Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Metabolic function test, Oxygen saturation, Pain assessment
Clinical narrative: Acute Pancreatitis; The initial case was missing the following minimum criteria: Unspecified Drug. Upon receipt of follow-up information on 20May2022, this case now contains all required information to be considered valid.  This is a literature report.  A 14-year-old female patient received BNT162b2 (BNT162B2), on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 31May2021, for COVID-19 immunisation; pentacel, administration date: 23Mar2007; pentacel, administration date: 28May2007; pentacel, administration date: 06Aug2007; pentacel, administration date: 13Aug2007; tdap (adol/adult), administration date: 20Feb2012; tdap (adol/adult), administration date: 02Oct2019; ipv (polio), administration date: 02Oct2019; mmr, administration date: 08May2008; mmr, administration date: 28Jan2009; hepatitis B vaccine ((ped/adol)), administration date: 02Oct2019; hepatitis B vaccine ((ped/adol)), administration date: 21Jan2020; hepatitis B vaccine ((ped/adol)), administration date: 01Jul2020; varivax (Varicclla), administration date: 18Feb2008; varivax (Varicclla), administration date: 02Oct2019; hepatitis a vaccine ((ped/adol)), administration date: 21Jan2020; hepatitis a vaccine ((ped/adol)), administration date: 26Feb2021; menACWY-crm, administration date: 02Oct2019; meningococcal vaccine (Meningococcal 1 Historical), administration date: 18Feb2008. The following information was reported: PANCREATITIS ACUTE (hospitalization, medically significant, life threatening), outcome "recovering", described as "Acute Pancreatitis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: normal; Amylase (normal high range 100): 57 IU/l, notes: normal; Aspartate aminotransferase: normal; Blood bicarbonate: 19 mmol/L, notes: dehydration; Blood calcium: 10.2 mg/dl; Blood cholesterol: 239 mg/dl, notes: elevated; 17 mg/dl; Blood creatinine: 0.90 mg/dl, notes: dehydration; Blood iron: ultimately revealed iron deficiency; Blood pressure measurement: 120/66 mmHg; Blood triglycerides: 473 mg/dl; Blood urea: 18 mg/dl, notes: dehydration; Body mass index: 36.44, notes: kg/m2; Body temperature: 37.3 Centigrade, notes: oral; Computerised tomogram: confirmed the finding of inflammation, notes: throughout the abdomen and pelvis with a moderate amount of ascites and central inflammatory change surrounding the pancreas suggesting pancreatitis as the etiology. It also showed fatty liver and trace left pleural effusion; Computerised tomogram abdomen: evidence of pancreatitis; Full blood count: was significant for elevated, notes: white blood cells count (18.6 bil/L) with predominant neutrophils and microcytic hypochromic anemia (hemoglobin 11.1 g/dL, mean corpuscular volume 80 fL, mean corpuscular hemoglobin 25 pg, mean corpuscular haemoglobin concentration 32g/dL); Gamma-glutamyltransferase: normal; Haemoglobin: 11.1 g/dl, notes: microcytic hypochromic anemia; Heart rate: 124, notes: beats per minute; Human chorionic gonadotropin: negative; laboratory test: showed a lipase level of 88 U/L, notes: (normal range 7-60 U/L), then 25 U/L with resolution of leukocytosis (white blood cells 7.5 bil/L); Lipase: elevated; Lipase (7-60): 135 IU/l, notes: elevated; 88 IU/l; 25 IU/l; Lipids: showed elevated cholesterol, notes: (239 mg/dL), triglycerides (473 mg/dL), and low high-density lipoprotein cholesterol (17 mg/dL); Liver function test: normal; Mean cell haemoglobin: 25 pg, notes: microcytic hypochromic anemia; Mean cell haemoglobin concentration: 32 g/dl, notes: microcytic hypochromic anemia; Mean cell volume: 80, notes: fL, microcytic hypochromic anemia; Metabolic function test: was suggestive of dehydration (blood urea nitrogen, notes: 18 mg/dL,creatinine 0.90 mg/dL, bicarbonate 19 mmol/L) but was otherwise normal; Oxygen saturation: 97 %; Pain assessment: 8/10, notes: in severity dull/aching in character,in the epigastrium, umbilical and right lower quadrant, insidious in onset, nonradiating, exacerbated by palpation, movement and vomiting, relieved with rest and antacids; Physical examination: showed an obese teenage female in no acute, notes: distress, Abdomen was soft, nondistended but tender (especially in umbilical region and right lower quadrant) with guarding. There was no hepatomegaly or splenomegaly. Bowel sounds were heard in all 4 quadrants. There was no costovertebral angle tenderness bilaterally. There were no signs of dehydration. The rest of the physical examination was normal; Respiratory rate: 18, notes: breaths per minute; Respiratory viral panel: negative; SARS-CoV-2 test: negative; Ultrasound abdomen: showed trace pericholecystic, notes: ascites without any evidence of cholecystitis, gallstones,or common bile duct dilation; Urine analysis: showed mild proteinuria, notes: and 3+ red blood cells (due to menses) but did not suggest infection; Vital signs measurement: blood pressure 120/66 mm Hg, pulse 124 beats, notes: per minute, temperature: 37.3 C (oral), respiratory rate 18 breaths per minute, SpO2 97%, height 172.7 cm (5' 8?), weight 109 kg (239 Lb 10.2 oz), and body mass index 36.44 kg/m2; White blood cell count: 7.5 x10 9/l, notes: leukocytosis; 18.6 x10 9/l, notes: elevated. Therapeutic measures were taken as a result of pancreatitis acute.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2  cannot be excluded for the reported events of Acute 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