chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Herpes zoster, Malaise, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (administered a few years before the reporting date). On 24th June 2018, the patient received the 1st dose of SHINGRIX. On 1st August 2018, 38 days after receiving SHINGRIX, the patient experienced feeling unwell. On 3rd August 2018, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the feeling unwell was recovering/resolving and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the feeling unwell and rash to be related to SHINGRIX. Additional information was reported as follows: The patient did not have any history of shingles. About a week and a half before the reporting date, the patient received vaccine in the left arm. In the previous week of reporting, she did not feel good, but not sure if that was related. On Friday, the patient began to develop rash and bumps from her chin up on the right side of her face. The patient also experienced eruption on the right eye lid. The patient went to an urgent care a day before the date of reporting, and was treated for Shingles with Valtrex and Prednisone at the reporting time. She noted the bumps did not appear to be blisters and only the eye one looked like it could had been however it was better after beginning Valtrex. The contact details of the urgent care physician was provided. The patient declined primary care provider (PCP) information, as he had not been made aware, and she noted she was being treated so she did not believe a need to let him know or to see him.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 86-year-old male patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza. On an unknown date, the outcome of the influenza was recovered/resolved. The reporter considered the influenza to be unrelated to SHINGRIX. Additional information was received as follows: The case was reported by the patient's wife. The reporter stated that the patient presented back to the pharmacy to receive the second shot and the pharmacist denied stating that he was beyond the timeframe. The reporter stated the cutoff date he noted was 22nd July 2018. The reporter noted the reason for the delay of the 2nd dose of SHINGRIX was due to medical reasons. The patient had the flu about 1 to 2 months before the reporting date. The reporter denied any relationship to the SHINGRIX vaccination. The reporter would have the pharmacist call back to GlaxoSmithKline for discussion on the delayed time. This case has been linked to the case US2018143099 (wife's case), reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chills, Dysstasia, Fatigue, Gait inability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018 14:30, the patient received the 2nd dose of SHINGRIX 50 mcg/mg. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, unable to walk, activities of daily living impaired and difficulty in standing. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, activities of daily living impaired and difficulty in standing were unchanged and the outcome of the unable to walk was unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, unable to walk, activities of daily living impaired and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was administered in the left arm. The patient experienced muscle pain, loss of muscle control in legs, chills, shivering, and fatigue. The patient stated she was not able to do normal daily activities and the last couple days she had been in the bed. The patient was also having trouble sitting and standing while using the bathroom. Last three days from the date of reporting, the patient had been suffering with all kinds of adverse events. Due to the adverse reactions the patient visited her primary care doctor on 5th August 2018. Doctor mentioned to her that she was experiencing flu like symptoms and it was not related to the vaccine. The patient had three vials of blood drawn for blood test. Her white blood cell count was low, but her doctor mentioned it was nothing to be concerned about. The patient was still waiting on results of other vials of blood there were sent out for testing. No further details were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Muscle disorder, Myalgia, White blood cell count decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018 14:30, the patient received the 2nd dose of SHINGRIX 50 mcg/mg. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, unable to walk, activities of daily living impaired and difficulty in standing. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, activities of daily living impaired and difficulty in standing were unchanged and the outcome of the unable to walk was unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, unable to walk, activities of daily living impaired and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was administered in the left arm. The patient experienced muscle pain, loss of muscle control in legs, chills, shivering, and fatigue. The patient stated she was not able to do normal daily activities and the last couple days she had been in the bed. The patient was also having trouble sitting and standing while using the bathroom. Last three days from the date of reporting, the patient had been suffering with all kinds of adverse events. Due to the adverse reactions the patient visited her primary care doctor on 5th August 2018. Doctor mentioned to her that she was experiencing flu like symptoms and it was not related to the vaccine. The patient had three vials of blood drawn for blood test. Her white blood cell count was low, but her doctor mentioned it was nothing to be concerned about. The patient was still waiting on results of other vials of blood there were sent out for testing. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Varicella
