Age: 89.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Full blood count abnormal, Hypersensitivity vasculitis, Imaging procedure, Palpable purpura, Pancytopenia
Clinical narrative: Initial unsolicited report received from the literature on 29 Aug 2016. The following is verbatim from the article: Abstract: An 89-year-old woman with well-controlled diabetes mellitus and hypertension presented with a 3-day history of a pruritic eruption on the legs. On examination, she had nonblanching erythematous to-violaceous macules that coalesced into patches, in addition to palpable purpura, on the bilateral lower extremities. She otherwise felt well and denied fever, chills, dysuria, nausea, vomiting, abdominal pain, or upper respiratory symptoms. She denied taking new medications. Biopsy findings from a purpuric papule on the thigh were consistent with leukocytoclastic vasculitis. Complete blood count showed mild anemia and thrombocytopenia. Urinalysis result was within normal limits. Without an obvious infection or medication trigger, the patient's history of paraproteinemia was suspected as a possible inciting factor. The hematology department determined that there was a possibility of lymphoma; however, the patient was otherwise asymptomatic and elected to monitor rather than intervene. Five days after initial presentation, the eruption was markedly improved, with predominantly postinflammatory hyperpigmentation remaining. Complete resolution occurred within 3 weeks. One year later, the patient presented with a recurrence of scattered erythematous nonblanching macules and palpable purpura on the bilateral lower extremities. Similar to the previous episode, review of systems was otherwise negative. She denied taking new medications or having recent infection. Complete blood count showed mild pancytopenia. Urinalysis result was within normal limits. During the interim, the patient had undergone radiologic imaging and had no evidence of a clinically significant lymphoma. Chart review revealed that the patient had received the influenza vaccine 11 days before the onset of the current eruption. Upon further investigation, it was discovered that the patient also received the influenza vaccine 11 days before the onset of the initial eruption 1 year before. The final diagnosis was suspected to be LCV secondary to the influenza vaccine, given the identical onset of the episodes 11 days after vaccination and complete resolution between the 2 exposures. The patient was counseled to avoid the influenza vaccine next year. This case involves an 89 year old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, dose and dose in series, route and site of administration was not reported) on an unspecified date. The patient had a medical history of well-controlled diabetes, hypertension, paraproteinemia, initial pruritic eruption that had occurred 11 days after receiving influenza vaccine the previous year. Also Five days after initial presentation of eruption, there was a predominantly post inflammatory hyperpigmentation. The patient had received Influenza vaccine 1 year before current vaccination. The patient denied taking any concomitant medications. On an unspecified date, 11 days following vaccination, the patient had pruritic eruption on the legs, nonblanching erythematous-to-violaceous macules that coalesced into patches, in addition to palpable purpura, on the bilateral lower extremities and mild pancytopenia. On unknown date after vaccination, the patient had Mild anemia, thrombocytopenia and a possibility of lymphoma. The patient was diagnosed with suspected to be LCV (Leukocytoclastic vasculitis) secondary to the influenza vaccine  Lab data included electromyography: Urinalysis result within normal limits, Biopsy findings from a purpuric papule on the thigh were consistent with leukocytoclastic vasculitis, Complete blood count that showed mild anemia and thrombocytopenia and radiologic imaging that showed no evidence of a clinically significant lymphoma. Complete blood count showed mild pancytopenia. The patient had not received any corrective treatment. The event suspected to be LCV secondary to the influenza vaccine was resolved on unspecified date (within 3 weeks) and outcome of the events, mild anemia and thrombocytopenia was unknown. Upon internal review, the company decided to consider the event as serious because of important medical event Leukocytoclastic vasculitis, lymphoma, thrombocytopenia. Documents held by sender: none. Sender's Comments: This case concerns an 89 years old female patient who received INFLUENZA VACCINE and after 11 days of vaccination developed Leukocytoclastic vasculitis. Possibility of lymphoma was considered, however she had no evidence of a clinically significant lymphoma upon radiological imaging studies. Patient had a history of paraproteinemia which could have made the patient more susceptible to the eruptions. However, time to onset of event was compatible with administration of influenza vaccine. Also, similar events were reported on the subsequent vaccination of Influenza vaccine. Based on the available information, the contributory role of the vaccine cannot be excluded.