Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cognitive disorder, Dehydration, Vision blurred
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of cognitive disturbance in a 16-year-old female patient who received BEXSERO (batch number 16G101, expiry date 31st May 2019) for prophylaxis. On 24th July 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 24th July 2018, less than a day after receiving BEXSERO, the patient experienced cognitive disturbance, blurred vision and dehydration. On 24th July 2018, the outcome of the cognitive disturbance and blurred vision were recovered/resolved. On an unknown date, the outcome of the dehydration was unknown. It was unknown if the reporter considered the cognitive disturbance, blurred vision and dehydration to be related to BEXSERO. Additional information was received as follows: The patient received BEXSERO on the left arm. The healthcare professional did not hear anything from the patient after administering the 1st dose of BEXSERO, till the reporting date, when the patient came to see healthcare professional for the 2nd dose of BEXSERO, she reported that 30 minutes after arriving back home, after receiving the 1st dose of BEXSERO, she had blurry vision and could not recognize her friends. This event lasted for 4 to 5 hours and resolved spontaneously. The patient did not seek additional care or did not do anything to manage side effects. The healthcare professional did not think events were related to vaccine stating that the patient might have been dehydrated or something. But the healthcare professional was calling GlaxoSmithKline to see if this adverse event had previously been reported or if the vaccine was contraindicated. This case was reported by a physician via sales rep and described the occurrence of cognitive disturbance in a 16-year-old female patient who received BEXSERO (batch number 16G101, expiry date 31st May 2019) for prophylaxis. On 24th July 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 24th July 2018, less than a day after receiving BEXSERO, the patient experienced cognitive disturbance, blurred vision and dehydration. On 24th July 2018, the outcome of the cognitive disturbance and blurred vision were recovered/resolved. On an unknown date, the outcome of the dehydration was unknown. It was unknown if the reporter considered the cognitive disturbance, blurred vision and dehydration to be related to BEXSERO. Additional information was received as follows: The patient received BEXSERO on the left arm. The healthcare professional did not hear anything from the patient after administering the 1st dose of BEXSERO, till the reporting date, when the patient came to see healthcare professional for the 2nd dose of BEXSERO, she reported that 30 minutes after arriving back home, after receiving the 1st dose of BEXSERO, she had blurry vision and could not recognize her friends. This event lasted for 4 to 5 hours and resolved spontaneously. The patient did not seek additional care or did not do anything to manage side effects. The healthcare professional did not think events were related to vaccine stating that the patient might have been dehydrated or something. But the healthcare professional was calling GlaxoSmithKline to see if this adverse event had previously been reported or if the vaccine was contraindicated. This case was reported by a physician via sales rep and described the occurrence of cognitive disturbance in a 16-year-old female patient who received BEXSERO (batch number 16G101, expiry date 31st May 2019) for prophylaxis. On 24th July 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 24th July 2018, less than a day after receiving BEXSERO, the patient experienced cognitive disturbance, blurred vision and dehydration. On 24th July 2018, the outcome of the cognitive disturbance and blurred vision were recovered/resolved. On an unknown date, the outcome of the dehydration was unknown. It was unknown if the reporter considered the cognitive disturbance, blurred vision and dehydration to be related to BEXSERO. Additional information was received as follows: The patient received BEXSERO on the left arm. The healthcare professional did not hear anything from the patient after administering the 1st dose of BEXSERO, till the reporting date, when the patient came to see healthcare professional for the 2nd dose of BEXSERO, she reported that 30 minutes after arriving back home, after receiving the 1st dose of BEXSERO, she had blurry vision and could not recognize her friends. This event lasted for 4 to 5 hours and resolved spontaneously. The patient did not seek additional care or did not do anything to manage side effects. The healthcare professional did not think events were related to vaccine stating that the patient might have been dehydrated or something. But the healthcare professional was calling GlaxoSmithKline to see if this adverse event had previously been reported or if the vaccine was contraindicated.