chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Generalised tonic-clonic seizure, Pallor, Syncope
Clinical narrative: Observed by parents. Pt. eyes rolled up and she slumped over on exam table. Parents observed a 5 second tonic clonic upper extremity seizure. Pt. awoke, was pale. Pulse oximetry 99. BP: 90/60. I examined pt after episode. She remained stable. I explained syncopal episode with stress and that rarely is this even a seizure disorder. Parents aware to call with any concerns.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included ADVAIR, LUNESTA, Atorvastatin, gabapentin, ALLEGRA, CELEXA, PROAIR, SPIRIVA, buspirone and metoprolol. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth and injection site swelling. On 16th April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site warmth and injection site swelling to be probably related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. Less than a day after receiving SHINGRIX, the patient experienced a lot of pain at the injection site. The patient had swelling at the injection site. The area was also hot to touch. It had spread all the way down towards her inner arm. No further details were known.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number adult patients who received SHINGRIX. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that many of his patients had reported various adverse events following SHINGRIX. They reported soreness that kind of thing. The healthcare professional did not have any detailed information about specific lot numbers and expiry dates or even specific patient data or an estimate of how many patients might had been affected. The healthcare provider just stated that he heard these sort of nebulous complaints regularly regarding SHINGRIX.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 59-year-old male patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, pain in arm and blister. On an unknown date, the outcome of the erythema, pain in arm and blister were not recovered/not resolved. It was unknown if the reporter considered the erythema, pain in arm and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in right arm. The patient reported that the redness and blisters were near the adhesive of the band aid (CURAD brand) that looked like two cigarette burns. The patient reported that he was not sure if it was from the band aid or the SHINGRIX, or a combination of both. The patient reported that he did not have any issues with band aids in the past. Also, the patient reported that he had redness three inches below the injection site. The patient planned to follow-up with his physician on an unknown date. The patient reported that he took a picture of his arm, and would be glad to email it to agency, if needed.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Pyrexia, Rash macular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, erythromacular rash, fever and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, erythromacular rash, fever and chills were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, erythromacular rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist. The age at vaccination was not reported. The health care professional reported that the patient experienced a red rash at the injection site, described as red spots. The health care professional declined to provide any additional information. This is 1 of the 4 cases reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 54-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than year after receiving SHINGRIX, the patient experienced myalgia and pain. On an unknown date, the outcome of the myalgia and pain were unknown. It was unknown if the reporter considered the myalgia and pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist said that the patient did not want to receive the 2nd dose due to the adverse reactions experienced after 1st dose. The health care professional was asking what the vaccine efficacy was for SHINGRIX after 1st dose. The health care professional was driving in his car so he did not have any additional details on the patients demographics or lot number since health care professional was not calling from the pharmacy and was calling while driving. No further information was provided. This case has been linked with case US2018071840, reported by the same reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cold sweat, Fatigue, Headache, Hypersomnia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concomitant products included Atorvastatin, desloratadine, Metformin ER, Venlafaxine, glipizide and Insulin LANTUS. On 11th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 12th April 2018, the patient experienced cold sweat, headache, tiredness, inability to work, stiff joint, joint pain and sleep excessive. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain, tiredness and stiff joint were not recovered/not resolved and the outcome of the cold sweat and headache were recovered/resolved and the outcome of the inability to work, joint pain, sleep excessive and feeling unwell were unknown. The reporter considered the injection site pain, cold sweat, headache, tiredness, inability to work and stiff joint to be related to SHINGRIX. It was unknown if the reporter considered the joint pain, sleep excessive and feeling unwell to be related to SHINGRIX. Additional details were provided as follows; At 5:00, the patient received a dose of SHINGRIX in right deltoid. On 12th April 2018, 1 day after receiving SHINGRIX, the patient had soreness at the injection site but the patient claims that the following day she felt like a truck hit her. She described the patient's experience as cold sweats, headache, feeling tired, and joint pain. She slept a lot and missed work the next day. She was fine eating. On 17th April 2018, the patient left a message that she was still not feeling 100 percent and she still had pain at the injection site and joint stiffness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Impaired work ability, Injection site pain, Joint stiffness, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concomitant products included Atorvastatin, desloratadine, Metformin ER, Venlafaxine, glipizide and Insulin LANTUS. On 11th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 12th April 2018, the patient experienced cold sweat, headache, tiredness, inability to work, stiff joint, joint pain and sleep excessive. