Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Reflux gastritis, Tryptase, Vaccination site reaction
Clinical narrative: Allergy; Asthmatic attack; Blood sugar decreased; Coughing; Difficulty breathing; Dizzy; Face red; Facial flushing; Heart rate increased; Palpitations; Presyncope; Reflux gastritis; Sweaty hands; Vaccination site reaction; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low) and HYPERHIDROSIS (Sweaty palms) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Hypothyroidism, Polycystic ovarian syndrome, Raynaud's phenomenon, Penicillin allergy and Drug allergy (Cephalosporins). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and MONTELUKAST for Allergy, LEVOTHYROXINE for Hypothyroidism, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Polycystic ovarian syndrome.   On 30-Dec-2020 at 2:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PALPITATIONS (feeling of palpitaions). On 30-Dec-2020 at 3:02 PM, the patient experienced HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low), HYPERHIDROSIS (Sweaty palms), COUGH (Coughing) and DIZZINESS (Felt dizzy). On 06-Jan-2021, the patient experienced DYSPNOEA (Trouble breathing), HYPERSENSITIVITY (Feeling of having allergic reactions to several things) and VACCINATION SITE REACTION (Covid arm). On 05-Feb-2021, the patient experienced REFLUX GASTRITIS (Reflux), ASTHMA (Asthma attacks brough on by smells) and PRESYNCOPE (going to pass out). The patient was treated with OMEPRAZOLE for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low), HYPERHIDROSIS (Sweaty palms), COUGH (Coughing), DIZZINESS (Felt dizzy) and REFLUX GASTRITIS (Reflux) had resolved with sequelae, DYSPNOEA (Trouble breathing), ASTHMA (Asthma attacks brough on by smells), HYPERSENSITIVITY (Feeling of having allergic reactions to several things) and PRESYNCOPE (going to pass out) had resolved and VACCINATION SITE REACTION (Covid arm) and PALPITATIONS (feeling of palpitaions) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Blood glucose: 43 (Low) Low. On 30-Dec-2020, Heart rate: 169 (High) High. On an unknown date, Antibody test: 8.5 (normal) 8.5 and 44.5 (abnormal) 44.5. On an unknown date, Tryptase: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low), HYPERHIDROSIS (Sweaty palms), COUGH (Coughing), DIZZINESS (Felt dizzy), DYSPNOEA (Trouble breathing), REFLUX GASTRITIS (Reflux), ASTHMA (Asthma attacks brough on by smells), HYPERSENSITIVITY (Feeling of having allergic reactions to several things), PRESYNCOPE (going to pass out), VACCINATION SITE REACTION (Covid arm) and PALPITATIONS (feeling of palpitaions) to be related.  The antibody level was measured when the patient's symptoms were worst and the level was 44.5. The patient was put on asthma medications. The patient stated she had never been on asthma medication in her life. The patient had to take 3 weeks of steroids to breathe and she had to start omerprazole after steroids. The antibody level fell to 8.5 and the symptoms were less severe. The patient was able to come off asthma medications, except Montelukast. The patient got tested for Mast Cell Activation Syndrome (MCAS), but tryptase test was negative.  Treatment included snack intake for blood sugar, diphenhydramine (Benadryl), steroids unspecified, omeprazole and Montelukast.  Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patients demographics, Medical history, lab tests, Concomitant medications, new events, out come of the events, and narrative were updated  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.