Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: International normalised ratio normal, Melaena, Metabolic function test abnormal, Thrombosis, Vomiting
Clinical narrative: Vomiting bright red blood and clots on early AM 8/25; develop melena; Thrombosis; Vomited on day following vaccines (8/22) improved some within 2 days then vomiting bright red blood and clots on early AM 8/25, progressed to coffee ground emesis by 8am 8/25; Aspartate aminotransferase increased; Metabolic function test abnormal; Gastrointestinal pathogen panel; Abdominal X-Ray; Admitted on 8/25, endoscopy done and no source of bleeding; White blood cell count normal; X-Ray normal; International normalised ratio normal; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2683641-1. The original narrative from the sender is as follows:  Vomited on day following vaccines (8/22) improved some within 2 days then vomiting bright red blood and clots on early AM 8/25, progressed to coffee ground emesis by 8am 8/25 and then developed melena. Admitted on 8/25, endoscopy done and no source of bleeding. Resolved within 1-2 days, discharged on 8/30.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events Vomiting, Haematemesis, Melaena, and Thrombosis. The causal relationship between Vaxelis and the reported events Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-Ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-Ray normal, and International normalised ratio normal was assessed as not applicable, due to the nature of these events.  No further information is expected.  COMPANY COMMENT:  Vomiting, Haematemesis, Melaena, and Thrombosis were assessed as serious due to hospitalization, whereas Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal,  and International normalised ratio normal  were assessed as non-serious.  Vomiting is listed, whereas Haematemesis, Melaena, Thrombosis, Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal,  and International normalised ratio normal are unlisted for Vaxelis as per the Reference Safety Information.  Considering the current knowledge on Vaxelis (Vomiting is listed as per Regulatory Authority safety information) and the onset latency (events occurred 1 day after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history of adverse events after the first vaccination with Vaxelis), the causal relationship between Vaxelis and the reported events Vomiting, Haematemesis, Melaena, and Thrombosis cannot be excluded and is assessed as related.  The causal relationship between Vaxelis and the events  Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal,  and International normalised ratio normal was assessed as not applicable, due to the nature of these events.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Vomiting, Haematemesis, Melaena, and Thrombosis were assessed as serious due to hospitalization, whereas Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal,  and International normalised ratio normal  were assessed as non-serious.  Vomiting is listed, whereas Haematemesis, Melaena, Thrombosis, Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal,  and International normalised ratio normal are unlisted for Vaxelis as per the Reference Safety Information.  Considering the current knowledge on Vaxelis (Vomiting is listed as per Regulatory Authority safety information) and the onset latency (events occurred 1 day after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history of adverse events after the first vaccination with Vaxelis), the causal relationship between Vaxelis and the reported events Vomiting, Haematemesis, Melaena, and Thrombosis cannot be excluded and is assessed as related.  The causal relationship between Vaxelis and the events  Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal,  and International normalised ratio normal was assessed as not applicable, due to the nature of these events.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.