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, chickenpox and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chickenpox and injection site erythema were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, chickenpox and injection site erythema to be related to SHINGRIX. Additional details were as follows: The age at vaccination was not reported but the patient could be 53 or 54 years old. The physician reported that the patient experienced chicken pox breakout all over the body along with redness and swelling at the injection site with an area of 5 to 10 inches in diameter. This case was linked with US2018143086, reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of slight temperature in a 60-year-old male patient who received SHINGRIX (batch number 75659 ?, expiry date 25th April 2020) for prophylaxis. The reported lot number does not match with any GSK lot number. On 20th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by medical assistant (MA). The health care professional stated that the patient experienced persistent low grade fever that remained ongoing. On 11th June 2018, the patient received 2nd dose of SHINGRIX. The health care professional stated that the vaccines were administered at a different facility.  The health care professional was not sure when persistent low grade fever started, only able to provide, sometime after the first dose. The health care professional was unsure how long after the vaccine the fever started.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.  On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a full series of hepatitis B with an unknown brand 16 years ago. The patient had titers drawn recently, but they were found low (therapeutic response decreased) so they went ahead and gave a 4th dose of Engerix-B was administered on 11th June 2018. At the time of reporting, the nurse stated that she did not have time to give information on further details the representative. No additional questions were asked because the nurse was in a hurry. Lab Comments: Lab test performed on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nausea, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 20th March 2018, 4 hrs after receiving SHINGRIX, the patient experienced feeling cold, nausea, somnolence and headache. On an unknown date, the outcome of the feeling cold, nausea, somnolence and headache were recovered/resolved. It was unknown if the reporter considered the feeling cold, nausea, somnolence and headache to be related to SHINGRIX. Additional information was reported as follows: About 4 to 5 hours after the vaccination, the patient was freezing cold, nauseous, had a headache and could not stay awake. She could not get out of her bed for about 20 hours. The patient had denied to contact her physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 75-year-old female patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 6 days after receiving SHINGRIX, the patient experienced fever, chills, sweating and nausea. On an unknown date, the outcome of the fever, chills, sweating and nausea were unknown. It was unknown if the reporter considered the fever, chills, sweating and nausea to be related to SHINGRIX. Additional details were provided as follows: On 2nd May 2018, the patient received 1st dose. As reported by the healthcare professional, the patient had no problems with the first time (with initial injection). The patient developed fever, sweats, chills and nausea after 2nd dose. No further information was reported regarding the event.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 10th April 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, diarrhea, pain in arm and chills. On an unknown date, the outcome of the nausea, vomiting, diarrhea, pain in arm and chills were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, diarrhea, pain in arm and chills to be related to SHINGRIX. Additional details were provided as follows: The patient reported having nausea, vomiting once and diarrhea the evening of getting the 1st dose of SHINGRIX. The patient also noted sore arm and chills. These issues resolved after 1 day, she planned to get the next shot. The patient was very upset about 2nd shot not being available. All questions were not asked as the report was not her priority of the call. She had not reported these issues to her physician but provided physician's name.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st July 2018, the patient received the 2nd dose of SHINGRIX. On 21st July 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced underdose. On an unknown date, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the underdose was unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: Less than a year after receiving 1st dose of SHINGRIX, the patient experienced the injection site reactions which lasted 4 days.  The area of injection was unknown. The exact onset time was also unknown. On 21st July 2018, the patient received her 2nd dose in the left arm at different pharmacy at approximately 4:20 PM.  There was some concern that she might not had received the full dose because a droplet was seen on the counter near the area she had received the injection, which led to underdose. There were no injection site reactions reported for the 2nd dose. There were no additional details regarding the administration of the 2nd dose as the reporter was the not the person who administered it. The pharmacist did not have the lot number of the box. The reporter gave a lot number of the patient information sheet.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling, Pyrexia, Rash, Serum sickness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of serum sickness in a 16-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included MENVEO for prophylaxis. Previously administered products included MENVEO (1st dose received on an unknown date). On 3rd August 2018, the patient received the 1st dose of BEXSERO and the 2nd dose of MENVEO. In August 2018, less than a week after receiving BEXSERO and MENVEO, the patient experienced serum sickness, hand swelling, rash and fever. In August 2018, the outcome of the serum sickness, hand swelling, rash and fever were recovered/resolved. It was unknown if the reporter considered the serum sickness, hand swelling, rash and fever to be related to BEXSERO and MENVEO. