Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Tongue discomfort, Tongue ulceration, Vaccination complication
Clinical narrative: Freezing to death/ it was terrible; Their lips are cracked on the corners and hurt; They were in pain; Face swelled up; Tong was burning and swelling; Arm swelled/The armpit swelled up pretty good; Mouth had ulcers/Mouth broke up really bad; Floor of the mouth was swelled; Left breast swelled up; Skin around the lips is red and swelling; Skin around the lips is red and swelling; Ulcers underneath their tong; Saliva has dyed up, and the food now sticks to their mouth and cheeks; Lips are cracked on the corners and hurt; Tong hurts all the time; They stayed in bed; Rash in their belly and chest; Glands were swollen; Tong was burning/when they eat spice it burns them/tong feels like it got burn with hot coffee; Mouth is still burning/lips burn; Had trouble/had bad problems; Lymph nodes underneath their left arm swelled up; Chills; This spontaneous case was reported by a physician and describes the occurrence of TONGUE DISCOMFORT (Tong was burning/when they eat spice it burns them/tong feels like it got burn with hot coffee), ORAL DISCOMFORT (Mouth is still burning/lips burn), VACCINATION COMPLICATION (Had trouble/had bad problems), FEELING COLD (Freezing to death/ it was terrible) and LIP PAIN (Their lips are cracked on the corners and hurt) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back injury (broken back from before). Concurrent medical conditions included Gouty arthritis, Impaired work ability (hands do not work very good), Allergy (Allergic to 3M Tegaderm transparent dressing) and Muscle cramp (Muscle cramp pain(taking MagniLlife muscle cramp pain reliever)). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), LOSARTAN POTASSIUM (COZAAR), FUROSEMIDE, GABAPENTIN, ALLOPURINOL, OMEPRAZOLE, EZETIMIBE, FENOFIBRATE, IPRATROPIUM, TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), FLUTICASONE, AZELASTINE HYDROCHLORIDE (ASTEPRO), CLONAZEPAM (KLONOPIN), OMEGA-3-ACID ETHYL ESTER (OMEGA 3 ACID ETHYL ESTERS), INSULIN HUMAN (HUMULIN R), MONTELUKAST SODIUM (SINGULAIR), ANASTROZOLE, LEVOTHYROXINE SODIUM (SYNTHROID), CARISOPRODOL, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ASPIRIN [ACETYLSALICYLIC ACID], PARACETAMOL (TYLENOL), IBUPROFEN, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), UBIDECARENONE (CO Q 10 [UBIDECARENONE]), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), VITAMIN D3, POLYETHYLENE GLYCOL 3350 and THIAMINE (VITAMIN B1 [THIAMINE]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION COMPLICATION (Had trouble/had bad problems). On an unknown date, the patient experienced TONGUE DISCOMFORT (Tong was burning/when they eat spice it burns them/tong feels like it got burn with hot coffee), ORAL DISCOMFORT (Mouth is still burning/lips burn), FEELING COLD (Freezing to death/ it was terrible), LIP PAIN (Their lips are cracked on the corners and hurt), PAIN (They were in pain), SWELLING FACE (Face swelled up), SWOLLEN TONGUE (Tong was burning and swelling), PERIPHERAL SWELLING (Arm swelled/The armpit swelled up pretty good), MOUTH ULCERATION (Mouth had ulcers/Mouth broke up really bad), MOUTH SWELLING (Floor of the mouth was swelled), BREAST SWELLING (Left breast swelled up), LIP ERYTHEMA (Skin around the lips is red and swelling), LIP SWELLING (Skin around the lips is red and swelling), TONGUE ULCERATION (Ulcers underneath their tong), SALIVA ALTERED (Saliva has dyed up, and the food now sticks to their mouth and cheeks), CHAPPED LIPS (Lips are cracked on the corners and hurt), GLOSSODYNIA (Tong hurts all the time), BEDRIDDEN (They stayed in bed), RASH (Rash in their belly and chest), LYMPHADENOPATHY (Glands were swollen), LYMPHADENOPATHY (Lymph nodes underneath their left arm swelled up) and CHILLS (Chills). The patient was treated with AMOXICILLIN for Yeast infection, at a dose of 500 milligram three times a day; FLUCONAZOLE (DIFLUCAN) for Yeast infection, at a dose of 200 milligram four times per day; NYSTATIN (oral) for Yeast infection, at a dose of 100000Unit/ml 4 times a day for over 30 days and CLOTRIMAZOLE (cutaneous) at a dose of On lip's skin. At the time of the report, TONGUE DISCOMFORT (Tong was burning/when they eat spice it burns them/tong feels like it got burn with hot coffee), VACCINATION COMPLICATION (Had trouble/had bad problems), FEELING COLD (Freezing to death/ it was terrible), LIP PAIN (Their lips are cracked on the corners and hurt), PAIN (They were in pain), SWELLING FACE (Face swelled up), SWOLLEN TONGUE (Tong was burning and swelling), PERIPHERAL SWELLING (Arm swelled/The armpit swelled up pretty good), MOUTH ULCERATION (Mouth had ulcers/Mouth broke up really bad), MOUTH SWELLING (Floor of the mouth was swelled), BREAST SWELLING (Left breast swelled up), LIP ERYTHEMA (Skin around the lips is red and swelling), LIP SWELLING (Skin around the lips is red and swelling), TONGUE ULCERATION (Ulcers underneath their tong), SALIVA ALTERED (Saliva has dyed up, and the food now sticks to their mouth and cheeks), CHAPPED LIPS (Lips are cracked on the corners and hurt), BEDRIDDEN (They stayed in bed), RASH (Rash in their belly and chest) and LYMPHADENOPATHY (Glands were swollen) outcome was unknown, ORAL DISCOMFORT (Mouth is still burning/lips burn) and GLOSSODYNIA (Tong hurts all the time) had not resolved and LYMPHADENOPATHY (Lymph nodes underneath their left arm swelled up) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Antinuclear antibody: negative (Negative) The patient got tested for Sjogren's Syndrome and was Negative (AD, Anti-SS-A/-SS-B). On an unknown date, Blood test: negative (Negative) Tested for tested for RA and came back negative. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive for Sars-cov-2 antibody IgG test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included MagniLlife muscle cramp pain reliever, 1 tablet a day  Patient stated their mouth broke up really bad, so their dentist thought it was a yeast infection. They had consulted with 4 different doctors already, a family doctor, a dermatologist, an ENT (ears, nose and throat) doctor and a, gastroenterologist. The dermatologist thought the patient may have had COVID-19 before taking the vaccine, and then the vaccine caused an adverse event.  The ENT said it was not a yeast infection and referred the patient to a rheumatoid arthritis doctor. Patient is scheduled to see them on 18Oct2021. The gastroenterologist suggested it could be Sjogren's Syndrome but the patient tested negative for it.   This case was linked to MOD-2021-350549 (Patient Link).