Age: 77.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Dysstasia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: she could no longer stand; soreness at injection site; redness at injection site; swelling at injection site; bilateral leg muscle weakness; so tired that she slept all day; muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included heart disorder (sleeps on left arm due to unspecified cardiac issues) and spondylarthritis.   On 06-DEC-2023, the patient received Shingrix (right arm) and COVID-19 VACCINE (right arm). On 06-DEC-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at injection site), injection site erythema (Verbatim: redness at injection site) and injection site swelling (Verbatim: swelling at injection site). On 07-DEC-2023, the patient experienced muscle weakness lower limb (Verbatim: bilateral leg muscle weakness), tiredness (Verbatim: so tired that she slept all day), muscle soreness (Verbatim: muscle soreness) and difficulty in standing (Verbatim: she could no longer stand). The outcome of the injection site pain, injection site erythema and injection site swelling were unknown and the outcome of the muscle weakness lower limb, tiredness and muscle soreness were resolved (duration 1 day) and the outcome of the difficulty in standing was resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle weakness lower limb, tiredness, muscle soreness and difficulty in standing to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, muscle weakness lower limb, tiredness, muscle soreness and difficulty in standing to be related to Shingrix.   Additional Information: GSK receipt date: 08-DEC-2023 The reporter was the patient. On 6th December 2023, in the afternoon, received both a SHINGRIX (dose number unspecified) and a COVID-19 Vaccine (manufacturer unspecified) in the right arm. The reporter did not had lot number to provide at the time of call.  By that night, patient experienced soreness, redness and swelling at the injection site. Then next morning, patient went outdoors to pick up garbage and when she reached down, she found that she could no longer stand.  Due to bilateral leg weakness, she had to sit there until a neighbor came to assist her back into the house.  The patient had muscle soreness and was so tired that she slept the rest of the day.  The following day, she felt fine. The reporter requested that GlaxoSmithKline (GSK) not contact her physician right away, please wait until she had a chance to visit the physician.  On 06-DEC-2023, less than a day after receiving Covid-19 Vaccine, the patient experienced injection site pain, injection site erythema and injection site swelling. On 07-DEC-2023, 1 day after receiving Covid-19 Vaccine, the patient experienced muscle weakness lower limb, tiredness, muscle soreness and difficulty in standing. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle weakness lower limb, tiredness, muscle soreness and difficulty in standing to be related to Covid-19 Vaccine. The reporter did not provide any further details. The reporter consented to follow up.