chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: CSF test abnormal, Demyelinating polyneuropathy, Dysphonia, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre Syndrome in a 73-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK022133). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 26th January 2019, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Guillain Barre Syndrome, numbness in leg and paralysis were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the Guillain Barre Syndrome, numbness in leg, paralysis and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at injection site which resolved after 2 days. The patient experienced numbness in the feet and legs. He was sent to the hospital emergency room and was admitted. At the time of reporting, he could only move his finger tips and toes. On Tuesday, 29th January 2019, 9 days after receiving SHINGRIX, the patient still could not move and was paralyzed. A lumbar puncture was done along with nerve conduction. A diagnosis of Guillain-Barre syndrome was made. The patient was then intubated. The patient remains in intensive care unit (ICU) at time of report, and was receiving infusions of IG. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Hypokinesia, Laboratory test, Lumbar puncture, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre Syndrome in a 73-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK022133). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 26th January 2019, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Guillain Barre Syndrome, numbness in leg and paralysis were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the Guillain Barre Syndrome, numbness in leg, paralysis and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at injection site which resolved after 2 days. The patient experienced numbness in the feet and legs. He was sent to the hospital emergency room and was admitted. At the time of reporting, he could only move his finger tips and toes. On Tuesday, 29th January 2019, 9 days after receiving SHINGRIX, the patient still could not move and was paralyzed. A lumbar puncture was done along with nerve conduction. A diagnosis of Guillain-Barre syndrome was made. The patient was then intubated. The patient remains in intensive care unit (ICU) at time of report, and was receiving infusions of IG. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Nausea, Nerve conduction studies abnormal, Paraesthesia, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre Syndrome in a 73-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK022133). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 26th January 2019, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Guillain Barre Syndrome, numbness in leg and paralysis were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the Guillain Barre Syndrome, numbness in leg, paralysis and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at injection site which resolved after 2 days. The patient experienced numbness in the feet and legs. He was sent to the hospital emergency room and was admitted. At the time of reporting, he could only move his finger tips and toes. On Tuesday, 29th January 2019, 9 days after receiving SHINGRIX, the patient still could not move and was paralyzed. A lumbar puncture was done along with nerve conduction. A diagnosis of Guillain-Barre syndrome was made. The patient was then intubated. The patient remains in intensive care unit (ICU) at time of report, and was receiving infusions of IG. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre Syndrome in a 73-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK022133). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 26th January 2019, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Guillain Barre Syndrome, numbness in leg and paralysis were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the Guillain Barre Syndrome, numbness in leg, paralysis and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at injection site which resolved after 2 days. The patient experienced numbness in the feet and legs. He was sent to the hospital emergency room and was admitted. At the time of reporting, he could only move his finger tips and toes. On Tuesday, 29th January 2019, 9 days after receiving SHINGRIX, the patient still could not move and was paralyzed. A lumbar puncture was done along with nerve conduction. A diagnosis of Guillain-Barre syndrome was made. The patient was then intubated. The patient remains in intensive care unit (ICU) at time of report, and was receiving infusions of IG. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Intensive care, Lumbar puncture, Nerve conduction studies, Paralysis, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre Syndrome in a 73-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK022133). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 26th January 2019, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Guillain Barre Syndrome, numbness in leg and paralysis were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the Guillain Barre Syndrome, numbness in leg, paralysis and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at injection site which resolved after 2 days. The patient experienced numbness in the feet and legs. He was sent to the hospital emergency room and was admitted. At the time of reporting, he could only move his finger tips and toes. On Tuesday, 29th January 2019, 9 days after receiving SHINGRIX, the patient still could not move and was paralyzed. A lumbar puncture was done along with nerve conduction. A diagnosis of Guillain-Barre syndrome was made. The patient was then intubated. The patient remains in intensive care unit (ICU) at time of report, and was receiving infusions of IG. The reporter consented to follow up.
Age: 45.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Culture, Erythema, Skin lesion, Ultrasound scan abnormal
Clinical narrative: Patient is a 45-year-old male seen in consultation for Dr. for evaluation of right arm injection site. Patient states he had the flu injection in his right arm in October 2018 at work. Patient states after injection, he noticed a "big boil" in his proximal right upper extremity. Patient states that his PCP ordered an ultrasound and opened the lesion about 1-2 months following injection. When lesion was lanced, patient reports drainage. Patient states his PCP gave him antibiotics and a cream for the wound. Denies fever, sweats, chills. Denies erythema currently. Denies drainage since lesion was lanced by PCP. Rates pain 1-2/10. Patient had ultrasound of the soft tissues of the right upper arm performed on 2/4/19 which revealed the following per report: Scanning of the site of clinical abnormality reveals a small hypoechoic abnormality in the superficial subcutaneous fat measuring 10 x 3 x 10 mm; nonspecific abnormality presumably relates to infection/inflammation.
