chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle pain; Headache; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, muscle pain and headache. On an unknown date, the outcome of the fever, muscle pain and headache were unknown.   It was unknown if the reporter considered the fever, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of shingrix, experienced fever, muscle pain and headache.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site redness; Injection site itching; This case was reported by a consumer and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced redness and itching about an inch below the injection site which started a day after injection and had continued a week after injection. It was very itchy at times. The patient asked what was the usual range of time. The patient was concerned about the reaction as it was lasting for a week. The pharmacist reported that the individual responses can vary, but the majority of solicited local adverse reactions and general adverse events seen with Shingrix in the two pivotal clinical trials had a median duration of 2 to 3 days.  Solicited adverse reactions were collected for 7 days after each dose. Some patients may continue to experience reactions beyond 3 days. Unsolicited adverse events were collected for 30 days after each dose. The pharmacist recommend that if localized reaction occurs, such as soreness, redness, itching, or swelling at the injection site, apply a cold compress to the injection site. Consider giving an analgesic (pain reliever) or antipruritic medication.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Somnolence
Clinical narrative: arm a bit sore; a bit achy/ slightly aching; feeling groggy; This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included acyclovir.   On 21st August 2019, the patient received the 1st dose of Shingrix. On 22nd August 2019, 1 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced pain in arm, pain and groggy. On an unknown date, the outcome of the pain in arm, pain and groggy were unknown.   It was unknown if the reporter considered the pain in arm, pain and groggy to be related to Shingrix.  Additional case details were provided as follows: The patient was taking acyclovir 1g (1000mg) daily due to dentist induced herpes virus.  The patient received Shingrix in right arm. The batch number and expiry date was not known. The next morning, she woke up to achy right arm and feeling groggy.  The patient stated, she had no real side effects except her arm was sore, was slightly aching but nothing serious. The patient did not want to receive mail from GlaxoSmithKline and did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2015).   In September 2018, the patient received the 1st dose of Shingrix. In November 2018, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. In November 2018, patient came down with a very mild case of the shingles. The patient enquired when it was time for them to get the second Shingrix injection in January 2019. The patient was advised not to have it because of recent bout with the shingle. For tolerance of 2nd dose of vaccine, refer case US2019AMR154678. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: arm has a very red rash; Arm very sore / arm hurts; feverish; This case was reported by a consumer and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received in 2015) and Shingrix with an associated reaction of herpes zoster (received 1st dose in September 2018 on unknown date, refer case US2019AMR154665.).   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced red rash, pain in arm and fever. On an unknown date, the outcome of the red rash, pain in arm and fever were not recovered/not resolved.   It was unknown if the reporter considered the red rash, pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported at time of reporting. When the patient went to get the second Shingrix injection in January 2019, the patient was advised not to have it because of her my recent bout with the shingles. In July 2019, the patient talked to the pharmacist at her local pharmacy about Shingrix. They said since it had been over 6 months since the first injection. The patient would need to get the first dose again which patient did two weeks ago (August 2019) and the second injection in 2 to 6 months. After receiving the first dose the second time, the patient's arm had a very red rash, very sore and feverish and hurts. The patient read that these type of side effects should clear up in a few days yet patient still experiencing them after several weeks. The patient was confused as to whether should proceed with the second injection come October of 2019 considering the patient had 2 injections within a year, had shingles and now this reaction. The patient asked that what was there recommendation based on patient history as explained above.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Injection site pain, Pain
Clinical narrative: tender injection spot; feeling achey/lots of aches; headache; chills; fever/body temperature; Feeling miserable; This case was reported by a consumer and described the occurrence of injection site tenderness in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019 10:00, the patient received Shingrix. On 21st August 2019, less than a day after receiving Shingrix, the patient experienced feeling miserable. On 21st August 2019 09:00, the patient experienced injection site tenderness, pain, headache, chills and fever. On an unknown date, the outcome of the injection site tenderness, pain, headache, chills, fever and feeling miserable were unknown.   It was unknown if the reporter considered the injection site tenderness, pain, headache, chills, fever and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and was feeling ache and went to bed, had a headache, chills, 102 degree temperature, lots of aches, and tender injection spot. Felt miserable all night. The fever has broken at reporting time. The reporter asked how long would these symptoms last.