Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Coating in mouth, Dyspepsia, Fatigue, Gastrooesophageal reflux disease, Oral candidiasis
Clinical narrative: Sinuses were running after 2nd shot; Throat was burning after  2nd shot; Sores in the mouth after  2nd shot; White dots in the mouth after  2nd shot; Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot; Tired; Thinks she has Oral Candida Yeast Infection after 2nd dose; GERD; Burning in stomach after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinuses were running after 2nd shot), THROAT IRRITATION (Throat was burning after  2nd shot), STOMATITIS (Sores in the mouth after  2nd shot), COATING IN MOUTH (White dots in the mouth after  2nd shot), ORAL DISCOMFORT (Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot), FATIGUE (Tired), ORAL CANDIDIASIS (Thinks she has Oral Candida Yeast Infection after 2nd dose), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) and DYSPEPSIA (Burning in stomach after 2nd shot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies).    On 08-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced SINUSITIS (Sinuses were running after 2nd shot) (seriousness criterion hospitalization), THROAT IRRITATION (Throat was burning after  2nd shot) (seriousness criterion hospitalization), STOMATITIS (Sores in the mouth after  2nd shot) (seriousness criterion hospitalization), COATING IN MOUTH (White dots in the mouth after  2nd shot) (seriousness criterion hospitalization), ORAL DISCOMFORT (Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), ORAL CANDIDIASIS (Thinks she has Oral Candida Yeast Infection after 2nd dose) (seriousness criterion hospitalization), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) (seriousness criterion hospitalization) and DYSPEPSIA (Burning in stomach after 2nd shot) (seriousness criterion hospitalization). The patient was treated with FLUTICASONE at a dose of UNK dosage form, qd; IPRATROPIUM at a dose of UNK dosage form, qd; AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 865 Tab; AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 125 Tab and PANTOPRAZOLE at a dose of UNK dosage form. At the time of the report, SINUSITIS (Sinuses were running after 2nd shot), THROAT IRRITATION (Throat was burning after  2nd shot), STOMATITIS (Sores in the mouth after  2nd shot), COATING IN MOUTH (White dots in the mouth after  2nd shot), ORAL DISCOMFORT (Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot), FATIGUE (Tired), ORAL CANDIDIASIS (Thinks she has Oral Candida Yeast Infection after 2nd dose), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) and DYSPEPSIA (Burning in stomach after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Other treatment medication included Magic Mouth wash (Diphenhydramine, Lidocaine, Nystatin) and Sweet Potato on the mouth sores  Company comment -This case concerns a 83-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Sinusitis, throat irritation, stomatitis, coating in mouth, oral discomfort, Fatigue, oral Candidiasis, gastroesophageal reflux disease , and dyspepsia. The events occurred 38 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-335425 (Patient Link).; Sender's Comments: This case concerns a 83-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Sinusitis, throat irritation, stomatitis, coating in mouth, oral discomfort, Fatigue, oral Candidiasis, gastroesophageal reflux disease , and dyspepsia. The events occurred 38 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.