Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia oral, Respiratory rate, Respiratory tract oedema, Swollen tongue
Clinical narrative: Swelling of upper airways (lips, tongue, throat,uvula or larynx); Angioedema; Allergic reaction; Mild tongue swelling; Weird sensation in tongue; Glands were swollen; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) and RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), SWOLLEN TONGUE (Mild tongue swelling), PARAESTHESIA ORAL (Weird sensation in tongue), LYMPHADENOPATHY (Glands were swollen) and FATIGUE (Fatigue). On 05-Apr-2021 at 10:25 AM, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). On an unknown date, the patient experienced RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) (oral) on 05-Apr-2021 at a dose of 10 mg once a day. On 05-Apr-2021 at 11:05 AM, ANGIOEDEMA (Angioedema) had resolved. At the time of the report, RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) had resolved, ALLERGY TO VACCINE (Allergic reaction), SWOLLEN TONGUE (Mild tongue swelling) and LYMPHADENOPATHY (Glands were swollen) had not resolved and PARAESTHESIA ORAL (Weird sensation in tongue) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 100/73 (Low) 100/73 and 109/77 (Low) 109/77. On 04-May-2021, Heart rate: 65 (Inconclusive) 65 and 66 (Inconclusive) 66. On 04-May-2021, Respiratory rate: 12 (Inconclusive) 12 and 12 (Inconclusive) 12.     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.   No relevant concomitant medications were reported. On 04-Apr-2021 at 10:25 a.m Patient vitals were Heart rate 65.,resiratory rate 12 and blood pressure of 100/73.  On 04-Apr-2021 at 10:35 a.m. Patient vitals were Heart rate 66, respiratory rate 12 and blood pressure 109/77.On 05-Apr-2021 at 10:25 a.m Patient had Angioedema. It resolved after 40 minutes at 11:05 a.m. The first observation of angioedema was mild tongue swelling followed by swelling of upper airways(lips, tongue, throat, uvula or larynx ).Patient went to Doctor's office/ urgent care /return to vaccine clinic and Follow up with Allergist on 14-04-2021. Treatment for the event included cetirizine (Zyrtec).  Company Comment:  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 19-May-2021: Follow-up information received on 20MAY2021 contains no new information. On 14-Jul-2021: Follow-up information was received: Patient demographics, lab data, vaccine batch number, treatment drug and new events Angioedema, Airway edema and Fatigue were added. This case was upgraded from non-serious to serious due to the addition of new events angioedema and airway edema; 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.