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain, tiredness and stiff joint were not recovered/not resolved and the outcome of the cold sweat and headache were recovered/resolved and the outcome of the inability to work, joint pain, sleep excessive and feeling unwell were unknown. The reporter considered the injection site pain, cold sweat, headache, tiredness, inability to work and stiff joint to be related to SHINGRIX. It was unknown if the reporter considered the joint pain, sleep excessive and feeling unwell to be related to SHINGRIX. Additional details were provided as follows; At 5:00, the patient received a dose of SHINGRIX in right deltoid. On 12th April 2018, 1 day after receiving SHINGRIX, the patient had soreness at the injection site but the patient claims that the following day she felt like a truck hit her. She described the patient's experience as cold sweats, headache, feeling tired, and joint pain. She slept a lot and missed work the next day. She was fine eating. On 17th April 2018, the patient left a message that she was still not feeling 100 percent and she still had pain at the injection site and joint stiffness.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Insomnia, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shivering in a 45-year-old male patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included AMBIEN and methimazole. On 17th April 2018 09:30, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, insomnia, labored breathing, headache and fever. On an unknown date, the outcome of the shivering, insomnia, labored breathing, headache and fever were recovering/resolving. The reporter considered the shivering, insomnia, labored breathing, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The reporter gave permission to contact patient's health care physician and had provided contact details for the same.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX. The patient's past medical history included neoplasm malignant (20 years ago). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received the 1st dose in 2017 about 2.5 months before the date of reporting, refer case US2018GSK072987). Concurrent medical conditions included lymphedema (in left arm). On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, mobility decreased, fatigue, headache, fever, shivering, nausea and appetite absent. On 19th April 2018, the patient experienced inability to work and feeling bad. On an unknown date, the outcome of the pain in arm, mobility decreased, fatigue, headache, fever, shivering and nausea were recovering/resolving and the outcome of the inability to work, feeling bad and appetite absent were unknown. The reporter considered the pain in arm, fatigue, headache, fever, shivering and nausea to be related to SHINGRIX. It was unknown if the reporter considered the mobility decreased, inability to work, feeling bad and appetite absent to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's concomitant medications included cocoa supplement and multivitamins. At 12:00 hours, the patient received SHINGRIX on right arm. After vaccination, the patient came home and her arm was immediately hurting and it got worse and worse over the day until she could barely lift her arm. The patient became very fatigued, to the point that she could barely move. She experienced splitting headache, fever, chills, nausea and shivering. One day after receiving the SHINGRIX vaccine (on the day of reporting), the patient had to take off work because she felt so bad. The patient felt a bit better and was going to try some tea and scrambled eggs. The patient had not eaten in 24 hours.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX. The patient's past medical history included neoplasm malignant (20 years ago). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received the 1st dose in 2017 about 2.5 months before the date of reporting, refer case US2018GSK072987). Concurrent medical conditions included lymphedema (in left arm). On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, mobility decreased, fatigue, headache, fever, shivering, nausea and appetite absent. On 19th April 2018, the patient experienced inability to work and feeling bad. On an unknown date, the outcome of the pain in arm, mobility decreased, fatigue, headache, fever, shivering and nausea were recovering/resolving and the outcome of the inability to work, feeling bad and appetite absent were unknown. The reporter considered the pain in arm, fatigue, headache, fever, shivering and nausea to be related to SHINGRIX. It was unknown if the reporter considered the mobility decreased, inability to work, feeling bad and appetite absent to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's concomitant medications included cocoa supplement and multivitamins. At 12:00 hours, the patient received SHINGRIX on right arm. After vaccination, the patient came home and her arm was immediately hurting and it got worse and worse over the day until she could barely lift her arm. The patient became very fatigued, to the point that she could barely move. She experienced splitting headache, fever, chills, nausea and shivering. One day after receiving the SHINGRIX vaccine (on the day of reporting), the patient had to take off work because she felt so bad. The patient felt a bit better and was going to try some tea and scrambled eggs. The patient had not eaten in 24 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On 30th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st December 2017, 1 days after receiving SHINGRIX, the patient experienced injection site pain, headache, fatigue and fever. In January 2018, the outcome of the injection site pain, headache, fatigue and fever were recovered/resolved. The reporter considered the injection site pain, headache, fatigue and fever to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The pain described as moderate at injection site. The events resolved 24 hours after presentation.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site mass, Injection site nodule
