Age: 26.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Grand mal convulsion, Injection site pain, Nuclear magnetic resonance imaging, Tongue biting, Unresponsive to stimuli
Clinical narrative: Initial case received on 12 January 2011 from a consumer, who is also the patient. A female patient received an injection of ADACEL in November 2010 (lot number and exact date of vaccination not reported; date also noted as "6 weeks ago"). She subsequently experienced a grand mal seizure. She underwent a CT scan and blood work; results were not provided. The patient also noted that she had a sore arm at the injection site. She had a history of asthma, with no history of seizure disorder, no known allergies, and no reported illness at the time of vaccination. She noted that she had received an influenza vaccine in August 2010. Outcome was unknown. Follow-up information was received from a consumer, who was the patient, on 19 January 2011. On 06 January 2011, the patient woke up to take care of her baby just after midnight. She was in a recliner nursing and experienced a grand mal seizure. Her husband called 911. The patient's breathing was heavy and her eyes rolled back in her head. The patient was also grinding her teeth, had bitten her tongue and was unresponsive. The patient's seizure lasted five minutes. She was seen in the emergency room. The patient had a computed tomography (CT) scan, blood work and urinalysis which were normal. A magnetic resonance imaging (MRI) scan was done and the results were pending. She did not regain full clarity until 8:00 AM. The patient had a slow gradual return to normalcy. The patient's asthma only flares up once a year. The patient's concomitant medications included prenatal, fish oil and inhaler prn. The patient did not receive any other vaccinations within 4 weeks of the ADACEL. The patient had no adverse events following prior vaccinations. The outcome was reported as recovered. Follow-up information was received 10 February 2011 from a physician's office and on 11 February 2011 from a pharmacist. The patient was given a prescription for ADACEL from her physician. ADACEL, lot number C3516AA was administered by the pharmacist on 25 October 2010 at the pharmacy. According to the pharmacist, the patient had not experienced any further incidents since the initial event. Neither reporter had any additional information to provide. Contact information was provided for the patient's OB-GYN and the emergency room where the patient may have been evaluated. No additional information was provided at the time of the report. Follow-up information received on 14 February 2011 reported that the patient had no adverse event following prior vaccinations. The patient received a left deltoid IM injection of ADACEL, sanofi pasteur lot number 03516AA (lot number does not exist). There were over 2 months between vaccination and the reporting of the seizure which occurred at midnight on 06 January 2011. No further information was available. The outcome remained recovered. Follow-up information was received from a health care professional on 08 March 2011. The lot number of the ADACEL was corrected to   [Due to memory limitations, the remainder of this text could not be compared.]  ed to C3516AA from 3516AA. No additional information at this time. The outcome remained recovered. Documents held by sender: None.