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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD [MFR # FR-1577272925-E2015-02581] on 18-MAR-2015. Case received from the Health Authorities on 13-Mar-2015 under reference number GR20150001. A 13 year-old female patient with no medical history nor concomitant medication had received the first and only dose of GARDASIL (batch number unknown) via intramuscular route on 28-Jul-2013. On 16-Nov-2013 a biological work up showed platelet count at 98 G/l and neutrophil count at 0.8 G/l. Further regular work up showed neutrophil count fluctuating between 0.66 and 1.7 G/l and platelet count between 50 and 120 G/l. On 25-Jan-2014 platelet count was at 51 G/l and neutrophil count was at 1.7 G/l. Differential diagnosis work up showed normal myelogram with regeneration of bone marrow. Autoimmune work up showed positive anti-neutrophil antibodies, slightly positive antineutrophil cytoplasmic antibodies, negative anti-PR3, anti-MPO and antinuclear antibodies. Coomb test was negative as well as rheumatoid factor. No antiphospholipid syndrome was found. Because of positive ANCA and antineutrophil antibodies, diagnosis of peripheral bicytopenia autoimmune was concluded. On 24-Feb-2014, neutrophils and platelets count were respectively 1.74 and 61 G/l. On 22-Mar-2014 those were 0.67 and 72 G/l. On 7-Jul-2014 those were 3.51 and 61 G/l. Final outcome is not recovered. The Health Authorities assessed the case as serious due to other medically important condition: haematological disorder. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as C2 S1 L1 according to the method of assessment.
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