Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Vaccination site nodule, Vomiting
Clinical narrative: celiac disease worsen; celiac disease worsen/nerve issues worsen; nerve issues worsen; she slept during 24 hours; diarrhea; she did not eat because wanted to throw up all the time; soreness in her throat and her glands around that area; there was soreness in her arm pit; bones hurt; right arm swollen; soreness in throat; swollen adrenal glands; she had a big node/big node in right arm; This spontaneous case was reported by a patient and describes the occurrence of COELIAC DISEASE (celiac disease worsen) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Celiac disease (Recent change in status : gotten worse), Nervous system disorder NOS (Recent change in status : gotten worse), Allergy (a lot of allergies) and Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, NORTRIPTYLINE, SERTRALINE HYDROCHLORIDE (ZOLOFT), MONTELUKAST SODIUM (SINGULAIR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and BIOTIN for an unknown indication.    On 31-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 31-Oct-2022, the patient experienced BONE PAIN (bones hurt), PERIPHERAL SWELLING (right arm swollen), OROPHARYNGEAL PAIN (soreness in throat), ADRENOMEGALY (swollen adrenal glands), VACCINATION SITE NODULE (she had a big node/big node in right arm ), DIARRHOEA (diarrhea), VOMITING (she did not eat because wanted to throw up all the time), LYMPH NODE PAIN (soreness in her throat and her glands around that area) and AXILLARY PAIN (there was soreness in her arm pit). On 01-Nov-2022, the patient experienced HYPERSOMNIA (she slept during 24 hours). On an unknown date, the patient experienced COELIAC DISEASE (celiac disease worsen) (seriousness criterion medically significant), CONDITION AGGRAVATED (celiac disease worsen/nerve issues worsen) and NERVOUS SYSTEM DISORDER (nerve issues worsen). On 02-Nov-2022, HYPERSOMNIA (she slept during 24 hours) had resolved. At the time of the report, COELIAC DISEASE (celiac disease worsen), NERVOUS SYSTEM DISORDER (nerve issues worsen), BONE PAIN (bones hurt), PERIPHERAL SWELLING (right arm swollen), OROPHARYNGEAL PAIN (soreness in throat), ADRENOMEGALY (swollen adrenal glands), VACCINATION SITE NODULE (she had a big node/big node in right arm ), DIARRHOEA (diarrhea), VOMITING (she did not eat because wanted to throw up all the time), LYMPH NODE PAIN (soreness in her throat and her glands around that area) and AXILLARY PAIN (there was soreness in her arm pit) had not resolved and CONDITION AGGRAVATED (celiac disease worsen/nerve issues worsen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2022, SARS-CoV-2 test: Positive.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concomitant products included multi vitamin. No treatment was given. It was reported that symptoms were still ongoing.  Company comment: This spontaneous case concerns a female patient of unknown age, with medical history of coeliac disease, who experienced the unexpected, serious (medically significant) event of coeliac disease (condition aggravated) an unknown time after the fourth dose of mRNA-1273.222. Coeliac disease can present relapses as part of the natural history of the disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to MOD-2021-079136, MOD-2021-049473 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with medical history of coeliac disease, who experienced the unexpected, serious (medically significant) event of coeliac disease (condition aggravated) an unknown time after the fourth dose of mRNA-1273.222. Coeliac disease can present relapses as part of the natural history of the disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.