Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Tongue started feelin weird and swollen, swelling of upper airways; Tongue started feelin weird and swollen; Dizzy; Little trouble breathing, difficulty breathing; Arm hurt something terrible; Sensation of throat closing; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Tongue started feelin weird and swollen, swelling of upper airways), FEELING ABNORMAL (Tongue started feelin weird and swollen), DIZZINESS (Dizzy), DYSPNOEA (Little trouble breathing, difficulty breathing) and PAIN IN EXTREMITY (Arm hurt something terrible) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Asthma, Hay fever since 1971, Drug allergy (Claritin - anaphylaxis/hives) in 2002, Drug allergy (Penicillin - anaphylaxis/hives) in 1972, Drug allergy (Robutissin - Red blotches/itching) in 1984, Reactive airways disease (Has improved) since 1971, Fatty liver (Improved with healthier diet) since December 2020 and Diverticulosis (Improved with healthier diet) since December 2020. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, BACILLUS COAGULANS (PROBIOTIC GUMMIES) for Diverticulitis, TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for Fatty liver, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) for Immunisation, CIMICIFUGA RACEMOSA RHIZOME, CIMICIFUGA RACEMOSA ROOT (BLACK COHOSH [CIMICIFUGA RACEMOSA RHIZOME;CIMICIFUGA RACEMOSA ROOT]) for Menopause.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced SWOLLEN TONGUE (Tongue started feelin weird and swollen, swelling of upper airways), FEELING ABNORMAL (Tongue started feelin weird and swollen), DIZZINESS (Dizzy), DYSPNOEA (Little trouble breathing, difficulty breathing), PAIN IN EXTREMITY (Arm hurt something terrible), THROAT TIGHTNESS (Sensation of throat closing) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 16-Jan-2021, PAIN IN EXTREMITY (Arm hurt something terrible) had resolved. At the time of the report, SWOLLEN TONGUE (Tongue started feelin weird and swollen, swelling of upper airways), FEELING ABNORMAL (Tongue started feelin weird and swollen), DIZZINESS (Dizzy), DYSPNOEA (Little trouble breathing, difficulty breathing) and THROAT TIGHTNESS (Sensation of throat closing) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      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 medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Completed ADR form. Address /phone number correction, race, ethnicity, height, weight, past medical history, pregnancy status, previous allergic reactions, concomitant medications, event outcome received.; 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.