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: tender injection spot; feeling achey/lots of aches; headache; chills; fever/body temperature; Feeling miserable; This case was reported by a consumer and described the occurrence of injection site tenderness in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019 10:00, the patient received Shingrix. On 21st August 2019, less than a day after receiving Shingrix, the patient experienced feeling miserable. On 21st August 2019 09:00, the patient experienced injection site tenderness, pain, headache, chills and fever. On an unknown date, the outcome of the injection site tenderness, pain, headache, chills, fever and feeling miserable were unknown.   It was unknown if the reporter considered the injection site tenderness, pain, headache, chills, fever and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and was feeling ache and went to bed, had a headache, chills, 102 degree temperature, lots of aches, and tender injection spot. Felt miserable all night. The fever has broken at reporting time. The reporter asked how long would these symptoms last.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 21st August 2019, 1 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The patient reported that, received vaccine on tuesday afternoon and experienced chills on wednesday late afternoon. The patient did not provide any other personal information.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Dysphagia, Feeding disorder, Oropharyngeal discomfort, Swelling face
Clinical narrative: feel bloated; my throat didnt feel right; cant eat much; face is a little swollen; Its getting hard to swallow; This case was reported by a consumer and described the occurrence of bloated feeling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On 18th August 2019, 5 days after receiving Shingrix, the patient experienced bloated feeling, throat discomfort, unable to eat, facial swelling and swallowing difficult. On an unknown date, the outcome of the bloated feeling, throat discomfort, unable to eat, facial swelling and swallowing difficult were unknown.   It was unknown if the reporter considered the bloated feeling, throat discomfort, unable to eat, facial swelling and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On or about the 18th August 2019, the patient noticed that her throat did not feel right. It's getting hard to swallow. Overall, she felt bloated, and could not eat much. The patient face was a little swollen, but no one else would notice. The patient noticed it because of her facial lines were not as noticeable. The patient stated that she read the information that states that reactions usually occur within a few hours after receiving the vaccine. The patient asked if it possible that she getting a delayed reaction to it.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. It was reported that the patient experienced flu like symptom, after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Musculoskeletal pain, Myalgia, Restlessness
Clinical narrative: Very sore upper right arm at the injection site; Sore shoulder/ very sore upper right arm/shoulder; Muscle aches on the right side; Shivering; Had a very restless night; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included tadalafil (Cialis).   On 22nd August 2019, the patient received the 1st dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, shoulder soreness, muscle pain, shivering and restlessness. On an unknown date, the outcome of the injection site pain, shoulder soreness, muscle pain, shivering and restlessness were unknown.   It was unknown if the reporter considered the injection site pain, shoulder soreness, muscle pain, shivering and restlessness to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received Shingrix in the right upper arm.  The patient took usual dose of adalafil 20 mg (Cialis) yesterday after dinner, before bedtime. No other medications were taken. The patient was fine throughout the evening until bedtime and then started to have symptoms including a very sore upper right arm or shoulder at the site of the injection, muscle aches on the right side and shivering through the night and into the morning. The patient had a very restless night. The patient wore winter layers in the office on 23rd August 2019, which helped. The patient did not reported fever.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue
Clinical narrative: shivering; Upset stomach; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivering, upset stomach and tiredness. On an unknown date, the outcome of the shivering, upset stomach and tiredness were unknown.   It was unknown if the reporter considered the shivering, upset stomach and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose and experienced shivering, upset stomach and tiredness. The patient asked how many days the side effects would last.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Chills, Dizziness, Feeling abnormal
Clinical narrative: Feel bad; chills; headache; nauseated; threw up/ threw up twice last; no energy; dizzy; muscle pain; waking up at night; left hand was burning; feels like Flu A; This case was reported by a consumer and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE with an associated reaction of influenza (received both Flu A shot and experienced Flu A on unknown date, refer case).   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation and influenza-like symptoms. On 23rd August 2019, the patient experienced feeling bad. On an unknown date, the outcome of the chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation, influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient got Shingrix in the left deltoid. The patient had all of the symptoms by 10pm in the night of 22nd August 2019. The reporter stated that she had chills, headache, nauseated, threw up twice last night, no energy, dizzy, muscle pain. She kept waking up at night and her left hand was burning. The patient said this feels like Flu A. The patient still had the symptoms on 23rd August 2019 and she felt bad.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Middle insomnia, Myalgia, Nausea
