chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia, Sjogren's disease, hypothyroidism and white blood cell count low. Previously administered products included ZOSTAVAX. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had fibromyalgia, Sjogren's disease, hypothyroidism, low white blood cell count and weakened immune system (all conditions prior to receive SHINGRIX vaccine). After receiving SHINGRIX, the patient experienced fever, flu-like symptoms and did not feel well for a few days. The patient's injection site was also swollen and very painful such that she could not move it. The contact details of the physician were provided. For tolerance to the 2nd dose of SHINGRIX, refer case US2018GSK194539.
Sex: F
Vaccine: VARZOS
Symptoms: Fluid retention, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included rotator cuff injury. Previously administered products included SHINGRIX (1st dose vaccinated on an unknown date at the pharmacy). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, fluid retention and shoulder pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the fluid retention and shoulder pain were unknown. It was unknown if the reporter considered the pain in arm and fluid retention to be related to SHINGRIX. The reporter considered the shoulder pain to be unrelated to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The exact age of the patient was unknown but reported to be 65 years or older. The patient experienced pain in the injected arm after vaccination with SHINGRIX. The pain had not resolved, till it had been two or three weeks after vaccination with the second dose of SHINGRIX. The patient carried out a Magnetic resonance imaging (MRI), which showed fluid in her arm. It was unknown if the fluid was causing the pain. The patient was also experiencing shoulder pain at the time of reporting but this could be due to the previous injury to her rotary cup as per the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug hypersensitivity (the patient was generally sensitive to medicines). On 15th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, nausea, headache, appetite absent, tiredness, shivers and diarrhea. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea, headache, appetite absent and tiredness were not recovered/not resolved and the outcome of the shivers and diarrhea were unknown. It was unknown if the reporter considered the injection site pain, nausea, headache, appetite absent, tiredness, shivers and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced mild injection site pain after the dose. The next morning, she felt tired and nauseated and had shivers and diarrhea. She had not been able to eat or drink. She contacted her physician and was instructed to wait another day. She was feeling a little better on the day of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug hypersensitivity (the patient was generally sensitive to medicines). On 15th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, nausea, headache, appetite absent, tiredness, shivers and diarrhea. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea, headache, appetite absent and tiredness were not recovered/not resolved and the outcome of the shivers and diarrhea were unknown. It was unknown if the reporter considered the injection site pain, nausea, headache, appetite absent, tiredness, shivers and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced mild injection site pain after the dose. The next morning, she felt tired and nauseated and had shivers and diarrhea. She had not been able to eat or drink. She contacted her physician and was instructed to wait another day. She was feeling a little better on the day of reporting.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. Previously administered products included ZOSTAVAX (received many years before the time of reporting) and SHINGRIX with an associated reaction of injection site pain (received 1st dose refer case US2018GSK196387). On 17th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 18th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced strong adverse eves after receiving SHINGRIX. The patient had more pain at the site of injection, low grade fever, dizzy, nausea, very agitated, feels profoundly tired and profoundly fatigued. The patient also noticed that her eyes keep crossing, but she did not know if it was because of being so tired. All symptoms started the second day after the vaccine. On the day of reporting the patient felt 80 percent better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Strabismus, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. Previously administered products included ZOSTAVAX (received many years before the time of reporting) and SHINGRIX with an associated reaction of injection site pain (received 1st dose refer case US2018GSK196387). On 17th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 18th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced strong adverse eves after receiving SHINGRIX. The patient had more pain at the site of injection, low grade fever, dizzy, nausea, very agitated, feels profoundly tired and profoundly fatigued. The patient also noticed that her eyes keep crossing, but she did not know if it was because of being so tired. All symptoms started the second day after the vaccine. On the day of reporting the patient felt 80 percent better.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hives in a female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site hives, injection site rash and injection site itching. On an unknown date, the outcome of the injection site hives, injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site hives, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. The patient experienced itchiness and two hives or bumps at the injection site. All symptoms had resolved. The duration was unknown. The reporter did not had additional patient information.