Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral coldness, Post herpetic neuralgia, Rash
Clinical narrative: migraines; Vertigo; extreme heaviness in my right arm; Electric shock feeling; weakness in hand and arm; Sensitive fingertips; Suspected vaccination failure; Shingles; Post herpetic neuralgia; water/shock sensitivity; Feeling of extreme shock when attempted to apply shaving cream on legs. Washing hands or showering; Pain progressed to pinched nerve-like feeling in shoulder and shoulder-blade area; Itchy rash; Blistering rash appeared in a straight line across right shoulder/ blistering rash along the waistline, just below bra-line and down thigh/Mid- July, another line appeared up calf beginning on the ankle/ Varicella-like rash; Burning; Tenderness at site; Cold sensation down arm; tingling in right hand and fingers/Pins & needles in fingertips/ extreme electric shocks in arm; Numbness in hand and fingers; Extreme tenderness in fingertips/ pain in hand; Vomiting; Achy; Chills; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4FNSF) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15-MAR-2021, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, the patient received the 1st dose of Shingrix. On 15-MAR-2021, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vomiting (Verbatim: Vomiting), pain (Verbatim: Achy), chills (Verbatim: Chills). On 16-MAR-2021, the patient experienced injection site tenderness (Verbatim: Tenderness at site), feeling cold (Verbatim: Cold sensation down arm), tingling of extremity (Verbatim: tingling in right hand and fingers/Pins & needles in fingertips/ extreme electric shocks in arm), numbness in hand (Verbatim: Numbness in hand and fingers) and pain in fingers (Verbatim: Extreme tenderness in fingertips/ pain in hand). On 22-MAR-2021, the patient experienced itchy rash (Verbatim: Itchy rash), blistery rash (Verbatim: Blistering rash appeared in a straight line across right shoulder/ blistering rash along the waistline, just below bra-line and down thigh/Mid- July, another line appeared up calf beginning on the ankle/ Varicella-like rash) and burning sensation (Verbatim: Burning). On 12-APR-2021, the patient experienced shoulder pain (Verbatim: Pain progressed to pinched nerve-like feeling in shoulder and shoulder-blade area). On 16-APR-2021, the patient experienced sensitive skin (Verbatim: water/shock sensitivity) and activities of daily living impaired (Verbatim: Feeling of extreme shock when attempted to apply shaving cream on legs. Washing hands or showering). On 18-MAY-2021, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). On an unknown date, the patient experienced migraine (Verbatim: migraines), vertigo (Verbatim: Vertigo), heaviness in arm (Verbatim: extreme heaviness in my right arm), electric shock sensation (Verbatim: Electric shock feeling), weakness of limbs (Verbatim: weakness in hand and arm) and increased skin sensitivity (Verbatim: Sensitive fingertips), . The outcome of the vaccination failure was unknown and the outcome of the shingles, post herpetic neuralgia, injection site tenderness, vomiting, pain, chills, feeling cold, tingling of extremity, numbness in hand, itchy rash, burning sensation, migraine, vertigo and electric shock sensation were not reported and the outcome of the pain in fingers, shoulder pain, sensitive skin, activities of daily living impaired, weakness of limbs and increased skin sensitivity were not resolved and the outcome of the blistery rash was resolved and the outcome of the heaviness in arm was resolving.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site tenderness, vomiting, pain, chills, feeling cold, tingling of extremity, numbness in hand, pain in fingers, itchy rash, blistery rash, burning sensation, shoulder pain, sensitive skin, activities of daily living impaired, migraine, vertigo, heaviness in arm, electric shock sensation, weakness of limbs and increased skin sensitivity to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. It was unknown if the company considered the injection site tenderness, vomiting, pain, chills, feeling cold, tingling of extremity, numbness in hand, pain in fingers, itchy rash, blistery rash, burning sensation, shoulder pain, sensitive skin, activities of daily living impaired, migraine, vertigo, heaviness in arm, electric shock sensation, weakness of limbs and increased skin sensitivity to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-Mar-2024 The patient received Shingrix vaccine and in the evening experienced vomiting in the evening, achy with chills. On 16th March 2021, patient continued achiness with chills all day, tenderness at site, cold sensation down arm (IV-like feeling), numbness and tingling in right hand and fingers, pins & needles and extreme tenderness in fingertips. On 22nd March 2021, patient had itchy, blistering rash appeared in a straight line across right shoulder with extreme burning. On 12th April 2021, patients pain progressed to pinched nerve-like feeling in shoulder and shoulder blade area, made a chiropractor appointment to see if this would help to alleviate the pain. After 3 visits, there was no improvement and it was too painful to continue. On 16th April 2021, one month after administration of the Zoster, Recombinant Adjuvanted Shingrix (2nd dose), the pain intensity has become progressively worse and feels like I am carrying dead weight, where she need to hold her arm up like it was in a sling.  The patient had burning sensation on fingertips, IV like feeling persists throughout right arm. Her outreached arm felt like it was being shocked.  The patient felt extreme shock when attempted to apply shaving cream on legs, Washing hands or showering difficult due to water/shock sensitivity. Unable to use fingertips on right hand. The patient reported adverse reaction to AHN primary care at 9:30 am. On 19th April 2021, patient had appointment at 2:20 pm with Primary Care EMG/NCV Tests ordered. On 18th May 2021, EMG scheduled with at 1:00pm. EMG showed no large nerve damage and no underlying condition. The neurologist stated he was convinced and she ended up getting shingles and had post herpetic neuralgia from the Shingrix shot. On May and June 2021, all above symptoms continued at the same pain intensity. Tried Gabapentin twice. Medication triggered migraines and vertigo; therefore was not worth continuing. As an Administrative Professional, she was no longer able to use computer keyboard, mouse/mousepad with right hand. She was adapted to using the mouse with my left hand and tap the keyboard using a pencil. She purchased a stand-up desk, so her right arm could be stabilized against the raised desk or office cabinet above. On July and August 2021, in 1st week in July, she broke out in a blistering rash along the waistline, just below bra-line and down thigh. In mid- July, another line appeared up calf beginning on the ankle and it took six weeks for all to be completely healed over. At the time of the rash in multiple sites, both the extreme electric shocks and extreme heaviness in her right arm seemed to lessen.  The chronic pain, electric shock feeling, sensitivity in fingertips and weakness in right hand and arm still persists. On September 2021, while out for her daily hour-long walk at lunchtime, she felt a strange jolt under her right breast. It was strong enough to stop her in my tracks. She was stopped, looked around and continued walking. This happened again 10 minutes apart. The following day, On 15th September 2021, she experienced another rash in a line from the top of her right breast the whole around the bottom of the breast. Approximately 20 chickenpox-like rash. This rash was very itchy with extreme burning once the blistered broke open. The patient contacted the physician office on 16th September 2021, where she had received the Shingrix vaccine, to ask for the lot number to see if it had been re-called for any reason. This lot number had not been re-called. On October 2021 to April 2023, the rashes continued, oddly on the 15th of month but would heal over within a day. On January 2024, another burning blistering rash in a line across the chest that healed over within a day. Now going on three years, the chronic burning pain in her right hand and extreme sensitivity in the fingertips still persists, in addition to a generalized weakness and recurring pain in her right arm and shoulder. She was unable to do my day-to-day without significant pain. Something as simple as washing her hands was difficult. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.