Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Feeling abnormal, Incorrect route of product administration, Loss of personal independence in daily activities, Malaise, Pain in extremity
Clinical narrative: Felt bad / malaise / how horrible she felt; Pain in her (right) shoulder; Arm was sore; Not feeling good in her head; not able to work; Intramuscular formulation administered by other route; Low energy; Vision has changed/deteriorated in 2 weeks; Cataracts atrelated / increasing size of cataracts; This case was reported by a consumer via call center representative and described the occurrence of vision abnormal aggravated in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE VACCINE) for prophylaxis.   The patient's past medical history included influenza (had flu twice) and shingles. Concurrent medical conditions included iron decreased, overweight, cataract (for 20-25 years), sinus disorder, vision decreased (patient's vision had gotten a lot worse since last year from the reporting date and her glasses were not helped) and contact lens wearer (patient wearing rigid gas permeable contact lenses).   On 17th August 2020 17:00, the patient received the 1st dose of Shingrix. On 17th August 2020, the patient received FLUZONE VACCINE. In August 2020, 2 weeks after receiving Shingrix, the patient experienced vision abnormal aggravated (serious criteria GSK medically significant), cataract aggravated (serious criteria GSK medically significant), malaise, shoulder pain, energy decreased, pain in arm, feeling bad and activities of daily living impaired. On 17th August 2020, the patient experienced intramuscular formulation administered by other route. The patient was treated with ophthalmologicals (nos). Shingrix was discontinued. In September 2020, the outcome of the malaise, shoulder pain, pain in arm, feeling bad and activities of daily living impaired were recovered/resolved. On an unknown date, the outcome of the vision abnormal aggravated, cataract aggravated and energy decreased were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the vision abnormal aggravated, cataract aggravated, malaise, shoulder pain, energy decreased, pain in arm, feeling bad and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The patient's (family history) grandmother had a history of ischemic stroke. The patient did not eat meat. The patient received 1st dose at pharmacy in right deltoid and she indicated that she would not be getting the second dose of the series. The patient was not sure if vaccine was given intramuscularly or not and she said she did not feel the injection as it was happened but about 24 hours later her right arm was sore. The patient received the Fluzone shot on the same day in her left arm and she was unable to find the Shingrix lot number on the paperwork but did provide the pharmacy's contact information, patient said that she felt bad for a week after receiving the Shingrix shot. The patient's symptoms started 24 hours after the shot and she said she had pain in her (right) shoulder and had malaise but was different from the flu.  The patient was not currently employed but stated that she did not think she would have been able to work due to how horrible she felt. It was 5 to 7 days before patient felt better from the reporting date. The reporter wanted to found out if Shingrix could cause change in vision, as per package Insert: optic ischemic neuropathy was reported in 3 subjects (0.02 percent) who received Shingrix (all within 50 days after vaccination) and 0 subjects who received placebo; available information was insufficient to determine a causal relationship with Shingrix. The reporter would like someone from GlaxoSmithKline to contact her new eye doctor. The reporter would have an appointment with this doctor on October 21, 2020 and she states she was between doctors right now.  The reporter went to an ophthalmologist and spent 400 Dollar there. The patient's vision had gotten a lot worse since last year from the reporting date and her glasses were not helped.  The patient had bad vision, vision had decreased, right eye was much worse, vision loss was continued to change, vision had changed/deteriorated in 2 weeks.  The reporter could not see out of her new glasses on the right side and vision loss was continued. The patent was 54 years old and healthy and she used to exercise for 1.5 hours per day but she had not been able to do that since the Shingrix shot due to low energy. The patient did blood work on the day of vaccination and the blood work showed that she had low iron. The patient did not felt good in her head and was unsure if the cause was sinuses or side effect from Shingrix vaccine that was also assiciated with previously reported vision changes. The patient's eye doctor informed consumer that the cataracts atrelated and are no longer dots or specs and they had became bigger than dots.  The reporter unsure if increased size of cataracts associated with Shingrix or not. The reporter wanted someone to contact her MD. This case had been linked with US2020191513, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020191513:same reporter