Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Excessive eye blinking, Feeling abnormal, Induration, Injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (last year 2018), seizure (seizure, non epileptic due to trauma from a surgery years ago) and surgery. On 19th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a month after receiving SHINGRIX, the patient experienced seizure (serious criteria GSK medically significant), transient visual loss (serious criteria GSK medically significant), difficulty sleeping, arm infection, contusion, excessive eye blinking, tremor, speech impairment nos, pruritus, abdominal bloating and injury. On 19th February 2019, the patient experienced pain in arm, feeling bad, nausea, vomiting, stomach burning sensation of, stomach cramps and sickness. On 20th February 2019, the patient experienced erythema of extremities, swelling arm, skin warm and induration. The patient was treated with antibiotics nos, antiemetics and antinauseants (Nausea Medication (Nos)), analgesic, nos (Pain Medication (Not Specified)) and non-drug therapy (Cold Compresses). On an unknown date, the outcome of the seizure, transient visual loss, feeling bad, nausea, vomiting, stomach burning sensation of, stomach cramps, sickness, erythema of extremities, swelling arm, skin warm, induration, difficulty sleeping, arm infection, contusion, excessive eye blinking, tremor, speech impairment nos, pruritus, abdominal bloating and injury were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the seizure, transient visual loss, pain in arm, feeling bad, nausea, vomiting, stomach burning sensation of, stomach cramps, sickness, erythema of extremities, swelling arm, skin warm, induration, difficulty sleeping, arm infection, contusion, excessive eye blinking, tremor, speech impairment nos, pruritus, abdominal bloating and injury to be related to SHINGRIX. Additional details were provided as follows: The patient had no previous vaccines for shingles and had history of seizure, non-epileptic, due to trauma from a surgery years ago. The patient received dose of SHINGRIX in the left arm. The patient stated that evening had slight pain in arm and started feeling bad. Later that evening, the patient had nausea and vomiting. The patient stated it felt like to her there was pulling on her insides of stomach. The patient was sick throughout the night, her stomach was burning. The next morning her arm was very painful and the redness had covered from one side to the other, about the size of her fist. The patient felt heat in the redness and it was hard. The patient made calls to her pharmacist and let them know, the patient was seen by her physician on the following Friday, who said the patient had an infection in her arm, placed her on antibiotics and nausea medication and encouraged over-the-counter pain medication use. The patient stated, at the time of reporting she had pain in the arm, the patient did not sleep at night due to the pain. The patient was applying cold compresses. The patient stated the redness was black like a bruise, at the time of reporting. The patient noted she also had a seizure from the trauma of all the events. This occurred last Tuesday, the patient felt bad, her eyes blinked a lot, the patient lost her sight momentarily and had tremors. The patient said her voice or speech became like that of someone who had a had a stroke. The patient said at the time of reporting, walking into the doctor office it was like she was about to have another seizure. The patient added her stomach was bloated and was being referred to a GI physician. The patient did not plan to get the second shot of SHINGRIX and was advised by her physician not to. The patient consented to follow up.