Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral coldness, Sleep disorder, Tendonitis, Vaccine positive rechallenge
Clinical narrative: severe pain at arm of injection, left arm, deltoid / Pain radiates to the scapula and forehand / Cannot sleep on that arm; severe tendonitis; muscle pains; Worst pain at the injection site; hand gets cold; hand gets / numb; cannot move shoulder back at all. Cannot bend shoulder backward and has limited mobility.; shooting pains radiate from injection site, from the muscle, up the shoulder / through the neck / to the left side of my head / radiates to the scapula and forehand / Trigeminal radiation of pain / sometimes very disabling; shooting pains radiate from injection site, from the muscle, up the shoulder; shooting pains radiate from injection site, from the muscle / through the neck; shooting pains radiate from injection site, from the muscle / to the left side of my head; symptoms remain the same or worsen at times; This case was reported by a physician and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 2A3Z9, expiry date 14th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 12th September 2020 with batch number N42DE, expiry date 4th June 2022, refer case US2021069885). Concurrent medical conditions included pain in arm, tendonitis, muscle pain, injection site pain, cold hands, numbness in hand, joint range of motion decreased, pain, shoulder pain, neck pain and headache.   On 23rd December 2020, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm, tendonitis, muscle pain, injection site pain, cold hands, numbness in hand, joint range of motion decreased, pain, shoulder pain, neck pain, headache and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, tendonitis, muscle pain, cold hands and joint range of motion decreased were not recovered/not resolved and the outcome of the injection site pain, numbness in hand, pain, shoulder pain, neck pain, headache and condition aggravated were unknown.   It was unknown if the reporter considered the pain in arm, tendonitis, muscle pain, injection site pain, cold hands, numbness in hand, joint range of motion decreased, pain, shoulder pain, neck pain, headache and condition aggravated to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix in left arm deltoid and experiencing severe pain at arm of injection. The patient had been experiencing severe tendonitis and muscle pains and they were not easing up. Symptoms started after first dose; three months after the second dose, the symptoms remain the same or worsen at times. Pain radiated to the scapula and forehand. Worst pain at the injection site. Sometimes, the patient's hand gets cold and numb and I cannot move shoulder back at all. The patient could not bend shoulder backward and had limited mobility.  The patient could not sleep on that arm. Sometimes shooting pains radiate from injection site, from the muscle, up the shoulder and through the neck and sometimes to the left side of my head. Trigeminal radiation of pain at times, sometimes very disabling like shoulder was going to be ripped apart. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021069885:same reporter