Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included GARDASIL 9 and MENACTRA. On 10th August 2016, the patient received the 1st dose of BEXSERO .5 ml. On 12th August 2016, 2 days after receiving BEXSERO, the patient experienced unable to walk (serious criteria GSK medically significant) and mobility decreased. In August 2016, the patient experienced headache (serious criteria other: as per reporter), shortness of breath, nausea and diarrhea. On an unknown date, the outcome of the headache, unable to walk and mobility decreased were recovering/resolving and the outcome of the shortness of breath, nausea and diarrhea were recovered/resolved. It was unknown if the reporter considered the headache, unable to walk, shortness of breath, mobility decreased, nausea and diarrhea to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The vaccine was purchased with public funds. Approximately at 12 noon, the patient received BEXSERO as well as GARDASIL in her left deltoid and MENACTRA in her right deltoid. The patient left the office after vaccination. The reporter did not know the exact time when the patient experienced the symptoms. The patient reported a severe headache, nausea, one incident of diarrhea and shortness of breath and was taken to the emergency room on 11th August 2016, at approximately 10:00 am. The patient was discharged. On 12th August 2016, the patient came back to the pediatrician's office. She reported that her headache was less severe. She was not able to sit up or ambulate and was sent to the faculty practice's own hospital's emergency room which was a different facility that she was first seen in. On 19th August 2016, the patient would return to the physician's office for follow up.        This case was reported by a nurse via call center representative and described the occurrence of headache in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included GARDASIL 9 and MENACTRA. On 10th August 2016, the patient received the 1st dose of BEXSERO .5 ml. On 12th August 2016, 2 days after receiving BEXSERO, the patient experienced unable to walk (serious criteria GSK medically significant) and mobility decreased. In August 2016, the patient experienced headache (serious criteria other: as per reporter), shortness of breath, nausea and diarrhea. On an unknown date, the outcome of the headache, unable to walk and mobility decreased were recovering/resolving and the outcome of the shortness of breath, nausea and diarrhea were recovered/resolved. It was unknown if the reporter considered the headache, unable to walk, shortness of breath, mobility decreased, nausea and diarrhea to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The vaccine was purchased with public funds. Approximately at 12 noon, the patient received BEXSERO as well as GARDASIL in her left deltoid and MENACTRA in her right deltoid. The patient left the office after vaccination. The reporter did not know the exact time when the patient experienced the symptoms. The patient reported a severe headache, nausea, one incident of diarrhea and shortness of breath and was taken to the emergency room on 11th August 2016, at approximately 10:00 am. The patient was discharged. On 12th August 2016, the patient came back to the pediatrician's office. She reported that her headache was less severe. She was not able to sit up or ambulate and was sent to the faculty practice's own hospital's emergency room which was a different facility that she was first seen in. On 19th August 2016, the patient would return to the physician's office for follow up.               This case was reported by a nurse via call center representative and described the occurrence of headache in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included GARDASIL 9 and MENACTRA. On 10th August 2016, the patient received the 1st dose of BEXSERO .5 ml. On 12th August 2016, 2 days after receiving BEXSERO, the patient experienced unable to walk (serious criteria GSK medically significant) and mobility decreased. In August 2016, the patient experienced headache (serious criteria other: as per reporter), shortness of breath, nausea and diarrhea. On an unknown date, the outcome of the headache, unable to walk and mobility decreased were recovering/resolving and the outcome of the shortness of breath, nausea and diarrhea were recovered/resolved. It was unknown if the reporter considered the headache, unable to walk, shortness of breath, mobility decreased, nausea and diarrhea to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The vaccine was purchased with public funds. Approximately at 12 noon, the patient received BEXSERO as well as GARDASIL in her left deltoid and MENACTRA in her right deltoid. The patient left the office after vaccination. The reporter did not know the exact time when the patient experienced the symptoms. The patient reported a severe headache, nausea, one incident of diarrhea and shortness of breath and was taken to the emergency room on 11th August 2016, at approximately 10:00 am. The patient was discharged. On 12th August 2016, the patient came back to the paediatrician's office. She reported that her headache was less severe. She was not able to sit up or ambulate and was sent to the faculty practice's own hospital's emergency room which was a different facility that she was first seen in. On 19th August 2016, the patient would return to the physician's office for follow up.