAIN UPPER (Stomach Pain) and MUSCLE SWELLING (Huge muscle) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscular dystrophy. Concurrent medical conditions included Contrast media allergy (Allergic to Contrast Dye.  Allergy to all types of injectable dyes.  Reactions include anaphylaxis, loss of muscle control, drop in blood pressure, incontinence), Asthma, Hay fever, Central core disease, Complex regional pain syndrome, Blurry vision, Poor vision and Double vision. Concomitant products included TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for Muscle relaxant.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to Vaccine), DYSPNOEA (Short Of Breath), FEELING ABNORMAL (Foggy Brain), ABDOMINAL PAIN UPPER (Stomach Pain), MUSCLE SWELLING (Huge muscle), INCONTINENCE (Incontinence), PERIORBITAL SWELLING (Puffy Eyes), PAROSMIA (Strong Chemical Smell), ARTHRALGIA (Joint pain), HEADACHE (Massive Headache), RASH (Rash on the chest, Injection Site, and Hands) and FATIGUE (Cloud Come Over Her (Fatigue)). On 31-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Weak Muscle). On 29-Mar-2021, the patient experienced VISUAL IMPAIRMENT (cannot se or read). On an unknown date, the patient experienced PRURITUS (Itching), URTICARIA (Urticaria), PALPITATIONS (Irregular heart rate), HEART RATE INCREASED (Heart Rate > 100 beats/ min), DYSPHAGIA (Difficulty swallowing), WHEEZING (Wheezing), FLUSHING (Flushing), DIARRHOEA (Diarrhoea), DYSGEUSIA (Unusual taste), COUGH (Cough), DYSPHONIA (Hoarnesness), CHEST DISCOMFORT (Chest tightness), VERTIGO (Vertigo) and NAUSEA (Nausea). The patient was treated with OXYGEN ongoing since an unknown date for Shortness of breath, at an unspecified dose and frequency and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Severe reaction to Vaccine), DYSPNOEA (Short Of Breath), FEELING ABNORMAL (Foggy Brain), ABDOMINAL PAIN UPPER (Stomach Pain), MUSCLE SWELLING (Huge muscle), INCONTINENCE (Incontinence), PRURITUS (Itching), URTICARIA (Urticaria), PALPITATIONS (Irregular heart rate), HEART RATE INCREASED (Heart Rate > 100 beats/ min), DYSPHAGIA (Difficulty swallowing), WHEEZING (Wheezing), FLUSHING (Flushing), DIARRHOEA (Diarrhoea), DYSGEUSIA (Unusual taste), COUGH (Cough), DYSPHONIA (Hoarnesness), CHEST DISCOMFORT (Chest tightness), ARTHRALGIA (Joint pain), NAUSEA (Nausea), RASH (Rash on the chest, Injection Site, and Hands) and FATIGUE (Cloud Come Over Her (Fatigue)) outcome was unknown, MUSCULAR WEAKNESS (Weak Muscle), VISUAL IMPAIRMENT (cannot se or read) and VERTIGO (Vertigo) had not resolved and PERIORBITAL SWELLING (Puffy Eyes), PAROSMIA (Strong Chemical Smell) and HEADACHE (Massive Headache) had resolved.            Treatment for adverse reactions also included antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-Jun-2021 contains non-significant followup On 23-Jun-2021: Follow-up information received on 23-Jun-2021 contains AE details and medical history