Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Myoclonus, Nausea, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received on 31 January 2011 via another manufacturer (reference number WAES 1009USA00016) who had received the original report from a physician. The following is verbatim from report: "Information has been received from a physician concerning a 15 year old female with no pertinent medical history who on 14-AUG-2010 was vaccinated intramuscularly with a dose of GARDASIL. (Lot Number is 665547/1318Y). It was part of the adolescent regime; she had gotten other shots that day. On 14-AUG-2010 the patient had a jerky reaction, headache and weakness in her arms after vaccination. The patient was rushed to the emergency room and was hospitalized. The patient had neurological testing done with normal results, she was on medicine but her mom did not know the name of it, she experienced tremors on 30-AUG-2010 and the family physician prescribed gabapentin. At the time of this report, the outcomes were unknown. Follow up information was received from the registered nurse (R.N.) who reported that the patient was 14 year old and had no known drug allergies (NKDA). On 14-AUG-2010, the patient was vaccinated with a dose of GARDASIL and a dose of MENACTRA in the right deltoid and a dose of VARIVAX (Merck) (MSD) (lot # 666761/0093Z) and a dose of Tdap in the left deltoid. There was no other concomitant medication. The nurse provided the name of the ER and indicated that there was "no admission". The nurse considered the events to be not disabling or life-threatening. She reported that she "had not seen the patient since the day the vaccines were given, but had heard that hand splints were needed two weeks after the event for flaccid arms, current status unknown". Additional information was reported by a medical assistant in the neurologist's office. It was reported that "the patient was seen twice - once on 16-AUG-2010 and then again on 31-AUG-2010. Follow up information was received from the Certified Medical Assistant (C.M.A.) who reported that the patient was seen on 16-AUG-2010 for jerking movement (described as tetany; not seizure). The patient was unable to straighten her right arm and she was prescribed SKELAXIN for muscle spasms. When she referred to Neurologist, neurology consult showed that Electroencephalography and other testing were normal, no seizure activity, and "etiology unknown". The patient was seen again on 30-AUG-2010, her exam presented normal and she was considered as recovered. She was prescribed Gabapentin 3 times daily as needed. The patient could go to school but to be abstained from sports for two weeks. Follow-up information was received from a physician and a medical record. The 14 year old, right-handed female with no allergies on 14-AUG-2010 was vaccinated with GARDASIL, VARIVAX (Merck), MENACTRA, "chickenpox", and Tdap in a car van. On the same date, the patient began jerking, uncontrollably. She went to ER and was given muscle relaxer which helped, but jerking unchanged when medicine wore off. The patient then saw neurology and MRI/EEG were normal. The patient also had right upper extremity jerking, tetany (for 3 weeks), weakness, headache (2 days), fever/chills (for 2 days), numbness (2 days), having vital space, now intermittent. On 16-AUG-2010, the patient was in the physician's office, presenting complaints of severe pain in her right arm and constant jerking that started on 14-AUG-2010 after she received shots. The mother stated that about three hours after vaccine the patient developed twitching in her right arm, intermittently. She was able to still use her arm but only with restrains. She described some tingling in both her hands. She denied any neck pain. She did have headaches that particular day, and then the headaches were mild. She did go to emergency room twice and once she was given ATIVAN. CT scan of her head and blood work were unremarkable. She was discharged. The patient was prescribed lorazepam which she tried but it made her sick so she was taking FLEXERIL 5 mg as needed. There was no altered awareness. She did have a slight fever on 14-AUG-2010 but this had resolved. Physical examination was within normal limits except that she had put a splint on her right arm and intermittently, she does have tremulous movements of the right upper extremity and sometimes almost like a startled response with both upper extremities. Other examinations were all in normal range. The patient was given the following medications: FLEXERIL 5 mg t.i.d., TYLENOL 500 mg 2 tablets, every 6 hours, ADVIL 200 mg 2 tablets, every 4 hours. Physician's assessment: This patient has a diagnosis of what appears to be acute onset of stiffness and hyperreflexia as well as what appears to be