Sex: F
Vaccine: HPV9, MEN
Symptoms: Head injury, Immediate post-injection reaction, Inappropriate schedule of product administration, Inflammation, Laboratory test
Clinical narrative: This spontaneous report was received from a consumer refers to a 17 year old female patient. The patient's drug reactions/allergies included seasonal allergies to pollen. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date in November 2016, the patient was vaccinated with first dose of GARDASIL 9 (lot, expiry date, dose and route were not reported) for Human papillomavirus (HPV) prevention(prophylaxis). Subsequently on an unknown date in January 2017, the patient was vaccinated with second dose of GARDASIL 9 (lot, expiry date, dose and route were not reported) for HPV prevention. The reporter stated that, the patient's physician initially told her family that she did not need to get the third dose, however, the reporter said approximately on 12-MAR-2019 (reported as about a week ago) the patient was vaccinated with third dose of GARDASIL 9 (strength, dose, lot number, and expiration date were unknown) for HPV prevention under the physician's recommendation in order to complete the series even though the 3rd dose was administered very late (inappropriate schedule of vaccine administration). Other suspect therapies included meningococcal vaccine (unspecified)(MENINGITIS SHOT) which was concomitantly given in the right arm almost in the same exact spot. The reporter stated that, the patient did not have any side effects or issues to neither the first or second dose, however, after she was given the 3rd dose more recently ("a week ago") she immediately developed a lot of pain, swelling and inflammation in her right arm down to her wrist area and her arm became "hot" to the touch as well(feeling hot). Approximately on 13-MAR-2019 (reported as the next day, after the patient had received the third shot) as she "was holding up her arm to put her shirt on to go to school," the patient suddenly felt "pain in her chest" (chest pain) and she had "trouble breathing" and she ended up "dropping 'to the floor not completely passed out but almost passed out(dizziness). The reporter said the patient was helped up from the floor and sat up by her family and the patient had become very "cold" and she was "shaking badly" as if she looked like she was "having seizures" and the patient appeared "delirious." The reporter said that, the patient also was complaining that she had felt very thirsty so the family took her to the kitchen to get some water and at that point the patient suddenly fell to the floor again in the kitchen this time completely passed out and she "banged" her head and face because of the abrupt fall. The reporter said the patient 's parents immediately called the ambulance and the unconscious patient was rushed to a local unknown emergency room where she was "given fluids" and she was prescribed some Ibuprofen for the "pain and swelling" in the patient's arm and chest. The reporter also said at the unknown emergency room(ER)they performed "a lot of tests and blood work" and the patient eventually was released from the ER "about 4 or 5 hours later" hence confirmed no hospitalization had occurred. The reporter also added the patient had been "put on bed rest" for a few days and so the patient was out of school all of last week. The reporter mentioned that some of the symptoms like the pain and swelling had subsided a bit but the patient was still displaying(??-MAR-2019) "some mental confusion" and some issues with focusing as well. The reporter said she did not understand why the patient had no problems with the first and second dose of the GARDASIL 9 she received but after getting the 3rd dose recently why she has had so many bad side effects and the situation with her  passing out was "just horrible."  The outcome of loss of consciousness, confusional state, vision blurred, fall, injury, thirst, tremor, feeling cold, dizziness, dyspnoea, chest pain, feeling hot, inflammation, peripheral swelling, pain, delirium and seizure was reported as recovering. The causality assessment was not provided by the reporter. No product quality complaint involved. Upon internal review, the events loss of consciousness, delirium and seizure were determined to be medically significant.