Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: redness at the injection site, looks as if someone puched arm; Pain at injection site, looks as if someone puched arm; tired and fatigued; looks as if someone puched her in the arm; chills; nausea; manic symptoms, feels like drank 10 cups of coffee; Anxiety; unable to sit still; unable to sleep; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 34L52, expiry date 6th July 2023) for prophylaxis.   Previously administered products included LEVAQUIN with an associated reaction of manic symptom (received dose of Levaquin in 2017 and experienced manic symptoms). Concomitant products included venlafaxine hydrochloride (Efexor).   On 30th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th May 2022, 12 hrs after receiving Shingrix, the patient experienced manic symptom, anxiety, restlessness and sleeplessness. On 31st May 2022, the patient experienced chills and nausea. On an unknown date, the patient experienced injection site erythema, injection site pain, fatigue and pain in arm. The patient was treated with paracetamol (Tylenol) and clonazepam. On an unknown date, the outcome of the injection site erythema, injection site pain, manic symptom, anxiety, restlessness, sleeplessness, fatigue and pain in arm were not recovered/not resolved and the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, manic symptom, anxiety, restlessness, sleeplessness, chills, nausea, fatigue and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The pharmacist was reporting on behalf of the patient.  The reporter reported that the patient received first dose of Shingrix into right deltoid, and approximately 12 hours later, the patient experienced manic symptoms, anxiety, unable to sit still, and unable to sleep.  The pharmacist reported that the patient still had manic issues at the time of the reporting. The pharmacist also reported that the patient experienced redness and pain at the injection site, but was unsure it that had resolved. AE (adverse event) filed. The patient had a red, sore arm near injection site. The patient reported it looks as if someone punched her in the arm.  The patient was taking Tylenol for this.  The patient reported that she experienced chills and nausea the day after the Shingrix vaccine and also reported that she was very tired and fatigued. The patient reported that manic symptoms. The patient reported that she felt like she drank ten cups of coffee. The patient reported that when she lays down she can not sleep, patient was restless.  The patient's doctor just prescribed her Clonazepam at bedtime to the end of the week to alleviate symptoms. The patient reported that she currently taking Effexor. The patient reported that she had an adverse reaction to Levaquin in 2017 in which she also experienced manic symptoms. The patient gave consent to follow up with HCP (Health care professional).