Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Erythema, Exercise tolerance decreased, Eyelid ptosis
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL injection (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Follow up information was received on 11-DEC-2015 from a physician via a Questionnaire and Medical Records concerning a 14 year old male patient non-smoker, non-alcohol use with a history of febrile seizures as a child (at 1 and 2 years of age), bipartite patella, cellulitis (2011), allergy to cephalexin (rash) and a family history of early fatal MI (paternal grandfather), leukemia (cousin who died at age 11) and elevated cholesterol (paternal uncle). On 18-APR-2015 at 11:00 A.M, was vaccinated with GARDASIL injection (lot: K006960) intramuscular injection / arm (# of previous doses 2). On 18-APR-2015, the physician reported the patient experienced syncope during exercise, subsequent exercise intolerance and fatigue that resulted in persistent or significant disability/ incapacity. The physician reported the patient improved after 5 months and was 80% back to normal. The patient underwent a EKG that was within normal limits, and an echocardiogram, EEG and CT of brain (no results provided). On 18-APR-2015, the patient presented to the emergency room with complained of feeling disoriented, fatigued, numb, dizzy and got pale after playing basketball. The patient drank water and Gatorade afterwards then passed out when his mother stepped away. The patient regained consciousness shortly thereafter. His mother reported the temperature in the gym was very warm. The patient's blood pressure was slightly low at 104/63. The patient's laboratory results (Chemistry and Hematology) were within normal range, except for a slightly low RBC of 4.34. The patient was treated with IV fluids. Diagnosis: syncope, likely due to dehydration. On 20-APR-2015, the patient was seen by his physician in follow-up of his diagnosis of syncope (also reported as a fainting episode). The patient reported he feels dizzy if he looks up or down for too long. The patient's blood pressure was 108/65 mm (sitting), 98/63 mm (supine) and 110/68 mm (standing). Assessment: "Vasopressor" syncope. The patient was instructed to assume a squatting position to increase blood flow to the head and get close to the ground in the event syncope occurs in the future. 18-MAY-2015, the patient was seen in consultation for a cardiology evaluation related to chief complaint of syncope. The patient's multi-system review of systems were negative from a cardiac standpoint. The patient's EKG, Doppler and Echocardiogram were concluded as a normal study for age with good biventricular wall motion. Assessment: likely vasovagal type syncope possibly exacerbated by dehydration and overheating. His physical examination findings are consistent with that of likely benign ventricular ejection type murmur (innocent). On 29-MAY-2015, the patient was seen by his physician in follow-up of his recent paroxysmal events. The patient reported he took 2 weeks off sporting practices. On 15-MAY-2015, the patient fainted while doing planks bumping his head on the floor. He was evaluated in the emergency room with no etiology found, and subsequently had cardiac evaluation including an EKG, echocardiogram which were both negative. His event monitor showed no correlation with symptoms of fatigue or breathlessness. He was diagnosed with syncope. On 25-MAY-2015 and again on 28-MAY-2015 he had abnormal perceptual events of things appearing bright and seeing sparkles in front of his eyes. This was not associated with headache and lasted about 5-15 minutes. He had a cardiac event monitor on at the time and it showed no abnormalities. He also notes a single episode of dizziness that had occurred on 27-MAY-2015. The mother notes that during both episodes of altered perception there may have been brief periods when he did not remember conversations that he had had. Assessment: Paroxysms. It was noted that there had been some episodes of vasodepressor syncope. Further neurological testing was recommended. On 15-JUN-2015, the patient again experienced syncope after exercise during conditioning. The patient's laboratory tests (chemistry and hematology) results were within normal limits except for a low RBC 4.31, HGB 13.1, HCT 38.7 and lymph 10.7% and high neutrophils 85.1%. He also had a neurological work up that revealed a normal sleep deprived EEG and normal Holter. On 6-JUL-2015, after starting a basketball game, the patient became diaphoretic, and hyperventilation. His symptoms typically come on with running in a hot environment. On 21-JUL-2015, the patient was seen in follow up because of concern of ongoing symptoms. The patient's medications listed: CLARITIN. The patient's current symptoms included rapid fatigue with exercise, seems to need more sleep, heat intolerance, sweats easily, intermittent diarrhea (low lactose diet-better). The patient's mother found an article from the Medical Journal that noted a number of cases (NOS) of headache, orthostatic intolerance, fatigue, nausea after HVP vaccine. These were patients who were referred for tilt table testing because of orthostatic symptoms (refer to MARRS# 1503DNK006617). The patient reported doing pull ups and push-ups and could jog ok when in cool weather, not fast running in heat. Assessment: Vasodepressor Syncope. Current symptoms are consistent with vasodepressor syncope and reduced exercise tolerance and fatigue. On 22-JUN-2015, the patient was seen in consultation by neurology for chief complaint of syncope x 3. Pt underwent a complete neurological examination. Assessment: spell, brain versus heart. The patient scheduled to have a sleep deprived EEG, and a 24 hour EEG would be considered. 25-JUN-2015, the patient's awake and sleep EEG was normal. On 25-AUG-2015, the pt was seen by neurology for evaluation of new symptoms. It was noted on 09-AUG-2015, 11-AUG-2015, 12-AUG-2015 and 21-AUG-2015 the patient had a fairly stereotype constellation of symptoms, each time with running but not always vigorously running. He describes having fairly severe significant left temple pain, causing him to grab the area of pain for about 5 minutes. Pain was moderate for about 5 minutes followed by left eyelid ptosis with some double vision. Pain was mild for about 5 minutes. He felt off balance. He also stated, when he sits down he has a hard time getting back up. He states he cannot get up because his mind will not make his body work. He has redness of the sclerae and face as well as eye twitching. Assessment: Possible 3rd nerve palsy with ptosis and double vision, transient. 14-SEP-2015, the pt was seen again by neurology. The patient first had several syncopal episodes when he became hot while playing basketball. Apparently this has resolved and he has tolerated this better and hydrates well. Now he has had two to three episodes of left ptosis and double vision with some significant left temporal pain. Presently this has resolved as well. He has been able to play basketball vigorously without any symptoms. CT angio of the brain showed no aneurysms. MRI scan with and without contrast was totally normal. The physician reportedly did not have any clear explanation for the patient's most recent possible partial 3rd nerve palsy. The patient's mother was instructed to call next time he has any significant symptoms. Syncope during exercise, subsequent exercise intolerance and fatigue were considered disabling by the reporter. All available medical records will be provided upon request. Additional information has been requested.