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 15 or 16 years old. The reporting nurse was very experienced giving BEXSERO and MENVEO vaccines. The batch numbers for BEXSERO and MENVEO were unknown. The patient had both of BEXSERO and MENVEO vaccines administered on Friday and between Friday and Sunday, the patient experienced a fever, bilateral hand swelling and a rash on his arms and chest. The patient went to the emergency room on Sunday but was not admitted. The patient then saw an allergist who diagnosed him with possible serum sickness reaction. The nurse had a question whether the patient should be administered the 2nd dose of BEXSERO and was referred to medical information. The sales representative was concerned the nurse might also report the adverse event.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Grip strength decreased, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received in May 2018 (see case US2018GSK149565)). On 8th August 2018 09:00, the patient received the 2nd dose of SHINGRIX. On 8th August 2018 18:00, 9 hrs after receiving SHINGRIX, the patient experienced feeling cold, shivering, headache, fever, general body pain, tingling of extremity and grip strength decreased. On an unknown date, the outcome of the feeling cold, shivering, headache, fever, tingling of extremity and grip strength decreased were recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the feeling cold, shivering, headache, fever, general body pain, tingling of extremity and grip strength decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had same experience as of 1st dose but the symptoms were worse for this dose. The patient thought she had to go to the emergency room because she had a temperature of 102.5 with shivering, headache and body aches. This case was linked with US2018GSK149565, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received in May 2018 (see case US2018GSK149565)). On 8th August 2018 09:00, the patient received the 2nd dose of SHINGRIX. On 8th August 2018 18:00, 9 hrs after receiving SHINGRIX, the patient experienced feeling cold, shivering, headache, fever, general body pain, tingling of extremity and grip strength decreased. On an unknown date, the outcome of the feeling cold, shivering, headache, fever, tingling of extremity and grip strength decreased were recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the feeling cold, shivering, headache, fever, general body pain, tingling of extremity and grip strength decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had same experience as of 1st dose but the symptoms were worse for this dose. The patient thought she had to go to the emergency room because she had a temperature of 102.5 with shivering, headache and body aches. This case was linked with US2018GSK149565, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Amnesia, Chills, Fatigue, Headache
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 an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced fatigue, shivering, memory loss, upset stomach, abnormal vision, headache and fever. On an unknown date, the outcome of the fatigue, shivering, memory loss, upset stomach, abnormal vision, headache and fever were not recovered/not resolved. It was unknown if the reporter considered the fatigue, shivering, memory loss, upset stomach, abnormal vision, headache and fever to be related to SHINGRIX. Additional details were as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in the left arm approximately 2 to 3 months before the reporting date. The patient reported that he experienced the symptoms a week after receiving the SHINGRIX vaccine. The vision problem was stated as being an issue when he drives. The patient also said he had a hard time remembering things lately.  The patient had provided contact details of his physician.
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Pyrexia, Visual impairment
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 an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced fatigue, shivering, memory loss, upset stomach, abnormal vision, headache and fever. On an unknown date, the outcome of the fatigue, shivering, memory loss, upset stomach, abnormal vision, headache and fever were not recovered/not resolved. It was unknown if the reporter considered the fatigue, shivering, memory loss, upset stomach, abnormal vision, headache and fever to be related to SHINGRIX. Additional details were as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in the left arm approximately 2 to 3 months before the reporting date. The patient reported that he experienced the symptoms a week after receiving the SHINGRIX vaccine. The vision problem was stated as being an issue when he drives. The patient also said he had a hard time remembering things lately.  The patient had provided contact details of his physician.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 23rd March 2018 (see case US2018GSK149542)). On 21st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and shooting pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the pain in arm and shooting pain were unknown. It was unknown if the reporter considered the pain in arm and shooting pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient was experiencing sore arm and shooting pain which was going up and down the left arm. As per pharmacist, the patient followed up with his physician a day before the date of reporting and was started on antibiotics. The patient was also scheduled for magnetic resonance imaging and electrocardiogram. No further details were provided. This case was linked with US2018GSK149542, reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, headache, fever and injection site warmth. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site erythema, headache, fever and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site erythema, headache, fever and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. The patient experienced redness at the injection site, described as an 8 X 7 cm circle at the injection site. The patient noted the site was hot to the touch. The patient also experienced headache and fever. At the time of reporting, the symptoms were improving.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling cold, Feeling hot
