Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. On 4th July 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia, headache, fever, chills, pain in arm, erythema of extremities, swelling arm, general body pain, feeling unwell, mobility decreased and feels awful. On an unknown date, the outcome of the myalgia, headache, fever, chills, pain in arm, erythema of extremities, swelling arm, general body pain, feeling unwell, mobility decreased and feels awful were recovered/resolved. The reporter considered the myalgia, headache, fever, chills, pain in arm, swelling arm, general body pain, feeling unwell, mobility decreased and feels awful to be related to SHINGRIX. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient had vaccine side effects but she felt very ill. The patient did not think it was an adverse reaction but she had fever, chills, myalgia, arm red, arm pain and unable to move it for 3 days. The patient wanted to know if she could get the booster dose in 3 to 6 months, then she would be as sick or likely had less of a reaction. And if it could be as bad or worse, then she would likely not get the booster. The patient wanted to consult with representative who works closely with SHINGRIX. Later the call was transferred to a pharmacist as the patient requested. The patient felt terrible the day after the SHINGRIX vaccine and she experienced headache, myalgia, fever, chills and very painful, red, swollen arm. The patient could not get out of bed and she did not know if the booster vaccine would be the same, worse or likely not as bad. The pharmacist told the patient that, it could not be predicted how many patient will respond after receiving any vaccine, including the first or second dose of SHINGRIX. But there was some information that safety could share with her from the data collected in the clinical trials. While the patient's particular situation might not be the same, in general during the clinical trials they had seen that the patients reported that headache and shivering occurred more frequently during the second dose compared to the first dose of SHINGRIX. Grade 3 general adverse events (which were defined as an adverse event that prevented normal daily activities of the patient's) that were reported more frequently after dose 2 compared to dose 1 were headache, shivering, myalgia and fatigue. The patient had been provided with the link containing the SHINGRIX prescribing information. The patient told that, that link was helpful and as the patient was a nurse, she knew the first dose bolsters immunity but was not sure if the increased immunity would make the 2nd dose better or worse. Since the patient had what she considered a fairly adverse event contain prevented any activity, she did not think that she would put herself through this or a more severe reaction for another dose. The patient was asking about the effectiveness of just receiving the 1st dose of SHINGRIX. The pharmacist had consulted her that, the SHINGRIX trials had patients receiving 2 doses of SHINGRIX and they did not have any approved information regarding the efficacy after only one dose and suggested to her that since you were a nurse you might be able to call and get additional information from medical information department on this topic. The patient was agreed and she would be discussed with her physician. The patient had provided some additional information about the adverse events. The patient reported that, she did not report any adverse reactions to her physician as they occurred on (4th July 2018). The patient had fireworks, in her arm, head and all over her body. She knew it was the SHINGRIX and she had to just let the adverse events resolved. The patient gave consent to contact her physician and provided contact details for the same. At the time of this report, the patient felt comfortable and stated that all the symptoms were resolved. At the time of this report, the event sore arm was persisting. The patient had been informed that, the safety department might follow up with her or her physician to gather more information regarding her experienced with SHINGRIX.