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 67-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 19th April 2018 02:40, the patient received the 1st dose of SHINGRIX .5 ml. On 19th April 2018 02:40, immediately after receiving SHINGRIX, the patient experienced injection site lump and injection site bruising. On an unknown date, the outcome of the injection site lump and injection site bruising were unknown. The reporter considered the injection site lump and injection site bruising to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX in the left deltoid. The patient experienced a hard lump or knot at the injection site and the pharmacist described the lump or knot as being bigger than a penny and raised possibly 1 by 8th to 1 by 4th inches. Less than a day after receiving SHINGRIX, the site looked as if it was starting to bruise.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shivering in a 53-year-old female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, 12 hours after receiving SHINGRIX, the patient experienced shivering, fever, headache and myalgia. On 10th April 2018, the patient experienced nausea, light headedness and welts. On 14th April 2018, the patient experienced tiredness. In April 2018, the outcome of the shivering, fiver, tiredness, nausea, light headedness and welts were recovered/resolved. On an unknown date, the outcome of the headache and myalgia were not recovered/not resolved. It was unknown if the reporter considered the shivering, fever, headache, tiredness, nausea, light headedness, myalgia and welts to be related to SHINGRIX. Additional details were provide as follows: The reporting nurse practitioner was the patient. The patient received SHINGRIX on an unknown arm. One day after vaccination, the patient experienced nausea, lightheadedness, dizziness and welts on arms. Five days after vaccination, the patient experienced tiredness. Only partial information was provided by the sales representative from the nurse practitioner.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shivering in a 53-year-old female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, 12 hours after receiving SHINGRIX, the patient experienced shivering, fever, headache and myalgia. On 10th April 2018, the patient experienced nausea, light headedness and welts. On 14th April 2018, the patient experienced tiredness. In April 2018, the outcome of the shivering, fiver, tiredness, nausea, light headedness and welts were recovered/resolved. On an unknown date, the outcome of the headache and myalgia were not recovered/not resolved. It was unknown if the reporter considered the shivering, fever, headache, tiredness, nausea, light headedness, myalgia and welts to be related to SHINGRIX. Additional details were provide as follows: The reporting nurse practitioner was the patient. The patient received SHINGRIX on an unknown arm. One day after vaccination, the patient experienced nausea, lightheadedness, dizziness and welts on arms. Five days after vaccination, the patient experienced tiredness. Only partial information was provided by the sales representative from the nurse practitioner.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on unknown deltoid. The patient had flu like symptoms for longer than five days. The symptoms did fully resolve. The field representative had very limited information. All information described and reported in fields encompasses all information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chills in a adult patient who received SHINGRIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced chills, nausea, dizziness and general body pain. In April 2018, the outcome of the chills, nausea, dizziness and general body pain were recovered/resolved. The reporter considered the chills, nausea, dizziness and general body pain to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 17th April 2018, the patient received the initial SHINGRIX vaccine in the doctor's office and late afternoon on the same day, the patient experienced chills, body aches, nausea and dizziness. This information was left by the physician the after hour on voicemail.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site inflammation in a 72-year-old female patient who received SHINGRIX. On 18th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. In April 2018, less than an hours receiving SHINGRIX, the patient experienced injection site inflammation, injection site itching, injection site pain, injection site warmth and injection site erythema. In April 2018, the outcome of the injection site inflammation, injection site itching, injection site pain, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site inflammation, injection site itching, injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who reported for herself. The health care professional stated that the pharmacist who administered the SHINGRIX vaccine to her told her that he had 2 patients who had to go the Emergency Room after receiving the vaccine. She stated they weren't admitted and they didn't die. This is all the information she provided to the reporter. The patient had previous vaccinations but had never experienced these types of side effects with other vaccines. The patient was administered SHINGRIX in the left deltoid and within hours (less than a hour), her left arm became inflamed and hot to touch. Less than a day after receiving vaccination, Then a red area about the size of an apple appeared and prevailed until yesterday. She said the area was painful to the touch. Two days after receiving vaccination, the patient experienced injection site itching. The reporter did not know the lot number or expiration date. Even though she said her symptoms have resolved, she was still