Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Ear canal erythema, Erythema, Herpes zoster, Herpes zoster infection neurological
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of herpes zoster infection neurological in a 72-year-old male patient who received SHINGRIX. Co-suspect products included OFEV capsule for pulmonary fibrosis. Concurrent medical conditions included pulmonary fibrosis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started OFEV 150 mg twice daily (300 mg daily). In April 2018, 3 days after receiving SHINGRIX, the patient experienced herpes zoster infection neurological (serious criteria GSK medically significant), pain, rash, ear canal erythema, vesicles, mucosa vesicle, vesicular eruption, papular rash, facial paresthesia and crust. The patient was treated with ADVIL, Ice Pack and TYLENOL. The action taken with OFEV was unknown. On an unknown date, the outcome of the herpes zoster infection neurological, pain, rash, ear canal erythema, vesicles, mucosa vesicle, vesicular eruption, papular rash, facial paresthesia and crust were unknown. The reporter considered the herpes zoster infection neurological, pain, rash, ear canal erythema, vesicles, mucosa vesicle, vesicular eruption, papular rash, facial paresthesia and crust to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician assistant. The reporter provided his electronic chart notes describing the patient's adverse events. The electronic chart note was electronically signed by the reporter on 24th April 2018 at 10:36 AM. The patient received his SHINGRIX vaccine exactly one week ago before the preparation of the electronic chart note and about three days prior to the onset of symptoms. The patient experienced classic herpes zoster (HZ) to the V2 distribution to the right trigeminal nerve on his face. The patient started having tingling and abnormal skin sensation to his right face and jaw that began 3 days after the SHINGRIX vaccine. 2 days before the signing of the electronic chart note, the pain became more severe, in which case he applied an ice pack. Less than a week after vaccination, the patient experienced rash to the jaw, right auditory canal erythema with small vesicles at the opening to the canal, blisters to his chin and inner mouth, honey-colored crusting and vesiculopapular eruption. One day before the signing of electronic chart note (yesterday), the started to develop a rash to the right jaw line which is worsened as of today. At the time of signing of electronic chart note, the patient had noted blisters to his chin and inner mouth. The patient denied any fever, headache, stiff neck, or vision change. He denied any hearing loss, tinnitus, or vertigo. He had been taking ADVIL and TYLENOL without relief. Tympanic membrane (TM) was without bulging or erythema. Oral mucosa moist with vesicles noted at the right lower inner lip into the right cheek without erythema or evidence of cellulitis. Skin was reported with vesiculopapular eruption to the right V2 distribution of the trigeminal nerve more notably involving the angle of the jaw and more centrally to the right chin where there were ruptured vesicles with honey-colored crusting. Assessment and plan reported in electronic chart note was reported as below: The reporter mentioned that he did not see many case reports of shingles being caused so quickly after SHINGRIX vaccination, however this was a new vaccine. The reporter consider possible association with the patient's baseline medication, OFEV, for his pulmonary fibrosis. The reporter would prescribe Valacyclovir 1000 mg three times daily. This does appear to be more aggressive course of SHINGRIX although no evidence of Ramsey Hunt syndrome, emergency precautions given for any hearing loss, redness of the eye, fevers, etc. the reporter would prescribe Mupirocin for topical blisters and tramadol for pain. Close follow up for any new or worsening symptoms would be done. The patient was recommended to report to VAERS. Follow up would be done in one week if not contacted specifically at phone extension. The physician assistant's theory was that the SHINGRIX possibly caused these symptoms in combination the patient's OFEV therapy.