Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Flushing, Heart rate, Malaise
Clinical narrative: Dizziness; did not feel well; felt very on the edge and could not think straight; a large red area on my R arm; Diarrhea; Feels Tired/fatigue; Sore arm; Throat hurt and feel closing; Swollen tongue; Throat hurt and feel closing; Rash; Flushed; Harder to breath; feeling hot/feeling warm; tachycardia; began feeling very odd/felt pretty awful; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Throat hurt and feel closing) and SWOLLEN TONGUE (Swollen tongue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Allergy to insect sting (Allergy to cockroaches, dust mites,) and Allergy to plants (allergy to sycamore). Concomitant products included VITAMIN C [ASCORBIC ACID] for Immune disorder prophylaxis, MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy.    On 27-Dec-2020 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced FLUSHING (Flushed), DYSPNOEA (Harder to breath), FEELING HOT (feeling hot/feeling warm) and TACHYCARDIA (tachycardia). On 27-Dec-2020 at 8:15 AM, the patient experienced THROAT TIGHTNESS (Throat hurt and feel closing) (seriousness criterion life threatening), SWOLLEN TONGUE (Swollen tongue) (seriousness criterion life threatening), OROPHARYNGEAL PAIN (Throat hurt and feel closing) and RASH (Rash). On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feels Tired/fatigue). On 30-Dec-2020, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE ERYTHEMA (a large red area on my R arm). On 31-Dec-2020, the patient experienced THINKING ABNORMAL (felt very on the edge and could not think straight). 31-Dec-2020, the patient experienced MALAISE (did not feel well). On an unknown date, the patient experienced FEELING ABNORMAL (began feeling very odd/felt pretty awful). an unknown date, the patient experienced DIZZINESS (Dizziness). On 27-Dec-2020, DYSPNOEA (Harder to breath) had resolved. On 30-Dec-2020, PAIN IN EXTREMITY (Sore arm) had resolved. On 31-Dec-2020, DIARRHOEA (Diarrhea) had resolved. On 11-Jan-2021, TACHYCARDIA (tachycardia) had resolved. On 15-Feb-2021, THROAT TIGHTNESS (Throat hurt and feel closing) had resolved. At the time of the report, SWOLLEN TONGUE (Swollen tongue), OROPHARYNGEAL PAIN (Throat hurt and feel closing), RASH (Rash), FLUSHING (Flushed), FEELING HOT (feeling hot/feeling warm), THINKING ABNORMAL (felt very on the edge and could not think straight), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (a large red area on my R arm), MALAISE (did not feel well) and FATIGUE (Feels Tired/fatigue) outcome was unknown and FEELING ABNORMAL (began feeling very odd/felt pretty awful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, Blood pressure measurement: 132/97 (Inconclusive) 132/97, 121/74 (Inconclusive) 121/74 and 130/69 (Inconclusive) 130/69. On 27-Dec-2020, Heart rate: 135 (Inconclusive) 132, 117 (Inconclusive) 117 and 113 (Inconclusive) 113. On 27-Dec-2020, Respiratory rate: 20 (Inconclusive) 20 and 18 (Inconclusive) 18. On 31-Dec-2020, Heart rate: 140s (High) 140s. On 01-Jan-2021, Heart rate: 140-1150s (High) 140-1150s.     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.   Treatment for the events included epipen, iv solumedrol, Benadryl (diphenhydramine) and propranolol.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: The patient information, vaccine information, concomitant drugs, event updates, additional events and treatment were provided. On 05-Apr-2021: Event outcome and onset date were updated.; Reporter'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; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.