Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gastrointestinal disorder
Clinical narrative: missed  a week of work; Hives ppeared in patches, around neck, abdomen, left arm, both breasts , right shoulder,  appearance of welts; itching hives; hives warmth to touch; uncontrollable Shivering; Fatigue, very fatigued; Dizziness; Myalgia; Weakness; Severe Headache; Gastrointestinal symptoms; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included diphenhydramine hydrochloride (Benadryl (Topical)).   On 26th November 2022, the patient received the 1st dose of Shingrix. On 26th November 2022, 1 hr after receiving Shingrix, the patient experienced shivering, fatigue, dizziness, myalgia, weakness, headache and gastrointestinal symptom nos. On 10th December 2022, the patient experienced hives, pruritus and skin warm. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the shivering, dizziness, myalgia, weakness, headache, gastrointestinal symptom nos and activities of daily living impaired were recovering/resolving and the outcome of the fatigue, hives, pruritus and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the shivering, fatigue, dizziness, myalgia, weakness, headache, gastrointestinal symptom nos, activities of daily living impaired, hives, pruritus and skin warm to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comments: The patient reported that she received first dose of Shingrix, in the left arm at a local pharmacy. The patient reported experiencing uncontrollable shivering, fatigue, dizziness, myalgia, weakness, severe headache, and gastrointestinal symptoms approximately an hour after receipt of dose. The patient reported all of those symptoms were greatly reduced by Friday 9th December 2022, with the exception of the fatigue.  The patient reported they were still very fatigued as of day of reporting.  The patient reported having to miss a week of work, due to their symptoms.  The patient reported developing hives on Saturday, 10th December 2022. The hives appear in patches on different parts of their bodies, before disappearing.  The patient reported hives had the appearance of welts. Hives were very itchy and warm to the touch.  The patient reported hives began around their neck on Saturday.  On Sunday, caller reported hives appeared on the right side of their abdomen and under the left arm. The patient reported hives appeared around both breasts on the day of reporting. The patient reported a few hours after the appearance of the hives around both breasts, the hives then appeared on the right shoulder and up the right side of the neck.  The patient reported all of the hives had resolves, except the hives on the right shoulder and on the right side of the neck. The patient reported most of the hives resolved after approximately 4 hours.  The patient reported being unaware of any allergies to any of the ingredients in the Shingrix vaccine. The reporter was consented to follow up. THe patient received Benadryl oral and topical as concomitant medication. Note: As per discrepancy in structural field and narrative the outcome of event shivering, dizziness, myalgia, weakness, severe headache, and gastrointestinal symptoms captured as recovering conservatively and clarification raised for same. Benadryl oral was not coded as per convention can not code NOS medication.