Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood urine, Cholelithiasis
Clinical narrative: Cholelithiasis;   This is a non-Pfizer sponsored interventional study report from License Party for protocol BNT162-17. Other Case identifier(s): US-BNTAG-1630.  Initial information received on 16-Jan-2023: This is a serious case of cholelithiasis (MedDRA PT: cholelithiasis) from clinical trial BNT162-17. A 40-year-old female subject received booster injection with BNT162b2 (BNT162b2) on 28-Jul-2022 with a dose of 30 mcg for SARS-CoV-2 vaccination. Previously, the patient had received three injections of 30 mcg Comirnaty (BNT162b2) on 03-Mar-2021, 24-Mar-2021 and 29-Oct-2021 prior to the booster injection 113 days after booster vaccination with BNT162b2 the patient experienced cholelithiasis (cholelithiasis) on 18-Nov-2022. This case is serious due to inpatient hospitalisation. Relevant medical history includes overweight since 2000, gallstones, headaches since 2012 and environmental allergies since 2021. Relevant past medical history includes abortion in 2006. Relevant concomitant medication includes Ibuprofen (ibuprofen) for headaches and Diphenhydramine (diphenhydramine) for environmental allergies. On 18-Nov-2022 the subject developed mild abdominal pain (abdominal pain) which turned into severe abdominal pain on 20-Nov-2022. The woman went to her primary care physician (PCP) on 20-Nov-2022 at which time her PCP instructed her to go to the hospital. The subject was admitted to the hospital on 20-Nov-2022 and was diagnosed with cholelithiasis (cholelithiasis) of severe intensity (FDA Guidance). The patient underwent cholecystectomy on 21-Nov-2022 and was discharged from the hospital on same day (21-Nov-2022). Since 21-Nov-2022 she was treated with Oxycodone (oxycodone) (oral, 5 mg PRN, until 22-Nov-2022), Ibuprofen (ibuprofen) (oral, 400 mg PRN, until 28-Nov-2022) and Acetaminophen (paracetamol) (oral, 500 mg PRN, until 28-Nov-2022) for pain prophylaxis after cholelithiasis. The investigator became aware of the event on 16-Jan-2023. The investigator considers gallstones to be suspected cause of the event. At the time of reporting, the event has resolved with date of 21-Nov-2022. No further information is available at that time. Additional information has been requested.  BioNTech SE comment: The reporting investigator considers the event cholelithiasis to be serious due to inpatient hospitalisation. The sponsor agrees to the investigator's assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (BNT162b2). The sponsor agrees to the investigator's assessment. In accordance with the sponsor's SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. Temporal relationship between the occurrence of the event and the administration of the study drug is not plausible since the event occurred 113 days after last vaccination. The investigator attributed the event to patient's gallstones presenting a plausible alternative explanation. The benefit-risk profile of Multivalent BNT162b2 (BNT162b2) is not affected by this event and no change in the reference safety information is required at that time.  Both investigator and BioNTech SE considered there was not a reasonable possibility that the event "Cholelithiasis" was related to BNT162b2.  Comirnaty is under agreement with BioNTech SE.  Follow-up (02Feb2023): This is a non-Pfizer sponsored interventional study follow-up report from License Party (Biontech SE) for protocol BNT162-17. Other Case identifier(s): 2023FOS000072, US-BNTAG-1630 .  Follow-up information received on 02-Feb-2023/03-Feb-2023/06-Feb-2023 (FU#1): The investigator provided updates to dates based on the medical records. The subject developed mild abdominal pain on 18-Nov-2022, which became severe on 21-Nov-2022 and she was instructed to go to hospital by primary care physician (PCP). She was admitted on 21-Nov-2022 and diagnosed with cholelithiasis. The patient had elevated alkaline phosphatase (235 U/L), elevated alanine aminotransferase (1,390 U/L), and elevated aspartate aminotransferase (557 U/L), trace protein in urine, and 2+ blood in urine on 21-Nov-2022. Per medical records received on 02-Feb-2023, ultrasound was performed on 21-Nov-2022 revealing gallstones in the gallbladder. Abdominal MRI without and with contrast showed gallstones on 22-Nov-2022. Cholecystectomy was performed on 22-Nov-2022. The patient was treated with Oxycodone (oral, 5 mg PRN) from 22-Nov-2022 until 23-Nov-2022, Ibuprofen (oral, 400 mg PRN) from 22-Nov-2022until 28-Nov-2022, and Acetaminophen (oral, 500 mg PRN) from 22-Nov-2022until 28-Nov-2022. The patient was discharged on 22-Nov-2022. Following reconciliation request action taken with study drug was updated to dose not changed (still retain not applicable). At the time of reporting, the event has resolved with date of 22-Nov-2022. No further information has been requested.   Biontech comments: The reporting investigator considers the event cholelithiasis to be serious due to inpatient hospitalisation. The sponsor agrees to the investigator assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (BNT162b2). The sponsor agrees to the investigator assessment. In accordance with the sponsor SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. Temporal relationship between the occurrence of the event and the administration of the study drug is not plausible since the event occurred 113 days after last vaccination. The investigator attributed the event to patient gallstones presenting a plausible alternative explanation. The benefit-risk profile of Multivalent BNT162b2 (BNT162b2) is not affected by this event and no change in the reference safety information is required at that time. Medical Re-Assessment after follow-up information received on 02-Feb-2023/03-Feb-2023/06-Feb-2023 (FU#1): The investigator changed the event stop date resulting in a duration of the event of 5 days (previously 4 days) and provided further information on event course, treatment and lab values. The case is still assessed as serious due to inpatient hospitalisation by the reporting investigator and the sponsor. The reporting investigator assessed the event still as not related to the treatment with BNT162b2 (BNT162b2). The sponsor still agrees to the investigators assessment. The new information does not change the sponsor causality assessment, which remains not related. In accordance with the sponsor SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is still not applicable. The benefit-risk profile of BNT162b2 (BNT162b2) is still not affected by this event and no change in the reference safety information is required at that time.   Both investigator and BioNTech SE considered there was not a reasonable possibility that the event "Cholelithiasis" was related to BNT162b2.  BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: BioNTech SE comment: The reporting investigator considers the event cholelithiasis to be serious due to inpatient hospitalisation. The sponsor agrees to the investigator's assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (BNT162b2). The sponsor agrees to the investigator's assessment. In accordance with the sponsor's SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. Temporal relationship between the occurrence of the event and the administration of the study drug is not plausible since the event occurred 113 days after last vaccination. The investigator attributed the event to patient's gallstones presenting a plausible alternative explanation. The benefit-risk profile of Multivalent BNT162b2 (BNT162b2) is not affected by this event and no change in the reference safety information is required at that time.