Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Malaise, Syncope
Clinical narrative: Initial unsolicited report received from a nurse manager via other compnay (Pfizer) (under reference number-2016410867) on 07-Sep-2016. This case involves a 16-year-old female patient, who was vaccinated with one injection of MENACTRA via intramuscular route (batch number, expiry date, dose and site of administration not reported), one 0.5 ml first injection of TRUMENBA via intramuscular route (manufacturer: pfizer) (batch number, expiry date and site of administration not reported) and one injection of GARDASIL via intramuscular route (batch number, expiry date, dose and site of administration not reported) on Aug-2016 (date unspecified, reported as last Thursday). Patient's medical history and concomitant medications were not reported. On an unspecified date in Aug-2016, following the vaccination, the patient was fainting and later did not feel well and was taken to hospital. The reporter did not know if the patient had been admitted to the hospital or not. Patient required emergency room visit. Lab test and concomitant medication was not reported. Outcome of the events were reported as unknown. It was also reporter that " patient originally fainted and later felt better". Documents held by sender: none. Follow-up information received from a nurse manager via other company (Pfizer) (under reference number-2016410867) on 30-Sep-2016. This case involves a 17-year-old female patient, who was vaccinated with second dose of MENACTRA via intramuscular route (batch number: U5392AA), one 0.5 ml first dose of TRUMENBA via intramuscular route (batch number: M77282, expiry date: 30-Jun-2017) in left arm and third dose of GARDASIL via intramuscular route (batch number: M013636), in left arm on 26-Aug-2016 at 12:50. The patient's medical history included anemia from 2012 to 2014, diarrhea for 2 weeks and on an unspecified date she also had dizzy spells which is still ongoing. On 27-Aug-2016, one day post vaccination patient had seizure, headache and weakness. The patient was previously vaccinated with one dose of MENACTRA and second dose of GARDASIL on an unspecified date. The patient was hospitalized for 2 days (unspecified date). Culture and other diagnostic test - cerebro-spinal fluid culture and blood culture tests were negatives. On 27 August 2016: X ray chest Portable; Clinical Indication: Pneumonia; Findings: The heart is normal in size. There is no pleural fluid. Impression: Normal heart size and there is no pneumonia. On 27 August 2016: CT examination of the head without contrast; Clinical Indication: Meningitis. Dose information: estimated dose for this examination in total is DLP 791 mGy-cm. Multidetector sections were obtained from the base of the skull through the vertex. This was performed without IV contrast administration. Findings: there is no hemorrhage present. There is no infarct present. The ventricular system and sulci are unremarkable. The visualized sinuses are unremarkable. Impression: normal CT examination of the head. On 27 August 2016: Throat screen for Streptococcus Group A has done. Result: Negative On 27 Aug AT 14:08, Hematology CBC/differential: white blood cell 8.3x 10(3/mcL), red blood cell, 4.11X10(6)/mcL, Hemoglobin: 12.3gm/dl, Hematocrit: 36.8%, Mean Corpuscular Volume: 90FL, Mean Corpuscular Hemoglobin: 30PG, Platelet count: 174%, Mean platelet volume: 11.4FL, Neutrophils Auto% 77.8%, lymphocytes auto% 10.6%, monocytes auto% 0.2%, basophil auto% 0.2%, Neutrophils Abs 6.4x 10(3)/mcl, Lymp abs 0.9x10(3)/mcl, mono abs 0.9x 10(3)/mcl, Eosinophils Abs 0.0 x 10(3)/mcl, Basophils Abs 0.0x 10(3)/mcl. 27 August 2016 at 14:08, General chemistry: Lactic acid: 1.1 mmol/L Routine chemistry: Glucose 90 mg/dL, blood urea nitrogen BUN: 6 mg/dL, Creatinine: 0.6 mg/dl, blood urea nitrogen BUN/creat ratio: 10, Sodium: 138 mmol/L, Potassium: 3.6 mmol/L, Chloride: 107 mmol/l Calcium: 8.3 mg.dl, Total protein: 7.4 mg/dl Albumin: 3.9 gm/dl Bilirubin total: 0.7 mg/dl, Alanine aminotransferase ALT: 20 unit/l Alkaline phosphate: 75 unit/L, aspartate aminotransferases: 13 unit/L Beta HCG (human chorionic gonadotropin test): <1 On 27 August 2016 at 14:08 Cardiac test: Total Creatine kinase 80 unit/L and (CK), C-reactive protein: 23.600 mg/L. 27 August 2016 at 15:05: urine analysis Color: Yellow Appear: Clear PH: 6.0 Specific gravity: 1.010 Glucose: Negative ketones: 16 mg/dL Urobilinogen: 0.2 IU/dL Blood: moderate Protein: negative Nitrite: Negative WBC: 0-2/ HPF RBC: 10 to 15 / HPF Squamous epithelial: 6-10/ HPF. On an 27 August 2016 at 16:11 the infectious Lyme disease was reported as less than 0.75. On 27 August 2016 at 16:12 Body fluid analysis: Color CSF: Colorless Clarity CSf: Clear GLucose CSF: 60 mg/dl protein CSF: 21.0 mg/dl RBC CSF: 1 /cubic mm WBC CSF: 0/ cubic mm Supernatant: Colorless. The outcome of the events were reported as recovering. The reporter assessed the causal relationship with suspect vaccine as possible. Sender's Comments: Follow-up received on 30-SEP-2016, case upgraded to serious as patient was hospitalized. A 16 years old experienced seizure, Syncope, Feeling unwell, Weakness and Headache after vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE (meningococcal group B vaccine) and HUMAN PAPILLOMA VIRUS VACCINE. Time to onset is compatible with the role of vaccine. Also reported that CFS culture and BLOOD culture was negative. Details regarding relevant medical history, concurrent condition, concomitant medication, previous medical history are needed for complete assessment of the case. As three vaccines administered simultaneously, the role of each component cannot be assessed.