Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrooesophageal reflux disease, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Atrial fibrillation; Upset  stomach; Diarrhea; her voice goes and is really soft; Having seasonal allergies; allergies; Body aches; sneezing; common cold; runny nose; Sore throat; Very Wrinkly& Dry Arms; looks very crapey and older; So tired; throwing up; GERD; irritable bowel syndrome; feels disabled; hypertension; increased heart rate; increased blood pressure; Swelling Ankles & Lower Leg; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021-BI-073949(17).  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; nintedanib esilate (OFEV), first regimen from 10Jul2020 (Lot number: 902505, 5226, 003108, 002482, 10370) to 26Dec2020 at 300 mg 1x/day, second regimen (Batch/Lot number: unknown) at 150 mg 1x/day and third regimen (Lot number: 3817, 9495, 101421, 102708, 103584) at 200 mg (200 mg (1 in 0.5 day)), all oral for idiopathic pulmonary fibrosis. The patient's relevant medical history included: "Stroke" (unspecified if ongoing), notes: Disease Comments: 2 To 3 Years Ago. Concomitant medication(s) included: VALSARTAN oral. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization.  The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2020, outcome "unknown"; PAIN (non-serious) with onset 2020, outcome "unknown", described as "Body aches"; DIARRHOEA (non-serious) with onset 2020, outcome "unknown", described as "Diarrhea"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 2020, outcome "unknown", described as "GERD"; SEASONAL ALLERGY (non-serious) with onset 2020, outcome "unknown", described as "Having seasonal allergies"; FATIGUE (non-serious) with onset 2020, outcome "unknown", described as "So tired"; OROPHARYNGEAL PAIN (non-serious) with onset 2020, outcome "unknown", described as "Sore throat"; PERIPHERAL SWELLING (non-serious) with onset 2020, outcome "unknown", described as "Swelling Ankles & Lower Leg"; ABDOMINAL DISCOMFORT (non-serious) with onset 2020, outcome "unknown", described as "Upset  stomach"; DRY SKIN (non-serious) with onset 2020, outcome "unknown", described as "Very Wrinkly& Dry Arms"; MULTIPLE ALLERGIES (non-serious) with onset 2020, outcome "unknown", described as "allergies"; NASOPHARYNGITIS (non-serious) with onset 2020, outcome "unknown", described as "common cold"; FEELING ABNORMAL (non-serious) with onset 2020, outcome "unknown", described as "feels disabled"; APHONIA (non-serious) with onset 2020, outcome "unknown", described as "her voice goes and is really soft"; HYPERTENSION (non-serious) with onset 2020, outcome "unknown"; BLOOD PRESSURE INCREASED (non-serious) with onset 2020, outcome "unknown", described as "increased blood pressure"; HEART RATE INCREASED (non-serious) with onset 2020, outcome "unknown", described as "increased heart rate"; IRRITABLE BOWEL SYNDROME (non-serious) with onset 2020, outcome "unknown"; SKIN WRINKLING (non-serious) with onset 2020, outcome "unknown", described as "looks very crapey and older"; RHINORRHOEA (non-serious) with onset 2020, outcome "unknown", described as "runny nose"; SNEEZING (non-serious) with onset 2020, outcome "unknown"; VOMITING (non-serious) with onset 2020, outcome "unknown", described as "throwing up".   The event "diarrhea" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Increased, notes: Test Name: Blood Pressure Test Date: Unknown Result Unstructured Data (free text): Increased; Blood pressure systolic: 170's; Computerised tomogram: No Worsening, notes: Ct Showed No Worsening compared To Last Year; Heart rate: Increased; Mouth breathing: Passed, notes: Test Name: Breathing Test Date: Unknown Result Unstructured Data: Passed A Breathing Test. The action taken for nintedanib esilate was unknown. Therapeutic measures were taken as a result of diarrhoea.  The reporter's assessment of the causal relationship of "atrial fibrillation", "upset  stomach", "diarrhea", "her voice goes and is really soft", "having seasonal allergies", "allergies", "body aches", "sneezing", "common cold", "runny nose", "sore throat", "very wrinkly& dry arms", "looks very crapey and older", "so tired", "throwing up", "gerd", "irritable bowel syndrome", "feels disabled", "hypertension", "increased heart rate", "increased blood pressure" and "swelling ankles & lower leg" with the suspect product(s) BNT162b2 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.  