Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dysphonia, Erythema, Hypersensitivity, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included sunburn (in August 2017). Previously administered products included Allergy shot. Concurrent medical conditions included allergy. On 18th March 2019 13:45, the patient received the 1st dose of SHINGRIX. In March 2019, 7 hrs 15 min after receiving SHINGRIX, the patient experienced localized erythema, localized itching, allergy aggravated, sensitive skin and hives. On 18th March 2019, the patient experienced injection site pain, injection site erythema and injection site itching. On 23rd March 2019, the patient experienced hoarseness. The patient was treated with steroids NOS. On 20th March 2019, the outcome of the injection site pain, injection site erythema and injection site itching were recovered/resolved. On an unknown date, the outcome of the localized erythema and localized itching were not recovered/not resolved and the outcome of the allergy aggravated and sensitive skin were unknown and the outcome of the hives and hoarseness were recovering/resolving. The reporter considered the localized erythema, localized itching, allergy aggravated, sensitive skin, hives, injection site pain, injection site erythema, injection site itching and hoarseness to be related to SHINGRIX. Additional details were provided as follows: In August 2017, the patient had a fairly bad sunburn all over her body. On 18th March 2019 at approximately 1:45 PM, the patient received 1st dose of SHINGRIX, in the right arm. On the same day by 9 to 10 PM, the patient's back was red and itchy. Less than a day after vaccination, the patient also experienced pain at the injection which was red and itchy. After 1 day, it had also started to become red and itchy on her upper chest at morning and patient referred that as hives. The patient had spoken to two doctors. The first doctor said to speak with the allergist. He also suggested not to receive 2nd dose or suggested pre loading with medication to prevent a reaction or at least greatly reduce it. The allergist did not recommend pre loading with anti-histamines and steroids prior to receiving the 2nd shot of SHINGRIX because as per his opinion the patient might not knew if she was allergic or not. The patient had many allergies and she got steroid pack. On 20th March 2019, the injection site reactions were recovered. On 22nd March 2019, the patient did not hurt due to water during shower. On 23rd March 2019 after 5 days, the patient's voice became hoarse. On 25th March 2019 at morning, during the shower, the patient's chest and back redness and itchiness, which was started to resolve was reappeared. The patient stated that, due to the bad sunburn her skin became more sensitive, because normally the redness did not appear on the areas of her skin that had been covered by her bathing suit. The patient did not know if the vaccine was still attacking or the steroid pack was responsible for this as the patient took her last dose of steroid pack at morning only. Therefore, the patient was going to contact her doctor to give him an update and the number and ask that he call and see if she should receive the 2nd shot, which would be in September. The patient also enquired to GlaxoSmithKline representative regarding any further advice or recommendations regarding this matter. If she should indeed receive the 2nd injection as it was unpleasant for 3 to 4 days and she was 6 days out and was still red. The patient was disappointed, since she was on a COBRA GlaxoSmithKline plan, so the vaccine was free but it cost dollar 25 co pay for the doctor and another dollar 15 for medicine to counteract the reaction. The patient thought that, these reactions were due to SHINGRIX because by day two, the vaccine injection site was showing issues as well as her upper chest and back. The patient gave consent to follow up. Note: The patient stated her skin became sensitive after the sunburn that she previously had, also stated she developed many allergies, she referred rash on chest as hives. Therefore, we have considered time to onset for allergy aggravated, sensitive skin and hives as 7 hours 15 minutes similar to time to onset for rash on her back and chest.