chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: rash on forearms, top of legs, chest and back; fatigue; headache; slight fever; little shivering; muscle soreness; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Shingrix (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2018, 1 days after receiving Shingrix, the patient experienced fatigue, headache, fever, shivering, muscle soreness and upset stomach. On 11th October 2018, the patient experienced generalized rash. On an unknown date, the outcome of the fatigue, headache, fever, shivering, muscle soreness and upset stomach were recovering/resolving and the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the fatigue, headache, fever, shivering, muscle soreness, upset stomach and generalized rash to be related to Shingrix. Additional details were reported as follows: The reporter stated that next day (10th October 2018) after receiving shingrix she experienced fatigue, headache, slight fever, a little shivering, muscle soreness, and a little stomach upset. The reporter stated that these symptoms were better at the time of reporting but not completely resolved. The reporter stated that at the time of reporting (11th October 2018) 2 days after receiving shingrix she noticed that she was developing a rash on her forearms, top of her legs, chest and back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised
Clinical narrative: rash on forearms, top of legs, chest and back; fatigue; headache; slight fever; little shivering; muscle soreness; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Shingrix (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2018, 1 days after receiving Shingrix, the patient experienced fatigue, headache, fever, shivering, muscle soreness and upset stomach. On 11th October 2018, the patient experienced generalized rash. On an unknown date, the outcome of the fatigue, headache, fever, shivering, muscle soreness and upset stomach were recovering/resolving and the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the fatigue, headache, fever, shivering, muscle soreness, upset stomach and generalized rash to be related to Shingrix. Additional details were reported as follows: The reporter stated that next day (10th October 2018) after receiving shingrix she experienced fatigue, headache, slight fever, a little shivering, muscle soreness, and a little stomach upset. The reporter stated that these symptoms were better at the time of reporting but not completely resolved. The reporter stated that at the time of reporting (11th October 2018) 2 days after receiving shingrix she noticed that she was developing a rash on her forearms, top of her legs, chest and back.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hypotension, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of felt faint in a 62-year-old male patient who received Shingrix (batch number 4LP5Y, expiry date unknown) for prophylaxis. On 6th September 2018, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced felt faint, low blood pressure, fever, tremor, chills and myalgia. On an unknown date, the outcome of the felt faint, low blood pressure, fever, tremor, chills and myalgia were unknown. It was unknown if the reporter considered the felt faint, low blood pressure, fever, tremor, chills and myalgia to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the left deltoid. The patient had very high fever, shaking, chills, myalgia, went to emergency room (ER) because blood pressure low and he thought he was going to pass out. The reporter agreed to be contacted on follow up. Lab Comments: On an unknown date, the patient blood pressure was measured.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of felt faint in a 62-year-old male patient who received Shingrix (batch number 4LP5Y, expiry date unknown) for prophylaxis. On 6th September 2018, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced felt faint, low blood pressure, fever, tremor, chills and myalgia. On an unknown date, the outcome of the felt faint, low blood pressure, fever, tremor, chills and myalgia were unknown. It was unknown if the reporter considered the felt faint, low blood pressure, fever, tremor, chills and myalgia to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the left deltoid. The patient had very high fever, shaking, chills, myalgia, went to emergency room (ER) because blood pressure low and he thought he was going to pass out. The reporter agreed to be contacted on follow up. Lab Comments: On an unknown date, the patient blood pressure was measured.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Influenza, Nausea, Palpitations
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea in a female patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received the 2nd dose of Shingrix. In October 2018, less than a day after receiving Shingrix, the patient experienced nausea, exhaustion, fever, influenza and heart racing. On an unknown date, the outcome of the nausea, exhaustion, fever, influenza and heart racing were recovering/resolving. It was unknown if the reporter considered the nausea, exhaustion, fever, influenza and heart racing to be related to Shingrix. Additional details were reported as follows: The patient had Shingrix shots on Wednesday. The patient's physician was hesitant to give her the 2nd dose, but since she did not ever want to get Shingles, she had the 2nd shot. Within hours, it kicked in again, and the patient got the same hideous symptoms nausea, exhaustion, high fever, exhausted, flu, in addition to which her heart was racing in the middle of the night last night (she read that could be another side effect). At the time of reporting, the patient was marginally better and her fever was down (on third day). The patient was asking why there were some people did not