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 61-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced syncope, feeling unwell and dizziness. On an unknown date, the outcome of the syncope was not recovered/not resolved and the outcome of the feeling unwell and dizziness were unknown. It was unknown if the reporter considered the syncope, feeling unwell and dizziness to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, the patient felt under the weather for a few days after the dose of SHINGRIX. This then led to bouts of syncope that had not resolved. The healthcare professional stated that, he was not sure if it was true syncope by definition of loss of consciousness but rather dizziness. The healthcare professional called to check on post-marketing information and when reporter transferred to a vaccines medical information system (MES) he informed them it was not true syncope by definition but more like dizziness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pulmonary thrombosis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional information was reported as follows: The patient's age at vaccination was 73 years. After vaccination with the first dose of SHINGRIX, the patient experienced muscle pain in her neck which was severe for about a week and then subsided but the pain never really went completely went away. This case was linked to case US2018GSK198908 (2nd dose), reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: 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 injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient was over the age of 65 years. The events took a month to fade. The patient wanted to remain anonymous. For further tolerance, refer case US2018GSK195450.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dyspnoea, Fatigue, Feeling abnormal, Impaired driving ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced rash, injection site swelling, injection site erythema, injection site warmth, fever and shortness of breath. On 17th October 2018, the patient experienced injection site pain, driving ability disturbed, fatigue, muscle weakness and fuzzy. On 18th October 2018, the patient experienced unsteadiness. On 20th October 2018, the patient experienced pruritus. The patient was treated with Steroid Cream. On an unknown date, the outcome of the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness were unknown. It was unknown if the reporter considered the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine at 13:30 PM. The patient experienced pain as the vaccine was administered. Around 4 PM, 2 hours and 30 minutes after receiving SHINGRIX, her head felt fuzzy and she was afraid to drive. Less than a day after receiving SHINGRIX, the patient experienced extreme fatigue and tiredness and muscle weakness. By 7 PM, she fell into a deep sleep and stayed in bed for about 3 hours. At 10:15 PM, she went to the restroom and went back to sleep. On Thursday, 1 day after receiving SHINGRIX, she was still fatigued with muscle weakness and felt wobbly. On Friday, 2 days after receiving SHINGRIX, the patient was still hurting and the injection site was red, hot and swollen. On Saturday, 3 days after receiving SHINGRIX, she had itching that spread around her upper arm. The patient had a rash that looked like chickenpox down her arm and legs down to her shins as well as on her face. Her dermatologist gave her a steroid cream. The heat had gone down a little. The patient had an appointment with her internist the day after reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced rash, injection site swelling, injection site erythema, injection site warmth, fever and shortness of breath. On 17th October 2018, the patient experienced injection site pain, driving ability disturbed, fatigue, muscle weakness and fuzzy. On 18th October 2018, the patient experienced unsteadiness. On 20th October 2018, the patient experienced pruritus. The patient was treated with Steroid Cream. On an unknown date, the outcome of the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness were unknown. It was unknown if the reporter considered the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine at 13:30 PM. The patient experienced pain as the vaccine was administered. Around 4 PM, 2 hours and 30 minutes after receiving SHINGRIX, her head felt fuzzy and she was afraid to drive. Less than a day after receiving SHINGRIX, the patient experienced extreme fatigue and tiredness and muscle weakness. By 7 PM, she fell into a deep sleep and stayed in bed for about 3 hours. At 10:15 PM, she went to the restroom and went back to sleep. On Thursday, 1 day after receiving SHINGRIX, she was still fatigued with muscle weakness and felt wobbly. On Friday, 2 days after receiving SHINGRIX, the patient was still hurting and the injection site was red, hot and swollen. On Saturday, 3 days after receiving SHINGRIX, she had itching that spread around her upper arm. The patient had a rash that looked like chickenpox down her arm and legs down to her shins as well as on her face. Her dermatologist gave her a steroid cream. The heat had gone down a little. The patient had an appointment with her internist the day after reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced rash, injection site swelling, injection site erythema, injection site warmth, fever and shortness of breath. On 17th October 2018, the patient experienced injection site pain, driving ability disturbed, fatigue, muscle weakness and fuzzy. On 18th October 2018, the patient experienced unsteadiness. On 20th October 2018, the patient experienced pruritus. The patient was treated with Steroid Cream. On an unknown date, the outcome of the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness were unknown. It was unknown if the reporter considered the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine at 13:30 PM. The patient experienced pain as the vaccine was administered. Around 4 PM, 2 hours and 30 minutes after receiving SHINGRIX, her head felt fuzzy and she was afraid to drive. Less than a day after receiving SHINGRIX, the patient experienced extreme fatigue and tiredness and muscle weakness. By 7 PM, she fell into a deep sleep and stayed in bed for about 3 hours. At 10:15 PM, she went to the restroom and went back to sleep. On Thursday, 1 day after receiving SHINGRIX, she was still fatigued with muscle weakness and felt wobbly. On Friday, 2 days after receiving SHINGRIX, the patient was still hurting and the injection site was red, hot and swollen. On Saturday, 3 days after receiving SHINGRIX, she had itching that spread around her upper arm. The patient had a rash that looked like chickenpox down her arm and legs down to her shins as well as on her face. Her dermatologist gave her a steroid cream. The heat had gone down a little. The patient had an appointment with her internist the day after reporting.