Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Oral discomfort, Paraesthesia oral, Presyncope, Syncope, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of Guillain Barre syndrome in a 69-year-old male patient who received BOOSTRIX (batch number KP95K, expiry date 3rd December 2017). Concomitant products included ALTACE, Aspirin, carvedilol, Ferrous Sulphate, omeprazole, Probiotics, Tramadol, vitamin D and tizanidine. On 16th August 2016, the patient received BOOSTRIX (intramuscular) .5 ml. In August 2016, less than a week after receiving BOOSTRIX, the patient experienced lower extremities weakness of (serious criteria disability), stomach discomfort and burning sensation in face. On 16th August 2016, the patient experienced Guillain Barre syndrome (serious criteria disability, GSK medically significant and other: as per reporter) allergic reaction (serious criteria disability and other: as per reporter), unwell, paresthesia oral and dizziness. On 18th August 2016, the patient experienced syncopal attack. In September 2016, the patient experienced hives. On an unknown date, the patient experienced chest burning and oral discomfort. The patient was treated with prednisone, Steroids and Antihistamines. On an unknown date, the outcome of the Guillain Barre syndrome and allergic reaction were not recovered/not resolved and the outcome of the lower extremities weakness of, unwell, paresthesia oral, dizziness, stomach discomfort, syncopal attack, burning sensation in face, chest burning, oral discomfort and hives were unknown. The reporter considered the Guillain Barre syndrome, allergic reaction, lower extremities weakness of, unwell, paresthesia oral, syncopal attack and hives to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the dizziness, stomach discomfort, burning sensation in face, chest burning and oral discomfort to be related to BOOSTRIX. Additional details were reported as follows: On 16th August 2016, after vaccination the patient began to feel unwell on his way home from the office. The patient returned to the office, and was subsequently transported to the emergency room via ambulance. The patient complained of tingling in his mouth and tongue and felt that he would pass out within the hour. The patient was diagnosed with an allergic reaction to the BOOSTRIX injection and was treated with Steroids and Antihistamines. At that time the patient had no trouble breathing or swallowing and motor skills were normal. The patient was discharged to home with prednisone 40mg daily for 5 days. The patient returned to the emergency room on 15th August 2016, feeling that he would pass out. The patient blood pressure was elevated and was again discharged to home with diagnosis of near syncopal episode. On 22nd August 2016, the patient seen in the office with complaints of burning in the face, weakness in his legs and butterflies in his stomach. He was referred to an allergist and a neurologist. On 23rd August 2016, the patient visited the Allergist who prescribed him antihistamines. On 7th September 2016, the patient was again seen in his LMD's office with persistent complaints of burning in chest and lips and weakness in legs. On 15th September 2016, at the LMD's office, blood pressure remained elevated, hives were noted and the patient complained of lightheadedness, burning in the mouth and weakness in his legs. On 17th November 2016, the LMD reflected that the neurologist thought the patient's symptoms were consistent with Guillain Barre. The patient's weakness in the legs was considered to be disabling and persisted at the time of reporting. He was considered to be reasonably healthy prior to this episode and was not known as a complainer. The patient also received CENTRUM as a treatment drug. The reporter was open to contact.