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In August 2018, the patient experienced erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of and feeling cold. On an unknown date, the outcome of the erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of, feeling cold and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Sunday, the patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. 24 hours after receiving SHINGRIX, the patient experienced freezing shivering in bed then had a fever (the patient's body temperature was recorded as 101.6 F) and tiredness. Less than a week after receiving SHINGRIX, the patient entire upper arm was red hot and swollen and it was just starting to resolve after three days. The patient experienced tiredness and remained in bed for 48 hours. At the date of reporting on the third day, the patient was still tired. The patient called the pharmacist who administered the shot so that she would not continue to administer it incorrectly. The pharmacist read the pamphlet and apologized and said she would administer it intramuscularly from then onwards. The patient could not imagine this was just an isolated event since the original shingles shot was given subcutaneously. That route was what medical personnel were used to. The patient thought that there should be more education or something on the box to alert personnel to give the injection intramuscularly. The patient asked whether she would had adequate protection with the SHINGRIX booster that was given subcutaneously. The reporter believed that others might had received this product subcutaneously as well. This case has been linked with US2018144853, reported by the same reporter. For the inappropriate route of vaccination in unspecified number of patients refer linked case US2018GSK149636.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In August 2018, the patient experienced erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of and feeling cold. On an unknown date, the outcome of the erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of, feeling cold and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Sunday, the patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. 24 hours after receiving SHINGRIX, the patient experienced freezing shivering in bed then had a fever (the patient's body temperature was recorded as 101.6 F) and tiredness. Less than a week after receiving SHINGRIX, the patient entire upper arm was red hot and swollen and it was just starting to resolve after three days. The patient experienced tiredness and remained in bed for 48 hours. At the date of reporting on the third day, the patient was still tired. The patient called the pharmacist who administered the shot so that she would not continue to administer it incorrectly. The pharmacist read the pamphlet and apologized and said she would administer it intramuscularly from then onwards. The patient could not imagine this was just an isolated event since the original shingles shot was given subcutaneously. That route was what medical personnel were used to. The patient thought that there should be more education or something on the box to alert personnel to give the injection intramuscularly. The patient asked whether she would had adequate protection with the SHINGRIX booster that was given subcutaneously. The reporter believed that others might had received this product subcutaneously as well. This case has been linked with US2018144853, reported by the same reporter. For the inappropriate route of vaccination in unspecified number of patients refer linked case US2018GSK149636.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Incorrect route of drug administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extremities hot feeling of in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extremities hot feeling of, fever, shivering, tiredness, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of, fever, shivering, tiredness, erythema, swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the extremities hot feeling of, fever, shivering, tiredness, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that a friend of her cousin's received SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The health care professional also stated that the patient experienced redness, hot arm, swelling, shivering, fever, and tiredness. This case has been linked with US2018144849, reported by the same reporter for herself.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extremities hot feeling of in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extremities hot feeling of, fever, shivering, tiredness, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of, fever, shivering, tiredness, erythema, swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the extremities hot feeling of, fever, shivering, tiredness, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that a friend of her cousin's received SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The health care professional also stated that the patient experienced redness, hot arm, swelling, shivering, fever, and tiredness. This case has been linked with US2018144849, reported by the same reporter for herself.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, influenza-like symptoms and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, influenza-like symptoms and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, influenza-like symptoms and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The reporting nurse was the patient. The age at vaccination was not reported, it could be 50 or 51 years old.  The patient experienced pain, redness and swelling at the injection site (left arm). The patient also experienced flu-like symptoms which were not specified. It was not known how soon symptoms developed after the injection of SHINGRIX.
