Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Red blood cell sedimentation rate normal, Splenomegaly, Stool analysis, Thrombocytopenia
Clinical narrative: Hepatosplenomegaly neutropenic; Hepato splenomegaly neutropenic; Thrombocytopenia immunocompromised; Thrombocytopenia immunocompromised; Patient developed adenitis; Patient developed splenomegaly autoimmune; Autoimmune dysfuction; This spontaneous report was identified from a line listing obtained on request by the Company from the FDA (Agency number 816350) under the Freedom of Information Act and refers to a13-year-old male patient. It was reported that the patient had an allergy to amoxicillin (AMOXIL). The patient had no concomitant medications, other illness at the time of vaccination and up to one month prior, nor chronic or long-standing health conditions.  On an unknown day in September 2016, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dosage form as prophylaxis (concentration,frequency of vaccination scheme, route and anatomical location of vaccination, lot number, and expiry date were not reported).  On an unknown day in October 2016, the patient developed adenitis (lymphadenitis) and splenomegaly with an autoimmune dysfunction (splenomegaly and autoimmune disorder). Laboratories were performed; however, the results were not provided.  At the time of this report, the patient had not recovered from the events.   The causal relationship between the vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the occurrence of the events was not reported.  The reporter considered that these events had caused disability or permanent damage.  Follow-up information has been received from a staff nurse on 13-FEB-2020.  The patient's historical vaccines included Hib conj vaccine (OMPC), hepatitis B virus vaccine rHBsAg (yeast) (COMVAX), diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (DTP/DTAP), hepatitis A virus vaccine (unspecified) (HEP A), influenza virus split virion 3v vaccine inactivated (INFLUENZA trivalent-3 &up), influenza virus 3v reassortant vaccine live intranasal (cold adapted Ann Arbor m (INFLUENZA trivalent nasal), diphtheria toxoid,pertussis acellular 3-component vaccine poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX), measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3) (MMR), pneumococcal conj vaccine (unspecified) (PNEUMOCOCCAL 7-child), poliovirus vaccine inactivated (unspecified) (POLIO/IPV) and varicella virus vaccine live (unspecified). Concomitant therapies included diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (DPT/TDAP), influenza virus split virion 4v vaccine inactivated (INFLUENZA QUADRIVALENT) and meningococcal vaccine (unspecified).  On 21-JUN-2016, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL-9) (lot # L018351 and expiry date: 11-AUG-2017) at a dose of 0.5 milliliter in the right deltoid for prophylaxis. On 26-SEP-2016, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL-9) (lot # M023169 and expiry date: 13-JUN-2018) at a dose of 0.5 milliliter in the left arm for prophylaxis.  On 22-NOV-2016, the patient experienced thrombocytopenia immunocompromised and hepato-splenomegaly neutropenic. On an unknown date in 2016, the patient's sed (sedimentation) rate was shown as 1. The patient's chest X-ray was negative.  On unknown dates, the patient underwent multiple CBCs (complete blood count), CMP (comprehensive metabolic panel), lipid panels, stool studies, CRP (C-reactive protein), CK (creatine kinase), PTT (partial thromboplastin time), PT (prothrombin time), EBV (Epstein-Barr virus) titers (results were not reported). No etiology ever discovered, and patient eventually evaluated and treated with immunosuppressants at hospital.  The patient was off immunosuppressants in the summer of 2019.  The outcome of the events was reported as not recovered. The causality of the events was considered as not related, as it was reported that, the events were not attributable to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL-9).  The reporter considered the events thrombocytopenia immuno-compromised and hepato-splenomegaly neutropenic to be medically significant.