Clinical narrative: Feel bad; chills; headache; nauseated; threw up/ threw up twice last; no energy; dizzy; muscle pain; waking up at night; left hand was burning; feels like Flu A; This case was reported by a consumer and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE with an associated reaction of influenza (received both Flu A shot and experienced Flu A on unknown date, refer case).   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation and influenza-like symptoms. On 23rd August 2019, the patient experienced feeling bad. On an unknown date, the outcome of the chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation, influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient got Shingrix in the left deltoid. The patient had all of the symptoms by 10pm in the night of 22nd August 2019. The reporter stated that she had chills, headache, nauseated, threw up twice last night, no energy, dizzy, muscle pain. She kept waking up at night and her left hand was burning. The patient said this feels like Flu A. The patient still had the symptoms on 23rd August 2019 and she felt bad.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Feel bad; chills; headache; nauseated; threw up/ threw up twice last; no energy; dizzy; muscle pain; waking up at night; left hand was burning; feels like Flu A; This case was reported by a consumer and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE with an associated reaction of influenza (received both Flu A shot and experienced Flu A on unknown date, refer case).   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation and influenza-like symptoms. On 23rd August 2019, the patient experienced feeling bad. On an unknown date, the outcome of the chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation, influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the chills, headache, nausea, vomiting, loss of energy, dizziness, muscle pain, nocturnal awakening, burning sensation, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient got Shingrix in the left deltoid. The patient had all of the symptoms by 10pm in the night of 22nd August 2019. The reporter stated that she had chills, headache, nauseated, threw up twice last night, no energy, dizzy, muscle pain. She kept waking up at night and her left hand was burning. The patient said this feels like Flu A. The patient still had the symptoms on 23rd August 2019 and she felt bad.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm pain/ Injection site pain; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included essential thrombocythemia. Concomitant products included ruxolitinib phosphate (Jakafi).   On 15th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The medical history and concomitant medication were not reported. On 15th May 2019, the patient went to his primary care physician (PCP) for his annual visit where he was given 1st Shingrix shot. The patient had no problems with it other than a sore arm. The patient received Jakafi tablets 15mg tablets BID on unknown date for essential Thrombocythemia (ET), which led to off label use.  The batch number and expiration date were not reported. On 06th August 2019, the patient went to get the 2nd dose but was refused because the manufacture recommended against it. There was no other information reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Malaise, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Vaccination failure; singles all over my abdomen, breasts,and, and keeps spreading; Blisters keep breaking out; Got very sick; Got very sick; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, blister, sickness and sickness. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin enacarbil. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, herpes zoster, blister, sickness and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and sickness to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, herpes zoster, blister and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received both the doses of Shingrix in the prescribed time lines. The patient was very sick from both the doses of Shingrix. Two weeks before the date of reporting, the patient experienced very very severe singles all over the abdomen, breasts and were spreading. The patient also experienced blisters that broke out. The patient wondered why the vaccine was received only to get them and get them so severe.  The patient was prescribed Valacyclovir and Gabapentin but it did not help. The patient was at a lost as to why got the terrible outbreak when everything possible was done  to prevent it.  The patient wondered if others have had the same reaction. The case US2019AMR155508 was found to be duplicate of case US2019AMR155496. Hence case US2019AMR155508 would be deleted and all the information of this case will be added in case US2019AMR155496 which is the case of record for this patient.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 7th August 2019, the patient received Shingrix .5 ml. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash but it was unknown when the rash was started. The reporter asked if Shingrix can cause shingles. The patient thought he had shingles but he had not been diagnosed by a doctor. There was discrepancy in the outcome reported in source document (recovering/resolving) and in the database it was reported as not recovered/not resolved. There was discrepancy in the reported route of administration in database (unknown) and in source document, it was reported parenteral.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Scab
Clinical narrative: Blisters; scabbing; This case was reported by a nurse via call center representative and described the occurrence of blister in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 16th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced blister and scab. On an unknown date, the outcome of the blister and scab were not recovered/not resolved.   It was unknown if the reporter considered the blister and scab to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 56 or 57 years. The patient received 1st dose of Shingrix on 21th May 2019, (batch number 53RF3, expiry date 17th October 2021). The patient received 2nd dose in left deltoid. The nurse reported that the patient received dose 2 of Shingrix and she noted blisters on her right lower calf and one blister formed on the back of her head. The blisters opened, and, they were scabbing over. The patient has not treated blisters with anything. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient had all allergic reaction to dose 1 of Shingrix. No other information was available. The reporter refused to provide any further information and hung up abruptly from the call.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019 14:00, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The nurse reported that they had large areas of redness on upper arm after having had the 2nd Shingrix shot at 2 pm. The reporter noticed that last night the redness seemed to be spreading. The reporter did not consent to follow-up. There was discrepancy in primary reporter in source document it was reported as (physician ) but in narrative it was (nurse).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; chills; body aches; Injection site soreness on her arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer linked case US2019153956).   On 19th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 21st August 2019, the patient experienced fever, chills and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, injection site pain and general body pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. The patient experienced body aches. 2 days after receiving Shingrix, the patient experienced fever, chills and injection site soreness on her arm. The patient stated that all had resolved at this time of report except for the soreness at injection site. The reporter consented to follow up. The consumer did not had vaccine information for this adverse event. The consumer consented to healthcare professional follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Generalized itching all over her body; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (on an unknown date received 1st dose an experienced injection site pain).   On 5th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 3 weeks after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's ex husband. The reporter stated that the patient after the second dose experienced generalized itching all over her body that has not subsided. The reporter was unable to give consent for follow up but will ask patient to contact GSK to provide more information. This case has been linked with case US2019AMR157393, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Discomfort, Headache, Heart rate increased, Impaired work ability
Clinical narrative: Headache / presented in the front and base of skull by neck; General Aches; General Discomfort; Fever; Increased Heart Rate; Increased Blood Glucose; Arm Pain at Injection Site; leaving work for the rest of the day; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 15 hrs after receiving Shingrix, the patient experienced headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work. On an unknown date, the outcome of the headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm around 6 pm at pharmacy approximately 2-3 months ago from the date of reporting. Less than a day, after vaccination with dose of shingrix, the patient experienced general body pain, general discomfort, heart rate increased, blood glucose increased, pain in arm. The patient reported that, 15 hours (at 9 am) after vaccination experienced headache, 18 hours (around noon) after vaccination experineced inability to work and 20 hours(by 2 pm) after vaccination experienced fever. The patient reported that, in the next morning experienced headache at 9 am, and around noon headache intensified to the point of leaving work for the rest of the day. The headache described as worst, that the patient ever had and that it presented in the front and base of skull by neck. The patient reported that, after getting home, the patient had fever of 100 to 101 degree. The patient stated that, heart rate was in mid 120s and blood glucose spiked to the 300s. On the next day of vaccination at 6 pm, the patient feeling better other than arm pain ferom injection. The patient reported that, the arm pain was lasted for about a week.      Lab Comments: on an unknown date, lab test were performed
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache / presented in the front and base of skull by neck; General Aches; General Discomfort; Fever; Increased Heart Rate; Increased Blood Glucose; Arm Pain at Injection Site; leaving work for the rest of the day; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 15 hrs after receiving Shingrix, the patient experienced headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work. On an unknown date, the outcome of the headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm around 6 pm at pharmacy approximately 2-3 months ago from the date of reporting. Less than a day, after vaccination with dose of shingrix, the patient experienced general body pain, general discomfort, heart rate increased, blood glucose increased, pain in arm. The patient reported that, 15 hours (at 9 am) after vaccination experienced headache, 18 hours (around noon) after vaccination experineced inability to work and 20 hours(by 2 pm) after vaccination experienced fever. The patient reported that, in the next morning experienced headache at 9 am, and around noon headache intensified to the point of leaving work for the rest of the day. The headache described as worst, that the patient ever had and that it presented in the front and base of skull by neck. The patient reported that, after getting home, the patient had fever of 100 to 101 degree. The patient stated that, heart rate was in mid 120s and blood glucose spiked to the 300s. On the next day of vaccination at 6 pm, the patient feeling better other than arm pain ferom injection. The patient reported that, the arm pain was lasted for about a week.      Lab Comments: on an unknown date, lab test were performed
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: External ear pain, Facial pain, Fatigue, Herpes zoster, Neck pain