Sex: F
Vaccine: MENB
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of painful rash in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced painful rash and erythematous rash. On an unknown date, the outcome of the painful rash and erythematous rash were unknown. It was unknown if the reporter considered the painful rash and erythematous rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported if the reporter knew that the patient would get this horribly painful rash that was still getting bigger after 5 days, he might have rethought it. Based on my patient's reaction to BEXSERO vaccine, the reporter could not say if his other kid would get it, and that he thought vaccines were so important, But this was not in the side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 60-year-old 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 feeling unwell and shoulder pain. On an unknown date, the outcome of the feeling unwell and shoulder pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years old. The patient felt crappy and could not get out of bed for 2 days and had sore shoulder for 2 days. The reporter did not agree to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination site pain in a 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 vaccination site pain and muscle pain. On an unknown date, the outcome of the vaccination site pain and muscle pain were unknown. It was unknown if the reporter considered the vaccination site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX into left deltoid. The SHINGRIX administered in retail pharmacy store that had no private rooms. The pain radiated around upper arm and down lateral muscle of abdomen. The patient advised that, SHINGRIX vaccine should be given in large muscle because the patient's deltoid was small. The patient stated, the problem was that if retail pharmacies were to administer SHINGRIX and if it was to be given in a large muscle, at the deltoid should not be listed as site of choice. The patient suggested, perhaps the lateral thigh (the patient could wear shorts). This might have created the further need for Pharmacists to be trained in identifying sites for injection other than the deltoid. The patient reported that the pain was severe. The patient did not want anyone having to deal with this pain and stated that, this pain was not normal, feels as if the muscle were ripped apart.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of injection site burning in a patient who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, immediately after receiving PEDIARIX, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to PEDIARIX. Additional details were reported as follows: The age at vaccination was not applicable. The physician and medical assistants reported to the other company that, when they gave PEDIARIX, the patients told that it burned. No additional information was provided.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site joint pain, Musculoskeletal stiffness, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site joint pain, back pain, limbs stiffness, headache and poor sleep. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site joint pain, back pain, limbs stiffness, headache and poor sleep were unknown. It was unknown if the reporter considered the injection site joint pain, back pain, limbs stiffness, headache and poor sleep to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The patient had contacted to ask if she can take ibuprofen 24 hours after receiving the SHINGRIX vaccine and would they interact typically. A day before reporting, the patient received the vaccine at 4:00 and stated that the effects of the vaccine were kicking her butt. The patient experienced shoulder pain at the injection site, back ache, leg stiffness, headache and did not sleep well night of vaccination. The product specialist informed the patient that as per the prescribing literature ibuprofen is not listed specifically and it stated that Drug Interactions: Immunosuppressive therapies may reduce the effectiveness of SHINGRIX. In addition, the product specialist stated that they were not allowed to give medical advice and referred the patient to her doctor (or pharmacist) as the primary resource for patient care. The patient replied that as per her research Ibuprofen was not immunosuppressive, and asked if that caused a different thought. The product specialist stated that then she might infer that it is not an immunosuppressive that it would reduce the effectiveness of SHINGRIX. The patient was informed that they did not have specific information on the use of Ibuprofen and SHINGRIX. The patient would be taken ibuprofen in about 15 minutes after vaccination. The patient provided contact details of the physician. The patient would be send a copy of the prescribing literature for SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Lethargy, Muscle spasms, Paraesthesia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of lethargy in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort. On an unknown date, the outcome of the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort were unknown. It was unknown if the reporter considered the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort to be related to SHINGRIX. Additional details were reported as follows: This case received from consumer via GlaxoSmithKline (GSK). The call center representative had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient stated that, she experienced a severe reaction to SHINGRIX vaccine. The patient experienced severe muscle cramping all over her body, felt electrical charge going up and down all over her spine. The patient had headache, she was sick to stomach and felt very lethargic. The reporter had agree to follow up via postal mail. This case did not include product complaint.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of lethargy in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort. On an unknown date, the outcome of the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort were unknown. It was unknown if the reporter considered the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort to be related to SHINGRIX. Additional details were reported as follows: This case received from consumer via GlaxoSmithKline (GSK). The call center representative had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient stated that, she experienced a severe reaction to SHINGRIX vaccine. The patient experienced severe muscle cramping all over her body, felt electrical charge going up and down all over her spine. The patient had headache, she was sick to stomach and felt very lethargic. The reporter had agree to follow up via postal mail. This case did not include product complaint.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Muscle spasms, Nausea, Neuralgia, Pain
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of lethargy in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort. On an unknown date, the outcome of the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort were unknown. It was unknown if the reporter considered the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort to be related to SHINGRIX. Additional details were reported as follows: This case received from consumer via GlaxoSmithKline (GSK). The call center representative had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient stated that, she experienced a severe reaction to SHINGRIX vaccine. The patient experienced severe muscle cramping all over her body, felt electrical charge going up and down all over her spine. The patient had headache, she was sick to stomach and felt very lethargic. The reporter had agree to follow up via postal mail. This case did not include product complaint.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of lethargy in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort. On an unknown date, the outcome of the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort were unknown. It was unknown if the reporter considered the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort to be related to SHINGRIX. Additional details were reported as follows: This case received from consumer via GlaxoSmithKline (GSK). The call center representative had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient stated that, she experienced a severe reaction to SHINGRIX vaccine. The patient experienced severe muscle cramping all over her body, felt electrical charge going up and down all over her spine. The patient had headache, she was sick to stomach and felt very lethargic. The reporter had agree to follow up via postal mail. This case did not include product complaint.