Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Nystagmus, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional (Nurse) on 10 September 2012. An 11-year-old male patient with no reported medical history and concomitant medications, had received intramuscular (IM) dose of ADACEL injection (lot number C4137AA) in right deltoid region on 30 August 2012. It was reported that, the patient had dizziness on 31 August 2012, double vision on 01 September 2012 and vomiting x2 (two episodes) on 03 September 2012. On 04 September 2012, the patient visited to doctors with slightly elevated BP 130/88. On 05 and 06 September 2012, the BP check was WNL. On 07 September 2012, the patient was seen by eye doctor who stated the examination was normal. On an unknown date the patient had CT scan done which was negative. On 08 September 2012, the patient was seen in ER at Medical Centre and underwent MRI which showed negative result. The patient had an appointment with pediatric ophthalmologist on 14 September 2012. Details of treatment was not reported. The patient's outcome was unknown. Follow-up information received from the healthcare professional on 10 September 2012. The reporter confirmed the date of birth to be 07 August 2012. Reporter also provided an address where followup requests should be sent. Patient outcome remains unknown. Documents held by sender: None. Follow-up information was received from the healthcare professional on 19 November 2012. The patient had received previous doses of ADACEL vaccine. On an unspecified date, the patient was started on antibiotics for sinus infection. The patient had history and symptoms concerning cerebellitis. The onset of symptoms happened quickly after receiving ADACEL vaccine. The reporter was unclear which component of vaccine triggered this reaction. On 30 August 2012 (Thursday), the patient had complained of arm hurting in the afternoon. On Friday, the patient complained of right feeling asleep. By afternoon, the patient had symptoms which indicated that his depth of perception was off. On Saturday morning, the patient woke up nauseated and dizzy. The patient had a difficulty in walking and appeared to stagger and walk as if "drunk". The patient was holding onto the walls or other stationary objects while walking. The patient had denied any weakness. It was reported that, the patient spent majority of the day in bed, sleeping. On Sunday, the patient complained of double vision which was not side-to-side but was rather up and down. On an unspecified date, the patient had poor appetite. The patient had no complaints of headaches but had reported eye pain. The patient's symptoms had persisted the whole week. On 10 September 2012, the patient still felt dizzy and off-balance. It was reported that, the patient's eyes were "jumping" and his motor skills were decreased. On 11 September 2012, the patient woke up and the event double vision had resolved. The patient had gradually felt better since 11 September 2012, but still had a bit of stomach ache and bilateral eye pain. The patient's appetite was slowly improving along with handwriting. The patient's eye examination revealed the following details: patient had achy feeling above eyes: 3/10 pain, red reflexes bilaterally, conjunctivae without lesions, freckle right eye, the patient had evidence of an esophoria on cross over testing, as well as nystagmus, the patient did fuse the fly but none of the animals or circles, visual acuity was good 20/20 in each eye, a definitive diagnosis was not obtained at the time of this report. The patient's blood pressure was 130/88 on 04 September 2012, was 124/70 on 05 September 2012, was 111/76 on 06 September 2012, was 133/93 on 08 September 2012 and was 123/80 on 13 September 2012. The patient pulse rate was 97 on 13 September 2012. On 04 September 2012, the patient underwent CT scan which revealed no acute intracranial abnormality. On 08 September 2012, the patient had brain MRI with and without contrast and the result was normal. As of 13 September 2012, the patient's cardiovascular, neurologist and respiratory examinations were normal. Corrective treatment details: patient received ZOFRAN intravenously on 08 September 2012 and was prescribed ZOFRAN 4 mg, one dose orally every 6 hours as needed for nausea/vomiting. As per the reporter, the patient had improved and had completely recovered from the events except for some headache on 24 September 2012 and occasional dizziness. Documents held by the sender: hospital consultation and laboratory reports.