chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in either June or July, refer linked case US2018GSK175505). On 4th September 2018, the patient received the 2nd dose of Shingrix. On 4th September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity and somnolence. On 5th September 2018, the patient experienced feeling abnormal. In September 2018, the patient experienced weight loss, stomach pain and gastric disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder were unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder to be related to Shingrix. Additional details were provided as follows: At 10 am, the patient received 2nd dose of Shingrix on left arm. The patient stated that with the second dose of the vaccine, when the injection was being given, it hurt. Later in the afternoon about 6:00 pm,8 hours after receiving Shingrix, the patient started having cold shakes that lasted for about three hours. Less than a day after receiving Shingrix , the patient's stomach felt like it was churning and was unable to eat or drink and just laid around all day. Several hours after receiving Shingrix, the patient tried to went to sleep that night and was able to sleep all night long which she said was not normal for her. One day after receiving Shingrix, the patient woke up the next morning and said that her body felt like it had been turned inside out. The patient could not think of any other way to describe what she was feeling but her stomach was still a problem. Most of the side effects had subsided but she still had stomach problems that lasted two weeks. The patient was able to eat and drink normally at the time of reporting. Less than 2 weeks after receiving Shingrix, the patient lost four pounds over three days after getting the second dose of the vaccine and she only weighed 100 pounds. The patient did not have a primary physician. She went to a clinic only when she needs to and at the time of reporting she was in good health.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 78-year-old male patient who received Shingrix for prophylaxis. Concurrent medical conditions included rheumatoid arthritis, prostate cancer, brachytherapy to prostate (prostate cancer radioactive seed implantation therpay) and radiation therapy (for treating prostate cancer for 28 days, ending on 3rd August 2018). On 20th March 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced headache, tiredness and muscle pain. On an unknown date, the outcome of the headache, tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the headache, tiredness and muscle pain to be related to Shingrix. Additional information was reported as follows: The case was reported by the patients's wife. The patient received the vaccine in left deltoid. The contact details of the physician was provided. For tolerance to next dose, refer case US2018GSK175636.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain in extremity, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Shingrix (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 14th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 14th September 2018, less than a day after receiving Shingrix, the patient experienced feeling unwell and tremor. On 15th September 2018, the patient experienced pain in arm and mobility decreased. On 14th September 2018, the outcome of the feeling unwell and tremor were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the mobility decreased was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, mobility decreased and tremor to be related to Shingrix. Additional information received as follows: The patient received Shingrix on the left arm. The healthcare professional reported that the patient experienced shakes that lasted for 4 hours then resolved. She did not feel good after but that had also resolved. Additionally, the patient's arm got so sore and she almost could not lift it. The arm soreness was resolving but till the time of reporting, she could not lift her arm fully.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain, Photophobia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 17-year-old female patient who received Bexsero (batch number ABX6C1AA, expiry date 30th August 2019) for prophylaxis. On 23rd August 2018, the patient received Bexsero. On 23rd August 2018, less than a day after receiving Bexsero, the patient experienced fever, headache, general body pain and photophobia. On an unknown date, the outcome of the fever, headache, general body pain and photophobia were recovered/resolved. It was unknown if the reporter considered the fever, headache, general body pain and photophobia to be related to Bexsero. Additional information received as follows: The healthcare professional reported that the patient experienced a fever (102 degree fahrenheit), light sensitivity, headache, and body aches which were started in the afternoon of vaccination day and resolved within 48 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of urinary incontinence in a 71-year-old female patient who received Shingrix (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 16th September 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2018, 19 hrs after receiving Shingrix, the patient experienced urinary incontinence. On an unknown date, the outcome of the urinary incontinence was unknown. It was unknown if the reporter considered the urinary incontinence to be related to Shingrix. Additional information received as follows: At 17:00, the patient received Shingrix. On 17th September 2018, at 12 noon, the patient experienced urinary incontinence. The patient experienced total three episodes of urinary incontinence between 12 noon and 3 pm. The healthcare professional reported that the patient had no prior history of urinary incontinence and had no obvious signs of urinary tract infection. The healthcare professional recommended that the patient consult her licensed medical doctor (LMD).