Clinical narrative: shingles; Achy; Fatigue; Sore on left cheek/Sore on Chin; Sore on back of ear; Sore on L posterior neck; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number N4C23, expiry date 15th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On 16th August 2019, 1 days after receiving Shingrix, the patient experienced shingles, pain, fatigue, facial pain, external ear pain and neck pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, pain, fatigue, facial pain, external ear pain and neck pain were recovering/resolving.   It was unknown if the reporter considered the shingles, pain, fatigue, facial pain, external ear pain and neck pain to be related to Shingrix.   Additional case details were provided as follows: The case was reported by medical assistant. The day after receiving dose 1 of Shingrix series, the patient was achy, had sores on his chin, left cheek, back of his ear, scalp and left posterior neck and had fatigue.  The patient reported to his provider's office on 19th August 2019 and was diagnosed with shingles.  He was prescribed Valtrex.  The patient again reported to his provider's office on 22nd August 2019 and reports all events were getting better. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Skin ulcer
Clinical narrative: shingles; Achy; Fatigue; Sore on left cheek/Sore on Chin; Sore on back of ear; Sore on L posterior neck; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number N4C23, expiry date 15th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On 16th August 2019, 1 days after receiving Shingrix, the patient experienced shingles, pain, fatigue, facial pain, external ear pain and neck pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, pain, fatigue, facial pain, external ear pain and neck pain were recovering/resolving.   It was unknown if the reporter considered the shingles, pain, fatigue, facial pain, external ear pain and neck pain to be related to Shingrix.   Additional case details were provided as follows: The case was reported by medical assistant. The day after receiving dose 1 of Shingrix series, the patient was achy, had sores on his chin, left cheek, back of his ear, scalp and left posterior neck and had fatigue.  The patient reported to his provider's office on 19th August 2019 and was diagnosed with shingles.  He was prescribed Valtrex.  The patient again reported to his provider's office on 22nd August 2019 and reports all events were getting better. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headache; shivering; fever; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 6th August 2019 10:00, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th August 2019 22:00, 12 hrs after receiving Shingrix, the patient experienced headache, shivering and fever. On an unknown date, the outcome of the headache, shivering and fever were recovered/resolved.   It was unknown if the reporter considered the headache, shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that he administered Shingrix around 10 AM. The patient visited the pharmacy and told the pharmacist that around 10 PM on the day of vaccination, she experienced headache, shivering and a low grade fever. The symptoms have resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Soreness; Swelling; Redness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, swelling and erythema. On an unknown date, the outcome of the pain in arm, swelling and erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm, swelling and erythema to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. 2 months ago from the reporting date, the patient received Shingrix on left arm. The patient experienced sore arm, swelling and redness from monday until thursday. The reporter did not consent to follow-up. The caller did not want correspondence sent to her PCP above but only to herself, if necessary. Both doses received at by a nurse. For tolerance to 2nd dose, refer linked case US2019AMR154371.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local reaction, Pain, Pyrexia
Clinical narrative: Soreness; Hot to touch; Erythema; Swollen; Fever; local reaction to immunization; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced pain, feeling hot, erythema, swelling, fever and local reaction. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain, feeling hot, erythema, swelling and local reaction were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain, feeling hot, erythema, swelling, fever and local reaction to be related to Shingrix.  Additional information received were as follows: This case was reported by medical assistant or immunization program coordinator on the line. The patient received Shingrix on right deltoid. On 21th August 2019, the patient reported to the clinic. The patient site was swollen, red, and hot to touch. On the reporting date, the patient again came back in and has erythema that grew to 15 by 13 cm, with warmth. The diagnosis was local reaction to immunization. The patient was given prednisone oral two 20 mg tablets once daily for 5 days and instructed to elevate and ice 4 times a day. The provider drew a border around the erthyema. The patient also reported soreness and fever. When the patient came into the clinic, the fever was controlled. The fever has resolved, but all other events were ongoing. No details were available regarding start date. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Soreness; Hot to touch; Erythema; Swollen; Fever; local reaction to immunization; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced pain, feeling hot, erythema, swelling, fever and local reaction. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain, feeling hot, erythema, swelling and local reaction were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain, feeling hot, erythema, swelling, fever and local reaction to be related to Shingrix.  Additional information received were as follows: This case was reported by medical assistant or immunization program coordinator on the line. The patient received Shingrix on right deltoid. On 21th August 2019, the patient reported to the clinic. The patient site was swollen, red, and hot to touch. On the reporting date, the patient again came back in and has erythema that grew to 15 by 13 cm, with warmth. The diagnosis was local reaction to immunization. The patient was given prednisone oral two 20 mg tablets once daily for 5 days and instructed to elevate and ice 4 times a day. The provider drew a border around the erthyema. The patient also reported soreness and fever. When the patient came into the clinic, the fever was controlled. The fever has resolved, but all other events were ongoing. No details were available regarding start date. The reporter consented to follow up.