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  • Department of Clinical Pharmacology, Canterbury District Health Board, Christchurch, New Zealand.
  • Department of Surgery, Canterbury District Health Board, Christchurch, New Zealand.
  • Department of Gastroenterology, Canterbury District Health Board, Christchurch, New Zealand.
  • Department of Medicine, University of Otago, Dunedin, New Zealand.
  • 截至 2021 年 6 月 22 日,全球已接种约 4 亿剂辉瑞-BioNTech COVID-19 mRNA 疫苗。目前,在提交给世界卫生组织的药物警戒报告中已报告了 176 例胰腺炎病例。 1 辉瑞-BioNTech COVID-19 mRNA 疫苗与胰腺炎之间没有流行病学联系的报道。我们报告了一例在第二剂辉瑞-BioNTech COVID-19 mRNA 疫苗接种后发生的急性坏死性胰腺炎。该病例已向新西兰药物警戒中心报告,患者已同意发表病例报告。

    一名 43 岁的新西兰欧洲男性在接种第二次 Pfizer-BioNTech COVID-19 mRNA 疫苗后 10 小时被诊断出患有急性坏死性胰腺炎。他有季节性鼻炎、湿疹和哮喘的特应性背景,所有这些都是“轻微的”。他不服用常规药物,根据需要服用褪黑激素 2 毫克夜间,西替利嗪 10 毫克治疗花粉热,倍他米松和润肤霜治疗皮炎。他没有著名的家族史,并且担任高级专业职务。他每周喝 6 个标准单位的酒精,从未吸烟,不使用消遣性药物——他的雇主定期进行药物检测。

    他在 2011 年曾患过一次胰腺炎,原因是在国外度假期间摄入大量酒精。他以前很好。无家族史,父亲吸烟,60多岁死于肺癌,母亲身体健康,有两个兄弟姐妹和三个孩子,他们都很好。他不知道他的大家庭中有任何值得注意的疾病。

    2021年5月,他接受了第二剂辉瑞-BioNTech COVID-19 mRNA疫苗;他当时很好。服药四小时后,他在晚餐时喝了两瓶 330 毫升的 5% 酒精啤酒。服药六小时后,他出现恶心、上腹痛和呕吐等不适。服药十小时后,入院时的血液检查包括:白细胞计数 18.5 × 10 9 /L (4-11),中性粒细胞 15.5 × 10 9 /L (1.9-7.5),淋巴细胞 0.8 × 10 9 /L (1.0–4.0),CRP < 3 mg/L (<5),脂肪酶 23 750 U/L (10–70),甘油三酯 3.3 mmol/L。诊断为急性胰腺炎。超声扫描显示胰腺炎,但没有胆石症的证据。他随后病情恶化,并于 5 月 17 日,即发病第 9 天进行计算机断层扫描 (CT) 扫描,显示有严重的坏死性胰腺炎并伴有积液。

    在专科肝胆外科团队入院期间,排除了胰腺炎的已知原因,包括类固醇使用、外伤、自身免疫性疾病家族史和感染。他没有肥胖、吸烟或大量饮酒的危险因素。他有先前急性胰腺炎发作的危险因素。在这个年龄组的新西兰欧洲人中,胰腺炎的发病率约为每年每 100 000 人中有 50 人。 2 特发性病例约占其中的 15%。

    使用 Naranjo 标准,由 Pfizer-BioNTech COVID-19 mRNA 疫苗评分“引起”的胰腺炎为 6“可能”。 3 临床病例讨论(包括肝胆外科医生、胃肠病学家和临床药理学家)得出结论,虽然不能排除特发性胰腺炎,但症状和发现与第二剂疫苗接种时的急性诱发事件一致。

    除了 VigiBase™ 报告的 176 例病例外,PubMed 和 Google Scholar™ 的搜索还发现了 Pfizer-BioNTech COVID-19 mRNA 疫苗后已发表的两例胰腺炎病例报告。这些是在第一剂辉瑞-BioNTech COVID-19 mRNA 疫苗接种后进行的。在一种情况下,在接种疫苗数小时后出现症状,另一种在接种疫苗后数天出现症状。 4, 5

    急性胰腺炎在 COVID-19 患者中很少见,但已经报道了典型的疾病模式。 6 这增加了对病毒或疫苗的免疫反应可能具有共同后遗症的可能性。

    该急性胰腺炎病例与 Pfizer-BioNTech COVID-19 mRNA 疫苗暂时相关,表明存在因果关系。应检查与 Pfizer-BioNTech COVID-19 mRNA 疫苗相关的胰腺炎病例的特征,以确定是否存在一致的模式。

