Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Malaise, Pallor, Syncope, Tinnitus
Clinical narrative: had tunnel vision; The patient collapsed on the couch; shortly after was pale, sweaty; shortly after was pale, sweaty; she felt ill; the patient had a ringing in her ears, tunnel vision, and eventually passed out.; the patient had a ringing in her ears, tunnel vision, and eventually passed out.; she didn't feel good. The patient eventually collapsed at the HCP office; The patient's blood pressure before administration was 120/80. While the patient was passed out her blood pressure read 88/54.; The FBE reports that the patient passed out for "quite a while" regained consciousness and passed out again; The FBE reports that the patients mother stated the patient was fatigued after returning home but was better by night time; This spontaneous report was received from a nurse and referred to a 14-year-old female patient.  The patient's medical history and concomitant therapies were not reported (also reported as the patient had no pertinent medical history and was not on any chronic medications). The patient's blood pressure before vaccine's administration was 120/80 (units not provided).  On 22-APR-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 milliliter, lot #1965079, (expiration date: 01-FEB-2026), administered intramuscularly for prophylaxis (strength and anatomical location not provided). The vaccine was not given with any other vaccines.   On this same date (22-APR-2024), the patient was "nervous" but seemed ok immediately after administration. Afterwards, she sat for 10-15 minutes post administration to be monitored by the health care professional (HCP). As the patient made it to the front of the office, she stated that she did feel good. The patient eventually collapsed at the HCP office (Ill-defined disorder). She passed out for "quite a while" regained consciousness and passed out again (Loss of consciousness). She was treated with recovery care, but it was not confirmed what type of care was rendered. While the patient was passed out her blood pressure read 88/54 (units not provided) (Blood pressure decreased). When she woke up, she was "sweaty and pale" and twenty minutes after waking up (unable to confirm how long patient lost consciousness for) she was able to leave the office. Before leaving the patient's blood pressure read 104/64 (units not provided). Patients mother stated the patient was fatigued (Fatigue) after returning home but was better by nighttime. On this same date, she recovered from loss of consciousness, Ill-defined disorder, blood pressure decreased and fatigue. On 24-APR-2024, during school breakfast the patient had a ringing in her ears (tinnitus), tunnel vision, and eventually passed out (Loss of consciousness). The patient took about 15-20 minutes to return back to normal and she recovered from loss of consciousness and tinnitus. In the morning of 28-APR-2024, she seemed to be fine but while making cupcakes but suddenly she felt ill (Malaise). Subsequently, she collapsed on the couch (Ill-defined disorder) shortly after was pale (Pallor), sweaty (Hyperhidrosis), had tunnel vision but it could not be confirmed if the patient passed out. It took about 20 minutes for the patient to come out of this state.  Thus, on this date, she recovered from tunnel vision, ill-defined disorder, pallor, hyperhidrosis and malaise. No additional reports were made. No additional information was provided.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the events of tunnel vision and loss of consciousness (onset 22-APR-2024 and 24-APR-2024) were determined to be medically significant.