Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Bone density abnormal, Dehydration, Laboratory test abnormal, Malaise
Clinical narrative: Put under the weather; This case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included total hysterectomy (she had a total hysterectomy when she was 42). Concurrent medical conditions included thyroid activity decreased and osteoporosis. Concomitant products included bupropion hydrochloride (Wellbutrin), atorvastatin calcium (Lipitor), acetylsalicylic acid (Aspirin), hydrochlorothiazide, estradiol, cetirizine hydrochloride (Zyrtec), levothyroxine, menatetrenone (Vitamin K2) and calcium.   On 25th February 2020, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details provided as follows: The patient received 1st dose of shingles vaccine 1.5 to 2 years ago and she received a dose of the shingles vaccine on 25th Feb 2020 and experienced osteoporosis and  reported that she doesn't know if it was the first dose or second dose, but she thinks that it must have been the second dose. The patient  reported that she has taken Aspirin for years and can't even remember when she started and was taking this because she wanted to offset side effects of estrogen. Caller reported that she had taken hydrochlorothiazide for 4 years and stopped in 2021 and reported that she was taking Hydrochlorothiazide before and after she had the stroke and reported that they recently took her off of Hydrochlorothiazide  because her labs said that she was dehydrated. Patient received Estradiol as an concomitant product and is still continuing and reported that she has been taking Estradiol for years. Caller reported that she has been taking Levothyroxine for years and reported that she was taking 75 mcg then 100 mcg now 112 mcg and she guessed her labs showed that she needed more. Patient received  concomitant Products Zyrtec for sinus and is still continuing. Caller reported that her blood pressure was not  real high when she began taking Hydrochlorothiazide and after she lost weight, her blood pressure was actually below normal. Caller reported that when she was overweight, her blood pressure was just elevated, about 135/80. Caller reported that she took the generic Zyrtec and reported that she took Zyrtec for years. Caller reported that she had started taking vitamins within the last year. Patient received Lipitor as a concomitant drug for cholesterol and reported that she was taken off of Lipitor because she was experiencing side effects. Caller was unable to provide product information for Lipitor. Caller reported that her bone density test about 3 years prior showed that she had osteopenia. Caller reported that her last bone density test showed osteoporosis and it really threw her as she was exercising, doing weight bearing exercise, had lost weight, and was eating right. Reporter asked what else can you do if you do all this and it gets worse. Caller reported that she would have been fine if her bone density was the same. Caller reported that she found out her thyroid levels were low since  many years ago, all after she had her hysterectomy. Caller reported that they do the Thyroid stimulating hormone (TSH )to see where it is. Caller reported that she had a total hysterectomy when she was 42 and  reported that she was put on estrogen following her hysterectomy and back then it was only Premarin. Caller reported that she couldn't get her balance. Caller reported that when she woke up from that surgery, she felt like a different person. that surgery, she felt like a different person. Caller reported that she took multi vitamin, vitamin B, vitamin K2, vitamin D3, and Calcium. Caller reported that she began taking the vitamin K2, D3, and Calcium because her last bone density test showed osteoporosis. Caller reported they just wanted to make sure she didn't have blood pressure problems. Caller reported that the Lipitor was dispensed in a pharmacy bottle and it just states to use before Mar2022. This case is linked with US2021AMR149519 (Wellbutrin), US2021AMR150392 (flu vaccine) and US2021AMR150404 (1st dose of shingles) via same patient and same reporter.   Upon internal review following corrections were performed on 22nd July 2021: On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced feeling unwell. The patient was also taking Levothyroxine for years and reported that she was taking 75 mcg then 100 mcg now 112 mcg and she guessed her labs showed that she needed more.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150404:Same reporter. US-GLAXOSMITHKLINE-US2021AMR150392:Same reporter. US-GLAXOSMITHKLINE-US2021AMR149519:Same reporter.