Sex: M
Vaccine: HEP
Symptoms: Haemoglobin normal, Hepatitis A antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: Aplastic Anemia After Vaccine Administration; Hypocellular marrow with 15% cellularity; diffuse skin lesions; bruises of his extremities; petechiae of oral mucosa; petechiae of the upper and lower extremities; occasional ecchymoses; ITP; This serious case was reported in a literature article and described the occurrence of aplastic anemia in a 25-year-old male patient who received Hepatitis B vaccine for prophylaxis. Literature Reference.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, immediately after receiving Hepatitis B vaccine, the patient experienced aplastic anemia (Verbatim: Aplastic Anemia After Vaccine Administration) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), hypocellular marrow (Verbatim: Hypocellular marrow with 15% cellularity) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), skin lesion (Verbatim: diffuse skin lesions) (serious criteria hospitalization and clinically significant/intervention required), contusion (Verbatim: bruises of his extremities) (serious criteria hospitalization and clinically significant/intervention required), oral mucosal petechiae (Verbatim: petechiae of oral mucosa) (serious criteria hospitalization and clinically significant/intervention required), petechia (Verbatim: petechiae of the upper and lower extremities) (serious criteria hospitalization and clinically significant/intervention required), ecchymosis (Verbatim: occasional ecchymoses) (serious criteria hospitalization and clinically significant/intervention required) and immune thrombocytopenic purpura (Verbatim: ITP) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone and immunoglobulins nos (Immunoglobulin I.V). The outcome of the aplastic anemia, hypocellular marrow, skin lesion, contusion, oral mucosal petechiae, petechia, ecchymosis and immune thrombocytopenic purpura were not reported.   The reporter considered the aplastic anemia, hypocellular marrow, skin lesion, contusion, oral mucosal petechiae, petechia, ecchymosis and immune thrombocytopenic purpura to be related to Hepatitis B vaccine.    The company considered the aplastic anemia, hypocellular marrow, skin lesion, contusion, oral mucosal petechiae, petechia and ecchymosis to be unrelated to Hepatitis B vaccine. The company considered the immune thrombocytopenic purpura to be related to Hepatitis B vaccine.   Additional Information: GSK Receipt Date: 04-JUN-2024 This case refers to the case 1 reported in literature article. The patient was a 25-year-old healthy male who presented to the emergency room with diffuse skin lesions and bruises of his extremities of 24-hr duration. His initial labs showed white blood cell count of 2200/mL, hemoglobin 14.6 g/dL, hematocrit 40percent, and platelet count 4000/mL. He received a booster dose of hepatitis B vaccine 7 days prior to admission. The only positive physical findings were petechiae of oral mucosa and petechiae of the upper and lower extremities with occasional ecchymoses. Liver function test showed Serum Glutamic-Pyruvic Transaminase (SGPT) 747, Serum Glutamic-Oxaloacetic Transaminase (SGOT) 222, bilirubin 0.8, and alkaline phosphatase 49. Follow-up laboratory tests showed decreasing liver function tests over a 2-week period. Initially he received prednisone and IVIG for Immune thrombocytopenia (ITP), but there was no improvement in his counts so on the 4th hospital day, a bone marrow biopsy was performed, which showed hypocellular marrow with 15percent cellularity. The number of megakaryocytes was markedly decreased. The patient was diagnosed with aplastic anemia shortly after receiving immunizations with hepatitis B vaccine (boost). After a month, a repeat bone marrow biopsy was performed which again showed 5percent cellularity. He ultimately received an allogeneic bone marrow transplant. The further work-up showed negative HIV tests. Serologic study for parvovirus, CMV IgM, and ANA was negative. Hepatitis A ab and hepatitis C Ab (HCVPCR), Hepatitis B core Ab, and hepatitis B surface Ag tests were negative. Hepatitis B surface Ab titers were high (greater than 150). A causal relationship between the vaccination and aplastic anemia was supported by close temporal relationship between these events and clinical and laboratory findings. The author hypothesized that an underlying immune predisposition might have enabled the vaccine to trigger the vigorous cytotoxic T lymphocyte response that possibly led to aplastic anemia.; Sender's Comments: Aplastic anaemia, Bone marrow failure, Skin lesion, Contusion, Mouth haemorrhage, Petechiae and  Ecchymosis are unlisted events which are considered unrelated to GSK Hepatitis B vaccine. Immune thrombocytopenia is a listed event which is considered related to GSK Hepatitis B vaccine.