Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immune thrombocytopenic purpura, Metabolic function test normal, Peripheral swelling, Platelet count decreased, Pruritus
Clinical narrative: Differential white blood cell count normal; Metabolic function test normal; Platelet count decreased; Ultrasound scan normal; Pruritus; Rash; Rash erythematous; Skin warm; Peripheral swelling; Injection site reaction; Limb discomfort; Erythema; Full blood count normal; Immune thrombocytopenic purpura; Haemoglobin normal; This report was identified from a line listing obtained on request by the Company from the FDA under the Act, concerning a 12-year-old female patient (HA# 728733). Information regarding her medical history, concurrent illnesses, prior vaccinations and other medications was not provided.   On 19-MAY-2016, the patient was vaccinated intramuscularly in the left arm with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # L036245, expiration date 09-FEB-2018 (exact dose was not reported) for prophylaxis; subcutaneously in left arm with a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # U5244AA (exact dose and expiration date were not provided) and intramuscularly in the right arm with a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) lot # U5216AA (exact dose and expiration date were not reported).   On the same date, a few hours after receiving the vaccinations, the patient developed swelling, erythema, itching, and warmth on left arm. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care was sought at local emergency room (ER) and the patient was hospitalized on an unknown date. The following tests were performed on 20-MAY-2016: ultrasound of arm, which did not show fluid accumulation, platelet level was 7000/microliter and 4000/microliter (later that day), hemoglobin and white blood cell count with differential were within normal limits and basic metabolic panel was unremarkable. Full blood count was normal in approximately 2016. The patient was prescribed the following medications: cephalexin (500 mg every 12 hours for 7 days), hydroxyzine (25 mg every 8 hours for 5 days), prednisone (20 mg once daily for 5 days). Left arm showed improvement after initiation of above therapy. Meanwhile, the patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. The patient continued cephalexin but held prednisone  and hydroxyzine. Subsequently, on an unknown date in about 2016, she was diagnosed with idiopathic thrombocytopenic purpura (ITP). The outcome of the events were reported as not recovered.   There was a concern that vaccines precipitated/caused ITP in this patient. The causality assessment between the other events and the suspected vaccines was not provided.  Follow-up information has been received from a healthcare professional via an Agency (HA# 728733) on 19-JUN-2019. The previously reported events required a doctor or another healthcare professional office/clinic visit and caused hospitalization for one day. The reporter considered the side effects to be important medical events.  As of 25-SEP-2019, the physician was not available. The receptionist was unable to locate the patient. Additional information had been requested.