chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received about 10 years before the date of reporting). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythematous rash and skin blotches. SHINGRIX was continued with no change. On an unknown date, the outcome of the erythematous rash and skin blotches were recovered/resolved. It was unknown if the reporter considered the erythematous rash and skin blotches to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the reporter for her husband. The pharmacy where they received the vaccine is onsite at the physician office. The age at vaccination was not reported. About 2 and a half months before the date of reporting, at 10:00 o clock, the patient received SHINGRIX. Twenty four hours after vaccination, the patient developed minor red blotchy bumps that never headed on his the front of his belly. The reporter stated that they did not go around his side or to his back just on the front. The event lasted for about a week but he never saw or reported it to a physician. This case has been linked with US2018141994, reported by the same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Listless, Malaise, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX (batch number 723BG, expiry date 13th July 2020) for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 31st May 2018, the patient experienced malaise, listless and fainting. On 31st May 2018, the outcome of the fainting was recovered/resolved. On 1st June 2018, the outcome of the malaise and listless were recovered/resolved. On 4th June 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain, malaise, listless and fainting to be related to SHINGRIX. Additional details were provided as follows: One day after receiving SHINGRIX, the patient experienced malaise, listlessness and also fainted the following day after receiving the vaccine. The symptoms made the patient feel as though he couldn't do anything, and persisted for 2 days after vaccination (the pain persisted longer- approximately 5 days).
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. On 22nd April 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, flu symptoms, fever, sickness, pain and daytime sleepiness. On an unknown date, the outcome of the fatigue, flu symptoms, fever and sickness were recovered/resolved and the outcome of the pain and daytime sleepiness were unknown. It was unknown if the reporter considered the fatigue, flu symptoms, fever, sickness, pain and daytime sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported that he received his first dose of SHINGRIX on 22nd April 2018 and that night he started to felt fatigued. He felt sick like he was coming down with the flu and he had a temperature with aches. He fall asleep for 7 hours during the middle of the day because of the fatigue he was experiencing. He claims that his symptoms started that Friday night and into the next day and the following day and then all of his symptoms resolved on Sunday. He claims that he received the vaccine around 6:00 PM at night. The patient reported that he received the vaccine on 22nd April 2018 which was a Sunday, however, he specifically stated that his symptoms started on Friday night and into the next day and the following day which contradicts his initial vaccination date. The reporter did not realize during phone conversation that 22nd April 2018 was a Sunday when he reported the information.
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. On 22nd April 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, flu symptoms, fever, sickness, pain and daytime sleepiness. On an unknown date, the outcome of the fatigue, flu symptoms, fever and sickness were recovered/resolved and the outcome of the pain and daytime sleepiness were unknown. It was unknown if the reporter considered the fatigue, flu symptoms, fever, sickness, pain and daytime sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported that he received his first dose of SHINGRIX on 22nd April 2018 and that night he started to felt fatigued. He felt sick like he was coming down with the flu and he had a temperature with aches. He fall asleep for 7 hours during the middle of the day because of the fatigue he was experiencing. He claims that his symptoms started that Friday night and into the next day and the following day and then all of his symptoms resolved on Sunday. He claims that he received the vaccine around 6:00 PM at night. The patient reported that he received the vaccine on 22nd April 2018 which was a Sunday, however, he specifically stated that his symptoms started on Friday night and into the next day and the following day which contradicts his initial vaccination date. The reporter did not realize during phone conversation that 22nd April 2018 was a Sunday when he reported the information.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood pressure increased, Chills, Cough, Dyspnoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice) and chemotherapy. Previously administered products included ZOSTAVAX. On 4th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th August 2018, 10 hrs after receiving SHINGRIX, the patient experienced exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever were recovered/resolved. The reporter considered the exhaustion, shortness of breath, tremor, chills, nausea, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough and neck pain to be related to SHINGRIX. It was unknown if the reporter considered the pain in extremity and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th August 2018, at 10:00 hours, the patient received SHINGRIX in the left arm. On 4th August 2018, at 20:00 hours, 10 hours, after receiving SHINGRIX, the patient experienced extreme exhaustion. Five minutes after the experienced the extreme exhaustion, she experienced a strong pain that started in the palms of her hands and the pain went up to her arms. The patient experienced a strong pain that started on the palms of her hands and soles of her feet that shot up to her legs, then her back and neck. Less than a day after receiving SHINGRIX, the patient experienced fever, shaking, chills, nausea, coughing, and gagging. Less than a day after receiving SHINGRIX, the patient experienced soreness in the arm in which she received the injection that lasted 2 days. At this point she went to urgent care and at urgent care they did some testing that revealed an elevated white blood cell count, elevated blood pressure, elevated heart rate and an abnormal electrocardiogram (EKG).  