Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Coating in mouth, Illness, Oral discomfort, Paraesthesia oral
Clinical narrative: she had COVID; tongue and mouth tingle, it was very sensitive/pretty bad burning tingling kind of feeling; mouth and lips burning/ issues with her mouth, gets up in my gums and like in front of my teeth or underneath my tongue, and then the outside edges of my lip; very sick; orangish yellow coat all the time; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she had COVID), PARAESTHESIA ORAL (tongue and mouth tingle, it was very sensitive/pretty bad burning tingling kind of feeling), ORAL DISCOMFORT (mouth and lips burning/ issues with her mouth, gets up in my gums and like in front of my teeth or underneath my tongue, and then the outside edges of my lip), ILLNESS (very sick) and COATING IN MOUTH (orangish yellow coat all the time) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052e21a and 007d21a) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Sulfonamide allergy (sulfa medication gives her a rash) and Allergy to antibiotic (Amoxicillin).   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (she had COVID), PARAESTHESIA ORAL (tongue and mouth tingle, it was very sensitive/pretty bad burning tingling kind of feeling), ORAL DISCOMFORT (mouth and lips burning/ issues with her mouth, gets up in my gums and like in front of my teeth or underneath my tongue, and then the outside edges of my lip), ILLNESS (very sick) and COATING IN MOUTH (orangish yellow coat all the time). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, COVID-19 (she had COVID), PARAESTHESIA ORAL (tongue and mouth tingle, it was very sensitive/pretty bad burning tingling kind of feeling), ORAL DISCOMFORT (mouth and lips burning/ issues with her mouth, gets up in my gums and like in front of my teeth or underneath my tongue, and then the outside edges of my lip), ILLNESS (very sick) and COATING IN MOUTH (orangish yellow coat all the time) had not resolved.            Patient concomitant medication include two thyroid medication and two hormone medications. It was reported that Patient had a procedure patient needed to take a COVID test. Patient was sick all weekend and had COVID like symptoms and orangish yellow coat all the time. Patient mentioned that she went to two different physicians in Oct 2021. Treatment medications include two different types of mouth washes, magic mouth wash, tongue biopsy was done, one medicine for yeast and one for bacteria, gabapentin another medication that makes patient very sleepy, medication not helped her, and patient tries not to take the medication.  Company comment-This spontaneous case concerns a female patient aged 51 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred on an unknown date in August 2021 after second dose of mRNA-1273 vaccination. Patient had received 1st dose of mRNA-1273 vaccine 28 days prior to 2nd dose. Patient experienced mouth and tongue tingling sensation, burning feeling, sensitive oral cavity with orangish yellow coating. She had covid with symptoms and sickness on unknown dates in August 2021 after 2nd vaccination. Consulted physicians in October 2021, treated with two different types of mouth washes, magic mouth wash, tongue biopsy was done, one medicine for yeast and one for bacteria, gabapentin which causes drowsiness. No further details on clinical course, other lab test results and treatment received were reported. Outcome of the event Covid 19 was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non serious) assessed as per medical judgement.   This case was linked to MOD-2022-611796 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient aged 51 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred on an unknown date in August 2021 after second dose of mRNA-1273 vaccination. Patient had received 1st dose of mRNA-1273 vaccine 28 days prior to 2nd dose. Patient experienced mouth and tongue tingling sensation, burning feeling, sensitive oral cavity with orangish yellow coating. She had covid with symptoms and sickness on unknown dates in August 2021 after 2nd vaccination. Consulted physicians in October 2021, treated with two different types of mouth washes, magic mouth wash, tongue biopsy was done, one medicine for yeast and one for bacteria, gabapentin which causes drowsiness. No further details on clinical course, other lab test results and treatment received were reported. Outcome of the event Covid 19 was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non serious) assessed as per medical judgement.