Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Hypoaesthesia oral, Mouth swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Dizziness; mouth is dry; redness/erythema; Hoarseness; Mouth swelling; tongue numbing; patient is not going to take second vaccination due to severity of her symptoms; Sneezing/Runny nose; Shortness of breath; Sinus pressure; Unusual Taste; prickling/tingling; tongue tingling; Throat irritation; tongue swelling; Tongue tremor; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of UPPER AIRWAY OBSTRUCTION (swelling of upper airways) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0296208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included Hives. Concurrent medical conditions included Sulfonamide allergy (Sulfa).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (Dizziness), DRY MOUTH (mouth is dry), DYSPNOEA (shortness of breath), SNEEZING (Sneezing/Runny nose), RHINORRHOEA (Sneezing/Runny nose), TASTE DISORDER (Unusual Taste), DYSPHONIA (hoarseness), PARAESTHESIA (prickling/tingling), ERYTHEMA (redness/erythema), SWOLLEN TONGUE (tongue swelling), UPPER AIRWAY OBSTRUCTION (swelling of upper airways) (seriousness criterion medically significant) and TREMOR (trembling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing from January 2021 for Adverse event, at a dose of 1 dosage form once a day; PREDNISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYTREC) ongoing from January 2021 for Adverse event, at a dose of 1 dosage form once a day. At the time of the report, DIZZINESS (Dizziness), DRY MOUTH (mouth is dry), SNEEZING (Sneezing/Runny nose), RHINORRHOEA (Sneezing/Runny nose), TASTE DISORDER (Unusual Taste), DYSPHONIA (hoarseness), PARAESTHESIA (prickling/tingling), ERYTHEMA (redness/erythema), SWOLLEN TONGUE (tongue swelling), UPPER AIRWAY OBSTRUCTION (swelling of upper airways) and TREMOR (trembling) had not resolved and DYSPNOEA (shortness of breath) had resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were provided by the reporter.  The patient visited a PCP, dentist, allergy doctor and dermatologist for consultation and treatment. The patient had blood work several times. Specific tests and Test results were not specified. The patient had 150 mg shot of a steroid for treatment. Type of steroid was not specified. The patient continued to experience dizziness event but it improved for a while.  This case was linked to MOD-2021-213901 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant Follow-up  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. Also, there is a Product dose omission event.