Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Somnolence, Tenderness
Clinical narrative: red bumps / on her back and stomach.  Just below her breasts down to her naval.; red bumps that itch / on her back and stomach.  Just below her breasts down to her naval; she was so fatigued / could hardly get out of bed.; she could hardly get out of bed; headache; felt nauseous; She slept all day / and then slept the whole night; she could hardly lift her left arm; severe shivering; felt cold; fever up to 102; she could hardly lift her left arm due to a stabbing pain/ arm was tender for 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Previously administered products included Shingrix (received 1st dose in her left arm and experienced slight pain in her left shoulder (refer case US2021053271)).   On 24th January 2021, the patient received the 2nd dose of Shingrix. On 24th January 2021, 2 hrs 30 min after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, shivering, feeling cold and fever. On 25th January 2021, the patient experienced fatigue, activities of daily living impaired, headache, nausea and sleepiness. On an unknown date, the patient experienced red rash and itchy rash. On 25th January 2021, the outcome of the shivering and feeling cold were recovered/resolved. On 26th January 2021, the outcome of the headache and nausea were recovered/resolved. On 27th January 2021, the outcome of the fever was recovered/resolved. On 28th January 2021, the outcome of the injected limb mobility decreased was recovered/resolved. In February 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fatigue, activities of daily living impaired and sleepiness were unknown and the outcome of the red rash and itchy rash were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, shivering, feeling cold, fever, fatigue, activities of daily living impaired, headache, nausea, sleepiness, red rash and itchy rash to be related to Shingrix.  Additional information was provided as follows: The patient received vaccine in left arm. Two and half hours after vaccination, the patient could hardly lift her left arm due to stabbing pain. The pain progressed throughout the night. It resolved a few days later by thursday but the arm was tender for 2 weeks.  Also, during the night of the second dose, she had severe shivering, felt cold and had a fever up to 102 degree celsius.  The cold feeling and shivering resolved by the afternoon the next day and the fever was gone by wednesday morning.  The morning after receiving the dose, she was so fatigued that she could hardly get out of bed also had a headache and felt nauseous.  The headache resolved by Tuesday afternoon and the nausea lasted about 27 hours.  She slept all day on Monday and woke for a few hours in early evening and then slept the whole night.  Approximately a week after the second dose, red bumps that itch presented on the patient's back and stomach, just below her breasts down to her naval.  They would resolve and then come back again.  This happened 4 to 5 times and were resolving at the time of reporting.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053271:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021053271:Same reporter US-GLAXOSMITHKLINE-US2021053253:same patient, same reporter , 2nd dose