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received SHINGRIX (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. The patient's past medical history included arthritis. On 23rd July 2018, the patient received SHINGRIX (intramuscular). On 24th July 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient experienced flu like symptoms beginning the day after receipt of the vaccine and the symptoms lasted for a day or 2 then resolved. The patient received vaccine on left deltoid. This was 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and feeling bad. On an unknown date, the outcome of the pain and feeling bad were unknown. It was unknown if the reporter considered the pain and feeling bad to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter was not comfortable reporting this as an adverse event. The reporter did not provide any patient or vaccine data.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received SHINGRIX (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia (treated, the patient was not in immunocompromised position). On 15th June 2018, the patient received SHINGRIX (intramuscular). On 16th June 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient experienced flu like symptoms beginning the day after receipt of the vaccine and the symptoms lasted for a day or 2 then resolved. The patient received SHINGRIX on right deltoid. This is 1 of the 4 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that 90 percent of patients receiving SHINGRIX complained of sore arm. This 1 of the 4 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was reported. The patient did not get the 1st dose of SHINGRIX at the reporter's facility. The patient experienced flu like symptoms after 1 to 2 days of the vaccination. The patient was not able to get out of bed for one and half days due to the symptoms. The reporter did not have the vaccine information.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic, Rash vesicular, Skin burning sensation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 80-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date 19th August 2019) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included drug allergy (was allergic to Thimerosal). On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th August 2018, less than a day after receiving SHINGRIX, the patient experienced vesicular rash, burning sensation skin and itchy rash. On an unknown date, the outcome of the vesicular rash, burning sensation skin and itchy rash were unknown. The reporter considered the vesicular rash to be probably related to SHINGRIX. It was unknown if the reporter considered the burning sensation skin and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Within 24 hours, the patient began to experience a rash on the left arm. The rash was further described as, going up and down the arm from below the injection site towards the elbow, almost like the shingles rash, like poison ivy, a bunch of little bumps which burned and itched. The patient stated the rash felt like shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, nausea, chills, pain and joint pain. On an unknown date, the outcome of the influenza-like symptoms, nausea, chills, pain and joint pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, nausea, chills, pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Few days ago, from the date of reporting, the patient received SHINGRIX and experienced flu-like symptoms, aching, joint pain, chills and nausea. The patient stated that if felt like he had severe case of the flu. The symptoms lasted for approximately 1 day. The reporter did not wish to provide any additional details. The patient wished to remain anonymous and did not wish to provide any additional details regarding the vaccine or event. This case has been linked with the case US2018195289 (patient's wife), reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, nausea, chills, pain and joint pain. On an unknown date, the outcome of the influenza-like symptoms, nausea, chills, pain and joint pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, nausea, chills, pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The age at vaccination was not reported. Few days ago, from the date of reporting, the patient received SHINGRIX and experienced flu-like symptoms, aching, joint pain, chills and nausea. The symptoms lasted for approximately 1 day. The reporter did not wish to provide any additional details. The patient wished to remain anonymous and did not wish to provide any additional details regarding the vaccine or event. This case has been linked with the case US2018195288 (patient's husband), reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain and myalgia. On an unknown date, the outcome of the pain and myalgia were unknown. It was unknown if the reporter considered the pain and myalgia 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 adult as per vaccine indication. The nurse reported that after receiving SHINGRIX, several patients experienced myalgia and soreness. The nurse did not have specific patient or vaccine information.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist did not have any further details as the patient did not get the injection at this pharmacy. The patient felt ill after the 1st injection. The pharmacist called to ask about efficacy after only one dose. The patient had an adverse reaction to it the first time she used it and it happened with other pharmacy that why she did not report it. The patient felt really ill, now the patient wanted to know how effective it would be if she did not get the 2nd dose of this SHINGRIX.
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Micturition disorder, Urine flow decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of slowing of urinary stream in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included PREVENAR 13 for prophylaxis. In October 2018, the patient received SHINGRIX and PREVENAR 13. In October 2018, less than a month after receiving SHINGRIX, the patient experienced slowing of urinary stream and micturition disorder. On an unknown date, the outcome of the slowing of urinary stream and micturition disorder were unknown. It was unknown if the reporter considered the slowing of urinary stream and micturition disorder to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received both the SHINGRIX and PREVENAR 13 vaccine on the same day last week. The patient presented slow stream, problems urinating side effect. The normal side effects passed but not this. The reporter wanted to know was this a known side effect.
