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Life Threatening? No
Write-up: Information has been received from a consumer concerning her 19 year old daughter, who was vaccinated with the first dose of GARDASIL vaccine (date unspecified), and on 13-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. The consumer reported her daughter experienced "pain at the injection site" after the first vaccination. The patient''s mother reported that on 21-MAR-2007, eight days after the second vaccination was administered, her daughter experienced a headache, neck pain, nausea and throat pain, and on approximately 22-MAR-2007, she felt "like her throat is closing up." On 22-MAR-2007 ("this morning"), her daughter felt worse when she woke up and was rushed to the emergency room. At the time of the report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up received from a physician included medical records received from the ER, and indicated that the patient was a college student, with no illness at the time of vaccination. The medical records confirmed concomitant vaccination with inlfuenza virus vaccine (unspecified) and meningococcal vaccine (unspecified), dates not specified (not confirmed by the physician). The ER medical records also indicated that on 22-MAR-2007, the patient presented with symptoms of headache (documented as at the base of the skull), and neck pain, with an original onset date of 21-MAR-2007 (also reported by the physician in follow up, an onset date of 22-MAR-2007). Other symptoms included "body aches," fever, chills, dizziness, weakness, and nausea (without vomiting). Vital signs in the ER included: blood pressure 110/70, pulse 100, respirations 20, and temperature 100.2F. The records documented that "airway/breathing" was within normal limits. Treatment included normal saline (intravenous), phenergan 12.5mg (intravenous), and TYLENOL. A complete blood count revealed the following: neutrophils 86.6%, lymphocytes 9.2%, and neutrophil count 9.3 (units not provided). The clinical impressionof the ER physician was noted as "acute febrile illness." The medical records documented that the patient "felt better" after treatment, and was discharged to home in "stable" condition on 22-MAR-2007. Vital signs at discharge were: BP 115/75, pulse 95, respirations 30, and temperature 99F, discharge instructions included acetaminophen or ibuprofen every 8 hours, and remain off of work/school for the next 2 days. At the time of this report, the physician confirmed that the patient had recovered from the events (date not specified). The follow up information (medical records) received on 09-APR-2007 also contained the following adverse expereinces: potassium low, 3.3 mmol/L (22-MAR-2007); sodium low, 132 mmol/L (22-MAR-2007); osmolality low, 272 mOsmol/kg (22-MAR-2007). No further informationis expected.
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