Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: symptoms were due to an allergic reaction to the Moderna; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (symptoms were due to an allergic reaction to the Moderna) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Muscle disorder NOS. Concomitant products included TIZANIDINE for Muscle relaxant.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (symptoms were due to an allergic reaction to the Moderna) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (symptoms were due to an allergic reaction to the Moderna) outcome was unknown.            She had to go to several doctors to figure out what was going on including her primary care, dermatologist, rheumatologist, ENT, acupunture, and allergist. Her allergist finally determined that her symptoms were due to an allergic reaction to the Moderna COVID-19 vaccine.  Due to allergic reaction to the Moderna patient experienced events such as couldn't brush teeth because her tongue burned even to this day, her lips still swell on the inside sometimes, within two weeks her entire mouth was swollen, Her lips and gums were peeling, mouth was dry as a bone, had no taste, She could not eat anything either, Her lips and gums were peeling and she states that she has sensitive lips.  He tested her and showed her a 21 page report of a study done which had profiles of patients with similar reaction to hers. The events of entire mouth swollen, lips and gums were peeling, mouth was dry as a bone and no taste, initially was worsened but became better after 6 months, outcome was reported as residual effects, and patient saw 7 doctors and also patient haven't experienced these similar events in the past. No treatment medication reported.  Company comment:  This is a spontaneous case concerning a 70 years old female patient, Concurrent medical conditions included Iodine allergy, who experienced the unexpected serious (medically significant) event of Hypersensitivity (reported as symptoms were due to an allergic reaction to the Moderna), which occurred unspecified days after booster dose of mRNA-1273 vaccine. Within two weeks after vaccination Patient experienced entire moth was swollen, lips and gums were peeling, mouth was dry as bone. Patient could not brush her teeth because patient tongue was burned and no taste. Patient could not eat anything, symptoms lasted for 6 months, lips was swell till today. patient states that patient had sensitive lips. Patient consulted dermatologist, rheumatologist, ENT, acupuncture, and allergist to known the reason for the symptoms, Her allergist finally determined that her symptoms were due to an allergic reaction due to the vaccine. Concurrent medical conditions included Iodine allergy is confounding for the event. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  This case was linked to MOD-2022-668066 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 70 years old female patient, Concurrent medical conditions included Iodine allergy, who experienced the unexpected serious (medically significant) event of Hypersensitivity (reported as symptoms were due to an allergic reaction to the Moderna), which occurred unspecified days after booster dose of mRNA-1273 vaccine. Within two weeks after vaccination Patient experienced entire mouth was swollen, lips and gums were peeling, mouth was dry as bone. Patient could not brush her teeth because patient tongue was burned and no taste. Patient could not eat anything, symptoms lasted for 6 months, lips was swell till today. patient states that patient had sensitive lips. Patient consulted dermatologist, rheumatologist, ENT, acupuncture, and allergist to known the reason for the symptoms, Her allergist finally determined that her symptoms were due to an allergic reaction due to the vaccine.Concurrent medical conditions included Iodine allergy is confounding for the event. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.