The urgent care sent the patient to the emergency room where she stayed for approximately 7 hours however, she was not admitted to the hospital. The patient released after 7 hours and told her to take Tylenol at home. One day, after receiving SHINGRIX, the patient slept all day on Sunday and when she woke up, the pain was gone and she was back to normal but still very tired. On the day of reporting all symptoms were gone and the patient was back to normal.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram abnormal, Fatigue, Heart rate increased, Nausea, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice) and chemotherapy. Previously administered products included ZOSTAVAX. On 4th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th August 2018, 10 hrs after receiving SHINGRIX, the patient experienced exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever were recovered/resolved. The reporter considered the exhaustion, shortness of breath, tremor, chills, nausea, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough and neck pain to be related to SHINGRIX. It was unknown if the reporter considered the pain in extremity and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th August 2018, at 10:00 hours, the patient received SHINGRIX in the left arm. On 4th August 2018, at 20:00 hours, 10 hours, after receiving SHINGRIX, the patient experienced extreme exhaustion. Five minutes after the experienced the extreme exhaustion, she experienced a strong pain that started in the palms of her hands and the pain went up to her arms. The patient experienced a strong pain that started on the palms of her hands and soles of her feet that shot up to her legs, then her back and neck. Less than a day after receiving SHINGRIX, the patient experienced fever, shaking, chills, nausea, coughing, and gagging. Less than a day after receiving SHINGRIX, the patient experienced soreness in the arm in which she received the injection that lasted 2 days. At this point she went to urgent care and at urgent care they did some testing that revealed an elevated white blood cell count, elevated blood pressure, elevated heart rate and an abnormal electrocardiogram (EKG).  The urgent care sent the patient to the emergency room where she stayed for approximately 7 hours however, she was not admitted to the hospital. The patient released after 7 hours and told her to take Tylenol at home. One day, after receiving SHINGRIX, the patient slept all day on Sunday and when she woke up, the pain was gone and she was back to normal but still very tired. On the day of reporting all symptoms were gone and the patient was back to normal.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia, Retching, Tremor, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice) and chemotherapy. Previously administered products included ZOSTAVAX. On 4th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th August 2018, 10 hrs after receiving SHINGRIX, the patient experienced exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever were recovered/resolved. The reporter considered the exhaustion, shortness of breath, tremor, chills, nausea, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough and neck pain to be related to SHINGRIX. It was unknown if the reporter considered the pain in extremity and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th August 2018, at 10:00 hours, the patient received SHINGRIX in the left arm. On 4th August 2018, at 20:00 hours, 10 hours, after receiving SHINGRIX, the patient experienced extreme exhaustion. Five minutes after the experienced the extreme exhaustion, she experienced a strong pain that started in the palms of her hands and the pain went up to her arms. The patient experienced a strong pain that started on the palms of her hands and soles of her feet that shot up to her legs, then her back and neck. Less than a day after receiving SHINGRIX, the patient experienced fever, shaking, chills, nausea, coughing, and gagging. Less than a day after receiving SHINGRIX, the patient experienced soreness in the arm in which she received the injection that lasted 2 days. At this point she went to urgent care and at urgent care they did some testing that revealed an elevated white blood cell count, elevated blood pressure, elevated heart rate and an abnormal electrocardiogram (EKG).  The urgent care sent the patient to the emergency room where she stayed for approximately 7 hours however, she was not admitted to the hospital. The patient released after 7 hours and told her to take Tylenol at home. One day, after receiving SHINGRIX, the patient slept all day on Sunday and when she woke up, the pain was gone and she was back to normal but still very tired. On the day of reporting all symptoms were gone and the patient was back to normal.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice) and chemotherapy. Previously administered products included ZOSTAVAX. On 4th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th August 2018, 10 hrs after receiving SHINGRIX, the patient experienced exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever were recovered/resolved. The reporter considered the exhaustion, shortness of breath, tremor, chills, nausea, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough and neck pain to be related to SHINGRIX. It was unknown if the reporter considered the pain in extremity and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th August 2018, at 10:00 hours, the patient received SHINGRIX in the left arm. On 4th August 2018, at 20:00 hours, 10 hours, after receiving SHINGRIX, the patient experienced extreme exhaustion. Five minutes after the experienced the extreme exhaustion, she experienced a strong pain that started in the palms of her hands and the pain went up to her arms. The patient experienced a strong pain that started on the palms of her hands and soles of her feet that shot up to her legs, then her back and neck. Less than a day after receiving SHINGRIX, the patient experienced fever, shaking, chills, nausea, coughing, and gagging. Less than a day after receiving SHINGRIX, the patient experienced soreness in the arm in which she received the injection that lasted 2 days. At this point she went to urgent care and at urgent care they did some testing that revealed an elevated white blood cell count, elevated blood pressure, elevated heart rate and an abnormal electrocardiogram (EKG).  