Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Medical diet, Product administered at inappropriate site, Renal impairment, Seizure like phenomena
Clinical narrative: is now hyponatremic, has been hospitalized 5 times; is having kidney issues, has been hospitalized 5 times; allergy to a component of the vaccine, has been hospitalized 5 times; started having tremors, has been hospitalized 5 times; cause her to fall to the ground and flop, has been hospitalized 5 times; she will not take the 2nd dose of the Shingrix; Dizzy; administered the vaccine into her stomach, has been hospitalized 5 times; administered the vaccine into her stomach, has been hospitalized 5 times; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 16th April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. In August 2021, the patient experienced tremor (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the patient experienced hyponatremia (serious criteria hospitalization), kidney dysfunction (serious criteria hospitalization and GSK medically significant), allergic reaction (serious criteria hospitalization), dizziness and incomplete course of vaccination. The patient was treated with furosemide (Lasix). On an unknown date, the outcome of the tremor, hyponatremia and dizziness were not recovered/not resolved and the outcome of the fall, kidney dysfunction, allergic reaction, intramuscular formulation administered by other route, vaccine administered at inappropriate site and incomplete course of vaccination were unknown.   The reporter considered the tremor, fall, hyponatremia, kidney dysfunction, allergic reaction and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The case was reported by patient herself. The patient received her 1st dose of Shingrix and her physician administered the vaccine into her stomach, which led to intramuscular formulation administered by other route. The patient did not provide any of the information for the vaccine she was given (dose, lot, expiration date).  Four months after the Shingrix vaccine, the patient reported she started having tremor that cause her to fell to the ground and flop around like a fish.  The patient had been hospitalized 5 times since receiving the Shingrix vaccine but could not provide the exact dates, aside from one of the hospitalizations occurred on Thanksgiving Day.  She reported on one of the hospitalizations, she received a Lasix push.  The patient reported that she was nowhyponatremic, since moving to her newretirement community where she stated she was fed a lowsodium diet.  The patient reported that she had an appointment on the next day of reporting with a nephrologist to discuss the kidney issues she was having.  The reporter stated that she thought all these issues are because she had an allergy to a component of the Shingrix vaccine, but she could not state what her allergies are.  It was rpeorted that the patient was experiencing dizziness at the time of reporting when she stood up to move to the restroom. This would be months after the reported dose of Shingrix. The patient stated that it was due to the low sodium levels, and kidney issues she had developed. The patient reported, she would not take the 2nd dose of the Shingrix. The reporter consented to follow up.