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old male patient who received Shingrix for prophylaxis. On 14th September 2018, the patient received the 1st dose of Shingrix. On 18th September 2018, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The pharmacist stated that the patient received a dose of Shingrix on Friday and came back to the pharmacy on the reporting date. The pharmacist thought that the patient might have the shingles rash. The patient said the shingles rash just started on the reporting date. The pharmacist stated that patient read online that, the shingles vaccine could cause shingles. The pharmacist referred the patient to see their physician to confirm the diagnosis of shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On 12th September 2018, the patient received the 1st dose of Shingrix. In September 2018, less than a week after receiving Shingrix, the patient experienced pain in arm. In September 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in left arm. The patient reported that she had some pain in the left arm following the injection. The caller not sure of the onset of the pain. She stated it hurt for 2 days and went away. She did not want to provide any additional information including date of birth.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 66-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included breast cancer. Concurrent medical conditions included arthritis. On 18th June 2018, the patient received the 1st dose of Shingrix. In June 2018, less than 2 weeks after receiving Shingrix, the patient experienced urinary tract infection. On an unknown date, the outcome of the urinary tract infection was recovered/resolved. It was unknown if the reporter considered the urinary tract infection to be related to Shingrix. Additional information was reported as follows: The patient recevied Shingrix vaccine on left arm. On 18th June 2018 morning, the patient as vaccinated with a dose of Shingrix. On 27th June 2018, the patient was diagnosed with urinary tract infection but thought  that it was present prior to the date of diagnosis but after the date of vaccination. The patient had denied permission to contact her physician.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, 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 53-year-old male patient who received Shingrix for prophylaxis. On 13th September 2018, the patient received Shingrix (intramuscular). On 14th September 2018, 1 days after receiving Shingrix, the patient experienced injection site pain. On 17th September 2018, the patient experienced feeling cold, shivering and tiredness. On 18th September 2018, the patient experienced headache. On 17th September 2018, the outcome of the feeling cold, shivering and tiredness were recovered/resolved. On an unknown date, the outcome of the injection site pain and headache were recovering/resolving. It was unknown if the reporter considered the injection site pain, feeling cold, shivering, tiredness and headache to be related to Shingrix. Additional information received as follows: At 2:00 pm, the patient received Shingrix on the left deltoid. At night, while driving home the patient began to felt tired and he went to bed. The patient experienced intense shivering and a cold feeling which he described as chills with violent shivering. The symptoms lasted for two hours and he went to sleep. On the reporting day, he continued to have a dull headache. The contact details of the physician were provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Diarrhoea, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Shingrix for prophylaxis. On 17th September 2018 11:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th September 2018, less than a day after receiving Shingrix, the patient experienced pain in arm, felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever, muscle pain and nausea. The patient was treated with ibuprofen and Tylenol. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever and muscle pain were recovered/resolved and the outcome of the nausea was recovering/resolving. It was unknown if the reporter considered the pain in arm, felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever, muscle pain and nausea to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient reported the soreness went from her upper arm to her hand. In September 2018, the outcome of the felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever and muscle pain were resolved. The patient planned to follow up with her physician on an unknown date. The contact details of the physician were provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, 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 63-year-old female patient who received Shingrix for prophylaxis. On 17th September 2018 11:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th September 2018, less than a day after receiving Shingrix, the patient experienced pain in arm, felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever, muscle pain and nausea. The patient was treated with ibuprofen and Tylenol. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever and muscle pain were recovered/resolved and the outcome of the nausea was recovering/resolving. It was unknown if the reporter considered the pain in arm, felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever, muscle pain and nausea to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient reported the soreness went from her upper arm to her hand. In September 2018, the outcome of the felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever and muscle pain were resolved. The patient planned to follow up with her physician on an unknown date. The contact details of the physician were provided.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 77-year-old male patient who received Shingrix (batch number G47M2, expiry date 11th October 2020) for prophylaxis. Previously administered products included Zostavax (Zostavax vaccine received about 4 years ago approximately per the patient). On 10th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2018, 30 days after receiving Shingrix, the patient experienced blister and pain. On an unknown date, the outcome of the blister was recovered/resolved and the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the blister and pain to be related to Shingrix. Additional details werre provided as follows: The patient received the first dose of the Shingrix at approximately 2:00 PM on left deltoid. The pharmacist had a patient report that a month after receiving the Shingrix vaccine, he experienced painful fluid filled blisters on his lower back and right hip on the right side. The blisters popped and eventually healed. The patient had no pain now but the blisters were painful at the time. The patient did not receive medical care for the blisters.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Enlarged uvula