Clinical course: This a report from a (withheld) Non-Trial Activity, number. #. Information was received concerning a 79 Year(s) old Female patient, who was taking OFEV, capsule (300 milligram (s), 1 every 1 Day). OFEV was taken via oral route. Indication for use was Idiopathic pulmonary fibrosis. The lot numbers were 902505, 5226, 003108, 002482, 103705, and 3817, 9495, 101421, 102708, 103584. The patient initiated treatment on 10Jul2020. On unknown date, patient was on OFEV 150 milligrams (mg). On unknown date, patient was on OFEV 200 milligrams (mg) 1 every 1 day. The patient was also taking Vaccine Covid-19 Pfizer Biontech which was considered an alternate suspect drug. The patient stated that she recently passed a breathing test. But has not had a computed tomography (CTI done to check to see if the OFEV is working due to a computed tomography (C1) scan not clearing her insurance. The patient stated that she got her second Pfizer shot and that she was throwing up for two days, and skipped her OFEV for two days because she was throwing up and did not want to waste the OFEV. Patient reported she was so tired she fell asleep one day last week, and missed an OFEV dose. Upon follow-up, patient had taken OFEV once in the past but since restarting it, it has not been bad. Patient had some loose stools but fell it was due to her diet Instead of the OFEV. It happened from time to time from eating. Upon follow-up. Patient reported she had an episode of diarrhea. Patient reported her valsartan was increased to 320 milligrams (mg) once a day by mouth. Patient had to watch salt intake. Patient had intermittent and quick diarrhea. Patient reported being on the OFEV 150 milligrams (mg) but the doctors were debating about decreasing dose to 100 milligrams (mg). Patient had increased blood pressure when took the 150 milligrams (mg) dose. Due to weather conditions in (state withheld), patient had lived with her daughter temporarily and reported atrial fibrillation complications last few nights. Patient reported per md her recent Computerized Tomogram (C1) showed no worsening compared to last year occasional diarrhea 1-2 times a month, better since OFEV dose was decreased to 100mg twice daily. Patient reported she has intermittent diarrhea which she ls taking an anti-diarrhea medication for and seeing a GI Doctor of Medicine (MD) who is scheduling for her to have a colonoscopy. Patient had been experiencing hypertension with systolic blood pressures In the 170's. Patient was out of OFEV, she last took it on 26Dec2020 and did not want to reorder until she sees her doctor (MD) next week. The patient reports recently completing colonoscopy and endoscopy with 4 biopsies. Has a follow up with results of biopsy in Jun2023. The status of Vaccine Covid-19 Pfizer Biontech was unknown. The status of OFEV is unknown.   The reporter did not provide a causal assessment for events Atrial fibrillation, COVID-19, Diarrheas recurrent, Voicelessness, Multiple allergies, Upset stomach, Seasonal allergy, General body pain, Sneezing, Common cold, Runny nose, Sore throat, dry skin, Skin winkling, Swelling of legs, Tiredness, Vomiting, GERO, irritable bowel syndrome, Feeling abnormal. Hypertension, Heart rate increased and Increased blood pressure. The reporter considered there was a reasonable causal relationship between therapy vaccine Covid-19 Pfizer BioNTech and event throwing up. For regulatory reporting purposes, (withheld) considers that there was a reasonable causal association between OFEV therapy and the events Diarrhea recurrent, Upset stomach, Vomiting, Hypertension and Increased blood pressure.   For regulatory reporting purposes, (withheld) considers that there was no reasonable causal association below OFEV therapy and the events Atrial fibrillation, COVID-19, Voicelessness, Multiple allergies, Seasonal allergy, General body pain, Sneezing. Common cold, Runny nose, Sore throat, Dry skin, Skin wrinkling, Swelling of legs, Tiredness, GERD. Irritable bowel syndrome, feeling abnormal and Heart rate increased.  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 provided, and a temporal association, a causal association between reported events and suspect BNT162B2 cannot be excluded.