chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Flushing, Hyperhidrosis, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed a bad injection site reaction. For tolerance after 2nd dose, refer case US2018GSK121414.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Night sweats, Nightmare, Pain, Presyncope, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed a bad injection site reaction. For tolerance after 2nd dose, refer case US2018GSK121414.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed a bad injection site reaction. For tolerance after 2nd dose, refer case US2018GSK121414.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of somnolence in a 67-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 24th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th June 2018, less than a day after receiving SHINGRIX and 83 days after receiving SHINGRIX, the patient experienced injection site reaction, injection site tenderness and wrong injection technique. On 25th June 2018, the patient experienced somnolence, fever, nightmare and generalized aching. On 26th June 2018, the patient experienced night sweat. On 27th June 2018, the patient experienced flushing and presyncope. On 29th June 2018, the patient experienced spasms. On an unknown date, the outcome of the somnolence, fever, nightmare, night sweat, flushing, presyncope and generalized aching were recovered/resolved and the outcome of the spasms was not recovered/not resolved and the outcome of the injection site reaction was recovering/resolving and the outcome of the injection site tenderness and wrong injection technique were unknown. It was unknown if the reporter considered the somnolence, fever, nightmare, night sweat, flushing, presyncope, injection site reaction, generalized aching and injection site tenderness to be related to SHINGRIX. The reporter considered the spasms to be possibly related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed an injection site reaction. It had mostly resolved, but was still a little tender. On the 2nd night after vaccination, the patient could not stay up past 8 PM, so he went to bed and later woke up feverish with bad multifocal pain all over his body. The pain lasted for 4 to 5 hours, and then he was finally able to sleep again. The patient then proceeded to have the worst nightmares in his life until dawn. On the 3rd night after vaccination, he had drenching night sweats such that, he was woken up and his sheets were soaked. The next day he was fine until around 10:30 AM when he had flushing and nearly fainted. The patient had to sit down for 30 to 60 minutes before he could function again. On the 4th night of vaccination, he had night sweats again. On the day of reporting, he had developed a spasm in his tricep where the injection was given. It was a fluttery spasm that came and gone but was not painful. He did know that for the 2nd injection the needle was inserted at more like a 45 degree angle than 90 degrees, though it was still intramuscular, which led to wrong injection technique. For tolerance after 1st dose, refer case US2018116420.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Flushing, Hyperhidrosis, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of somnolence in a 67-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 24th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th June 2018, less than a day after receiving SHINGRIX and 83 days after receiving SHINGRIX, the patient experienced injection site reaction, injection site tenderness and wrong injection technique. On 25th June 2018, the patient experienced somnolence, fever, nightmare and generalized aching. On 26th June 2018, the patient experienced night sweat. On 27th June 2018, the patient experienced flushing and presyncope. On 29th June 2018, the patient experienced spasms. On an unknown date, the outcome of the somnolence, fever, nightmare, night sweat, flushing, presyncope and generalized aching were recovered/resolved and the outcome of the spasms was not recovered/not resolved and the outcome of the injection site reaction was recovering/resolving and the outcome of the injection site tenderness and wrong injection technique were unknown. It was unknown if the reporter considered the somnolence, fever, nightmare, night sweat, flushing, presyncope, injection site reaction, generalized aching and injection site tenderness to be related to SHINGRIX. The reporter considered the spasms to be possibly related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed an injection site reaction. It had mostly resolved, but was still a little tender. On the 2nd night after vaccination, the patient could not stay up past 8 PM, so he went to bed and later woke up feverish with bad multifocal pain all over his body. The pain lasted for 4 to 5 hours, and then he was finally able to sleep again. The patient then proceeded to have the worst nightmares in his life until dawn. On the 3rd night after vaccination, he had drenching night sweats such that, he was woken up and his sheets were soaked. The next day he was fine until around 10:30 AM when he had flushing and nearly fainted. The patient had to sit down for 30 to 60 minutes before he could function again. On the 4th night of vaccination, he had night sweats again. On the day of reporting, he had developed a spasm in his tricep where the injection was given. It was a fluttery spasm that came and gone but was not painful. He did know that for the 2nd injection the needle was inserted at more like a 45 degree angle than 90 degrees, though it was still intramuscular, which led to wrong injection technique. For tolerance after 1st dose, refer case US2018116420.