Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: flat red areas; Lower back began itching/itching returned to back,nape of neck, behind both ears, right side and forearm / Itching spread to thighs, scalp, face,tops of feet,both forearms and rash on upper left arm; Itchy rash on upper left arm/Intermittent itchy rash with spread to lower left back/ raised rash on my left arm; possible hive below left eye / hives on back; allergic reaction; Fever was just under 102° / temperature of 99°/ Temperature was 98.8°; very cold; Full body muscle pain: arms, legs, upper back; I couldn't control my hands to unbutton my clothes; Unsteady while walking due to severe shivering; Worsening headache / severe headache; Felt unusually tired / Tiredness/ progressively worsening; Shivering / Shivering was so bad that I couldn't control my hands to unbutton my clothes / teeth chattering; body aches; Full body muscle pain: arms, legs, upper back/aching in upper left arm / mild upper left arm ache; bruising at bottom of lower rash; This case was reported by a consumer and described the occurrence of allergic reaction in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (mild case chickenpox at the age of 12 or 13 years). Previously administered products included Flu vaccine with an associated reaction of fatigue (1st dose received on 1st September 2020, refer case US2020AMR234499). Concurrent medical conditions included drug allergy (allergy to Sulfa drugs). Concomitant products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13).   On 16th November 2020 11:00, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced contusion. On 16th November 2020, the patient experienced shivering, general body pain, headache, tiredness, generalized muscle aches, mobility decreased, unsteady gait and pain in arm. On 16th November 2020 18:00, the patient experienced allergic reaction, fever and feeling cold. On 17th November 2020, the patient experienced hives. On 19th November 2020, the patient experienced pruritus and itchy rash. On 20th November 2020, the patient experienced erythema. The patient was treated with paracetamol (Tylenol) and prednisone. On 17th November 2020, the outcome of the shivering and unsteady gait were recovered/resolved. On 20th November 2020, the outcome of the pruritus and hives were recovered/resolved. On 21st November 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the allergic reaction, general body pain, itchy rash, fever, feeling cold, generalized muscle aches, mobility decreased, pain in arm, erythema and contusion were unknown and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the allergic reaction, shivering, general body pain, pruritus, itchy rash, headache, tiredness, fever, feeling cold, generalized muscle aches, mobility decreased, unsteady gait, hives, pain in arm, erythema and contusion to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself/himself. The patient never had shingles. On 16th November 2020, the patient felt unusually tired beginning early afternoon, progressively worsened. After 6 PM was very cold with temperature of 99 degree F, had full body muscle pain: arms, legs, upper back, Side effects were at their worst from 8 PM - 8 AM on 17th November 2020. The patient had worsening headache, shivering and teeth chattering, was unsteady while walking due to severe shivering. Shivering was so bad that patient could not control hands to unbutton clothes and went to be fully dressed. On 17th November 2020, fever was just under 102 degree F at 2:15 AM with severe headache. The patient placed a cold pack from the freezer on head throughout the night. Shivering and teeth chattering stopped about 4 AM. On 17th November 2020, the patient woke with severe headache with possible hive below left eye approximately at 6:30 - 7AM. The Temperature was 98.8 degree F at 8 AM. The patient slept until noon. Upon waking patient had only aching in upper left arm, no other side effects, possible hive were cleared. There was no further unsteadiness while walking. On 17th November 2020, mild headache returned around 1:30 PM The patient took 1 extra strength Tylenol at 2:20 PM, temperature was 99 degree F at 3 PM. The patient was instructed to continue Tylenol through Tuesday night only. The patient took 1 extra strength Tylenol at 6:20 PM, temperature remained 99 degree F On 18th November 2020, took last 1 extra strength Tylenol at 12:08 AM. On 18th November 2020, the patient woke with mild headache and body aches approximately 6:30 - 7AM. The temperature was 96 degree F at 11 AM, 98.6 degree F at 1 PM and 4 PM. The patient had intermittent mild headache and mild full body aches continued. On 19th November 2020, the temperature was 99 degree F at 8 PM and 12:05 AM. On 19th November 2020, the patient woke with headache, mild upper left arm ache and Itchy rash on upper left arm approximately 6:30 - 7AM. The temperature was 98.6 degree F at 10:30 AM, 98.4 degree F at 1:30 PM and 4:30 PM, 98.2 degree F at 8 PM. The patient had intermittent mild headache and mild upper left arm ache continued. The patient had intermittent itchy rash with spread to lower left back with hives. The patient had rash on left arm, hives on back had cleared. The patient was prescribed Prednisone 20 mg tabs to be taken 2 tabs once daily for 2 days. On 20th November 2020, the temperature was 98.4 degree F 12:05 AM, 96 degree F at 11 AM. On 20th November 2020, the patient woke with headache approximately 6:30 - 7AM. The rash on upper left arm was fading. Lower back began itching early afternoon with flat red areas with no hives. The patient had intermittent mild headache with no arm or body aches. The temperature was 98.6 degree F at 1:45 PM, 98 degree F at 7 PM, 97 degree Fat 11 PM. The patient took 2 Prednisone 20 mg tabs at 2 PM. The headache, rash and back itching was gone by 4 PM. The intermittent mild headache returned about 6 PM, sporadically continued. On 21st November 2020, the patient woke to mild headache and itchy back and right side about 7 AM, subsided about 9 AM. The temperature was 98 degree F at 8:20 AM, 98 degree F at 11:30 AM, 99.2 degree F at 4:30 PM, 98 degree F at 8 PM, 97 degree F at 11:30 PM. The rash on upper left arm had returned. The patient had intermittent mild headache, itching returned to back, nape of neck, behind both ears, right side and forearm. The patient took last 2 Prednisone 20 mg tabs at 1 PM with only headache relieved after 3 PM but returned at 4 PM. The itching spread to thighs, scalp, face, tops of feet, both forearms and rash on upper left arm. The headache and itch remained constant and varied in intensity. On 22nd November 2020, mild itching began at rash on upper left arm and then spread to more parts of the body. The temperature was 98.4 degree F at 10 AM, 97.4 degree F at 3 PM, 97.2 degree F at 11:30 PM.  Widespread mild itching had continued. On 23rd November 2020, mild itching began at rash on upper left arm and then spread to more parts of the body. The temperature was 98.4 degree F at 10:30 AM. The patient had raised rash on left arm, bruising at bottom of lower rash.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234499:same reporter