Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose decreased, Blood pressure immeasurable, Depressed level of consciousness, Dizziness, Hyperhidrosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #638328) and refers to a 17 year old female patient. Patient's current illnesses were none observed and medical history was none known or reported. Her other medication included SEASONIQUE birth control pill. On 03-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L019287, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with MENACTRA. On 03-JUN-2016, the patient was presented at an unspecified pharmacy with her mother to obtain MENACTRA immunization for public education policy requirements, also requested GARDASIL 9. Patient filled out and signed "Pharmacy Vaccine Screening Questionnaire/Consent Forms" for both vaccines. Injections were prepared by pharmacists, for administration, along with necessary supplies. Consent Forms were examined for completeness (no vaccines within past 4 weeks) and patient signatures. Patient's personal vaccine record indicated the previous vaccines were administered in a County facility many months prior. These two vaccines added a personal record. Injections administered Intramuscularly as noted on the form for each drug. Patient appeared normal with no adverse reaction. After a couple of brief comments, questions, and answers about returning for the two remaining GARDASIL 9 injections, the patient and her mother got up to leave. In less than 30 seconds, the patient's mother yelled in the pharmacy customer service window that the girl was passing out. She was instructed to have the girl sit down. The pharmacist immediately retrieved the Emergency Preparedness Kit and went across the hallway to where the girl was seated. She appeared drained of color ("grayish" skin tone) and diaphoretic. She was semi-conscious, responsive to strong stimuli (shaking, loud talking/questioning). Her respiration was shallow. Her carotid pulse was regular but weak. More help was summoned from other departments in the building. A nurse arrived with a blood pressure monitor, but there was no plug to power it near the patient. The nurse asked for cool, wet towels for patient's head and neck. They were supplied by the pharmacy. The pharmacist used the digital blood pressure cuff from the pharmacy to attempt to take her blood pressure. A good reading in her left arm could not be obtained. Other personnel in the building were instructed to call "911". Patient complained of nausea and being lightheaded and her throat "hurt". She was placed on the floor on her back with her head adjusted for ease of breathing and her feet were elevated. Her mother questioned her if she had eaten lunch. It was uncertain whether she had eaten or not. The radiology department technicians arrived with a portable oxygen tank and attached a nasal cannula to the patient and started administering oxygen. The radiologist on duty also arrived and assessed that everything that could be done was being done. The nurse and the radiologist looked for signs of "allergic reaction" (rash or raised skin on abdomen, arms, facial swelling, etc.) and could find no signs of such. Patient remained somewhat responsive and would answer questions. Blood pressure reading was attempted again. The reading in patient's right arm was 105/73 (unit unknown) with a pulse of 80. The Fire Department EMS and Ambulance arrived at approximately 15:20 hours. All building personnel moved back and let the EMS and ambulance crews take over using their equipment. All the information from the personnel at hand was dictated to them. They performed blood pressure checks and oxygen saturation checks. Blood pressure and pulse were within normal parameters for a person the patient's age. Oxygen saturation was 100%. A test for her blood sugar was done by a finger stick with a portable meter. The reading was 78 (unit unknown). Ambulance prepared the patient for transport and left for the emergency department at the hospital in the area, at approximately 15:25 hours. Copies of the "Questionnaire/Consent" form were faxed to the emergency department to aid in their assessment and treatment of the patient. Patient's mother reported that the patient recovered normally after administration of IV Fluids. The outcome of blood glucose decreased, pulse abnormal, pallor, oropharyngeal pain, nausea, hypopnoea, hyperhidrosis, dizziness and depressed level of consciousness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.