Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, International normalised ratio increased, Mouth haemorrhage, Platelet count decreased, Prothrombin time prolonged
Clinical narrative: This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a 53-year-old male subject who received Flu seasonal TIV Dresden. Co-suspect products included COUMADIN for an unknown indication, clopidogrel for an unknown indication and Acetyl Salicylic Acid for an unknown indication. Previously administered products included Levofloxacin with an associated reaction of urticaria. Concurrent medical conditions included diabetes mellitus, hypertension, coronary artery disease (with LAD stent in May 2007), coronary arterial stent insertion (LAD stent for Coronary artery disease), congestive heart failure, atrial fibrillation, obesity, diastolic dysfunction (ejection fraction of 45%), obstructive sleep apnea syndrome, chronic bronchitis, diabetic retinitis, diabetic neuropathy, right below knee amputation, Abdominal soreness for 2-3 months and seasonal allergies. On 7th December 2007, 13 days after receiving Flu seasonal TIV Dresden, the subject developed idiopathic thrombocytopenic purpura. Serious criteria included hospitalization, GSK medically significant and other: serious per reporter. Additional event(s) included coagulopathy on 7th December 2007 with serious criteria hospitalization and other: serious per reporter, ear hemorrhage on 7th December 2007 with serious criteria of hospitalization and other: Serious per reporter, epistaxis on 7th December 2007 with serious criteria of hospitalization and other: Serious per reporter, injection site hemorrhage on 7th December 2007 with serious criteria of hospitalization and other: Serious per reporter, mouth hemorrhage on 7th December 2007 with serious criteria of hospitalization and other: Serious per reporter and drug interaction. The outcome of idiopathic thrombocytopenic purpura was recovered/resolved. The outcome(s) of the additional event(s) included coagulopathy (recovered/resolved), ear hemorrhage (recovered/resolved), epistaxis (recovered/resolved), injection site hemorrhage (recovered/resolved), mouth hemorrhage (recovered/resolved) and drug interaction (unknown). It was unknown if the investigator considered the idiopathic thrombocytopenic purpura, coagulopathy, ear hemorrhage, epistaxis, injection site hemorrhage and mouth hemorrhage to be related to Flu seasonal TIV Dresden. Diagnostic results (unless otherwise stated normal values were not provided): On 10th December 2007, International normalised ratio result was 5 unknown, Platelet count result was less than 5 unknown and Prothrombin time result was 46.4 unknown. On 15th December 2007, International normalised ratio result was 1.1 unknown, Platelet count result was 7000 unknown, Prothrombin time result was 62.6 unknown and Prothrombin time result was 91 unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of Idiopathic thrombocytopenic purpura and COUMADIN coagulopathy in a 53-year-old male who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The corresponding Vaccine Adverse Event Reporting System (VAERS) ID is 311750. The patient was part of the study in which authors collected Adverse Event Following Immunization (AEFI) reports submitted to VAERS from July 1990 to April, 2016 and database from December 2009 to August 2016 for individuals receiving all available types of vaccines against the influenza virus recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. haemorrhages, overdosage and rhabdomyolysis, respectively). The authors applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. The patient's pre-existing and concurrent condition included hives after levofloxacin, atrial fibrillation, coronary artery disease with LAD stent placed in May 2007, Congestive heart failure (CHF), diabetes mellitus, hypertension and obesity, diastolic dysfunction and ejection fraction of 45%, obstructive sleep apnoea, chronic bronchitis, seasonal allergies, diabetic retinitis and neuropathy and right below the knee amputation. The patient had abdominal soreness for 2-3 months. No information on patient's family history was provided. The patient's co-suspect medication included COUMADIN. The other medications: clopidogrel and aspirin were considered under pharmacodynamic drug interactions. On 24th November 2007, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On 7 December 2007, 13 days after vaccination, the patient developed bruises on skin and bumps at the insulin injection site, bleeding from mouth, nose, ears and insulin injection sites. 3 days later, the patient presented to the emergency department and hospitalised with above symptoms. At the time of presentation, the International normalised ratio (INR) was found to be 5, prothrombin time was 46.4 and the Platelet count was less than 5 (units and normal range not provided for all), The prothrombin time was later found to 62.6 and platelets were 7000 (units and normal range not provided for all). 5 days after admission, platelets increased to 91 and INR decreased to 1.1 (units and normal range not provided for all). The patient was diagnosed with idiopathic thrombocytopenic purpura and COUMADIN coagulopathy. The patient was discharged after 5 days. The outcome of events was recovered. This case has been considered serious due to hospitalisation/as per author. The reporter considered the causality assessment as Indeterminate. [In this study, 'Cases without adequate information were classified as unclassifiable; cases with adequate information were categorized as 'consistent with a causal relationship' when the available evidence supported a causal relationship between the vaccine and the AEFI in the individual but it did not rule out the possibility that the AEFI may have been caused by a factor other than the vaccine, 'inconsistent with a causal association' when the available evidence did not support a causal relationship between vaccine administration and the reported AEFI in the individual, 'indeterminate' when the temporal relationship was consistent but the available evidence insufficient to support or rule out a causal relationship in the individual]. The author considered the drug-vaccine interaction as possible. [In this study, to assess the likelihood of interaction, we used a published and validated algorithm to assess drug-drug interactions (DDIs), known as Drug Interaction Probability Scale (DIPS), a 10-item tool specifically developed to assess the likelihood of DDIs. Higher total scores correspond to higher likelihood of drug-vaccine interaction (i.e. more than 8 equal to Highly Probable; 5-8 equal to Probable; 2-4 equal to Possible; less than 2 equal to doubtful). The authors concluded "The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza which is thus to be recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful". This is 1 of the 11 valid cases reported in the same literature article.