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of uvula swelling in a 71-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced uvula swelling. On an unknown date, the outcome of the uvula swelling was recovered/resolved. It was unknown if the reporter considered the uvula swelling to be related to Shingrix. Additional details were provided as follows: The patient experienced swollen uvula within a day after receiving Shingrix. Symptoms resolved one to two days after onset. The reporter declined to provide more information.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 82-year-old male patient who received Shingrix (batch number J4D5J, expiry date 8th February 2021) for prophylaxis. On 6th September 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, less than 2 weeks after receiving Shingrix, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to Shingrix. Additional details were provided as follows: The healthcare professional reported that after receiving 1st dose of Shingrix on left deltoid, the patient experienced redness over his whole deltoid, described as a rash, which lasted for 4 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Feeling abnormal, Impaired driving ability, Impaired work ability
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 59-year-old male patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th May 2018, 1 days after receiving Shingrix, the patient experienced fever, dizziness, disorientation, lethargy and foggy feeling in head. On an unknown date, the patient experienced driving ability disturbed and inability to work. On an unknown date, the outcome of the fever, dizziness, disorientation, lethargy and foggy feeling in head were recovered/resolved and the outcome of the driving ability disturbed and inability to work were unknown. The reporter considered the fever, dizziness, disorientation, lethargy, foggy feeling in head, driving ability disturbed and inability to work to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on unknown deltoid. On the following day of vaccination, the patient's body temperature was recorded as 100 degrees F. The patient had significant lethargy and a foggy head. The patient was disoriented and dizzy. All of the patient's side effects resolved within one week. In 2018, less than a week after receiving Shingrix, the patient's side effects significantly impacted his ability to drive and work. The patient also reported that he was a healthy male with no health issues. The patient believed that all of his side effects were related to the Shingrix vaccine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 59-year-old male patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th May 2018, 1 days after receiving Shingrix, the patient experienced fever, dizziness, disorientation, lethargy and foggy feeling in head. On an unknown date, the patient experienced driving ability disturbed and inability to work. On an unknown date, the outcome of the fever, dizziness, disorientation, lethargy and foggy feeling in head were recovered/resolved and the outcome of the driving ability disturbed and inability to work were unknown. The reporter considered the fever, dizziness, disorientation, lethargy, foggy feeling in head, driving ability disturbed and inability to work to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on unknown deltoid. On the following day of vaccination, the patient's body temperature was recorded as 100 degrees F. The patient had significant lethargy and a foggy head. The patient was disoriented and dizzy. All of the patient's side effects resolved within one week. In 2018, less than a week after receiving Shingrix, the patient's side effects significantly impacted his ability to drive and work. The patient also reported that he was a healthy male with no health issues. The patient believed that all of his side effects were related to the Shingrix vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Shingrix for prophylaxis. On 18th September 2018, the patient received Shingrix. In September 2018, less than a week after receiving Shingrix, the patient 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 reported. The patient only stated that he had the injection and felt achy. An attempt was made to try to get more information for the report. The patient did not want to provide any more information, he just wanted an answer to his question about the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Feeling abnormal, Herpes zoster, Impaired work ability
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 57-year-old female patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2018, 1 day after receiving Shingrix, the patient experienced shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy, dizziness and inability to work. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy and dizziness were recovered/resolved and the outcome of the inability to work was unknown. The reporter considered the shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy, dizziness and inability to work to be related to Shingrix. Additional details were provided as follows: The physician was the patient's (reporter's wife) husband who reported the case. The age at vaccination was not reported. The patient received Shingrix on an unknown deltoid and the patient experienced a temperature of over 100 degrees. She also had a foggy head, disorientation, dizziness and lethargy. The patient experienced rash on her lower leg and burning and stinging accompanied the rash. The patient had medical attention and a fellow physician in his practice confirmed that she had shingles. In 2018, Valtrex was administered and all her side effects had resolved. The patient's side effects significantly impacted her ability to drive and work.