either tremors or myoclonic jerks of her right upper extremity. I am concerned that this may be related to her vaccine. The possibility of a demyelinating process like acute demyelinating encephalomyelitis, post-vaccine, may be in the differential. This may involved the head or the spinal cord. The possibility of seizures is less likely since she is able to use her hand and the movement appears to be induced by touch. I will do a STAT MRI of her head and neck first. In the meantime she can take gabapentin 300 mg t.i.d. Based on the results of her MRI, further evaluation will need to be pursued. If she indeed has demyelinating lesions she will need to be referred to a pediatric neurologist a full workup. Post-vaccine demyelinating encephalitis is a well know complication. On 23-AUG-2010 the patient's mother returned to the office for follow-up. Since the patient's last visit her muscle spasms last for about a week and then resolved in her right upper extremity. Currently she was back to baseline. Currently she was off al medications. She had an MRI of her cervical spine and brain without contrast to evaluate for acute disseminated encephalomyelitis (ADEM) and this was a normal study. She also had a one-hour EEG done that was normal. Other examinations were within normal range. Physician's comments: This patient has a diagnosis of post-vaccine, what appears to be, myoclonus involving the right upper extremity and muscle spasms which lasted for about a week and then resolved. In reviewing literature a few cases of muscle spasm have been reported with the tetanus vaccine but I did not see any specifications related to the HPV vaccine. However, the patient has had a full workup for the possibility of acute demyelinating myelitis as well as seizures and all her workup is so far unremarkable. She is currently back to baseline. With regards to whether she should continue on the HPV vaccine I have left this to her mother since there is a possibility that this could be a rare complication of HPV though no absolute cases could be found after I reviewed the literature. I will only see her back on a p.r.n basis. On 31-AUG-2010 the patient's mother returned to the office for follow-up. According to the patient's mother she started having jerky movements again on Saturday for a brief time and then at school the next day. Her mother was called because she wanted to go home after having jerky movements in her right arm. According to her mother when she takes Gabapentin this helps her significantly. She did not take the afternoon dose and that is why her symptoms were precipitated. The patient has become very tearful throughout the interview when the physician asked her if she is stressed out and also told her that she cannot play sports if she has these symptoms. She had an MRI of her cervical spine and brain without contrast to evaluate for ADEM and this was a normal study. She also had a one-hour EEG done that was normal. Medications included gabapentin 300 mg 1 cap t.i.d. Physician's comments: This patient has a diagnosis of right upper extremity jerking which had resolved and then has returned. The etiology of this is not entirely clear. I had suspected myoclonus. There is no evidence of seizures based on her 48-hour ambulatory EEG during which she had several spells but the EEG was normal. I am also concerned about stress-induced movement disorder and I did have a long talk with the patient regarding this. She can take the gabapentin t.i.d as-needed since this is helping her. For the time being she should not play sports at least till she is symptom-free for two weeks. I will see her back in four weeks. On 15-SEP-2010 the patient's mother returned to the office for follow-up. Since her last visit she had a spell in school that occurred 14-SEP-2010 where she tells me she had eaten breakfast and was walking towards the gym around 12.00 noon when she felt very dizzy and lightheaded and then apparently fell down. No overt seizure activity was noted. The patient was somewhat spaced-out and was brought to the emergency room where her vital signs and electrolytes were normal. She has not had any major jerking episodes and her mother did start her on Gabapentin 300 mg b.i.d and stated this medication did make her sleepy. Certain stress issues were discussed with her by her parents and according to her mother this is mainly related to her ability to play sports. According to her mother when she is under stress she does a few jerks of her right arm but she is more concerned about some spacing out spells that she had noticed her daughter going through. Her father stated that he had seen a personality change in the patient after she had the HPV vaccination which was mentioned in my fast note. Current medication: DEPAKOTE 500 mg t.i.d., Amoxicillin 