aware of the vaccination site. The reporter did state she was told orally and in writing the possibility of these side effects. This case was linked to the case US2018071814, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reactions in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and pain. On an unknown date, the outcome of the injection site reaction and pain were unknown. It was unknown if the reporter considered the injection site reaction and pain to be related to SHINGRIX. Additional details were provide as follows: The reporter indicated that she had several patients that they experienced injection site reactions or were achy after receiving the vaccination. The reporter provided this information when she was discussing adverse event for other patient. The reporter was unable to provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes simplex test positive, Vaginal lesion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of herpes simplex in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced herpes simplex and vaginal lesion. On an unknown date, the outcome of the herpes simplex and vaginal lesion were unknown. It was unknown if the reporter considered the herpes simplex and vaginal lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and about a week after appeared to the office with vaginal lesions which tested positive for Herpes simplex virus - 2. The healthcare professional did not felt that this was directly related to the vaccine itself. This case has been linked with case US2018GSK072794, reported by same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of generalized rash in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was not reported if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced diffuse full-body rash after receiving SHINGRIX. Rash occurred within a few days after vaccination. No further details were known.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling cold, Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 60-year-old female patient who received SHINGRIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th April 2018, 1 days after receiving SHINGRIX, the patient experienced feeling cold, pain in arm, erythema of extremities, fever and chills. On 7th April 2018, the patient experienced headache. On 14th April 2018, the patient experienced vomiting. On 14th April 2018, the outcome of the feeling cold, pain in arm, vomiting, erythema of extremities, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the feeling cold, pain in arm, vomiting, erythema of extremities, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. On 7th April 2018, 3 days after receiving SHINGRIX, the patient experienced headache. On 14th April 2018, 10 days after receiving SHINGRIX, the patient experienced vomiting. The patient planned to follow-up with her physician on an unknown date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 60-year-old female patient who received SHINGRIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th April 2018, 1 days after receiving SHINGRIX, the patient experienced feeling cold, pain in arm, erythema of extremities, fever and chills. On 7th April 2018, the patient experienced headache. On 14th April 2018, the patient experienced vomiting. On 14th April 2018, the outcome of the feeling cold, pain in arm, vomiting, erythema of extremities, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the feeling cold, pain in arm, vomiting, erythema of extremities, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. On 7th April 2018, 3 days after receiving SHINGRIX, the patient experienced headache. On 14th April 2018, 10 days after receiving SHINGRIX, the patient experienced vomiting. The patient planned to follow-up with her physician on an unknown date.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included duloxetine, gabapentin, omeprazole, perphenazine, Sumatriptan, tramadol, trazodone, ziprasidone, carbidopa plus levodopa and methocarbamol. On 16th April 2018 08:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist reported that the patient experienced pain in her arm where she received SHINGRIX.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Immediate post-injection reaction, Influenza, Injection site discomfort
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 66-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site discomfort. In April 2018, the patient experienced flu symptoms, nausea and fatigue. On 19th April 2018, the patient experienced maculopapular rash, erythematous rash and shingles. In April 2018, the outcome of the injection site discomfort, flu symptoms, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the maculopapular rash and erythematous rash were not recovered/not resolved and the outcome of the shingles was unknown. It was unknown if the reporter considered the injection site discomfort, maculopapular rash, erythematous rash, flu symptoms, nausea, fatigue and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient was not on other medications and received no additional vaccines on the day of the SHINGRIX vaccine or four weeks prior. The patient received SHINGRIX vaccine in the left deltoid. The physician reported that the patient was administered the SHINGRIX vaccine at another location and she experienced a little site discomfort. A couple of days later, she had nausea and fatigue and then she got better. A few days later, she had nausea, fatigue with flu like symptoms and then she got better again. On 19th April 2018, the day of reporting, the patient was experiencing a rash that she described as a classic rash which is slightly maculopapular. No blisters were present but the rash was red. All of the patient's other symptoms have resolved except the rash and at the reporting time the patient was being treated for shingles currently. The physician claimed that she was currently not treating the patient with steroids to avoid reducing the efficacy of the vaccine. The placement of the rash was on the patient's left anterior chest wall on the left axilla and left back. She