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia, Rash, Skin burning sensation
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 57-year-old female patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2018, 1 day after receiving Shingrix, the patient experienced shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy, dizziness and inability to work. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy and dizziness were recovered/resolved and the outcome of the inability to work was unknown. The reporter considered the shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy, dizziness and inability to work to be related to Shingrix. Additional details were provided as follows: The physician was the patient's (reporter's wife) husband who reported the case. The age at vaccination was not reported. The patient received Shingrix on an unknown deltoid and the patient experienced a temperature of over 100 degrees. She also had a foggy head, disorientation, dizziness and lethargy. The patient experienced rash on her lower leg and burning and stinging accompanied the rash. The patient had medical attention and a fellow physician in his practice confirmed that she had shingles. In 2018, Valtrex was administered and all her side effects had resolved. The patient's side effects significantly impacted her ability to drive and work.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Shingrix for prophylaxis. On 18th September 2018, the patient received the 1st dose of Shingrix. In September 2018, less than a week after receiving Shingrix, the patient experienced headache, upset stomach, injection site pain, fever, injection site swelling, muscle pain, tiredness, shivering and injection site erythema. On an unknown date, the outcome of the headache, upset stomach, injection site pain, fever, injection site swelling, muscle pain, tiredness, shivering and injection site erythema were unknown. It was unknown if the reporter considered the headache, upset stomach, injection site pain, fever, injection site swelling, muscle pain, tiredness, shivering and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient called after hours and left a voicemail to report an adverse event. The patient was experiencing headache, shivering, upset stomach, muscle pain, tiredness and fever. The patient also states that she is experiencing pain, redness and swelling at the injection site. The patient did not provide any additional details on the voicemail.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Shingrix for prophylaxis. On 18th September 2018, the patient received the 1st dose of Shingrix. In September 2018, less than a week after receiving Shingrix, the patient experienced headache, upset stomach, injection site pain, fever, injection site swelling, muscle pain, tiredness, shivering and injection site erythema. On an unknown date, the outcome of the headache, upset stomach, injection site pain, fever, injection site swelling, muscle pain, tiredness, shivering and injection site erythema were unknown. It was unknown if the reporter considered the headache, upset stomach, injection site pain, fever, injection site swelling, muscle pain, tiredness, shivering and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient called after hours and left a voicemail to report an adverse event. The patient was experiencing headache, shivering, upset stomach, muscle pain, tiredness and fever. The patient also states that she is experiencing pain, redness and swelling at the injection site. The patient did not provide any additional details on the voicemail.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling in a adult 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 swelling, influenza-like symptoms and muscle pain. On an unknown date, the outcome of the swelling, influenza-like symptoms and muscle pain were unknown. It was unknown if the reporter considered the swelling, influenza-like symptoms and muscle pain to be related to Shingrix. Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that the patient experienced problems of swelling, muscle aches and flu-like symptoms after Shingrix. The healthcare professional would not provide any additional information outside of what was reported above.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eruption in a 77-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received in May 2018). In August 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced eruption, pruritus, erythema, skin irritation and raised rash. On an unknown date, the outcome of the eruption, pruritus and erythema were not recovered/not resolved and the outcome of the skin irritation and raised rash were unknown. It was unknown if the reporter considered the eruption, pruritus, erythema, skin irritation and raised rash to be related to Shingrix. Additional details were provided as follows: The patient received the second shot of the Shingrix approximately four weeks before the date of reporting in the early afternoon. The patient claimed that over a period of four weeks, he experienced periodic outbreaks of what looks like mosquito bites on his torso also claimed that they were itchy and outrageous and irritating. After three days, the outbreak would resolve and then another outbreak would appear. He described the outbreak as raised and red and he had one on his chest, hip, buttock and umbilicus over the four week period. One outbreak resolved and then everything would be quiet and then another outbreak appeared. This case has linked to case US2018GSK174669, reported by the same reporter for same patient.