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Night sweats, Nightmare, Pain, Presyncope, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of somnolence in a 67-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 24th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th June 2018, less than a day after receiving SHINGRIX and 83 days after receiving SHINGRIX, the patient experienced injection site reaction, injection site tenderness and wrong injection technique. On 25th June 2018, the patient experienced somnolence, fever, nightmare and generalized aching. On 26th June 2018, the patient experienced night sweat. On 27th June 2018, the patient experienced flushing and presyncope. On 29th June 2018, the patient experienced spasms. On an unknown date, the outcome of the somnolence, fever, nightmare, night sweat, flushing, presyncope and generalized aching were recovered/resolved and the outcome of the spasms was not recovered/not resolved and the outcome of the injection site reaction was recovering/resolving and the outcome of the injection site tenderness and wrong injection technique were unknown. It was unknown if the reporter considered the somnolence, fever, nightmare, night sweat, flushing, presyncope, injection site reaction, generalized aching and injection site tenderness to be related to SHINGRIX. The reporter considered the spasms to be possibly related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed an injection site reaction. It had mostly resolved, but was still a little tender. On the 2nd night after vaccination, the patient could not stay up past 8 PM, so he went to bed and later woke up feverish with bad multifocal pain all over his body. The pain lasted for 4 to 5 hours, and then he was finally able to sleep again. The patient then proceeded to have the worst nightmares in his life until dawn. On the 3rd night after vaccination, he had drenching night sweats such that, he was woken up and his sheets were soaked. The next day he was fine until around 10:30 AM when he had flushing and nearly fainted. The patient had to sit down for 30 to 60 minutes before he could function again. On the 4th night of vaccination, he had night sweats again. On the day of reporting, he had developed a spasm in his tricep where the injection was given. It was a fluttery spasm that came and gone but was not painful. He did know that for the 2nd injection the needle was inserted at more like a 45 degree angle than 90 degrees, though it was still intramuscular, which led to wrong injection technique. For tolerance after 1st dose, refer case US2018116420.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of somnolence in a 67-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 24th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th June 2018, less than a day after receiving SHINGRIX and 83 days after receiving SHINGRIX, the patient experienced injection site reaction, injection site tenderness and wrong injection technique. On 25th June 2018, the patient experienced somnolence, fever, nightmare and generalized aching. On 26th June 2018, the patient experienced night sweat. On 27th June 2018, the patient experienced flushing and presyncope. On 29th June 2018, the patient experienced spasms. On an unknown date, the outcome of the somnolence, fever, nightmare, night sweat, flushing, presyncope and generalized aching were recovered/resolved and the outcome of the spasms was not recovered/not resolved and the outcome of the injection site reaction was recovering/resolving and the outcome of the injection site tenderness and wrong injection technique were unknown. It was unknown if the reporter considered the somnolence, fever, nightmare, night sweat, flushing, presyncope, injection site reaction, generalized aching and injection site tenderness to be related to SHINGRIX. The reporter considered the spasms to be possibly related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed an injection site reaction. It had mostly resolved, but was still a little tender. On the 2nd night after vaccination, the patient could not stay up past 8 PM, so he went to bed and later woke up feverish with bad multifocal pain all over his body. The pain lasted for 4 to 5 hours, and then he was finally able to sleep again. The patient then proceeded to have the worst nightmares in his life until dawn. On the 3rd night after vaccination, he had drenching night sweats such that, he was woken up and his sheets were soaked. The next day he was fine until around 10:30 AM when he had flushing and nearly fainted. The patient had to sit down for 30 to 60 minutes before he could function again. On the 4th night of vaccination, he had night sweats again. On the day of reporting, he had developed a spasm in his tricep where the injection was given. It was a fluttery spasm that came and gone but was not painful. He did know that for the 2nd injection the needle was inserted at more like a 45 degree angle than 90 degrees, though it was still intramuscular, which led to wrong injection technique. For tolerance after 1st dose, refer case US2018116420.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lip blister, Oral herpes, Oral mucosal blistering, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 times) and immunosuppression (undefined immunosuppressed disease). On 22nd June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 23rd June 2018, the patient experienced fever blister, lip blister, chills and oral mucosa blister. