Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site pruritus, Injection site reaction, Malaise
Clinical narrative: Injection site itching; and erythematous macular rash at the site of shingles shot/patient awoke with a diffuse red rash on the face, trunk, lower extremities; and erythematous macular rash at the site of shingles shot/maculopapular pruritic rash; maculopapular pruritic rash; feeling of weakness in both legs/the patient felt numbness and weakness in both legs; headache; myalgia; malaise; feeling of weakness in both legs/the patient felt numbness and weakness in both legs; fewer lesions on upper extremities; This case was reported in a literature article and described the occurrence of injection site itching in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching (serious criteria hospitalization), red rash (serious criteria hospitalization), maculopapular rash (serious criteria hospitalization), itchy rash (serious criteria hospitalization), weakness of limbs (serious criteria hospitalization), headache (serious criteria hospitalization), myalgia (serious criteria hospitalization), malaise (serious criteria hospitalization), numbness of limbs (serious criteria hospitalization) and skin lesion (serious criteria hospitalization). The patient was treated with acyclovir and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching, red rash, maculopapular rash, itchy rash, weakness of limbs, headache, myalgia, malaise, numbness of limbs and skin lesion were recovering/resolving.   The reporter considered the injection site itching, red rash, maculopapular rash, itchy rash, weakness of limbs, headache, myalgia, malaise, numbness of limbs and skin lesion to be related to Shingrix.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of injection site itching; injection site rash (diffuse erythematous maculopapular rash); feeling of numbness and weakness in both legs; headache, myalgia, and malaise in a 54-years old female patient, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. The patient had no significant past medical history. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received Shingrix (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient presented with diffuse erythematous maculopapular rash, itching and a feeling of weakness in both legs. The patient's symptoms started with itching and erythematous macular rash at the site of shingles shot followed by headache, myalgia, and malaise which did not improve much with Benadryl. The next day, the patient felt numbness and weakness in both legs. On the third day, the patient awoke with a diffuse red rash on the face, trunk, lower extremities, fewer lesions on upper extremities. Her review of systems was negative except as mentioned. On examination, the patient was found to have a diffuse erythematous maculopapular pruritic rash, but no sensory, motor, cranial never or cerebellar signs. Infectious disease was consulted who recommended IV acyclovir considering early varicella with given morphology. The morphology of lesions did not change over a period of times and the VZV PCR of lesions came negative hence acyclovir was discontinued after three days. The patient's symptoms and rash improved over the hospital stay with supportive treatment, and the patient was discharged home on the fifth day of admission. This case has been considered as serious due to hospitalization. The author commented, "Shingrix is recommended by the Committee as the preferred shingles vaccine over live zoster vaccine (Zostavax) to prevent shingles and postherpetic neuralgia in immunocompetent adults age 50 years and older. The safety of shingrix was evaluated from the pool date of 8 clinical trials of more than 10,000 participants which showed 17% of vaccine recipients had grade 3 adverse events (preventing normal everyday activities). Grade 3 injection-site reactions (pain, redness, and swelling) were reported by 9.4% of vaccine recipients and grade 3 solicited systemic events (myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms) were reported by 10.8% of vaccine recipients. For grade 3 reactions, the median duration was 1 day for all systemic reactions and pain and 2 days for redness and swelling. The nature and duration of rash described in our patient has not been documented in any of the clinical trials." The author concluded, "Emergence of new adverse reactions which have not been reported are plausible with broader use of vaccine. Clinicians must have high index of suspicion for early recognition." This article corresponding to this case is not available for regulatory submission due to copyright restriction.