The urgent care sent the patient to the emergency room where she stayed for approximately 7 hours however, she was not admitted to the hospital. The patient released after 7 hours and told her to take Tylenol at home. One day, after receiving SHINGRIX, the patient slept all day on Sunday and when she woke up, the pain was gone and she was back to normal but still very tired. On the day of reporting all symptoms were gone and the patient was back to normal.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood pressure increased, Chills, Cough, Dyspnoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm and injected limb mobility decreased were unknown. The reporter considered the swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she spoke with someone she works with and the patient reported to her that after she received of SHINGRIX, her arm immediately became swollen and she could not left her arm. The swelling occurred in the arm in which the patient received the SHINGRIX injection. The patient visited her doctor for the symptoms and also went to physical therapy for the symptoms. The patient felt like it was caused by the vaccine and that the patient was much better now. The caller stated that she was not sure if the symptoms had resolved completely. The caller did not have any additional information regarding the event.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram abnormal, Fatigue, Heart rate increased, Nausea, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm and injected limb mobility decreased were unknown. The reporter considered the swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she spoke with someone she works with and the patient reported to her that after she received of SHINGRIX, her arm immediately became swollen and she could not left her arm. The swelling occurred in the arm in which the patient received the SHINGRIX injection. The patient visited her doctor for the symptoms and also went to physical therapy for the symptoms. The patient felt like it was caused by the vaccine and that the patient was much better now. The caller stated that she was not sure if the symptoms had resolved completely. The caller did not have any additional information regarding the event.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia, Retching, Tremor, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm and injected limb mobility decreased were unknown. The reporter considered the swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she spoke with someone she works with and the patient reported to her that after she received of SHINGRIX, her arm immediately became swollen and she could not left her arm. The swelling occurred in the arm in which the patient received the SHINGRIX injection. The patient visited her doctor for the symptoms and also went to physical therapy for the symptoms. The patient felt like it was caused by the vaccine and that the patient was much better now. The caller stated that she was not sure if the symptoms had resolved completely. The caller did not have any additional information regarding the event.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm and injected limb mobility decreased were unknown. The reporter considered the swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she spoke with someone she works with and the patient reported to her that after she received of SHINGRIX, her arm immediately became swollen and she could not left her arm. The swelling occurred in the arm in which the patient received the SHINGRIX injection. The patient visited her doctor for the symptoms and also went to physical therapy for the symptoms. The patient felt like it was caused by the vaccine and that the patient was much better now. The caller stated that she was not sure if the symptoms had resolved completely. The caller did not have any additional information regarding the event.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to doctor. The age at vaccination was not reported. The reporter indicated that she had a patient that received the SHINGRIX vaccination and experienced flu-like symptoms, fatigue, and arm pain. These symptoms lasted for approximately 4 to 5 days. The field representative indicated that the reporter had already reported these adverse events to VAERS. The field representative was unable to provide additional information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 7th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year 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 details were provided as follows: The case was reported by a medical assistant. The patient developed a rash (unsure of timing).
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Cough, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in an unspecified no number of adult patients 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 exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea were unknown. It was unknown if the reporter considered the exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The age at vaccination was not reported. The caller stated that her physician had a couple of patients who had reactions to SHINGRIX. The reporter was only able to provide symptoms; however, she did not have additional information regarding the patients or any other details. Lab Comments: Lab test done on an unknown date.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Nausea, Pain, Retching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in an unspecified no number of adult patients 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 exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea were unknown. It was unknown if the reporter considered the exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The age at vaccination was not reported. The caller stated that her physician had a couple of patients who had reactions to SHINGRIX. The reporter was only able to provide symptoms; however, she did not have additional information regarding the patients or any other details. Lab Comments: Lab test done on an unknown date.
