Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Fatigue, Flatulence, Hypertension
Clinical narrative: Abdominal bloating; Gas; Shoulder pain; Blood pressure high/went up to 140/80;150/80; Abdominal pain; Diarrhea; Dry mouth; Injection site pain; Constipation; Stomach pain; Dizziness; Nasal stuffiness; Lipase decreased; Lack of efficacy/pancreatin not working; Shortness of breath/Difficulty breathing; Nervous; Tired; Nasal mucosal erythema; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (manufacturer control number: 21K-163-3851042-00). A contactable consumer (patient) reported that a 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 27Jan2021 (Batch/Lot Number: 629262) as 1st dose single and dose 2 intramuscular on 17Feb2021 (Batch/Lot Number: EL9288) as 2nd dose, single for COVID-19 immunisation; pancreatin (CREON), orally from 2016 (Batch/Lot number was not reported) to 2019, at 2 capsules per meal (24000 Unit,6 in 1 D), orally from 2019 (Batch/Lot number was not reported) to 2020, at 3 capsules in morning, 2 capsules at lunch and 3 capsules at dinner (24000 Unit,8 in 1 D) and orally from 2020 (Batch/Lot number was not reported) and ongoing, at eight capsules per day with food (24000 Unit,1 in 1 D) for chronic pancreatitis. Medical history included alcohol use (a glass of red wine occasionally), diabetes and hypothyroidism, the patient's brother was allergic to penicillin so she could not take it, the patient was no tobacco user. Concomitant medications included insulin glargine (LANTUS) taken for diabetes; levothyroxine taken for thyroid, start and stop date were not reported; insulin lispro (HUMALOG) taken for diabetes. The patient experienced lack of drug effect in 2021, shortness of breath in Nov2020, dry mouth in Mar2021, abdominal bloating on an unspecified date, lipase decreased in Feb2021, nervous in 2020, tired in 2020, nasal stuffiness in Feb2021, blood pressure high in Mar2021, difficulty breathing in Feb2021, shoulder pain on an unspecified date, injection site pain on 17Feb2021, nasal mucosal erythema in 2020, gas on an unspecified date, abdominal pain in Mar2021, diarrhea in Mar2021, constipation in Feb2021, stomach pain in Feb2021, dizziness in Feb2021. Clinical course: On an unknown date, the patient experienced stomach bloating, right shoulder pain and Gas. In 2020, the patient experienced nervous, tired and redness inside the nose. In Nov2020, the patient experienced shortness of breath. In 2021, the patient experienced pancreatin not working/lack of efficacy. In Feb2021, the patient experienced low lipase units/decreased lipase, stuffy nose, difficulty breathing, constipation, stomach pain, diarrhea and dizziness. On 17Feb2021, the patient experienced Pain at the injection site. On 17Feb2021, the Pain at the injection site resolved. In Mar2021, the patient experienced dryness in the mouth, abdominal pain and diarrhea. On 17Mar2021, the patient experienced high blood pressure. In 2021, the diarrhea resolved. covid-19 vaccine was also considered suspect. The patient clarified that in 2018, all the adverse events reported happened. She had light lipase units and it was still low because normal was 11 lipase units. She was on six capsules per day before on an unknown date and shifted to eight units per day because of the signs and symptoms she still experiencing. Pancreatin bottle was product of and she was taking it as prescribed and also as per recommendations but in 2018, her current bottle of pancreatin that she was taking when she experienced the events. In Nov2020, she went to a pulmonologist for the shortness of breath back and she was given pump inhaler. Pancreatin was taken with food every time as prescribed. She did not discontinue taking pancreatin and the events did not resolve while taking pancreatin. It was unknown if the events she experienced considered to be due to lack of efficacy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. AER 21K-163-3852849-00 (1) and AER 21K-163-3851042-00 (2) are duplicate to each other for same event. AER  21K-163-3851042-00 (2) was retained and Case 21K-163-3852849-00 (1) was invalidated. The patient was treated with losartan, claritin, meclizine and albuterol sulfate. The patient underwent lab tests and procedures which included blood pressure measurement: went up to 140/80 in Mar2021, blood pressure measurement: went up to 150/80 in Mar2021, colonoscopy: okay, lipase: 8 U in 2017, lipase was only 7 to 8 in Jan2021, pulmonary function: normal on 19Mar2021, x-ray: normal on 15Mar2021. The action taken in response to the events for pancreatin was dose not changed. Therapeutic measures were taken as a result of all events. The outcome of events 'injection site pain' was recovered on 17Feb2021; of event 'diarrhea' was recovered in 2021; of event 'lack of drug effect and shoulder pain' was unknown; of rest events was not recovered.   For product pancreatin, reporter causality of events nervous and tiredness was probable; of events shoulder pain and lack of drug effect was not reported; of rest events was not assessable. For vaccine BNT162B2, reporter causality of event blood pressure high was not assessable; of event injection site pain was not related; of rest events was not reported.  The reporter's assessment of the causal relationship of events (except event injection site pain) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: The events are assessed as related except for the event injection site pain which has been unrelated and most likely due to the injection itself.  This case will be updated when new information becomes available.