Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Orbital myositis, Oropharyngeal pain, Pharyngitis, Sudden hearing loss, Tinnitus
Clinical narrative: Painful pharyngitis; Labrynthitis; IgM level was low showed that she has been exposed to Zoster virus but not recently; IgG high levels; Reactive airway disease; Randy Hunt Syndrome (chronic infection with zoster infection)/he had sudden left sided hearing loss and tinnitus/cold sore on his gums; left side Orbital myositis; This spontaneous report was received from a physician, concerning himself, a 77-year-old patient.  The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 24-AUG-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, once, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).   On an unknown date in 2008, the patient experienced randy hunt syndrome (chronic infection with zoster infection) (herpes zoster oticus) (Severe) and orbital myositis (Severe), resolved with nasal steroids. It was mentioned that he had a magnetic resonance imaging (MRI) (result not provided) and consulted experts. Then, in 2013, he had sudden left sided hearing loss and tinnitus, confirmed by otolaryngologist (ENT) with audiology testing. On 09-FEB-2018, the patient was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX) batch # 3z4kL (strength, formulation, expiry date, route of administration, and indication were not provided) and on 15- MAY-2018, he received the second dose of varicella zoster vaccine rge (cho) (SHINGRIX) (strength, formulation, lot #, expiry date, route of administration, and indication were not provided) (another suspect vaccine). It was reported that by happenstance steroid administration the symptoms went away, but it came back with a vengeance on unknown day in 2018 (reported as 2 months after varicella zoster vaccine rge [cho] [SHINGRIX]). On an unspecified day, he experienced new onset of painful pharyngitis with secretions in throat but no signs of inflammation despite repeated exams by ENT specialist. In addition, he had a normal biopsy under general anesthesia.  Then on unknown day in October 2020, the ENT specialist prescribed Valtrex (in response to suggestion by dentist because of a cold sore on his gums) and the symptoms disappeared (also reported as in one week the horrible pain went away), but it was reported that every time the patient stopped this medication it came back; he, eventually tapered off of it in 2022, and in 2023 unfortunately when stopped, the patient developed reactive airway disease (bronchial hyperreactivity) (Severe) that was poorly controlled, diagnosed by pulmonologist. In 2023 when he went off it was very severe, and on unknown day in May 2023, has been ill ever since reactive airway disease and pharyngitis just like before. Then, in 24-NOV-2023, he developed severe left sided hearing loss and tinnitus again, confirmed by audiology testing and received high dose prednisone (also reported as high doses of steroids) and dexamethasone injections in the ear and this brought mild improvement. In addition, Valtrex also showed large improvement in hearing loss and tinnitus and this went away except the tinnitus almost all gone due this medication.  On unknown day, he was diagnosed with labyrinthitis and, his immunoglobulin M was low at 0.62 (unit not provided), which showed that he had been exposed to plenty Zoster virus (varicella virus test positive), but not recently. On 16-APR-2024, high levels of immunoglobulin G (IgG) were found by a (polymerase chain reaction [PCR]) (blood immunoglobulin G increased). However, it was mentioned that this level of IgG was from the varicella zoster vaccine rge (cho) (SHINGRIX). On that same day (16-APR-2024), the patient received coronavirus 2019 (COVID 19) vaccination (unspecified), and suddenly all the inflammation became severe and had to restart prednisone (which was ongoing at the time of reporting).  Afterwards, it was reported that the physician would like to know the treatment for this condition. Dupilumab infusion (any experience with that), was an antibody to certain inflammatory factors used to decrease inflammation and Valtrex only worked on zoster and herpes simplex. It was tried to see an infection disease specialist, several refused, trying to get all records from ENT to send to infectious disease doctor as he had a pulmonologist and immunologist. Pulmonologist was knowledgeable in dupilumab administration, but it was for reactive airway disease not for Zoster issue (excess of eosinophil cells in bloodstream), however, it was considered that, zoster vaccine live (ZOSTAVAX) antibodies would help with that issue. It was mentioned that he had trouble getting care for this as all the physicians were stumped but could not deny the success of the Valtrex. Moreover, the patient would like access to infusion of antibodies to the suspect vaccine. At the time of reporting the outcome of the event of orbital myositis was reported as recovered, while the outcome of herpes zoster oticus, pharyngitis, bronchial hyperreactivity and labyrinths were considered as not resolved. The outcome of varicella virus test positive and blood immunoglobulin G increased were not provided.  The causal relationship between zoster vaccine live (ZOSTAVAX) and all the events was not provided (also reported as physician would like to know the treatments for this condition steaming from zoster vaccine live (ZOSTAVAX)). The causal relationship between blood immunoglobulin G increased was reported as related while with pharyngitis, labyrinthitis, varicella virus test positive, and bronchial hyperreactivity was not provided (the vaccine was administered after the remained events).  Upon internal review, the events herpes zoster oticus and orbital myositis were determined to be medically significant.  Lot # will be requested and submitted if received.