Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Faecal elastase test, Pancreatic failure, Stool analysis
Clinical narrative: Pancreatic exocrine insufficiency/Condition aggravated; Pancreatic exocrine insufficiency/Condition aggravated; This is a literature report.  A 54-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastroesophageal reflux disease" (unspecified if ongoing); "stable 3 mm gallbladder polyp" (unspecified if ongoing); "perimenopause on hormone replacement therapy" (unspecified if ongoing); "perimenopause on hormone replacement therapy" (unspecified if ongoing); "She denied alcohol use" (unspecified if ongoing); "She denied smoking" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cholecalciferol, notes: 2,000 IU daily; Levonorgestrel intrauterine device, notes: levonorgestrel intrauterine device; Estradiol, notes: 0.05 mg/24-hour patch,; Progesterone, notes: 100 mg daily. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "transient exocrine pancreatic dysfunction after pfizer-biontech covid-19 mRNA vaccination/symptom onset". The following information was reported: PANCREATIC FAILURE (medically significant), CONDITION AGGRAVATED (medically significant), all with latency 48 hrs after the suspect product(s) administration, outcome "recovered" and all described as "Pancreatic exocrine insufficiency/Condition aggravated". The patient underwent the following laboratory tests and procedures: Faecal elastase test: severely depressed faecal, notes: elastase, she was diagnosed with exocrine pancreatic insufficiency; greater than 800, notes: unit: ug/g; Stool analysis: non-bloody diarrhea up to, notes: 8 times / day. Therapeutic measures were taken as a result of pancreatic failure, condition aggravated.  Clinical course: A case of transient exocrine pancreatic insufficiency (EPI) that occurred after administration of the Pfizer-BioNTechCOVID-19 mRNA vaccine (Comirnaty). Case Report A 54-year-old female with gastroesophageal reflux disease, stable 3 mm gallbladder polyp, perimenopause on hormone replacement therapy, and no surgical history, presented with a 2-month history of diarrhea starting 24-hours after receiving the first dose of the Pfizer COVID-19 mRNA vaccine. She described explosive, watery, non-bloody diarrhea up to eight times per day with nocturnal symptoms, urgency, fecal incontinence, bloating, and abdominal cramping. She experienced partial symptomatic improvement weeks after the first dose of the vaccine; however, within 48 hours after the second dose (3 weeks following the first dose) her diarrhea worsened. She took loperamide 2 mg four times daily with minimal improvement. She denied sick contacts, travel, medication changes, alcohol use, smoking, and family history of pancreatic disease. Her medications included cholecalciferol 2,000 IU daily, levonorgestrel intrauterine device, estradiol 0.05 mg/24- hour patch, and progesterone 100 mg daily. Diagnostic evaluation five weeks after the second dose of the vaccine is outlined in Table 1. Due to the severely depressed fecal elastase, she was diagnosed with exocrine pancreatic insufficiency (EPI) and started on pancreatic enzyme supplementation with a pancrelipase (Creon) 48,000-152,000-240,000 units. She reported clinical response within days with resolution of all symptoms. She self-discontinued enzyme supplementation two months later, after returning to her baseline bowel habits of formed stool 1-2 times daily. A repeat fecal pancreatic elastase off enzyme supplementation was >800 ug/g. On follow up six months after initial presentation, she remained symptom free and had not received a booster of the COVID- 19 vaccine.; Sender's Comments: Based on the known limited information available the Causal relation between the events PANCREATIC FAILURE, CONDITION AGGRAVATED and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug 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.