Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Eosinophil count increased, Haemoglobin normal, Inflammation, Injection site oedema, Injection site pain
Clinical narrative: Seriousness criteria: Medically significant. Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from other health care professional via Health Authorities (under reference: 277449). This case involves a 52 years old male patient who experienced type III immune complex mediated reaction, mean cell volume abnormal, biopsy skin abnormal, blister, blood uric acid, complement factor abnormal, eosinophil count, dysaesthesia, eosinophil count increased, haemoglobin normal, inflammation, injection site oedema, injection site pain, lichenoid keratosis, lymphocyte count, skin lesion, musculoskeletal pain, monocyte count increased, neck pain, neutrophil count, paraesthesia, platelet count normal, radiculitis brachial, rash papular, skin lesion, skin lesion, vasculitis, white blood cell count normal, mean cell haemoglobin concentration and mean cell haemoglobin normal, while he received vaccine ADACEL. Patient denied any medical history. Medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included- Allopurinol, Pravastatin. On 03-Apr-2007, the patient received a dose of suspect ADACEL (lot: number not reported) via unknown route in unknown administration site. On 09-Apr-2007, the patient developed a serious type III immune complex mediated reaction six days following the administration of ADACEL. This event was assessed as medically significant. On 09-Apr-2007, the patient developed a non-serious type III immune complex mediated reaction, mean cell volume abnormal, biopsy skin abnormal, blister, blood uric acid, complement factor abnormal, eosinophil count, dysaesthesia, eosinophil count increased, haemoglobin normal, inflammation, injection site oedema, injection site pain, lichenoid keratosis, lymphocyte count, skin lesion, musculoskeletal pain, monocyte count increased, neck pain, neutrophil count, paraesthesia, platelet count normal, radiculitis brachial, rash papular, skin lesion, skin lesion, vasculitis, white blood cell count normal, mean cell haemoglobin concentration and mean cell haemoglobin normal six days following the administration of ADACEL. (Other relevant tests included: lab data not reported.) Final diagnosis was mean cell haemoglobin normal, mean cell haemoglobin concentration, white blood cell count normal, vasculitis, skin lesion, skin lesion, rash papular, radiculitis brachial, platelet count normal, paraesthesia, neutrophil count, neck pain, monocyte count increased, musculoskeletal pain, skin lesion, lymphocyte count, lichenoid keratosis, injection site pain, injection site oedema, inflammation, haemoglobin normal, eosinophil count increased, dysaesthesia, eosinophil count, complement factor abnormal, blood uric acid, blister, biopsy skin abnormal, mean cell volume abnormal and type iii immune complex mediated reaction. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for all the events. List of document held by sender: none. Sender's Comments: This case concerns an adult patient who presented with Arthus reaction and multitude of laboratory abnormalities after vaccination. The time to onset is compatible. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.