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Rash, Rash pruritic
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swollen joints in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swollen joints and itchy rash. On an unknown date, the outcome of the swollen joints and itchy rash were unknown. It was unknown if the reporter considered the swollen joints and itchy rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with the 1st dose of and developed a unilateral incredibly itchy rash on torso, elbow and knee. The patient's joints also blew up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of blistery rash in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 9 days after receiving SHINGRIX, the patient experienced blistery rash and pain. The patient was treated with antivirals for systemic use (Antiviral) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the blistery rash and pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. One week after getting SHINGRIX had pain and 2-3 days later developed a 2 area blister rash on midline. The patient went to urgent care, they prescribed antiviral and told the patient to follow up with provider. On 12th October 2018, Friday, the patient went to the physician. The pain was present till the reporting time but rash was almost healed. The physician prescribed pain medication. The patient thought this all was a reaction to SHINGRIX. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Condition aggravated, Dystonia, Fatigue, Gait disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dystonia aggravated in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dystonia and neuromuscular disorder nos. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken. On an unknown date, the outcome of the dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken were unknown. It was unknown if the reporter considered the dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient's symptoms were well managed for many years before the shot. The patient was extremely ill with the dose of SHINGRIX vaccine. The patient's neuromuscular disease and generalized dystonia much get worsen after the dose of SHINGRIX. At the time of reporting, the patient still had extreme fatigue, difficulty walking, difficulty getting up, pain throughout bones and muscles from the 1st week in September until the reporting date. The patient's neurologist told to not to get the second shot. The case had been logged accordingly in CRS with corresponding issue.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dystonia aggravated in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dystonia and neuromuscular disorder nos. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken. On an unknown date, the outcome of the dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken were unknown. It was unknown if the reporter considered the dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient's symptoms were well managed for many years before the shot. The patient was extremely ill with the dose of SHINGRIX vaccine. The patient's neuromuscular disease and generalized dystonia much get worsen after the dose of SHINGRIX. At the time of reporting, the patient still had extreme fatigue, difficulty walking, difficulty getting up, pain throughout bones and muscles from the 1st week in September until the reporting date. The patient's neurologist told to not to get the second shot. The case had been logged accordingly in CRS with corresponding issue.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, nausea, chills and diarrhea. On an unknown date, the outcome of the pain, nausea, chills and diarrhea were recovered/resolved. It was unknown if the reporter considered the pain, nausea, chills and diarrhea to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the nurse for herself. The age at the vaccination was not reported. The patient presented pain, waves of nausea, chills and some diarrhea. All reactions resolved within 4 days. The reporter agreed to be contacted for follow up.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of nausea in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (started from 20 years before the time of reporting). Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair Diskus). In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a month after receiving Influenza vaccine Quadrivalent 2018-2019 season and an unknown time after starting Advair Diskus, the patient experienced nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea. On an unknown date, the outcome of the nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea were unknown. It was unknown if the reporter considered the nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was received from a consumer via the vaccine patient assistance program. The age at vaccination was reported. The patient started Advair Diskus 20 years before the time of reporting. The last week before the reporting date the patient received the Flu shot and started experiencing flu like symptoms of nausea, soreness, fatigue, fever and diarrhea.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of nausea in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (started from 20 years before the time of reporting). Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair Diskus). In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a month after receiving Influenza vaccine Quadrivalent 2018-2019 season and an unknown time after starting Advair Diskus, the patient experienced nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea. On an unknown date, the outcome of the nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea were unknown. It was unknown if the reporter considered the nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was received from a consumer via the vaccine patient assistance program. The age at vaccination was reported. The patient started Advair Diskus 20 years before the time of reporting. The last week before the reporting date the patient received the Flu shot and started experiencing flu like symptoms of nausea, soreness, fatigue, fever and diarrhea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received many years before the time of reporting). On 21st May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year 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 patient did not experience any reaction other than minimal pain at the site of injection after receiving SHINGRIX. For further tolerance, refer case US2018190956.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pulmonary thrombosis. On 11th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced muscle pain, fatigue, shoulder pain and back pain. On 21st October 2018, the patient experienced chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the muscle pain, fatigue, shoulder pain and back pain were not recovered/not resolved and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue, chills, shoulder pain and back pain to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the second dose of SHINGRIX, the patient experienced the same muscle pain as after the first dose, also in additional to pain in the left side of her shoulder and back along with fatigue. The patient experienced chills one day before the date of reporting but on the date of reporting the chills were not present. This case was linked to case US2018192646 (1st dose), reported by the same reporter for the same patient.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old male patient who received Influenza vaccine for prophylaxis. Previously administered products included Typhoid vaccine (years before reporting date). Concomitant products included Albuterol, oxygen and SYMBICORT. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional information received as follows: The age at vaccination was not reported. The patient stated that he had gotten the flu vaccine (unknown manufacturer) and he had came down with the flu. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown. On 4th October 2018, the patient received flu vaccine. It was unknown if the suspect was the same dose, clarification has been requested for the same. The patient did not have any additional details regarding the flu vaccine. This has been linked to the case reported by the same reporter for the same patient received pharma product INCRUSE ELLIPTA.