Sex: U
Vaccine: VARZOS
Symptoms: Tremor, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in an unspecified no number of adult patients 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 exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea were unknown. It was unknown if the reporter considered the exhaustion, shortness of breath, tremor, chills, electrocardiogram abnormal, cough, gagging, white blood cell count increased, increased blood pressure, heart rate increased, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The age at vaccination was not reported. The caller stated that her physician had a couple of patients who had reactions to SHINGRIX. The reporter was only able to provide symptoms; however, she did not have additional information regarding the patients or any other details. Lab Comments: Lab test done on an unknown date.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pain in extremity, Pruritus, Rash, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (had an anaphylactic reaction to Prilocaine previously). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), sleepiness and rash. On an unknown date, the patient experienced pain in arm and pruritus. The patient was treated with ibuprofen and BENADRYL. In May 2018, the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the loss of consciousness, pain in arm, pruritus and rash were recovered/resolved. It was unknown if the reporter considered the loss of consciousness, pain in arm, pruritus, sleepiness and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient stated that the vaccine knocked her out and she slept for 2 days. She developed a rash within a week after that shot on her palms, the bottoms of her feet, under her arms, legs, under her breasts and down her stomach. The patient took BENADRYL and the rash resolved but it came back and resolved after a week and a half. The patient was instructed to take Ibuprofen for her sore arm.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a physician via out of hour services and described the occurrence of nausea in a 12-year-old female patient who received Menveo (batch number M17058, expiry date 30th April 2019) for prophylaxis. On 6th August 2018, the patient received the 1st dose of Menveo (intramuscular). On 6th August 2018, 2 hrs after receiving Menveo, the patient experienced nausea. In August 2018, the patient experienced vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to Menveo. Additional details were provided as follows: The patient after receiving vaccination remained in the office for 15 minutes and when she left was fine. The patient developed nausea on the way home and had been vomiting once an hour since the visit. There was no location reaction at the site and no fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2018, immediately after receiving SHINGRIX, the patient experienced erythematous rash. In April 2018, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have lot numbers or expiration dates. The patient experienced large rash that was super red about the diameter of a grapefruit after the first dose of the SHINGRIX series. The event lasted for 4 days. For tolerance effect after 2nd dose of SHINGRIX, refer linked case US2018GSK147866.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness, feeling hot and nausea. On an unknown date, the outcome of the muscle pain, tiredness, feeling hot and nausea were unknown. It was unknown if the reporter considered the muscle pain, tiredness, feeling hot and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting, the patient experienced muscle aches, nausea, tiredness and she felt like she had a fever, but she had no fever (felt feverish). The patient did not want to provide her address and she did not wanted to answer any questions. She said that the company could contact her directly by phone if needed.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included fibromyalgia. Concomitant products included denosumab (Prolia). In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovered/resolved.  It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, however it could be 70 or 71 years. The patient received vaccine in her left arm and experienced injection site reaction. Only partial information was provided.  The patient had to disconnect for an appointment. For tolerance after 2nd dose refer case US2018GSK147073.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of bedridden 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 bedridden, fever and influenza-like symptoms. On an unknown date, the outcome of the bedridden, fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the bedridden, fever and influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. A healthy patient reported that after a dose of SHINGRIX, she had to stay in bed for 10 days with flu-like symptoms and fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, lower extremities weakness of and headache. On an unknown date, the outcome of the general body pain, lower extremities weakness of and headache were unknown. It was unknown if the reporter considered the general body pain, lower extremities weakness of and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the GlaxoSmithKline's employee for herself. On Wednesday, the patient received SHINGRIX. On Thursday in the morning, the patient woke up to go to work and her body ached, her legs were weak such that she was not confident to use the stairs. The patient informed her supervisor and colleagues that she would not be in the office on Thursday and would get on her laptop later if she could. On Thursday, by around 2 PM, she felt confident walking around but still she had aches and a severe headache. When the patient's sister called her later that day to ask if she could meet up with her, the patient told her that she had a shot at the doctor's the day before and had a reaction. The patient's sister then immediately asked her if the shot was the shingles vaccine. This case has been linked to the US2018GSK141419, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Gait inability, Mental disorder, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of unable to walk in a adult female patient who received SHINGRIX for prophylaxis. 