Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Urticaria
Clinical narrative: Headache; Dizzy / Light headed; Blood pressure skyrocketed; Elevated serum calcium; Parathyroid levels; Potasium depleted; Hives / Chronic hives / Pressure hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) (batch number 353S5, expiry date 29th May 2021) for prophylaxis.   Concurrent medical conditions included gastroesophageal reflux disease and hypertension. Concomitant products included cetirizine hydrochloride (Zyrtec), ranitidine hydrochloride (Ranitidine), omeprazole, lisinopril, hydrochlorothiazide, potassium nos (Potassium), vitamins nos (Multivitamin), acetylsalicylic acid (Aspirin (Baby)) and benadryl (nos) (Benadryl).   On 28th January 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a month after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced headache, dizziness, increased blood pressure, serum calcium increased, parathyroid hormone increased and blood potassium decreased. The patient was treated with prednisone. On an unknown date, the outcome of the hives, headache, dizziness, increased blood pressure, serum calcium increased, parathyroid hormone increased and blood potassium decreased were unknown.   It was unknown if the reporter considered the hives, headache, dizziness, increased blood pressure, serum calcium increased, parathyroid hormone increased and blood potassium decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. This case had been reported by nurse. The agent did not collect date of birth of patient. The patient did not have an immediate reaction to the vaccine but was concerned of a delayed reaction.  The patient stated that within two weeks of receiving the vaccine she developed hives and continues to have hives daily. The allergist had diagnosed her with chronic hives and pressure hives.  Less than a year after receiving Shingrix, the patient's blood pressure had "skyrocketed" since vaccination requiring an increase in her blood pressure medication and that her potassium levels "got depleted" requiring supplementation. Less than a year after receiving Shingrix, the patient experienced headache, dizziness, and felt lightheaded. Additionally, the patient experienced elevated serum calcium levels, elevated parathyroid levels and was scheduled to see an endocrine surgeon next week regarding these issues. The patient initially treated the hives at home with Benadryl, however continues that a visit to the emergency room for treatment was required.  In the emergency room the patient was treated with a 10 day course of prednisone 20mg twice daily, Benadryl and 150mg of ranitidine twice daily. The patient did not have any prior history of allergies and continues that subsequent allergy testing has been completed by an allergist with results indicating she had no allergies; yet the hives persist.  The patient indicated that there was no changes to her routine, products used, etc. occurred since the time of vaccination and again emphasized that no allergies were found on testing. The patient stated that the allergist diagnosis (stated above) and that he informed her she would never have life threatening hives and all physicians involved (allergist, primary care and emergency room physicians) still recommend the second dose but she was concerned.  Regarding additional symptoms the patient stated her blood pressure was normally well controlled on 20mg lisinopril however dose had been doubled and additional medications added to regain control.  The patient already spoke to the pharmacist at CVS that administered the vaccine who called to verify no recalls had occurred on that particular batch, but agent unable to confirm if health care professional called to inquire and/or reported adverse event. Address provided was the patient address and not the vaccination address. The reporter consented to follow up. As per sales data sheet reported expiry date was changed from 1st February 2020 to 29th May 2021.      Lab Comments: On an unknown date lab test performed.