have side effects other than a very sore arm, which she really did not get. The patient's husband had virtually no bad effects with the 2nd shot. The patient was asking if her immune system was stronger than some other people and reacts more violently to the proteins released by the shot. Was it preferable and stated If anybudy get a stronger reaction does that mean you might had greater immunity to Shingles. She had suggested to ask the research department and let her know. The patient had searched the web and did not find an answer. She had never had negative reactions to any other vaccines, including flu shots, the pneumonia shots. This case has been linked to the US2018GSK186407, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea in a female patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received the 2nd dose of Shingrix. In October 2018, less than a day after receiving Shingrix, the patient experienced nausea, exhaustion, fever, influenza and heart racing. On an unknown date, the outcome of the nausea, exhaustion, fever, influenza and heart racing were recovering/resolving. It was unknown if the reporter considered the nausea, exhaustion, fever, influenza and heart racing to be related to Shingrix. Additional details were reported as follows: The patient had Shingrix shots on Wednesday. The patient's physician was hesitant to give her the 2nd dose, but since she did not ever want to get Shingles, she had the 2nd shot. Within hours, it kicked in again, and the patient got the same hideous symptoms nausea, exhaustion, high fever, exhausted, flu, in addition to which her heart was racing in the middle of the night last night (she read that could be another side effect). At the time of reporting, the patient was marginally better and her fever was down (on third day). The patient was asking why there were some people did not have side effects other than a very sore arm, which she really did not get. The patient's husband had virtually no bad effects with the 2nd shot. The patient was asking if her immune system was stronger than some other people and reacts more violently to the proteins released by the shot. Was it preferable and stated If anybudy get a stronger reaction does that mean you might had greater immunity to Shingles. She had suggested to ask the research department and let her know. The patient had searched the web and did not find an answer. She had never had negative reactions to any other vaccines, including flu shots, the pneumonia shots. This case has been linked to the US2018GSK186407, reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Dizziness, Feeling abnormal, Migraine, Nausea, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received Bexsero for prophylaxis. Co-suspect products included Fluarix Quadrivalent 2018-2019 season for prophylaxis. The patient's past medical history included migraine. On 2nd October 2018, the patient received the 2nd dose of Bexsero .5 ml and Fluarix Quadrivalent 2018-2019 season .5 ml. On 2nd October 2018, unknown after receiving Bexsero and Fluarix Quadrivalent 2018-2019 season, the patient experienced drug administration error. On 3rd October 2018, the patient experienced pain in arm, light headedness, weird feeling and migraine. On 4th October 2018, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the light headedness, weird feeling, migraine and nausea were recovering/resolving and the outcome of the drug administration error was unknown. It was unknown if the reporter considered the pain in arm, light headedness, weird feeling, migraine and nausea to be related to Bexsero and Fluarix Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother (GSK employee). In evening, the patient received Bexsero and Fluarix at different sites on same arm, which led to drug administration error. One day after receiving Bexsero and Fluarix, the patient experienced sore arm, lightheadedness and weird feeling. Later, the patient experienced a migraine. On 4th October 2018 in morning, 2 days after, migraine continued and patient felt nauseous. Arm was still sore but otherwise feeling better by evening. The patient did not visit to physician, emergency visit, or did not require hospitalization. The reporter agreed to receive follow up from GSK.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Vaccination error
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received Bexsero for prophylaxis. Co-suspect products included Fluarix Quadrivalent 2018-2019 season for prophylaxis. The patient's past medical history included migraine. On 2nd October 2018, the patient received the 2nd dose of Bexsero .5 ml and Fluarix Quadrivalent 2018-2019 season .5 ml. On 2nd October 2018, unknown after receiving Bexsero and Fluarix Quadrivalent 2018-2019 season, the patient experienced drug administration error. On 3rd October 2018, the patient experienced pain in arm, light headedness, weird feeling and migraine. On 4th October 2018, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the light headedness, weird feeling, migraine and nausea were recovering/resolving and the outcome of the drug administration error was unknown. It was unknown if the reporter considered the pain in arm, light headedness, weird feeling, migraine and nausea to be related to Bexsero and Fluarix Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother (GSK employee). In evening, the patient received Bexsero and Fluarix at different sites on same arm, which led to drug administration error. One day after receiving Bexsero and Fluarix, the patient experienced sore arm, lightheadedness and weird feeling. Later, the patient experienced a migraine. On 4th October 2018 in morning, 2 days after, migraine continued and patient felt nauseous. Arm was still sore but otherwise feeling better by evening. The patient did not visit to physician, emergency visit, or did not require hospitalization. The reporter agreed to receive follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling in a 75-year-old female patient who received Shingrix for prophylaxis. On 9th July 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved. It was unknown if the reporter considered the swelling and erythema to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. No other vaccines were given at the same time of Shingrix vaccination. The patient experienced swelling and redness expanding 3 to 4 inches for an estimated 4 to 5 weeks. The patient was instructed to apply compresses to the swelling. The reporter agreed to follow up from GlaxoSmithKline.