described the location as exactly T1 distribution. The physician had to disconnect the call to see a patient, therefore, no additional details were available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash erythematous, Rash maculo-papular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 66-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site discomfort. In April 2018, the patient experienced flu symptoms, nausea and fatigue. On 19th April 2018, the patient experienced maculopapular rash, erythematous rash and shingles. In April 2018, the outcome of the injection site discomfort, flu symptoms, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the maculopapular rash and erythematous rash were not recovered/not resolved and the outcome of the shingles was unknown. It was unknown if the reporter considered the injection site discomfort, maculopapular rash, erythematous rash, flu symptoms, nausea, fatigue and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient was not on other medications and received no additional vaccines on the day of the SHINGRIX vaccine or four weeks prior. The patient received SHINGRIX vaccine in the left deltoid. The physician reported that the patient was administered the SHINGRIX vaccine at another location and she experienced a little site discomfort. A couple of days later, she had nausea and fatigue and then she got better. A few days later, she had nausea, fatigue with flu like symptoms and then she got better again. On 19th April 2018, the day of reporting, the patient was experiencing a rash that she described as a classic rash which is slightly maculopapular. No blisters were present but the rash was red. All of the patient's other symptoms have resolved except the rash and at the reporting time the patient was being treated for shingles currently. The physician claimed that she was currently not treating the patient with steroids to avoid reducing the efficacy of the vaccine. The placement of the rash was on the patient's left anterior chest wall on the left axilla and left back. She described the location as exactly T1 distribution. The physician had to disconnect the call to see a patient, therefore, no additional details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX. On 13th April 2018, the patient received the 1st dose of SHINGRIX. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. In April 2018. the patient experienced injection site swelling, injection site erythema and injection site warmth. In April 2018, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the tiredness, injection site swelling, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. On Friday, the patient received SHINGRIX on an unknown arm. It was reported that the vaccine almost knocked the patient out. She was tired and slept most of the day on Saturday but the tiredness resolved after one day. Less than a week after receiving SHINGRIX, the patient's injection site was raised, red, and warm to the touch. The reporter did not want to provide additional details on the patient's experienced and stated that she would call back later on the date of reporting with further details.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concomitant products included amlodipine, atorvastatin, ibuprofen, metformin and sertraline. On 6th April 2018, the patient received SHINGRIX (intramuscular). On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 7th April 2018, the patient experienced injection site induration, injection site erythema and injection site swelling. On 11th April 2018, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site itching was not recovered/not resolved and the outcome of the injection site induration was unchanged. The reporter considered the injection site pain, injection site itching, injection site induration, injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional information was received as follows: On the next day after vaccination, the patient experienced swelling and redness at the injection site, which had spread from the arm to the armpit. The patient also experienced some hardness at the injection site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concomitant products included amlodipine, atorvastatin, ibuprofen, metformin and sertraline. On 6th April 2018, the patient received SHINGRIX (intramuscular). On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 7th April 2018, the patient experienced injection site induration, injection site erythema and injection site swelling. On 11th April 2018, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site itching was not recovered/not resolved and the outcome of the injection site induration was unchanged. The reporter considered the injection site pain, injection site itching, injection site induration, injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional information was received as follows: On the next day after vaccination, the patient experienced swelling and redness at the injection site, which had spread from the arm to the armpit. The patient also experienced some hardness at the injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX 9batch number B327C, expiry date 4th July 2020 and (batch number X3M27, expiry date 29th August 2020). Concurrent medical conditions included latex allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that her sister, who was nurse had received SHINGRIX vaccine. The vaccine was administered by the reporting pharmacist. The pharmacist noted that her sister was allergic to latex and made aware the product vial stoppers did not contain natural rubber latex. The pharmacist stated that she was also changed the needle to a new one before giving the injection after mixing it. The patient had quarter size area of hard, red and hot appears at the injection site the next day after her vaccination. She stated that it was the appearance of a normal reaction that was common with vaccinations. The pharmacist noted the injection site was given late in the day and the next morning the issues appeared. The events were resolved after a couple of days.