Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Laboratory test abnormal, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Acute adrenal crisis; Acute kidney injury, creatinine greater than 6/Acute renal failure; Hypothyroidism; Malaise, ER admitted for four days; Sore throat; Nausea; Vomiting; Wasn't sleeping well; Was fatigued; Intermittent slurred speech; pain and suffering; Loss of enjoyment of life; TSH was elevated at over 15; Loose stools for one day; This serious case was reported by a consumer and described the occurrence of adrenal crisis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUBLOK QUAD) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   The patient's past medical history included hypothyroidism. Concurrent medical conditions included addison's disease and immunocompromised (from long-term corticosteroid use).   In NOV-2020, the patient received Shingrix, FLUBLOK QUAD and PNEUMOVAX 23. On an unknown date, an unknown time after receiving Shingrix, the patient experienced adrenal crisis (Verbatim: Acute adrenal crisis) (serious criteria hospitalization and GSK medically significant), acute kidney injury (Verbatim: Acute kidney injury, creatinine greater than 6/Acute renal failure) (serious criteria hospitalization and GSK medically significant), hypothyroidism (Verbatim: Hypothyroidism) (serious criteria hospitalization and GSK medically significant), malaise (Verbatim: Malaise, ER admitted for four days) (serious criteria hospitalization), sore throat (Verbatim: Sore throat) (serious criteria hospitalization), nausea (Verbatim: Nausea) (serious criteria hospitalization), vomiting (Verbatim: Vomiting) (serious criteria hospitalization), difficulty sleeping (Verbatim: Wasn't sleeping well) (serious criteria hospitalization), fatigue (Verbatim: Was fatigued) (serious criteria hospitalization), loose stools (Verbatim: Loose stools for one day) (serious criteria hospitalization), slurred speech (Verbatim: Intermittent slurred speech) (serious criteria hospitalization), thyroid stimulating hormone increased (Verbatim: TSH was elevated at over 15) (serious criteria hospitalization), pain (Verbatim: pain and suffering) (serious criteria hospitalization) and impaired quality of life (Verbatim: Loss of enjoyment of life) (serious criteria hospitalization). The patient was treated with ondansetron (Zofran) and famotidine (Pepcid). The outcome of the adrenal crisis, acute kidney injury, hypothyroidism, malaise, sore throat, nausea, vomiting, difficulty sleeping, fatigue, slurred speech, thyroid stimulating hormone increased, pain and impaired quality of life were not reported and the outcome of the loose stools was resolved (duration 1 day).   It was unknown if the reporter considered the adrenal crisis, acute kidney injury, hypothyroidism, malaise, sore throat, nausea, vomiting, difficulty sleeping, fatigue, loose stools, slurred speech, thyroid stimulating hormone increased, pain and impaired quality of life to be related to Shingrix.     It was unknown if the company considered the adrenal crisis, acute kidney injury, hypothyroidism, malaise, sore throat, nausea, vomiting, difficulty sleeping, fatigue, loose stools, slurred speech, thyroid stimulating hormone increased, pain and impaired quality of life to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2023 This report was considered as legally significant case. The patient stated that she was hospitalized after being given three vaccines at the same time and filed her complaint on 5th April 2023. According to the complaint the patient had telemedicine visit on November 25, 2020. The patient was 60 years at the time, and she was advised to get the three vaccinations of a flu shot, Prevnar 13 and a shingles vaccine and it was not told to space out the vaccines. Five days later, the patient had three vaccinations. The complaint notes that a registered pharmacist would have to approve her being administered the three vaccines which were Flublok Quad 2020-2021, Pneumovax 23 and Shingrix. On December 3, 2020, she had another telemedicine appointment and reported symptoms that started after she received three vaccines.  The patient reported malaise, sore throat, nausea, vomiting, she was not sleeping well, fatigued and had loose stools for one day.  The patient was prescribed Zofran for the nausea and Pepcid and told to go to the emergency room if her symptoms did not improve because of her underlying Addison's Disease. Two days later, the patient went to emergency room and was admitted for four days. Her charts show she had intermittent slurred speech, her TSH was elevated at over 15, and she had acute kidney injury with a creatinine greater than 6. The lab values were remarkably deranged the complaint states.  The patient was diagnosed with acute adrenal crisis, hypothyroidism and acute renal failure.  The viral respiratory panel was negative. It was reported that she should had known vaccines could act as a stressor to induce adrenal crisis especially given to the patient with the history of hypothyroidism, Addison's Disease and being immune compromised from long-term corticosteroid use.  She also accused the defendants of negligence, saying they should had known of her Addison's Disease and immune compromised history based on her medications. She said they also should had consulted about administering three vaccines at one time to an immunocompromised patient. The patient suffered a medical emergency that required hospitalization, incurred medical expenses, suffered loss of enjoyment of life, pain and suffering and other damages. The consumer seeks compensatory damages, pre and post-judgment interests and other relief. In 2020, an unknown time after receiving Shingrix, FLUBLOK QUAD and PNEUMOVAX 23, the patient experienced adrenal crisis, acute kidney injury, hypothyroidism, malaise, sore throat, nausea, vomiting, difficulty sleeping, fatigue, loose stools, slurred speech, thyroid stimulating hormone increased, pain and impaired quality of life. It was unknown if the reporter considered the adverse events to be related to FLUBLOK QUAD and PNEUMOVAX 23.