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the fever blister, lip blister, chills, fever and oral mucosa blister were unknown. It was unknown if the reporter considered the fever blister, lip blister, chills, fever and oral mucosa blister to be related to SHINGRIX. Additional details were provided as follows: Approximately 1 day after receiving SHINGRIX, the patient developed a blister on her lip, which was described as a fever blister. One day after vaccination, the patient experienced chills and blisters inside her cheeks. The physician prescribed an unknown antiviral and the patient symptoms had improved a bit.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Skin haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy were recovering/resolving and the outcome of the skin bleeding was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, right after the vaccination, she experienced sore muscles and joints, injection site redness and swelling and this continued following the first week after the vaccination. The patient stated that, the soreness and muscle pain in the injected arm was so bad that she could not turn the keys to even start her car, lift up a cup of coffee or even vacuum her floors. The patient was unable to do the tasks which she usually could do. The soreness and pain traveled down to her right hip to the left hip and further followed up her left arm. She said it was like the soreness and pain was traveling across her body. The patient's daughter noticed that she saw bruising on patient's arm. The bruises looked more like blood running under the skin. It looked like streaks running down her arms and legs. The patient also stated that, the weird thing was that the bruising was down her right arm and left calf on her leg. Less than a month after the vaccination the patient experienced streaks running down her arms and legs, soreness across the body, tiredness, bruising on arm, unable to do tasks the patient usually could do and no energy to do anything. She could not make sense of what was happening to her. She was still experiencing the adverse effects till the time of reporting; however, they had started resolving at the time of reporting. At the time of reporting, the soreness and bruising were almost gone in her right arm and the left arm was getting better and the side effects in her right hip were not as bad as the left hip. The patient also stated that, all this went for a period of about 3 weeks. At the time of reporting, she still felt tired and had no energy to do anything. She had not contacted her physician. The patient could not remember the exact dates of vaccination and the event onset dates. The patient stated that she would not be getting the second dose of SHINGRIX.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy were recovering/resolving and the outcome of the skin bleeding was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, right after the vaccination, she experienced sore muscles and joints, injection site redness and swelling and this continued following the first week after the vaccination. The patient stated that, the soreness and muscle pain in the injected arm was so bad that she could not turn the keys to even start her car, lift up a cup of coffee or even vacuum her floors. The patient was unable to do the tasks which she usually could do. The soreness and pain traveled down to her right hip to the left hip and further followed up her left arm. She said it was like the soreness and pain was traveling across her body. The patient's daughter noticed that she saw bruising on patient's arm. The bruises looked more like blood running under the skin. It looked like streaks running down her arms and legs. The patient also stated that, the weird thing was that the bruising was down her right arm and left calf on her leg. Less than a month after the vaccination the patient experienced streaks running down her arms and legs, soreness across the body, tiredness, bruising on arm, unable to do tasks the patient usually could do and no energy to do anything. She could not make sense of what was happening to her. She was still experiencing the adverse effects till the time of reporting; however, they had started resolving at the time of reporting. At the time of reporting, the soreness and bruising were almost gone in her right arm and the left arm was getting better and the side effects in her right hip were not as bad as the left hip. The patient also stated that, all this went for a period of about 3 weeks. At the time of reporting, she still felt tired and had no energy to do anything. She had not contacted her physician. The patient could not remember the exact dates of vaccination and the event onset dates. The patient stated that she would not be getting the second dose of SHINGRIX.