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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a father referring to his 15 year old male son. The patient had allergy to monosodium glutamate (MSG). The father noted that the patient was "normal before the shot". His medical history prior to the shot was clean and there was no history of epilepsy on either side of the family. He had no issues at birth and the only noteworthy event during his childhood was an uneventful tonsillectomy. On 12-OCT-2011, 26-OCT-2012 and 26-SEP-2013, the patient was vaccinated with the first, second and third dose of GARDASIL (1 dose, route: injection) in the deltoid separately. Lot numbers were reported as 1860AA, 0636AA and H011350 (unsure if lot numbers were provided in dose order). On 04-AUG-2012, the patient was found unconscious on the laundry room floor and seemed stiff and postictal. Then on the same day, the patient was hospitalized. However, the first observed occurrence for his loss of consciousness happened in March 2013. On 08-MAR-2013, the patient was admitted for the emergency room. The patient had experienced multiple adverse experiences after completing therapy with GARDASIL including relapsing syncope with reoccurring tonic clonic movements. Description of the Syncope events: Each event followed the same template. The patient heard a gradual increase in roaring in his ears. He became lightheaded and pallor developed in his face. This "pre-syncope period" lasted for about 15 seconds. During the Syncope phase, his eyes roll upwards and he experienced tonic clonic movements for about 20-30 seconds. There was some vocalization (groaning). These events reoccurred on about a monthly basis over the last three years. He could recognize when an event will occur and can reverse the pending effect by lying down and bicycling his feet in the air. He had experienced these events while sleeping, while awake, while defecating, and one occurred after the patient moved from a sauna to take a shower. He has had two events at a hall cafeteria while ingesting a meal. Sleep deprivation seemed to make him more susceptible. All events occurred while he in a sedentary state and most events occurred in the late evening to early morning. On unknown dates, the patient also experienced, major depression and suicidal ideation. Cardiovascular adverse experience included hypotension. The patient had been "effectively diagnosed with epilepsy" and was "on anti-consultants empirically". These issues had caused major lifestyle complications which included restrictions on driving, swimming, bathing and the implied diagnosis of epilepsy was a major concern for the family. The patient had also admitted to the emergency room on 22-APR-2013, 28-MAR-2014 and 12-JAN-2015. The patient had had 5 multi-day video electroencephalograph (EEG) sleep deprived assessments. These were all "normal". They placed him on anticonvulsant (as empirical therapy) but he is still having breakthrough events. One event was caught while the patient was wearing an electrocardiograph (ECG) Halter; his heart rate was 50 beats per minutes when it occurred but there was no evidence of serious erythema, or of vagal slowing. He had a magnetic resonance imaging (MRI) head up tilt table test, an Echocardiogram and a take-home ECG halter. The patient was also an emergency medical technician (EMT) and tracked his own blood pressure. His blood pressure was very low. On Saturday 10-OCT-2015, the father measured his blood pressure at "97 over 42" and "his heart-rate was 52 beats per minute". He measured a diastolic blood pressure of 38 when he "woke up on 12-OCT-2015". He currently had a 24 hour blood pressure cuff on a halter. He had a stress on reporting day that came up "normal". They plan on running antibody assays with a rheumatologist. The outcome of events was reported as not recovered/not resolved. Upon internal review, suicidal ideation and epilepsy were considered to be medically significant. Additional information has been requested.
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