Sex: M
Vaccine: FLUX
Symptoms: Immunology test, Incorrect route of product administration, Leukocytosis, Liver function test normal, Malaise
Clinical narrative: Initial unsolicited valid serious case report received from a literature full article on 21-Nov-2018. The following is verbatim from the article: A 19-year-old patient who mistakenly received two doses of influenza vaccine 10 days before presentation, was admitted with malaise, weakness, and a purpuric non-blanching rash most prominent on the ankles followed by abdominal pain and hematochezia 72 h later. The diagnosis of influenza vaccine related Henoch Schonlein vasculitis was made. This complication, although rare, is the most common vasculitis related to immunization. This case involves a 19 years old male patient who experienced IgA vasculitis or henoch-schonlein purpura (HSP), left scrotal pain, palpable non-blanching purpuric rash on the calves, knees and elbows (but most prominent on the ankles), dry cough, rhinorrhea, diffuse myalgia, abdominal pain, headache, hematochezia, vomiting, bloody diarrhea, testicular ultrasound showed mild varicocele, thickening of the ascending colon walls, gastrointestinal bleeding and influenza vaccine which was administered twice in the same day; the initial dose was mistakenly administered subdermally, with an additional dose given intramuscularly, while he received vaccine Influenza Vaccine. The patient's past vaccination(s) and family history were not provided. He only referred severe seasonal allergies as relevant past medical history. On an unknown date, the patient received a first dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via sub dermal route in unknown administration site and second dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site. On an unknown date, the patient experienced a serious IgA vasculitis or Henoch Schonlein Purpura (HSP), left scrotal pain (scrotal pain), abdominal pain, hematochezia, bloody diarrhea (Diarrhoea haemorrhagic), testicular ultrasound showed mild varicocele (varicocele), gastrointestinal bleeding (Gastrointestinal haemorrhage) and thickening of the ascending colon walls (Gastrointestinal wall thickening) following the administration of Influenza Vaccine. The patient was hospitalized for these events. On an unknown date, two days post vaccination patient developed dry cough, rhinorrhea, diffuse myalgia (myalgia) and malaise. The patient was hospitalized for these events. On an unknown date, ten days post vaccination patient developed palpable non-blanching purpuric rash on the calves, knees and elbows (but most prominent on the ankles) (purpura), vomiting, headache and weakness. The patient was hospitalized for these events. Patient was also presented to emergency room. It was actual medication error due to Extra dose administered and Inappropriate route of vaccination as influenza vaccine which was administered twice in the same day the initial dose was mistakenly administered subdermally, with an additional dose given intramuscularly. Other relevant tests included was leukocytosis (11,500 WBC/ L) with 80 percent neutrophils and normal platelet counts (232,000 platelets/ L). Urinalysis, creatinine and liver function tests were within normal limits, C-reactive protein was 7.4 mg/dL (reference 3 mg/dL). A respiratory viral panel, HIV ELISA, RPR, HBsAg and HCV antibodies were negative. Both chest X-ray and CSF analyses showed no abnormalities, C3 and C4 levels were decreased but the rest of the rheumatologic panel (anti ds DNA, Anti-Ro, Anti-La, Anti-SM, Anti-RMP and anti neutrophil cytoplasmic antibodies) was negative, testicular ultrasound showed mild varicocele and an abdominal CT scan showed thickening of the ascending colon walls. Final diagnosis was vomiting, bloody diarrhea, headache, abdominal pain, diffuse myalgia, rhinorrhea, dry cough, palpable non-blanching purpuric rash on the calves, knees and elbows (but most prominent on the ankles), left scrotal pain, testicular ultrasound showed mild varicocele, gastrointestinal bleeding, hematochezia and IgA vasculitis or Henoch Schonlein Purpura (HSP). The patient received symptomatic pain management, along with one dose of intravenous methyl-prednisolone, followed by three additional doses of oral prednisone when the gastrointestinal bleeding resolved. He was discharged once the oral corticosteroid regimen was completed, as there was no recurrence of the gastrointestinal bleeding. The rest of the symptoms resolved within two weeks after hospital admission. At six months of follow up, the patient did not have any recurrence and never developed kidney dysfunction. HSP associated with influenza vaccination usually occur within 21 days after administration and most patients (73 percent) are younger than 17 years old. The patient was recovered from the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: This case involves a 19 years old male patient who experienced IgA vasculitis or Henoch-Schonlein Purpura, palpable non-blanching purpuric rash on the calves, knees and elbows, dry cough, rhinorrhea, diffuse myalgia, abdominal pain, headache, hematochezia, vomiting, bloody diarrhea, left scrotal pain, testicular ultrasound showed mild varicocele, thickening of the ascending colon walls, gastrointestinal bleeding post vaccination with Influenza Vaccine produced by unknown manufacturer. Moreover, patient received two doses in same day. Time to onset is compatible. More details regarding patient's medical history, condition at the time of vaccination, lab test ruling out alternate infectious etiologies are needed for complete assessment. Based upon available information, role of vaccine can not be assessed.