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy were recovering/resolving and the outcome of the skin bleeding was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, right after the vaccination, she experienced sore muscles and joints, injection site redness and swelling and this continued following the first week after the vaccination. The patient stated that, the soreness and muscle pain in the injected arm was so bad that she could not turn the keys to even start her car, lift up a cup of coffee or even vacuum her floors. The patient was unable to do the tasks which she usually could do. The soreness and pain traveled down to her right hip to the left hip and further followed up her left arm. She said it was like the soreness and pain was traveling across her body. The patient's daughter noticed that she saw bruising on patient's arm. The bruises looked more like blood running under the skin. It looked like streaks running down her arms and legs. The patient also stated that, the weird thing was that the bruising was down her right arm and left calf on her leg. Less than a month after the vaccination the patient experienced streaks running down her arms and legs, soreness across the body, tiredness, bruising on arm, unable to do tasks the patient usually could do and no energy to do anything. She could not make sense of what was happening to her. She was still experiencing the adverse effects till the time of reporting; however, they had started resolving at the time of reporting. At the time of reporting, the soreness and bruising were almost gone in her right arm and the left arm was getting better and the side effects in her right hip were not as bad as the left hip. The patient also stated that, all this went for a period of about 3 weeks. At the time of reporting, she still felt tired and had no energy to do anything. She had not contacted her physician. The patient could not remember the exact dates of vaccination and the event onset dates. The patient stated that she would not be getting the second dose of SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Contusion, Fatigue, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was reported as follows: The reporter was casually speaking to her neighbor about getting the vaccination. The patient described to the neighbor about the adverse event experienced by her. The reporter further stated that, the neighbor made the comment that his mother experienced the same side effects with the vaccine as she had (refer case US2018GSK121413). This was all the reported information.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was reported as follows: The reporter was casually speaking to her neighbor about getting the vaccination. The patient described to the neighbor about the adverse event experienced by her. The reporter further stated that, the neighbor made the comment that his mother experienced the same side effects with the vaccine as she had (refer case US2018GSK121413). This was all the reported information.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Skin haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was reported as follows: The reporter was casually speaking to her neighbor about getting the vaccination. The patient described to the neighbor about the adverse event experienced by her. The reporter further stated that, the neighbor made the comment that his mother experienced the same side effects with the vaccine as she had (refer case US2018GSK121413). This was all the reported information.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was reported as follows: The reporter was casually speaking to her neighbor about getting the vaccination. The patient described to the neighbor about the adverse event experienced by her. The reporter further stated that, the neighbor made the comment that his mother experienced the same side effects with the vaccine as she had (refer case US2018GSK121413). This was all the reported information.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was reported as follows: The reporter was casually speaking to her neighbor about getting the vaccination. The patient described to the neighbor about the adverse event experienced by her. The reporter further stated that, the neighbor made the comment that his mother experienced the same side effects with the vaccine as she had (refer case US2018GSK121413). This was all the reported information.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Contusion, Fatigue, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was stated as follows: This case was reported for the neighbors' mother. The reporter was casually speaking to her neighbor about getting the vaccine. The reporter said the neighbor made the comment that his mother experienced the same side effects with the vaccine as that of the reporter. She did not go into details other than the patient was vaccinated at almost the same time, when the reporter was vaccinated. This was all of the information she had. This case was linked to case US2018116441, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was stated as follows: This case was reported for the neighbors' mother. The reporter was casually speaking to her neighbor about getting the vaccine. The reporter said the neighbor made the comment that his mother experienced the same side effects with the vaccine as that of the reporter. She did not go into details other than the patient was vaccinated at almost the same time, when the reporter was vaccinated. This was all of the information she had. This case was linked to case US2018116441, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Skin haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was stated as follows: This case was reported for the neighbors' mother. The reporter was casually speaking to her neighbor about getting the vaccine. The reporter said the neighbor made the comment that his mother experienced the same side effects with the vaccine as that of the reporter. She did not go into details other