Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received SHINGRIX. On 9th May 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills and injection site pain. In May 2018, the patient experienced injection site erythema, myalgia, tiredness, injection site hyperesthesia and injection site swelling. On an unknown date, the outcome of the fever, tiredness, chills, injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the myalgia was unknown and the outcome of the injection site hyperesthesia was not recovered/not resolved. The reporter considered the fever, injection site erythema, injection site hyperesthesia, chills, injection site swelling and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. The reporter considered the tiredness to be possibly related to SHINGRIX. Additional details were provided as follows: The patient was an airline captain and said that his concern was that elderly persons who might received the SHINGRIX vaccine would not have good enough immune systems to handle it and said he was glad he did not have to fly a plane the next day after receiving the SHINGRIX vaccination and said he had already contacted the Food and Drug Administration (FDA) about his reaction. The patient had vaccinations previously his entire life and never had any reaction to any vaccine until the SHINGRIX vaccination. The patient's wife was a nurse and told him she had never seen a reaction  such as his in all her years as a registered nurse. The patient received SHINGRIX in the left deltoid muscle of the upper arm. It was reported that pain started during the injection (immediately) and lasted until might be 3 days later. In the early evening on the same day, the patient experienced chills with shivering and low grade fever which lasted for 2 days. Less than a week after vaccination, the patient experienced injection site erythema, possible myalgia, tiredness, touch sensitivity increased and injection site swelling. The entire area was described as the outside of his deltoid muscle of his left arm in which the vaccine had been administered was completely red and swollen, not just around the injection and was mildly painful thoughtnot excruciatingly painful. The patient could not recall exactly when the redness and swelling started after having received the vaccination. The patient considered taking some BENADRYL for the symptoms but did not take it. The upper left arm was still sensitive to the touch with redness at the time of reporting. The redness of the upper arm was improving, described as getting better each day. At the end of the call, when discussing the personal identifier solicited general adverse reactions, the reporter said he had had all of those listed (in the second bullet of the highlights of the prescribing information) except the headache and gastrointestinal symptoms, and then requested to end the call due to time constraints, so potential event of myalgia was added. The patient had denied permission to contact their physician.