Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: Aphthous ulcer, Autoimmune disorder, Laboratory test, Laryngeal ulceration, Pharyngeal ulceration
Clinical narrative: Directing towards an autoimmune disease; Canker sores appeared in my mouth, tongue, throat and larynx; I lost 12kg; ulcers in the tongue, throat and larynx; ulcers in the tongue, throat and larynx; ulcers in the tongue, throat and larynx; skin rashes(now they appeared much smaller, yes)/pimples appeared on my leg and arm; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (Directing towards an autoimmune disease) in a 71-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: astrazeneca. Past adverse reactions to the above products included No adverse event with astrazeneca. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN for Hypertension.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Directing towards an autoimmune disease) (seriousness criterion medically significant), APHTHOUS ULCER (Canker sores appeared in my mouth, tongue, throat and larynx), WEIGHT DECREASED (I lost 12kg), LARYNGEAL ULCERATION (ulcers in the tongue, throat and larynx), TONGUE ULCERATION (ulcers in the tongue, throat and larynx), PHARYNGEAL ULCERATION (ulcers in the tongue, throat and larynx) and RASH (skin rashes(now they appeared much smaller, yes)/pimples appeared on my leg and arm). At the time of the report, AUTOIMMUNE DISORDER (Directing towards an autoimmune disease), LARYNGEAL ULCERATION (ulcers in the tongue, throat and larynx), TONGUE ULCERATION (ulcers in the tongue, throat and larynx) and PHARYNGEAL ULCERATION (ulcers in the tongue, throat and larynx) outcome was unknown and APHTHOUS ULCER (Canker sores appeared in my mouth, tongue, throat and larynx), WEIGHT DECREASED (I lost 12kg) and RASH (skin rashes(now they appeared much smaller, yes)/pimples appeared on my leg and arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: no lesions appeared, neither in the lungs nor in the kidney (supported by negative proteinuria and the analysis of residues of urine was negative).. On an unknown date, Protein urine: Negative. On an unknown date, Urine analysis: Negative. On an unknown date, Weight: Lost 12 kg.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that after the vaccination patient suffered ulcers in the tongue, throat and larynx (not necessarily linked with the application of Moderna), something that had never happened to the patient previously. Patient lost 12 kg and moreover, pimples appeared on the leg and arm, biopsy was conducted of these due to suspicion of vasculitis, whose pathological result was that there are no signs of vasculitis. The existence of candida was investigated in the mouth and an analysis started. As a preventive measure, patient took antibiotic Fungicide for 15 days to fight candid, that was without any result. Patient reported that it was directing towards an autoimmune disease however, the vasculitis was ruled out. At the time of report, the patient was being treated with 20 mg of corticoids that had made the skin rashes disappear, but it was not possible to eliminate the ulcers (though now they appeared much smaller in size). Patient was asking help from Moderna for any possible treatments.  Company Comment: This is a spontaneous case concerning a 71-year-old patient of an unknown gender with a history of Hypertension, who experienced the serious (due to medically significant), event of autoimmune disorder, which occurred on an unknown date after a dose of mRNA-1273 BIVALENT .222 (Original and Omicron BA.4/BA.5). Patient received previous 2 doses of Astrazeneca COVID-19 vaccine. It was reported that after vaccination patient suffered ulcers in the tongue, throat and larynx (not necessarily linked with the application of Moderna). This had never happened to the patient previously. Patient lost 12 kg and moreover, pimples appeared on the leg and arm. Biopsy was done to rule out vasculitis. Pathological result was no signs of vasculitis. The existence of candida in mouth was investigated, and an analysis started. As a preventive measure, patient took antibiotic Fungicide for 15 days to fight candid, that was without any result. Patient reported that it was directing towards an autoimmune disease. At the time of report, the patient was being treated with 20 mg of corticoids that had made the skin rashes disappear, but it was not possible to eliminate the ulcers (though now they appeared much smaller in size). The benefit-risk relationship of mRNA-1273 BIVALENT .222 (Original and Omicron BA.4/BA.5) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2023: Follow-up received contains no new information.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 71-year-old patient of an unknown gender with a history of Hypertension, who experienced the serious (due to medically significant), event of autoimmune disorder, which occurred on an unknown date after a dose of mRNA-1273 BIVALENT .222 (Original and Omicron BA.4/BA.5). Patient received previous 2 doses of Astrazeneca COVID-19 vaccine. It was reported that after vaccination patient suffered ulcers in the tongue, throat and larynx (not necessarily linked with the application of Moderna). This had never happened to the patient previously. Patient lost 12 kg and moreover, pimples appeared on the leg and arm. Biopsy was done to rule out vasculitis. Pathological result was no signs of vasculitis. The existence of candida in mouth was investigated, and an analysis started. As a preventive measure, patient took antibiotic Fungicide for 15 days to fight candid, that was without any result. Patient reported that it was directing towards an autoimmune disease. At the time of report, the patient was being treated with 20 mg of corticoids that had made the skin rashes disappear, but it was not possible to eliminate the ulcers (though now they appeared much smaller in size). The benefit-risk relationship of mRNA-1273 BIVALENT .222 (Original and Omicron BA.4/BA.5) is not affected by this report.