Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Oral disorder, Paraesthesia oral, Pharyngeal swelling, Product dose omission issue
Clinical narrative: mouth lesions; tongue ulcers; I can't take 2nd Moderna shot until I know that it will not cause throat swelling.; Feeling of Swelling in Lips; lesions on inside lower lip; white lesions on tongue/white sores on sides of tongue; swelling in throat/worse swelling in throat /mild throat swelling; mild angioedema; worse swelling in throat; tingling of tongue; Ulcers in Mouth; excessive salivation; Soreness in lips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (mild angioedema) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to molds and Drug allergy (Ceclo, cipro). Concomitant products included ATORVASTATIN from 01-Jan-1994 to an unknown date for Cholesterol, BENAZEPRIL from 01-Jan-2011 to an unknown date and AMLODIPINE from 01-Jan-2014 to an unknown date for Hypertension, LIOTHYRONINE from 01-Jan-1970 to an unknown date and LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-1980 to an unknown date for Hypothyroidism.    On 02-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ANGIOEDEMA (mild angioedema) (seriousness criterion medically significant), CONDITION AGGRAVATED (worse swelling in throat), PARAESTHESIA ORAL (tingling of tongue), MOUTH ULCERATION (Ulcers in Mouth), SALIVARY HYPERSECRETION (excessive salivation), LIP PAIN (Soreness in lips), LIP ULCERATION (lesions on inside lower lip), STOMATITIS (white lesions on tongue/white sores on sides of tongue) and PHARYNGEAL SWELLING (swelling in throat/worse swelling in throat /mild throat swelling). On 04-Mar-2021, the patient experienced LIP SWELLING (Feeling of Swelling in Lips). On an unknown date, the patient experienced ORAL DISORDER (mouth lesions), TONGUE ULCERATION (tongue ulcers) and PRODUCT DOSE OMISSION ISSUE (I can't take 2nd Moderna shot until I know that it will not cause throat swelling.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, ANGIOEDEMA (mild angioedema), CONDITION AGGRAVATED (worse swelling in throat), PARAESTHESIA ORAL (tingling of tongue), MOUTH ULCERATION (Ulcers in Mouth), SALIVARY HYPERSECRETION (excessive salivation), LIP PAIN (Soreness in lips), LIP SWELLING (Feeling of Swelling in Lips), LIP ULCERATION (lesions on inside lower lip), STOMATITIS (white lesions on tongue/white sores on sides of tongue) and PHARYNGEAL SWELLING (swelling in throat/worse swelling in throat /mild throat swelling) had not resolved and ORAL DISORDER (mouth lesions), TONGUE ULCERATION (tongue ulcers) and PRODUCT DOSE OMISSION ISSUE (I can't take 2nd Moderna shot until I know that it will not cause throat swelling.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Benazepril 5 mg,n glass of water with orange juice. Patient has stopped taking Benazepril and started to take 60 mg Allegra every 12 hours for several days.  Patient has consulted ENT, allergist, primary care doctor, dentist and endocrinologist during this time. All but one advise not taking second Moderna shot. Could be an ace inhibitor reaction.  Company Comment: Patient has consulted ENT, allergist, primary care doctor, dentist and endocrinologist during this time. All but one advise not taking second Moderna shot.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-Jun-2021  included Adverse events mouth lesions, tongue tingling, miss dose of vaccine. On 23-Jun-2021: Follow-up received on 23-Jun-2021 and does not contain any new information On 23-Jun-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field On 06-Jul-2021: Follow-up information received on 06-JUL-2021 contains non-significant information.; 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.