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injected limb mobility decreased, Lethargy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 55-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Fluarix Quadrivalent 2018-2019 season for prophylaxis. Previously administered products included Flu vaccine (No adverse event). On 15th September 2018, the patient received Shingrix and Fluarix Quadrivalent 2018-2019 season. On 15th September 2018, 2 hrs after receiving Shingrix and Fluarix Quadrivalent 2018-2019 season, the patient experienced weakness, lethargy, chills, tremor, pain in arm, injected limb mobility decreased, activities of daily living impaired and tiredness. On an unknown date, the outcome of the weakness was recovering/resolving and the outcome of the lethargy, chills, tremor, pain in arm, injected limb mobility decreased, activities of daily living impaired and tiredness were unknown. It was unknown if the reporter considered the weakness, lethargy, chills, tremor, pain in arm, injected limb mobility decreased, activities of daily living impaired and tiredness to be related to Shingrix and Fluarix Quadrivalent 2018-2019 season. Additional details were provided as follows: At 3:00 pm, the patient received Shingrix on right side. The patient experienced pain in her right arm at rest and got worse with movement. The patient stated that she lost some function in her arm and was not able to fully raise her arm and she was extremely weak, tired, was shaking to the point of not being able to complete normal routines like driving. The patient stated she had severe chills. The patient stated she received the Flu vaccine at the same Pharmacy visit on her left arm and never had any adverse events to the Flu shot. The patient did not start feeling better until Monday morning (day of reprting).
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal disorder, Pain, Pain in extremity, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 55-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Fluarix Quadrivalent 2018-2019 season for prophylaxis. Previously administered products included Flu vaccine (No adverse event). On 15th September 2018, the patient received Shingrix and Fluarix Quadrivalent 2018-2019 season. On 15th September 2018, 2 hrs after receiving Shingrix and Fluarix Quadrivalent 2018-2019 season, the patient experienced weakness, lethargy, chills, tremor, pain in arm, injected limb mobility decreased, activities of daily living impaired and tiredness. On an unknown date, the outcome of the weakness was recovering/resolving and the outcome of the lethargy, chills, tremor, pain in arm, injected limb mobility decreased, activities of daily living impaired and tiredness were unknown. It was unknown if the reporter considered the weakness, lethargy, chills, tremor, pain in arm, injected limb mobility decreased, activities of daily living impaired and tiredness to be related to Shingrix and Fluarix Quadrivalent 2018-2019 season. Additional details were provided as follows: At 3:00 pm, the patient received Shingrix on right side. The patient experienced pain in her right arm at rest and got worse with movement. The patient stated that she lost some function in her arm and was not able to fully raise her arm and she was extremely weak, tired, was shaking to the point of not being able to complete normal routines like driving. The patient stated she had severe chills. The patient stated she received the Flu vaccine at the same Pharmacy visit on her left arm and never had any adverse events to the Flu shot. The patient did not start feeling better until Monday morning (day of reprting).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received Shingrix for prophylaxis. On 29th March 2018, the patient received the 1st dose of Shingrix. On 30th March 2018, 1 days after receiving Shingrix, the patient experienced general body pain, feeling abnormal and headache. On 31st March 2018, the outcome of the general body pain, feeling abnormal and headache were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling abnormal and headache to be related to Shingrix. Additional details were provided as follows: The caller reported the case for her husband. The next day after vaccination at 12:00, the patient experienced body aches, headache and feeling out of sorts. The symptoms resolved after a day. For tolerance to next dose, refer case US2018GSK174512.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. In March 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, weakness of arms, nocturnal awakening, numbness of upper extremities and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased, weakness of arms, nocturnal awakening, numbness of upper extremities and condition aggravated were unknown. The reporter considered the injection site pain, injected limb mobility decreased, weakness of arms, nocturnal awakening and numbness of upper extremities to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix in left upper arm. After both doses, the patient had severe pain at the injection site that was really, really bad for about 3 days and gradually subsided over a period of 2 to 3 weeks. After about 4 weeks, when the very sore and severe pain subsided from the shot, she began to had a constant numbing, weakening pain in her left upper arm in the area above her elbow. It had become so bad that she could not fully control the action of her arm in moving it and she certainly could not lift her arm up without pain or even turn it around to scratch her back. She wake up during the night and her arm was hurting her and she could not sleep due to the pain and sometimes wakes her up at night because of the aching. This effect was causing me to have weakness in this arm so she could not depend on lifting things with it and it limits her ability to move her arm. This pain continues to at the time of reporting, more than 2 months after the second shot. The pain was a spot on her arm a little lower down than the actual injection site, but still above her elbow. She had no problems with her right arm. The reporter stated that events must be listed as a possible side effect. No information was available regarding event onset data of injected limb mobility decreased, difficulty sleeping and numbness of upper extremities and which event started after which dose (1st or 2nd dose). Clarification raised.