than the patient was vaccinated at almost the same time, when the reporter was vaccinated. This was all of the information she had. This case was linked to case US2018116441, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was stated as follows: This case was reported for the neighbors' mother. The reporter was casually speaking to her neighbor about getting the vaccine. The reporter said the neighbor made the comment that his mother experienced the same side effects with the vaccine as that of the reporter. She did not go into details other than the patient was vaccinated at almost the same time, when the reporter was vaccinated. This was all of the information she had. This case was linked to case US2018116441, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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 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 information was stated as follows: This case was reported for the neighbors' mother. The reporter was casually speaking to her neighbor about getting the vaccine. The reporter said the neighbor made the comment that his mother experienced the same side effects with the vaccine as that of the reporter. She did not go into details other than the patient was vaccinated at almost the same time, when the reporter was vaccinated. This was all of the information she had. This case was linked to case US2018116441, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Induration, Mass, Nodule
Clinical narrative: This case was reported by a consumer and described the occurrence of mass in a female patient who received BEXSERO for prophylaxis. On 28th June 2018 21:00, the patient received the 1st dose of BEXSERO. In June 2018, less than a day after receiving BEXSERO, the patient experienced mass and induration. On an unknown date, the outcome of the mass and induration were unknown. It was unknown if the reporter considered the mass and induration to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient noticed knot kinda hard right shoulder on the edge. It made shoulder, the top of her arm to look abnormal. The patient got vaccines for Hepatitis and meningitis.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash 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 week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced the rash on her trunk within a few days of dosing. The patient also had slept pets she did not own. The patient did not go back for further treatment.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Flushing, Paraesthesia, Skin burning sensation
Clinical narrative: This case was reported by a other health professional and described the occurrence of facial flushing in a 56-year-old male patient who received SHINGRIX (batch number 9779K, expiry date unknown) for prophylaxis. Concurrent medical conditions included hypertension, gastroesophageal reflux disease, hyperlipidemia, aortic valve disease and sleep apnea. On 22nd May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th June 2018, 15 days after receiving SHINGRIX, the patient experienced facial flushing, burning sensation in face, burning sensation scalp and tingling sensation. On an unknown date, the outcome of the facial flushing, burning sensation in face, burning sensation scalp and tingling sensation were not recovered/not resolved. The reporter considered the facial flushing, burning sensation in face, burning sensation scalp and tingling sensation to be unlikely related to SHINGRIX. Additional information was received as follows: The patient experienced facial flushing, flushing of head, flushing of neck and flushing of scalp along with burning and pickling sensation.
Sex: F
Vaccine: RAB, RAB
Symptoms: Antibody test positive, Burning sensation, Dyspnoea, Exposure to communicable disease, Eye irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning leg in a female patient who received RABAVERT for prophylaxis. The patient's past medical history included animal bite. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced burning leg and vaccine administered at inappropriate site. On an unknown date, the outcome of the burning leg and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the burning leg to be related to RABAVERT. Additional details were reported as follows: The age at vaccination was not reported. The patient was tall and had thick thighs. The patient recently experienced what she thought was a bat bite and received two injections of RABAVERT at the emergency room, both administered in her thigh. After receiving 1st dose the patient experienced a burning sensation in her leg. The patient was not sure all of the problems were related to RABAVERT. Around the same time this was happening, her daughter had strep throat and was later diagnosed with scarlet fever and had a rash similar the reporter's. Strep throat and other illnesses were going through her household. Due to the fact that the injection was given in her thigh, the emergency room recommended she get a titer to check if the vaccine was effective. The titer came back with an antibody lever greater than or equal to 0.5 and said it was acceptable level. This case has been linked with case US2018GSK118064 (same patient for 2nd dose). The reporter said that she had reported these adverse events previously but duplicate case could not be found. Lab Comments: Lab test for rabies antibodies was done on an unknown date and the antibody titre was found to be greater than or equal to 5 and it was acceptable level.