    As of 22 June 2021, there have been about 400 000 000 doses of the Pfizer-BioNTech COVID-19 mRNA vaccine administered worldwide. At this time, 176 cases of pancreatitis have been reported in pharmacovigilance reports submitted to the WHO. 1 No epidemiological link between the Pfizer-BioNTech COVID-19 mRNA vaccine and pancreatitis has been reported. We report a case of acute necrotising pancreatitis following the second dose of the Pfizer-BioNTech COVID-19 mRNA vaccine. This case has been reported to the New Zealand Pharmacovigilance Centre and the patient has consented to publication of the case report.

    A 43-year-old, NZ European male was diagnosed with acute necrotising pancreatitis 10 h following the administration of his second Pfizer-BioNTech COVID-19 mRNA vaccine. He has a background of atopy with seasonal rhinitis, eczema, and asthma, all of which are “mild.” He takes no regular medications and takes as needed melatonin 2 mg nocte, cetirizine 10 mg for hay fever, and betamethasone and emollient cream for dermatitis. He has no family history of note and works in a senior professional role. He drinks six standard units of alcohol per week, has never been a tobacco smoker, and does not use recreational drugs—and his employer undertakes regular drug testing.

    He had a previous episode of pancreatitis in 2011, precipitated by high alcohol intake during a holiday abroad. He is otherwise previously well. There is no family history of note, his father was a smoker and died of lung cancer in his 60s, his mother is well, and he has two siblings and three children all of whom are well. He is not aware of any diseases of note in his extended family.

    In May 2021, he received his second dose of Pfizer-BioNTech COVID-19 mRNA vaccine; he was well at that time. Four hours after the dose, he had two 330 ml bottles of 5% alcohol beer with his dinner. Six hours after the dose, he became unwell with nausea, epigastric pain, and vomiting. Ten hours after the dose, blood tests on admission to hospital included: white cell count 18.5 × 10 9 /L (4–11), neutrophils 15.5 × 10 9 /L (1.9–7.5), lymphocytes 0.8 × 10 9 /L (1.0–4.0), CRP < 3 mg/L (<5), lipase 23 750 U/L (10–70), and triglycerides 3.3 mmol/L. Acute pancreatitis was diagnosed. An ultrasound scan showed pancreatitis without evidence of cholelithiasis. He subsequently deteriorated and a computer tomography (CT) scan on 17 May, day 9 of the illness, showed severe necrotising pancreatitis with collections.

    During the admission under a specialist hepatobiliary surgical team, known causes of pancreatitis were excluded, including steroid use, trauma, family history of autoimmune conditions, and infection. He did not have the risk factors of obesity, smoking, or heavy alcohol consumption. He had the risk factor of a previous episode of acute pancreatitis. The incidence of pancreatitis in New Zealand Europeans in this age group is approximately 50 per 100 000 per year. 2 Idiopathic cases represent about 15% of these.

    Using the Naranjo criteria, the pancreatitis being “caused” by the Pfizer-BioNTech COVID-19 mRNA vaccine score was 6 “probable.” 3 Clinical case discussion (including a hepatobiliary surgeon, gastroenterologist, and clinical pharmacologist) concluded that while idiopathic pancreatitis could not be excluded, the onset of symptoms and findings were consistent with an acute precipitating event around the time the second vaccine dose was administered.

    In addition to the 176 cases reported in VigiBase™, searches of PubMed and Google Scholar™ identified two published case reports of pancreatitis following the Pfizer-BioNTech COVID-19 mRNA vaccine. These were following administration of the first dose of the Pfizer-BioNTech COVID-19 mRNA vaccine. In one case, symptoms developed several hours after vaccine administration and the other several days after vaccine administration. 4, 5

    Acute pancreatitis is rare in patients with COVID-19 but characteristic patterns of illness have been reported. 6 This raises the possibility that an immune response to either the virus or the vaccine could have common sequalae.

    This case of acute pancreatitis was temporally associated with the Pfizer-BioNTech COVID-19 mRNA vaccine suggesting a causal link. The characteristics of pancreatitis cases associated with the Pfizer-BioNTech COVID-19 mRNA vaccine should be examined to see if a consistent pattern is present.