Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disseminated varicella zoster virus infection, Ear, nose and throat examination, Magnetic resonance imaging head, Viral test
Clinical narrative: disseminated zoster; This literature-non-study case was reported in a literature article and describes the occurrence of DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated zoster) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.      The patient's past medical history included Lumpectomy (breast cancer). Concurrent medical conditions included Breast cancer. Concomitant products included EXEMESTANE for Breast cancer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated zoster) (seriousness criteria hospitalization and medically significant). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Herpes zoster, at an unspecified dose and frequency; VALACYCLOVIR [VALACICLOVIR] (oral use) for Herpes zoster, at an unspecified dose and frequency; GABAPENTIN for Herpes zoster, at an unspecified dose and frequency; DULOXETINE HYDROCHLORIDE (CYMBALTA) for Herpes zoster, at an unspecified dose and frequency; PREDNISONE for Herpes zoster, at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] (intravenous use) for Herpes zoster, at an unspecified dose and frequency. At the time of the report, DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated zoster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ear, nose and throat examination: Exam was notable for a tender left ear canal with yellow drainage and concern for vesicle formation. On an unknown date, Magnetic resonance imaging head: unremarkable with no evidence of meningeal involvement or inflammation. On an unknown date, Viral test: (Positive) Swab obtained from the ear canal was positive for varicella zoster..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated zoster) to be related.    Patient had a history of breast cancer treated with neoadjuvant chemotherapy.  Patient presented to clinic with a four-day history of left sided back pain initially thought to be musculoskeletal.  One day after evaluation in clinic, she developed an erythematous vesicular rash in the distribution of the L1 dermatome on her back and thigh consistent with herpes zoster.  Valacyclovir was initiated. Her pain and rash progressed to the L2 dermatome despite her use of gabapentin, cymbalta, and over the counter analgesics, thus prednisone was added.   One week later, patient returned to the clinic for left ear pain, headache, fatigue, and chills.  Company Comment: This is a literature non-study case concerning a 50-year-old, female patient with a history of a history of breast cancer treated with neoadjuvant chemotherapy and lumpectomy on exemestane maintenance therapy, who experienced the serious (due to medically significant and Hospitalization) unexpected event of Disseminated varicella zoster virus infection. The event occurred 6 days after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) -reported as booster dose. The patient presented to clinic with a four-day history of left sided back pain initially thought to be musculoskeletal. The following day, she developed an erythematous vesicular rash in the distribution of the L1 dermatome on her back and thigh consistent with herpes zoster. Valacyclovir was initiated for seven days. Her pain and rash progressed to the L2 dermatome despite her use of gabapentin, cymblata, and over the counter analgesics; thus predisone was added. One week later, she returned to the clinic for left ear pain, headache, fatigue, and chills. Exam was notable for a tender left ear canal with yellow drainage and concern for vesicle formation. Swab obtained from the ear canal was positive for varicella zoster. MRI of the brain was unremarkable with no evidence of menigeal involvement or infammation. The patient was hospitalized for disseminated zoster and treated with intravenous acyclovir for four days and ultimately discharged with a 14 day course of oral valacyclovir. The outcome of the event was not reported. The mentioned medical history remains as a confounder. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 50-year-old, female patient with a history of a history of breast cancer treated with neoadjuvant chemotherapy and lumpectomy on exemestane maintenance therapy, who experienced the serious (due to medically significant and Hospitalization) unexpected event of Disseminated varicella zoster virus infection. The event occurred 6 days after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) -reported as booster dose. The patient presented to clinic with a four-day history of left sided back pain initially thought to be musculoskeletal. The following day, she developed an erythematous vesicular rash in the distribution of the L1 dermatome on her back and thigh consistent with herpes zoster. Valacyclovir was initiated for seven days. Her pain and rash progressed to the L2 dermatome despite her use of gabapentin, cymblata, and over the counter analgesics; thus predisone was added. One week later, she returned to the clinic for left ear pain, headache, fatigue, and chills. Exam was notable for a tender left ear canal with yellow drainage and concern for vesicle formation. Swab obtained from the ear canal was positive for varicella zoster. MRI of the brain was unremarkable with no evidence of menigeal involvement or infammation. The patient was hospitalized for disseminated zoster and treated with intravenous acyclovir for four days and ultimately discharged with a 14 day course of oral valacyclovir. The outcome of the event was not reported. The mentioned medical history remains as a confounder. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.