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypotension, Muscle twitching, Nervous system disorder, Product administered at inappropriate site, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning leg in a female patient who received RABAVERT for prophylaxis. The patient's past medical history included animal bite. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced burning leg and vaccine administered at inappropriate site. On an unknown date, the outcome of the burning leg and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the burning leg to be related to RABAVERT. Additional details were reported as follows: The age at vaccination was not reported. The patient was tall and had thick thighs. The patient recently experienced what she thought was a bat bite and received two injections of RABAVERT at the emergency room, both administered in her thigh. After receiving 1st dose the patient experienced a burning sensation in her leg. The patient was not sure all of the problems were related to RABAVERT. Around the same time this was happening, her daughter had strep throat and was later diagnosed with scarlet fever and had a rash similar the reporter's. Strep throat and other illnesses were going through her household. Due to the fact that the injection was given in her thigh, the emergency room recommended she get a titer to check if the vaccine was effective. The titer came back with an antibody lever greater than or equal to 0.5 and said it was acceptable level. This case has been linked with case US2018GSK118064 (same patient for 2nd dose). The reporter said that she had reported these adverse events previously but duplicate case could not be found. Lab Comments: Lab test for rabies antibodies was done on an unknown date and the antibody titre was found to be greater than or equal to 5 and it was acceptable level.
Sex: F
Vaccine: RAB, RAB
Symptoms: Respiratory arrest, Thermal burn, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning leg in a female patient who received RABAVERT for prophylaxis. The patient's past medical history included animal bite. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced burning leg and vaccine administered at inappropriate site. On an unknown date, the outcome of the burning leg and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the burning leg to be related to RABAVERT. Additional details were reported as follows: The age at vaccination was not reported. The patient was tall and had thick thighs. The patient recently experienced what she thought was a bat bite and received two injections of RABAVERT at the emergency room, both administered in her thigh. After receiving 1st dose the patient experienced a burning sensation in her leg. The patient was not sure all of the problems were related to RABAVERT. Around the same time this was happening, her daughter had strep throat and was later diagnosed with scarlet fever and had a rash similar the reporter's. Strep throat and other illnesses were going through her household. Due to the fact that the injection was given in her thigh, the emergency room recommended she get a titer to check if the vaccine was effective. The titer came back with an antibody lever greater than or equal to 0.5 and said it was acceptable level. This case has been linked with case US2018GSK118064 (same patient for 2nd dose). The reporter said that she had reported these adverse events previously but duplicate case could not be found. Lab Comments: Lab test for rabies antibodies was done on an unknown date and the antibody titre was found to be greater than or equal to 5 and it was acceptable level.
Sex: F
Vaccine: RAB, RAB
Symptoms: Antibody test positive, Burning sensation, Exposure to communicable disease, Product administered at inappropriate site, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning leg in a female patient who received RABAVERT for prophylaxis. The patient's past medical history included animal bite. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced burning leg and vaccine administered at inappropriate site. On an unknown date, the outcome of the burning leg and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the burning leg to be related to RABAVERT. Additional details were reported as follows: The age at vaccination was not reported. The patient was tall and had thick thighs. The patient recently experienced what she thought was a bat bite and received two injections of RABAVERT at the emergency room, both administered in her thigh. After receiving 1st dose the patient experienced a burning sensation in her leg. The patient was not sure all of the problems were related to RABAVERT. Around the same time this was happening, her daughter had strep throat and was later diagnosed with scarlet fever and had a rash similar the reporter's. Strep throat and other illnesses were going through her household. Due to the fact that the injection was given in her thigh, the emergency room recommended she get a titer to check if the vaccine was effective. The titer came back with an antibody lever greater than or equal to 0.5 and said it was acceptable level. This case has been linked with case US2018GSK118064 (same patient for 2nd dose). The reporter said that she had reported these adverse events previously but duplicate case could not be found. Lab Comments: Lab test for rabies antibodies was done on an unknown date and the antibody titre was found to be greater than or equal to 5 and it was acceptable level.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Periarthritis
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 and frozen shoulder. On an unknown date, the outcome of the pain in arm and frozen shoulder were unknown. It was unknown if the reporter considered the pain in arm and frozen shoulder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine formulation. The reporter did not have additional details on the incidents. She needed to check records for details but agreed to provide more information on follow up. No other information was received.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: Myalgia, fatigue, low grade fever. These symptoms have lasted 3 days now and interfered with customary activities.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect. Patient received an expired PROQUAD vaccine. Exp date: 03/06/2018.
Age: 28.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Syncope
Clinical narrative: Syncope following immunization. Pt did not call, called EMT, checked out by EMT, patient refused to go to hospital. Patient was able to walk out to car and answer all questions.