Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyskinesia, Electroencephalogram abnormal, Fatigue, Myalgia, No reaction on previous exposure to drug
Clinical narrative: A report was received from a mother of a 23 year old female vaccine (Ref. NA05-010756). The vaccine has a history of fibromyalgia and is allergic to multiple antibiotics including, erythromycin, penicillin, clarithromycin, azithromycin, clindamycin, cefprozil, SMX/TMP, gatifloxacin and doxycycline. The vaccines concomitant medication include Triphasil for endometriosis and fluoxetine. The vaccine has received influenza vaccine in the past without event. On Nov 1 2005, the vaccine received Fluvirin (batch number 61350), intramuscularly. Within 2 hours of vaccination the vaccine experienced tremors of the hands and arms, low grade fever (99.2 to 100F) and myalgias. Fever and myalgias resolved with in 24 hours. Tremors progressed to seizures increasing in severity and frequency. The mother described seizures and jerking with posturing. The vaccine as admitted to hospital for seizure disorder workup. She was given an EEG and brain MRI which were both negative for any disorder. She was started on an anticonvulsant. She was discharged from hospital on Nov 14 2005 with diagnosis of pseudo seizures. The vaccinee continues to have tremors, she experiences 40-50 episodes a day. Follow up information will be sought.  Follow-up report received on 26 Nov 2009: The patient had a medical history of drug allergy to all antibiotics, fibromyalgia and had experienced car accident in 2004. This patient had another dose of FLUVIRIN on 03 Nov 2009. She experienced arm tremors two hours after injection and then experienced "five hundred seizures in four weeks". The patient was hospitalized for six days at two different hospitals. The patient also developed confusion, exhaustion and a little memory loss on an unspecified date. The outcome of arm tremor, seizures, confusion and exhaustion was reported as fully recovered. Following internal review on 15 Apr 2010 of the data received on 25 Nov 2009, it was corrected to FLUVIRIN (batch number 61350). Follow-up report received on 29 Jun 2010 from consumer: Added ADACEL concomitant drug information. The patient's medical history included caesarean section, postural orthostatic tachycardia syndrome (Nov 2002), endometriosis, serum sickness, numerous surgeries due to strep bacteria settling in joints (1997-2001) and multiple drug allergies (penicillin, CEFZIL, propofol, BIAXIN, BACTRIM, ketamine, ZITHROMAX, CLEOCIN, BREVITAL, TEQUIN and doxycycline). It was reported that after car accident (occurred in 2004), the patient did not sustain a head injury, but suffered from cervical injuries as well as compression fractures of the spine between the lower thoracis and upper lumbar area. The patient was previously vaccinated with flu vaccines (Dec 2002 and Nov 2003) as well as meningitis vaccine (Jun 2000) and experienced unremarkable side effects. A chest CT was performed (date unspecified) and possibility of GUILLAIN-BARRE syndrome was ruled out. Electroencephalogram (EEG) showed some rhythmic slowing with abrupt return to base line suggesting a non epileptic origin. Head CT, brain MRI and blood work were normal. The patient's prolactin levels were 18.9 on 09 Nov 2005, 30.4 on 11 Nov 2005 and 37.2 on 12 Nov 2005 (suggesting true seizure activity as per neurologist). Urine analysis was negative for Wilson's disease and the patient was neurologically stable. The outcome of the events was not reported.