Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Computerised tomogram, Constipation, Neoplasm, Weight
Clinical narrative: Constipation; tumor growth; Bloating; This is a solicited report based on the information received by Pfizer from Regulatory Authority (MFR Control No. # 21K-163-4039839-00).  A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Jan2021 at the age of 77 years old (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; and pancreatin (CREON), oral from Apr2021 (Batch/Lot number was not reported) to May2021, at 24000 Unit, 6 in 1 D, oral from May2021 (Batch/Lot number was not reported) and ongoing, at 36000 Unit, 6 in 1 D for exocrine pancreatic insufficiency. Medical history included Alcohol use/one glass of wine every three month from unspecified date to Dec2019, weight loss in Apr2020, Suspected Cachexia from unspecified date to 2021, Abdominal cramps/Abdominal pain, Pancreatic cancer and non-smoker. The patient previously took BNT162B2 on Dec2020 at the age of 77 years old, dose 1, single via intramuscular for COVID-19 immunisation. The patient's concomitant medications were not reported. The patient experienced tumor growth in May2021 and patient took less Creon than prescribed due to less consumption of food. In Apr2021, the patient experienced bloating. In May2021, the bloating resolved. In Aug2021, the patient experienced constipation. In Aug2021, the constipation resolved. Recently in 2021, the patient began a high calorie fat diet via smoothing consumption and had a bowel movement for the first time last night on 12Aug2021. She would not experience any adverse events if the smoothie was ingested in the morning. The dose increase of Creon from 24,000 to 36,000 units had helped resolved the bloating. She had taken less than prescribed due to less consumption of food, but always took Creon orally with food, per USPI recommendations. The patient underwent laboratory tests which includes: in Aug2021 Body weight: weighed down to 77 pounds, May2021 Computed tomography scan: Tumor growth and Aug2021 Gained weight: 80 pounds. The action taken in response to the events for pancreatin was unknown. The outcome of tumor growth was unknown. The reporter's causality for the events of tumor growth, Bloating and constipation with Creon (Pancreatin) was no reasonable possibility. The reporter's causality for the event(s) of patient took less Creon than prescribed due to less consumption of food was not provided. The events were reported as medically important conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current information available the causal association of the suspect BNT162B2 for the reported events of tumour growth, bloating, constipation assessed as unrelated and is more likely due to inter-current medical condition of pancreatic cancer. The case will be reassessed further upon receipt of additional information.  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.