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site rash in a 55-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles. Concomitant products included Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site rash and blistery rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the injection site rash was unknown and the outcome of the blistery rash was recovered/resolved. It was unknown if the reporter considered the injection site rash and blistery rash to be related to Shingrix. Additional details were provided as follows: The patient experienced shingles twice previously but presented on different dermatome first at 48 and second case 3 years later. In late April or early May 2018, the patient received 2nd dose of Shingrix. The day after receiving Shingrix, the patient experienced rash at injection site as well as blistery rash on opposite arm (primarily forearm). The patient received antivirals right away and the rash lasted about a week. The reporter was agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a adult patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received Shingrix. In October 2018, less than a week after receiving Shingrix, the patient experienced diarrhea and dizziness. On an unknown date, the outcome of the diarrhea and dizziness were not recovered/not resolved. It was unknown if the reporter considered the diarrhea and dizziness 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 reporter asked how long will the side effects last. After vaccination with Shingrix, the patient had diarrhea and a little dizziness. The reporter asked whether events would worsen.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: This case was reported by a nurse via patient support programs and described the occurrence of nerve pain in a 88-year-old male patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received Shingrix .5 ml. In October 2018, less than a week after receiving Shingrix, the patient experienced nerve pain and numbness of upper extremities. On an unknown date, the outcome of the nerve pain and numbness of upper extremities were unknown. It was unknown if the reporter considered the nerve pain and numbness of upper extremities to be related to Shingrix. Additional details were provided as follows: The patient was given the vaccine on his left arm. The reporter was unsure if it was given correctly because the patient was having nerve pain and numbness in his left arm and left hand.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix. Additional details were provided as follows: This case was reported by nurse via email received during non- GSK business hours for herself. The age at vaccination was not reported. After receiving Shingrix, the patient had some of the side effects and asked if they are contagious. Especially around infants and children.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever 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 day after receiving Shingrix, the patient experienced fever, influenza-like symptoms, chills, pain, injection site wheal, injection site warmth and injection site erythema. On an unknown date, the outcome of the fever, influenza-like symptoms, chills, pain, injection site wheal, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms, chills, pain, injection site wheal, injection site warmth and injection site erythema to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received experienced flu-like symptoms (fever, chills, aches) within 8 to 12 hours of vaccination. On Day 3, the patient had a welt on arm near injection site was hot and red and lasted 1 day. The reporter did agree to be contacted for follow up information. This case has been linked with the case US2018GSK185204 with the 2nd dose received by same patient reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever 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 day after receiving Shingrix, the patient experienced fever, influenza-like symptoms, chills, pain, injection site wheal, injection site warmth and injection site erythema. On an unknown date, the outcome of the fever, influenza-like symptoms, chills, pain, injection site wheal, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms, chills, pain, injection site wheal, injection site warmth and injection site erythema to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received experienced flu-like symptoms (fever, chills, aches) within 8 to 12 hours of vaccination. On Day 3, the patient had a welt on arm near injection site was hot and red and lasted 1 day. The reporter did agree to be contacted for follow up information. This case has been linked with the case US2018GSK185204 with the 2nd dose received by same patient reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in an unspecifed number of adult patients 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 fever. On an unknown date, the outcome of the fever was not reported. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. It was reported that 2 to 3 patients experienced low grade fever after receiving Shingrix vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 67-year-old female patient who received Shingrix for prophylaxis. On 23rd May 2018, the patient received the 1st dose of Shingrix 50 µg. On an unknown date, less than a year after receiving Shingrix, the patient experienced itchy rash and scab. On an unknown date, the outcome of the itchy rash was recovered/resolved and the outcome of the scab was unknown. It was unknown if the reporter considered the itchy rash and scab to be related to Shingrix. Additional details were reported as follows: This case was reported via click to chat. The patient received Shingrix vaccine about 6 months before from the date of reporting. The patient had several individual small intensely itchy bumps, which started sometime in the summer of 2018, on trunk to shoulder, stomach and might be on back approximately 8 to 10 total, one at a time. They look like small insect bites and lasted for 2 to 3 days. The patient stated, bumps appeared one at a time and spread out more than she thought of a rash. After a few days, it dried up and with a minute scab. The patient asked could this be a side effect.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were unknown. It was unknown if the reporter considered the headache and nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had headaches and some nausea. The patient asked how long the side effects of the SHINGRIX vaccination could last.
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of lethargy in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose, (refer case US2018GSK183150)). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced lethargy and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the lethargy and pain were unknown. It was unknown if the reporter considered the lethargy and pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced no fever but lethargic and achy. The reporter did agree to be contacted for follow up information.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Feeling abnormal, Headache, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included chickenpox. In September 2018, the patient received the 1st dose of Shingrix. In September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, abdominal pain, diarrhea and vomiting. On an unknown date, the patient experienced headache, injection site itching, shingles and feeling bad. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the pain in arm, abdominal pain, diarrhea, vomiting, headache, injection site itching, shingles and feeling bad were unknown. It was unknown if the reporter considered the pain in arm, abdominal pain, diarrhea, vomiting, headache, injection site itching, shingles and feeling bad to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had the previously recommended Shingles shot about 3 years before the time of reporting. In 2018, 3 weeks before the time of reporting the patient received a dose of Shingrix. After vaccination the patient experienced terribly sore arm and it was lasted for 3 to 4 days. About 1 week later, the patient experienced severe abdominal pain with diarrhea and throwing up. Again 1 week later, the patient had headache and as per the patient it was worst headache in his life. The patient's head was hurt so badly and the patient started to throwing up and continued to did so for 24 hours along with raging diarrhea. The patient was in bed for next 2 days and felt bad at least for more 4 days. The patient was kept trying to figure out what was wrong with him. The patient also experienced itching at the injection site that was maddening. The patient was called to his physician's office told them he thought he was had a shingles outbreak at the injection site. The nurse told him to come in to the physician office and it was confirmed. The patient was understand the sore arm and all other events, but to actually get a case of shingles was outrageous to the patient. The patient was asked, did this mean he would now had shingles or at least the possibility of another outbreak,  The patient wanted to know for the rest of my life would the outbreak he had spread to other parts of his body. The patient's physician advised him to did not get the 2nd dose of vaccination. The patient was very upset. The patient very careful about personal exposure to anything contagious. The patient requested to email him back with the answers to his questions. The physician could only gave him a topical steroid cream and a pill to lessen the itch but itch was not stopped. The patient look forward to hearing back.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pruritus, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included chickenpox. In September 2018, the patient received the 1st dose of Shingrix. In September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, abdominal pain, diarrhea and vomiting. On an unknown date, the patient experienced headache, injection site itching, shingles and feeling bad. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the pain in arm, abdominal pain, diarrhea, vomiting, headache, injection site itching, shingles and feeling bad were unknown. It was unknown if the reporter considered the pain in arm, abdominal pain, diarrhea, vomiting, headache, injection site itching, shingles and feeling bad to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had the previously recommended Shingles shot about 3 years before the time of reporting. In 2018, 3 weeks before the time of reporting the patient received a dose of Shingrix. After vaccination the patient experienced terribly sore arm and it was lasted for 3 to 4 days. About 1 week later, the patient experienced severe abdominal pain with diarrhea and throwing up. Again 1 week later, the patient had headache and as per the patient it was worst headache in his life. The patient's head was hurt so badly and the patient started to throwing up and continued to did so for 24 hours along with raging diarrhea. The patient was in bed for next 2 days and felt bad at least for more 4 days. The patient was kept trying to figure out what was wrong with him. The patient also experienced itching at the injection site that was maddening. The patient was called to his physician's office told them he thought he was had a shingles outbreak at the injection site. The nurse told him to come in to the physician office and it was confirmed. The patient was understand the sore arm and all other events, but to actually get a case of shingles was outrageous to the patient. The patient was asked, did this mean he would now had shingles or at least the possibility of another outbreak,  The patient wanted to know for the rest of my life would the outbreak he had spread to other parts of his body. The patient's physician advised him to did not get the 2nd dose of vaccination. The patient was very upset. The patient very careful about personal exposure to anything contagious. The patient requested to email him back with the answers to his questions. The physician could only gave him a topical steroid cream and a pill to lessen the itch but itch was not stopped. The patient look forward to hearing back.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. In April 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient came down with a case of Shingles in September 2018. The physician described it as very mild, lower right abdominal area and was treated with VALTREX and had not seen the patient back for follow up. The physician did not agree to be contacted for follow up. This case was considered as suspected vaccination failure as confirmed laboratory test was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep 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 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had flu like symptoms for a few days. The patient refused to get a second dose of SHINGRIX. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 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 increased blood pressure. On an unknown date, the outcome of the increased blood pressure was recovering/resolving. It was unknown if the reporter considered the increased blood pressure to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient asked could the vaccination cause an increase in my blood pressure and reported that after vaccination her blood pressure had increased daily but  at the time of reporting it had decreased. Lab Comments: On an unknown date the patient's blood pressure was measured.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: This case was reported by a physician and described the occurrence of dizziness in a female patient who received Shingrix for prophylaxis. On 13th August 2018, the patient received the 2nd dose of Shingrix. On 14th August 2018, 1 days after receiving Shingrix, the patient experienced dizziness, mobility decreased, difficulty in standing, injection site erythema, injection site swelling and skin discoloration. On an unknown date, the outcome of the dizziness, mobility decreased, difficulty in standing and injection site swelling were unknown and the outcome of the injection site erythema and skin discoloration were recovered/resolved. It was unknown if the reporter considered the dizziness, mobility decreased, difficulty in standing, injection site erythema, injection site swelling and skin discoloration to be related to Shingrix. Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingles Shot in the afternoon. Next day morning, the patient was so dizzy that she could not sit up or stand up with holding onto the sides of the walls. The patient stayed on the couch until it passed around noon. Taking off the bandage the patient could see how pink and swollen it was the top pink spot was where the injection went in (the two dark spots were faded black and blue finger marks where her husband grabbed into her arms as he was unsteady getting up from a chair). The bottom pink was the same color and swollen as the injection site. The patient physically felt okay but the sites were still pink and swollen. The patient asked the pharmacist and she said should definitely let you them know for her records. This case was linked to the case US2018GSK121414, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This case was reported by a physician and described the occurrence of dizziness in a female patient who received Shingrix for prophylaxis. On 13th August 2018, the patient received the 2nd dose of Shingrix. On 14th August 2018, 1 days after receiving Shingrix, the patient experienced dizziness, mobility decreased, difficulty in standing, injection site erythema, injection site swelling and skin discoloration. On an unknown date, the outcome of the dizziness, mobility decreased, difficulty in standing and injection site swelling were unknown and the outcome of the injection site erythema and skin discoloration were recovered/resolved. It was unknown if the reporter considered the dizziness, mobility decreased, difficulty in standing, injection site erythema, injection site swelling and skin discoloration to be related to Shingrix. Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingles Shot in the afternoon. Next day morning, the patient was so dizzy that she could not sit up or stand up with holding onto the sides of the walls. The patient stayed on the couch until it passed around noon. Taking off the bandage the patient could see how pink and swollen it was the top pink spot was where the injection went in (the two dark spots were faded black and blue finger marks where her husband grabbed into her arms as he was unsteady getting up from a chair). The bottom pink was the same color and swollen as the injection site. The patient physically felt okay but the sites were still pink and swollen. The patient asked the pharmacist and she said should definitely let you them know for her records. This case was linked to the case US2018GSK121414, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 17th May 2018, refer US2018182631). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 29th September 2018, the patient experienced erythema and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved and the outcome of the erythema was recovering/resolving. It was unknown if the reporter considered the pain in arm, erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on left arm. The SHINGRIX was administered in the late afternoon. The patient experienced the soreness in her arm that lasted about 4 days. The patient's arm also became red from the shoulder area to an inch above her elbow and she had flu like symptoms. Both of these events presented the day after the injection.  The flu like symptoms lasted for 2 days. There was a small amount of redness present at the time of reporting. The patient's physician was her husband.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in an unspecifed number of adult patients 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was not reported. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reporter as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. It was reported that a few patients experienced redness at injection site after receiving SHINGRIX vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: 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 adult 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 in arm. On an unknown date, the outcome of the pain in arm was not reported. 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 age group was not reported but was selected as adult as per vaccine indication. The patient experienced arm pain after receiving SHINGRIX vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: 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 adult 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 in arm. On an unknown date, the outcome of the pain in arm was not reported. 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 age group was not reported but was selected as adult as per vaccine indication. The patient experienced arm pain after receiving SHINGRIX vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Age: 62.0
Sex: F
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 62-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose refer case US2018GSK141017). On 17th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The SHINGRIX vaccine was administered by a pharmacist. The VAERS details were updated. The patient experienced some soreness for two full days, but after that nothing, she did not experience the rash at all. This case has been linked with the case US2018GSK141017 reported by the same reporter for the same patient.
Sex: F
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 female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 reported as follows: The age at vaccination was not reported. In 2018, the patient received a dose of SHINGRIX. No further details were provided. This case has been linked with case US2018183655 (vaccinated with same lot number), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Condition aggravated, Oral herpes, Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018GSK182297). Concurrent medical conditions included cold sores lip (when exposed to shingles). On 29th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced palpitation, cold sores lip and adverse event. On an unknown date, the outcome of the palpitation, cold sores lip and adverse event were unknown. It was unknown if the reporter considered the palpitation, cold sores lip and adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the last Saturday, from the date of reporting and it gave all of the common side effects, in addition heart palpitations and a large cold sore on the patient's upper lip. The patient did see the potential for heart palpitations, but not cold sores. The patient thought that the formation of cold sores was a potential side effect of Shingles vaccine. This case is one of the 3 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-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, less than a year after receiving SHINGRIX, the patient experienced fever, chills, joint pain and tremor. On an unknown date, the outcome of the fever, chills, joint pain and tremor were recovered/resolved. It was unknown if the reporter considered the fever, chills, joint pain and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient informed the pharmacist that she experienced a similar experiences after 1st dose of SHINGRIX as that of 2nd dose (for tolerance of 2nd dose see case US2018180120).
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 patient experienced severe sore arm. This case has been linked to US2018077610, US2018GSK080935, US2018GSK186351 and US2018GSK186361, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Influenza, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea 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 nausea, exhaustion, fever and influenza. On an unknown date, the outcome of the nausea, exhaustion, fever and influenza were unknown. It was unknown if the reporter considered the nausea, exhaustion, fever and influenza to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had horrible side effects, including nausea, exhaustion, and a high fever of 101. The patient literally could not get up, she was so exhausted, like the worst flu she had. This case has been linked to the US2018GSK182295, reported by the same reporter.