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Muscular weakness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. In March 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, weakness of arms, nocturnal awakening, numbness of upper extremities and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased, weakness of arms, nocturnal awakening, numbness of upper extremities and condition aggravated were unknown. The reporter considered the injection site pain, injected limb mobility decreased, weakness of arms, nocturnal awakening and numbness of upper extremities to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix in left upper arm. After both doses, the patient had severe pain at the injection site that was really, really bad for about 3 days and gradually subsided over a period of 2 to 3 weeks. After about 4 weeks, when the very sore and severe pain subsided from the shot, she began to had a constant numbing, weakening pain in her left upper arm in the area above her elbow. It had become so bad that she could not fully control the action of her arm in moving it and she certainly could not lift her arm up without pain or even turn it around to scratch her back. She wake up during the night and her arm was hurting her and she could not sleep due to the pain and sometimes wakes her up at night because of the aching. This effect was causing me to have weakness in this arm so she could not depend on lifting things with it and it limits her ability to move her arm. This pain continues to at the time of reporting, more than 2 months after the second shot. The pain was a spot on her arm a little lower down than the actual injection site, but still above her elbow. She had no problems with her right arm. The reporter stated that events must be listed as a possible side effect. No information was available regarding event onset data of injected limb mobility decreased, difficulty sleeping and numbness of upper extremities and which event started after which dose (1st or 2nd dose). Clarification raised.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a mild case of Shingles after the 1st dose of Shingrix. No other information was provided by the patient. The reporter had previously contacted GlaxoSmithKline response center, however, no duplicate case was found. The patient's healthcare professional would contact medical information.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a 69-year-old female patient who received Shingrix for prophylaxis. 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 pain, erythema, swelling and skin warm. On an unknown date, the outcome of the pain, erythema, swelling and skin warm were unknown. It was unknown if the reporter considered the pain, erythema, swelling and skin warm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 68 or 69 years. After receiving Shingrix, the patient experienced redness, swelling, pain and warm to touch. The reporter did not agree to receive follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 64-year-old female patient who received Shingrix for prophylaxis. On 11th September 2018, the patient received the 1st dose of Shingrix .5 ml. In September 2018, less than a week after receiving Shingrix, the patient experienced shingles, influenza-like symptoms and rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, influenza-like symptoms and rash were unknown. It was unknown if the reporter considered the shingles, influenza-like symptoms and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient who received Shingrix last week Thrusday and came in (on the date of reporting) with a unilateral rash that extended from under her left breast to around the center of her spine. The nurse said it appeared to be shingles and that they were treating it as shingles with antiviral. The patient also had experienced flu like symptoms after the vaccine. The nurse said she should not be followed up unless the patient had requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Shingrix for prophylaxis. In September 2018, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, fatigue, injection site erythema and injection site warmth. On an unknown date, the outcome of the fever, fatigue, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the fever, fatigue, injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: On Saturday 15 September 2018, the patient received a dose of Shingrix. The patient had a low-grade fever afterwards and continued to have fatigue. The patient's injection site was red, hot and the area covered 3 inches by 6 inches. The patient was asking, if these side effects were normal. The symptoms were continuing for more than 72 hours and the patient was asking how long were these supposed to last.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shingles in a 59-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date without any adverse events). On 6th September 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2018, 7 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to Shingrix. Additional details were provided as follows: This case was reported by husband to patient's friend of family. The age at vaccination was not reported. The patient received Shingrix in the left arm. Approximately 7 days later the patient developed dry rash on lower back right side (smaller than 4 into 6 note card). On 20th September 2018, the patient saw dermatologist and told it was shingles. No lot number was available. The reporter did not agree to be contacted for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown. It was unknown if the reporter considered the bullous pemphigoid to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported.