Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hot flush, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included amlodipine, thyroxine sodium (Levothyroxine), liothyronine sodium (Liothyronine), losartan potassium (Losartan), pravastatin sodium (Pravastatin), paroxetine hydrochloride (Paroxetine) and metoprolol tartrate. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 1 day after receiving SHINGRIX, the patient experienced erythema of extremities, feeling bad, hot flashes, pain in arm and chills. 7 days after receiving vaccination, the patient experienced heart rate increased. SHINGRIX was discontinued. On an unknown date, the outcome of the erythema of extremities, heart rate increased, pain in arm and chills were recovered/resolved and the outcome of the feeling bad was unknown and the outcome of the hot flashes was recovering/resolving. It was unknown if the reporter considered the erythema of extremities, feeling bad, hot flashes, heart rate increased, pain in arm and chills to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the high on the left arm either the first, second, or third day of May 2018. The next day the patient noticed some redness and soreness of her left arm at the site of injection. The arm redness spread and got bigger halfway around her arm on both sides after a couple of days, and the soreness also included that whole area of redness. Within a day or two (less than a day) following the vaccination, the patient would have deep chills without any fever described as feeling like she was freezing and then she would get a hot flash. These two symptoms were described as being continuous  and made her felt sick described as feeling bad and ornery. One week after having the vaccination, the patient checked her blood pressure and heart rate. The patient heart rate was increased, described as being higher than her normal heart rate. The patient went to an urgent care facility due to the increased heart rate.   The physician performed an EKG (Electrocardiogram) at the urgent care facility and could find nothing wrong. The patient's cardiologist later read the results of the EKG (Electrocardiogram) and told her to visit her general practitioner to run blood tests to see what might have caused the increased heart rate. A month after the vaccination, her general practitioner did not run any blood tests and said that the symptom of increased heart rate was due to the SHINGRIX and that she could still see a circle on the arm where the redness had been but had largely faded out. There was no circle on the left arm or redness of the left arm or soreness. The physician told her that she still needs to have the second dose in the series, but she planned not to have the second dose in the series. The symptom of chills had now resolved. The hot flashes had not resolved but were described as improving in that they were now happening occasionally on a daily basis. The patient had not yet discussed the hot flashes with her health care professional. The reporter could not provide specific dosing details. The patient recently got a letter from the pharmacy. The patient called them and told her to contact GlaxoSmithKline to report the adverse event. The patient said her pharmacist told her he had not contacted GlaxoSmithKline about her symptoms. The patient described the symptoms of deep chills and hot flashes at first to have been in the beginning "happening 24/7".