Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
mild non-specific acute hepatitis/AIH/mild hepatic steatosis; Inflammatory myopathy/Bilateral shoulder girdle muscle weakness; developed acute COVID-19 infection; circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site; circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site; circular, raised, pruritic chest rash; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis) and IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Concurrent medical conditions included Hyperlipidemia and Gastroesophageal reflux disease. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis) (seriousness criterion medically significant), IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness) (seriousness criterion medically significant), COVID-19 (developed acute COVID-19 infection), VACCINATION SITE RASH (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site), VACCINATION SITE PRURITUS (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site) and RASH PRURITIC (circular, raised, pruritic chest rash). The patient was treated with Nirmatrelvir;Ritonavir for COVID-19, at an unspecified dose and frequency; Immunoglobulin human normal (Immunoglobulin) (intravenous use) for Idiopathic inflammatory myopathy, at an unspecified dose and frequency and Budesonide for Autoimmune hepatitis, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis), IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness), COVID-19 (developed acute COVID-19 infection), VACCINATION SITE RASH (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site), VACCINATION SITE PRURITUS (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site) and RASH PRURITIC (circular, raised, pruritic chest rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: did not improve, 153 U/L 3 months after receiving the Moderna COVID-19 booster and 124 U/L Nine months later the level remained elevated.. On an unknown date, Aldolase: 49 U/L Elevated. On an unknown date, Aspartate aminotransferase: did not improve, 90 U/L Elevated, 3 months after receiving the Moderna COVID-19 booster and 95 U/L Nine months later the level remained elevated.. On an unknown date, Biopsy liver: revealed mild non-specific acute hepatitis. On an unknown date, Biopsy skin: concerned for autoimmune process. On an unknown date, Blood alkaline phosphatase: levels remained normal throughout. On an unknown date, Blood bilirubin: levels remained normal throughout. On an unknown date, Blood creatine phosphokinase: 4098 U/L Elevated. On an unknown date, Hepatic enzyme: normalized over 2 months and began increasing again after the patient developed acute COVID-19 infection.. On an unknown date, Hepatitis viral test: Negative. On an unknown date, Physical examination: revealed a circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site. On an unknown date, Prothrombin time: levels remained normal throughout. On an unknown date, Ultrasound liver elastography: revealed no fibrosis and mild hepatic steatosis. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered AUTOIMMUNE HEPATITIS (mild non-specific acute hepatitis/AIH/mild hepatic steatosis), IDIOPATHIC INFLAMMATORY MYOPATHY (Inflammatory myopathy/Bilateral shoulder girdle muscle weakness), COVID-19 (developed acute COVID-19 infection), VACCINATION SITE RASH (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site), VACCINATION SITE PRURITUS (circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site) and RASH PRURITIC (circular, raised, pruritic chest rash) to be related. The author presented a case of multi-organ autoimmune pathology that developed after repeated exposure to COVID-19 through infection and vaccination. The patient discontinued all statin and alcohol use. Empiric treatment was received for AIH with budesonide did not improve AST and ALT levels. Elevated creatine kinase and aldolase were suspicious for inflammatory myopathy. The author reported that it was the first documented case of liver injury associated with COVID-19 exposure that contributed to a multi-organ autoimmune process. Though AST and ALT elevations could be seen in muscle injury, liver elastography and liver biopsy confirmed hepatic involvement. Given worsening symptoms with repeated COVID-19 exposure, prior autoimmune reactions should be reviewed when considering future COVID-19 booster doses. Patient history of other autoimmune reactions to COVID-19 raised clinician suspicion for viral exposure as an etiology for unexplained symptoms.; Reporter's Comments: Company comment: Occurrence of COVID 19 infection remains as confounder for worsening of the condition. The benefit-risk relationship of product is not affected by this report.
Gastroesophageal reflux disease; Hyperlipidemia
Test Name: ALT; Result Unstructured Data: did not improve; Test Name: ALT; Result Unstructured Data: Test Result:153 U/L;3 months after receiving the Moderna COVID-19 booster; Test Name: ALT; Result Unstructured Data: Test Result:124 U/L;Nine months later the level remained elevated.; Test Name: Aldolase; Result Unstructured Data: Test Result:49 U/L;Elevated; Test Name: AST; Result Unstructured Data: did not improve; Test Name: AST; Result Unstructured Data: Test Result:90 U/L;Elevated, 3 months after receiving the Moderna COVID-19 booster; Test Name: AST; Result Unstructured Data: Test Result:95 U/L;Nine months later the level remained elevated.; Test Name: Liver biopsy; Result Unstructured Data: revealed mild non-specific acute hepatitis; Test Name: Rash biopsy; Result Unstructured Data: concerned for autoimmune process; Test Name: alkaline phosphatase; Result Unstructured Data: levels remained normal throughout; Test Name: Bilirubin; Result Unstructured Data: levels remained normal throughout; Test Name: Creatine kinase; Result Unstructured Data: Test Result:4098 U/L;Elevated; Test Name: Liver enzymes; Result Unstructured Data: normalized over 2 months; Test Name: Liver enzymes; Result Unstructured Data: began increasing again after the patient developed acute COVID-19 infection.; Test Name: Viral and AIH workup; Test Result: Negative ; Test Name: Examination; Result Unstructured Data: revealed a circular, raised, pruritic chest rash, which she reported had first presented at her booster injection site; Test Name: Prothrombin time; Result Unstructured Data: levels remained normal throughout; Test Name: Liver elastography; Result Unstructured Data: revealed no fibrosis and mild hepatic steatosis