Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, PPV, RVX, VARZOS, VARZOS
Symptoms: Ankle fracture, Cardiac operation, Gait disturbance, Incomplete course of vaccination
Clinical narrative: broken ankle; Difficult to walk; Only got the first dose of shingrix; Heart surgery; This serious case was reported by a consumer via call center representative and described the occurrence of cardiac operation in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis, Pneumococcal vaccine for prophylaxis, Influenza vaccine (Influenza vaccin) for prophylaxis and COVID-19 vaccine for prophylaxis.   Previously administered products included Varicella zoster vaccine (Patient received very first dose years ago).   On 14-NOV-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix, RSV vaccine, Pneumococcal vaccine, Influenza vaccin and COVID-19 vaccine. In JAN-2024, between 2 and 4 months after receiving Shingrix, not applicable after receiving Shingrix and RSV vaccine and an unknown time after receiving Influenza vaccin, the patient experienced cardiac operation (Verbatim: Heart surgery) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced ankle fracture (Verbatim: broken ankle), walking difficulty (Verbatim: Difficult to walk) and incomplete course of vaccination (Verbatim: Only got the first dose of shingrix). The outcome of the cardiac operation, ankle fracture and walking difficulty were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the cardiac operation, ankle fracture and walking difficulty to be related to Shingrix. It was unknown if the reporter considered the ankle fracture and walking difficulty to be related to RSV vaccine.     The company considered the cardiac operation to be unrelated to Shingrix, Shingrix and RSV vaccine. It was unknown if the company considered the ankle fracture and walking difficulty to be related to Shingrix and RSV vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2024 Patient got the first dose of shingrix on 14-NOV-2023, Patient asked that does she had to get both again or just the second dose.  Also, can someone come to home to administer as patient had a broken ankle. Difficult to walk to pharmacy. Patient had heart surgery in January 2024 for unknown reason and recently suffered a broken ankle. Patient states that she had the very first Shingles vaccine years ago when it first came out but could not remember the name. The patient states that her therapist had a patient that did not receive the second dose of Shingrix and ended up getting shingles down her back and leg. The patient recently received the pneumonia vaccine, RSV vaccine (manufacturer not specified), FLU vaccine (manufacturer not specified) and the COVID vaccine booster. Till the time of reporting patient did not received the 2nd dose of shingrix which led to incomplete course of vaccination. This was 1 of 2 linked cases reported by the same reporter.; Sender's Comments: Cardiac operation  is an unlisted event which is considered unrelated to GSK vaccines Shingrix (1st dose and 2nd dose) and RSV vaccine. US-GSK-US2024AMR147047:same reporter