Sex: M
Vaccine: COVID19
Symptoms: Autoimmune pancreatitis, Blood immunoglobulin G, Carbohydrate antigen 19-9, Cholangiogram, Endoscopic retrograde cholangiopancreatography
Clinical narrative: seronegative type I autoimmune pancreatitis; This is a literature report for the following literature source(s). A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sphincterotomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation, reaction(s): "seronegative type I autoimmune pancreatitis". The following information was reported: AUTOIMMUNE PANCREATITIS (hospitalization, medically significant), outcome "recovered", described as "seronegative type I autoimmune pancreatitis". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: normal levels; Carbohydrate antigen 19-9 (normal high range 34): normal levels; 225 IU/ml, notes: elevated; Cholangiogram: intrahepatic biliary ductal dilatation with an, notes: irregular, beaded appearance, regions of restricted diffusion/hypoenhancement within both kidneys, and irregularity and beading of the main pancreatic duct, consistent with AIP with extrapancreatic IgG4-related disease; Endoscopic retrograde cholangiopancreatography: demonstrated a 2cm distal common bile duct, notes: structure; resolution of the stricture; multifocal intrahepatic and extra hepatic, notes: stricturing; confirming multifocal stricturing; Endoscopic ultrasound: demonstrated a diffusely heterogenic pancreas with, notes: features of pancreatitis; Admission labs: Admission labs demonstrated a cholestatic liver, notes: injury without eosinophilia; Liver function test: complete normalization; Magnetic resonance imaging: after eight weeks of therapy showed complete, notes: resolution of all biliary dilation and pancreatic/renal abnormalities. Therapeutic measures were taken as a result of autoimmune pancreatitis. Additional information: this case was the first case of suspected vaccine-induced seronegative Type I autoimmune pancreatitis (AIP) with IgG4-related disease occurring after a single dose of the Pfizer-BioNTech COVID-19 vaccine. A previously healthy 65-year-old male presented to a community hospital with one week of jaundice. Two weeks prior, he had received his first dose of the COVID-19 vaccine. Admission labs demonstrated a cholestatic liver injury without eosinophilia. After initial imaging, an endoscopic ultrasound demonstrated a diffusely heterogenic pancreas with features of pancreatitis (lobularity, stranding). Endoscopic retrograde cholangiopancreatography (ERCP) demonstrated a 2cm distal common bile duct stricture. A sphincterotomy was performed and fully covered metal stent was placed (due to minor post-sphincterotomy bleeding). The patient's jaundice resolved, and he was discharged. He received his second dose of the COVID-19 vaccine shortly after hospitalization. The patient underwent the following laboratory tests and procedures: Blood bilirubin: 12 mg/dl, notes: 3 weeks post first vaccine dose; 2 mg/dl, notes: 6 weeks post first vaccine dose; 1 mg/dl, notes: 10 weeks post first vaccine dose; 4 mg/dl, notes: 12 weeks post first vaccine dose; 18 mg/dl, notes: 16 weeks post first vaccine dose (start of therapy); 12 mg/dl, notes: 18 weeks post first vaccine dose; 7 mg/dl, notes: 20 weeks post first vaccine dose; 2 mg/dl, notes: 24 weeks post first vaccine dose; 1 mg/dl, notes: 28 weeks post first vaccine dose; 1 mg/dl, notes: 34 weeks post first vaccine dose. Conclusion(s): We report a case of seronegative Type I AIP with IgG4-related disease in a previously healthy patient occurring after Pfizer-BioNTech COVID-19 vaccination. While this clinical presentation is typically associated with elevated serum IgG4 levels, our case implicates an alternate immunogenic trigger. Although such rare side effects of vaccination need to be recognized, they should not prevent physicians from recommending COVID-19 vaccination.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of seronegative type I autoimmune pancreatitis. 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