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 unable to walk, crying, lancinating pain and mental disorder. On an unknown date, the outcome of the unable to walk, crying, lancinating pain and mental disorder were unknown. It was unknown if the reporter considered the unable to walk, crying, lancinating pain and mental disorder to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the GlaxoSmithKline's employee. The patient was 50-something years old at the time of reporting. The reporter's sister told to the reporter that, the patient (her friend) called her the day before after her second shot and was crying, doubled over in pain on the floor and she could not walk. The reporter had been trying to get her contact information as well as permission to be contacted as the patient suffered from severe mental illness. The reporter was asking an advice as to how she should proceed further. This case has been linked to the US2018GSK141418, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (injection site warmth and erythema experienced after 1st dose received in May 2018, refer case US2018143673). Concurrent medical conditions included fibromyalgia. Concomitant products included denosumab (Prolia). On 5th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, however it could be 70 or 71 years. The patient received vaccine in her left arm and experienced the injection site reactions. Only partial information was provided. The patient had to disconnect for an appointment.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 55-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On 20th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 20th June 2018, immediately after receiving SHINGRIX, the patient experienced erythematous rash. On 6th August 2018, the patient experienced itchy upper limbs and rash. On 7th August 2018, the patient experienced blister. In June 2018, the outcome of the erythematous rash was recovered/resolved. On an unknown date, the outcome of the itchy upper limbs, rash and blister were not recovered/not resolved. It was unknown if the reporter considered the erythematous rash, itchy upper limbs, rash and blister to be related to SHINGRIX. Additional details were provided as follows: The patient did not have lot numbers or expiration dates. On 2nd April 2018, the patient received 1st dose of SHINGRIX (refer linked case US2018143071). The patient received 2nd dose of SHINGRIX on left deltoid. The patient experienced large rash that was super red about the diameter of a grapefruit after the second  dose of the SHINGRIX series, which lasted for 4 days. Forty seven days after receiving SHINGRIX, the patient experienced spot on the thigh, itching and a rash in the opposite arm. Forty eight days after receiving SHINGRIX, the patient experienced few blisters on the thigh.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Anxiety, Apnoea, Loss of consciousness, Nausea, Pallor
Clinical narrative: 08/14/2018 Pt. anxious before appointment, as reported by mom. After receiving second vaccination, pt. passed out. I called out to our nursing director and administrator RN. An ammonia stick was broken and waved under patient's nose. We transferred pt. onto floor. He experienced approximately 60 seconds of apnea. I positioned his airway and 911 was called. At this time I noted he lost control of his bladder. Pt. came to and complained of nausea, no vomiting noted. He was very pale. EMS arrived to assess patient. Glucose = 112, B/P = 90/60. Mom didn't want child taken to ER, but after EMS provided education, mom agreed. He was taken to Hospital. Our health officer, Dr. was notified.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Urinary incontinence
Clinical narrative: 08/14/2018 Pt. anxious before appointment, as reported by mom. After receiving second vaccination, pt. passed out. I called out to our nursing director and administrator RN. An ammonia stick was broken and waved under patient's nose. We transferred pt. onto floor. He experienced approximately 60 seconds of apnea. I positioned his airway and 911 was called. At this time I noted he lost control of his bladder. Pt. came to and complained of nausea, no vomiting noted. He was very pale. EMS arrived to assess patient. Glucose = 112, B/P = 90/60. Mom didn't want child taken to ER, but after EMS provided education, mom agreed. He was taken to Hospital. Our health officer, Dr. was notified.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Ophthalmic herpes zoster
Clinical narrative: Broke out in shingles in left eye cornea - forehead and head on 7-8-2018. I had shingles in October 2014 in same place. The SHINGRIX shot was my 2nd dose. My first dose was given March 13, 2018. Still have pain in right arm where administered 2nd dose.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal sensation in eye, Corneal disorder, Corneal scar, Eye swelling, Headache
Clinical narrative: Broke out in shingles in left eye cornea - forehead and head on 7-8-2018. I had shingles in October 2014 in same place. The SHINGRIX shot was my 2nd dose. My first dose was given March 13, 2018. Still have pain in right arm where administered 2nd dose.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site pain, Ocular hyperaemia, Pain
Clinical narrative: Broke out in shingles in left eye cornea - forehead and head on 7-8-2018. I had shingles in October 2014 in same place. The SHINGRIX shot was my 2nd dose. My first dose was given March 13, 2018. Still have pain in right arm where administered 2nd dose.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Screaming, Visual impairment
Clinical narrative: Broke out in shingles in left eye cornea - forehead and head on 7-8-2018. I had shingles in October 2014 in same place. The SHINGRIX shot was my 2nd dose. My first dose was given March 13, 2018. Still have pain in right arm where administered 2nd dose.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Site where vaccine given is red, swollen and tender. 10 x 15 cm.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No known event. Pt checked on with mother. No adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Mobility decreased, Nausea, Pyrexia
Clinical narrative: Pt reported numbness in hands and feet as well as severe fatigue where she could barely get out of bed accompanied with nausea and a fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pain, tenderness and swelling at injection site beginning within 3 hours of injection and extending into day 3. Mild fatigue beginning 12 hours after injection lasting 48 hours; did not prevent normal activities. 48 hours following injection episode of diarrhea lasting 3 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Swollen arm, Flu-like symptoms (muscle aches, fatigue).