500 mg t.i.d. Other examinations were in normal ranges. Physician's comments: This patient has a diagnosis of spells of spacing out along with jerking. She has already had an MRI of her head without contrast that was normal. She also had a one-hour EEG which was mainly done for her jerking spells. She did not have any spacing out on this study and this was normal. At this time I would like to complete a more extensive workup and do an MRI of her head with contrast. We will also do a 48-hour ambulatory EEG to evaluate for epileptiform activity. I will refer her to a cardiologist for a full cardiac workup for syncope. Lastly, the possibility of stress-induced symptoms is still in the differential and the patient is under some stress in school. I had started her on DEPAKOTE for seizures and this would also help underlying anxiety. I have advised her to hold off the DEPAKOTE on the days of the EEG and I will check on her in three weeks. Follow-up information received on 18-JAN-2011 from a physician and medical records noted that a 14 yr old female was vaccinated with HPV, MENACTRA, varicella and Tdap on 13-AUG-2010. After receiving vaccinations she developed right upper extremity tetany and muscle contracture. On 14-AUG-2010 she developed numbness and headache. She was seen by neurology. MRI/EEG were normal. The patient has not recovered and is still being treated. On 05-OCT-2010, the patient was seen in follow-up and her whole body jerks have improved dramatically. She has not had any major passing out spells. She was started on physical therapy with stretching. She was seen by a Pediatric Cardiologist and the work-up was unremarkable. He felt that she had an element of GI reflux. She is complaining of worse headaches which are moderate in intensity and aching, occurring two to three times a week. MRI of cervical spine and brain to evaluate ADEM was normal, a one-hour EEG was normal and MRI of head was normal. Assessment: the patient has a diagnosis of common migraines and tension headaches. Some of her headaches are suggestive of complicated migraines also. She was started on LYRICA 50mg hs to be gradually increased until she gets to 50mg in the morning and 100mg at night. On 19-NOV-2010, the patient was seen in follow-up. She again has spasms of her right arm, this time also involving her right leg. She had felt somewhat unwell and by late evening she was having frequent tremors. She wore a sling to school and managed to type and continues classes. She had pain on her right side and her mom tried to massage it, but the pain got worse. She did not tolerate pregabalin. She was started on NORFLEX 100mg daily and since then her symptoms have resolved. Assessment: diagnosis of right hemi-body spasm and tremors, etiology unclear. The physician had no clear explanation for her symptoms and did suggest to her mother that she may be having a hysterical reaction secondary to stress but her mother absolutely denies this. She did make a psychiatrist appointment but has not kept up on it. She was referred to a movement disorder specialist. The patient can continue orphenadrine citrate. She will do for physical therapy twice a week for the next six weeks. On 10-DEC-2010, the patient was seen by a neurology specialist for problems with the right side of her body. In August she had immunizations, a few hours later developed jerkiness. She only had one shaky spell the past week. Her mother reports that she has seen the shakiness when the patient appears to be asleep. She has also had headaches associated with blurring of vision and dizziness as if she was about to faint, right-sided throbbing so severe she laid down. There was photophobia, phonophobia and sometimes nausea. She was better with EXCEDRIN. There was no obvious trigger. She is on prn orphenadrine 100mg extended release for when she is having twitching. Assessment: it is not clear what the twitchy spells are. A normal EEG during a spell goes against a seizure disorder. If she really was asleep and twitching, that goes against a movement disorder. The spells have been improving. The headaches seem to be migraines. Patient was to begin a headache diary and also keep track of the spells. The physician stated "for now we will on the HPV vaccinations." Tetany, muscle contracture, numbness and headache were considered disabling and noted to require medical/surgical intervention by the physician. Upon internal review, acute demyelinating encephalomyelitis post vaccine and seizure are determined to be other important medical event. All available medical records will be provided upon request. Additional information has been requested." It is noted that the patient's age was reported as both 14 and 15 years of age by the other manufacturer. Documents held by sender: None.