Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
Vaccine-induced autoimmunity; new-onset autoimmune conditions following vaccination with mRNA-based vaccines; Primary hyperthyroidism in setting of Graves disease; Celiac disease; Autoimmune gastritis; Ulcerative proctitis; This is a literature report for the following literature source(s). Vaccine-induced autoimmunity has been previously described with many protein subunit vaccines. Many mechanisms have been proposed, though it is largely thought to occur via molecular mimicry. In the wake of the COVID-19 pandemic that saw the rapid development and distribution of several new vaccines using novel technology, there are emerging reports of new-onset autoimmune conditions following vaccination with mRNA-based vaccines. Per case description or methods, the patient is a 47-year-old woman with a history of iron-deficiency anemia and atopic dermatitis. Her family history is notable for 2 children with biopsy-proven Celiac disease, one of whom additionally has Graves' disease. She initially presented for an intermittent, pruritic lower extremity rash that developed after her second mRNA-based COVID-19 vaccine. Celiac serologies were negative (she was gluten-free at the time) but her HLA-DQ2 haplotype was positive. Punch biopsy of her rash was notable for intra- and subepidermal splitting with granular IgA deposition at the dermal/ epidermal junction, consistent with dermatitis herpetiformis. Several months later, she received a booster and shortly thereafter, she presented to the emergency room with acute palpitations, tremor, and diarrhea. TSH was undetectable with elevated free T4 and TSI consistent with primary hyperthyroidism in setting of Graves' disease; she was started on treatment with methimazole and beta blockade. Due to ongoing evidence of malabsorption, she underwent upper endoscopy that was consistent with treated Celiac disease (increased duodenal lymphocytes with preserved villous architecture) as well as atrophic gastritis and elevated IF antibody suggestive of autoimmune gastritis. She later developed hematochezia; colonoscopy had evidence of chronic active proctitis, and in conjunction with a mildly elevated fecal calprotectin, she was additionally diagnosed with ulcerative proctitis and started on mesalamine with resolution of symptoms. Per discussion, the case highlights a striking example of vaccine-induced autoimmunity, wherein the patient developed several new-onset autoimmune conditions, particularly gastrointestinal disorders, upon receiving mRNA-based vaccines. Given only a small subset of patients experience this phenomenon, it suggests there may exist a genetic predisposition for autoimmunity triggered by vaccination. The case underscores the need to use mRNA-based vaccines with caution in patients at high risk for autoimmunity.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of autoimmune diseases might not be fully excluded, considering the temporal relationship. However, the patient had underlying atopic dermatitis with family history/2 children positive for autoimmune disorders (Celiac disease and Graves' disease), the genetic predispositions could be major contributors towards these occurrences. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-PV202500046529 Same article, drug, and patient; different event and dose;
Medical History/Concurrent Conditions: Atopic dermatitis; Gluten free diet; Iron deficiency anemia
Test Name: Punch biopsy of her rash; Result Unstructured Data: Test Result:Intra- and subepidermal splitting; Comments: With granular IgA deposition at the dermal/ epidermal junction, consistent with dermatitis herpetiformis; Test Name: TSH; Result Unstructured Data: Test Result:Undetectable; Comments: Consistent with primary hyperthyroidism in setting of Graves' disease; Test Name: Colonoscopy; Result Unstructured Data: Test Result:Evidence of chronic active proctitis; Test Name: Upper endoscopy; Result Unstructured Data: Test Result:Consistent with treated Celiac disease; Comments: Increased duodenal lymphocytes with preserved villous architecture as well as atrophic gastritis; Test Name: Fecal calprotectin; Result Unstructured Data: Test Result:Mildly elevated; Test Name: HLA-DQ2 haplotype; Test Result: Positive ; Test Name: IF antibody; Result Unstructured Data: Test Result:Elevated; Comments: Suggestive of autoimmune gastritis; Test Name: Celiac serologies; Test Result: Negative ; Test Name: TSI; Result Unstructured Data: Test Result:Elevated; Comments: Consistent with primary hyperthyroidism in setting of Graves' disease; Test Name: Free T4; Result Unstructured Data: Test Result:Elevated; Comments: Consistent with primary hyperthyroidism in setting of Graves' disease