Age: 45.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Furuncle, Incisional drainage, Injection site reaction, Ultrasound scan abnormal
Clinical narrative: Patient is a 45-year-old male seen in consultation for Dr. for evaluation of right arm injection site. Patient states he had the flu injection in his right arm in October 2018 at work. Patient states after injection, he noticed a "big boil" in his proximal right upper extremity. Patient states that his PCP ordered an ultrasound and opened the lesion about 1-2 months following injection. When lesion was lanced, patient reports drainage. Patient states his PCP gave him antibiotics and a cream for the wound. Denies fever, sweats, chills. Denies erythema currently. Denies drainage since lesion was lanced by PCP. Rates pain 1-2/10. Patient had ultrasound of the soft tissues of the right upper arm performed on 2/4/19 which revealed the following per report: Scanning of the site of clinical abnormality reveals a small hypoechoic abnormality in the superficial subcutaneous fat measuring 10 x 3 x 10 mm; nonspecific abnormality presumably relates to infection/inflammation.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Pain
Clinical narrative: Severe headache, joint pain, nausea, body aches.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Patient stated that after receiving the vaccination her injection site immediately became hot, red and swollen. She states that the injection site still burns and tingles when she touches it. She also says that her arm hurts when she lefts her left arm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain, Pain in extremity
Clinical narrative: Patient stated that after receiving the vaccination her injection site immediately became hot, red and swollen. She states that the injection site still burns and tingles when she touches it. She also says that her arm hurts when she lefts her left arm.
Sex: M
Vaccine: MENB
Symptoms: Interchange of vaccine products
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received BEXSERO for prophylaxis. Previously administered products included TRUMENBA (1st dose received in November 2018). On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown. Additional details were provided as follows: The age at vaccination was not reported. Registered nurse administered a dose of BEXSERO and when the system PRIR had came on, she had noticed that the patient had 1st dose of TRUMENBA not BEXSERO and was administered already, which led to interchange of vaccine products.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 25-JAN-2019, the patient was vaccinated with one dose of improperly stored M-M-R II with lot number R001659 and expiration date on 17-JAN-2020, administered for prophylaxis (strength, dose, route of administration and anatomical injection site were not reported)  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 Fahrenheit degrees for 1 hour and 27 minutes time frame. There were not previous temperature excursions. The call was placed because of a Digital Data logger report. No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2016, the patient completed GARDASIL series. On 28-JAN-2019, the patient was vaccinated with GARDASIL 9 (route, lot#, expiry date unknown) for prophylaxis inadvertently after completing the GARDASIL series (accidental exposure to product). The patient had no adverse effects (no adverse event). No PQC was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Amblyopia strabismic, Arthralgia, Blepharospasm, Cataract
Clinical narrative: Information has been received on 31-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered unexplained rashes, arthralgias, fatigue, tremors, headaches, unexplained weight loss, and hair loss and was diagnosed with Lupus Erythematosus. In addition, the patient's vision gradually decreased to the point that it was severely blurred, and she could no longer drive or read any longer. As a result, the patient was diagnosed with strabismic amblyopia, cataract, dry eye syndrome, blepharospasm and nuclear sclerosis. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Lupus Erythematosus, strabismic amblyopia, cataract/nuclear sclerosis, dry eye syndrome, and blepharospasm were considered to be disabling. Upon internal review, Lupus Erythematosus and cataract/nuclear sclerosis were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cataract nuclear, Dry eye, Fatigue, Headache, Impaired driving ability
Clinical narrative: Information has been received on 31-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered unexplained rashes, arthralgias, fatigue, tremors, headaches, unexplained weight loss, and hair loss and was diagnosed with Lupus Erythematosus. In addition, the patient's vision gradually decreased to the point that it was severely blurred, and she could no longer drive or read any longer. As a result, the patient was diagnosed with strabismic amblyopia, cataract, dry eye syndrome, blepharospasm and nuclear sclerosis. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Lupus Erythematosus, strabismic amblyopia, cataract/nuclear sclerosis, dry eye syndrome, and blepharospasm were considered to be disabling. Upon internal review, Lupus Erythematosus and cataract/nuclear sclerosis were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Rash, Systemic lupus erythematosus, Tremor, Vision blurred
Clinical narrative: Information has been received on 31-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered unexplained rashes, arthralgias, fatigue, tremors, headaches, unexplained weight loss, and hair loss and was diagnosed with Lupus Erythematosus. In addition, the patient's vision gradually decreased to the point that it was severely blurred, and she could no longer drive or read any longer. As a result, the patient was diagnosed with strabismic amblyopia, cataract, dry eye syndrome, blepharospasm and nuclear sclerosis. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Lupus Erythematosus, strabismic amblyopia, cataract/nuclear sclerosis, dry eye syndrome, and blepharospasm were considered to be disabling. Upon internal review, Lupus Erythematosus and cataract/nuclear sclerosis were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment, Weight decreased
Clinical narrative: Information has been received on 31-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered unexplained rashes, arthralgias, fatigue, tremors, headaches, unexplained weight loss, and hair loss and was diagnosed with Lupus Erythematosus. In addition, the patient's vision gradually decreased to the point that it was severely blurred, and she could no longer drive or read any longer. As a result, the patient was diagnosed with strabismic amblyopia, cataract, dry eye syndrome, blepharospasm and nuclear sclerosis. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Lupus Erythematosus, strabismic amblyopia, cataract/nuclear sclerosis, dry eye syndrome, and blepharospasm were considered to be disabling. Upon internal review, Lupus Erythematosus and cataract/nuclear sclerosis were considered to be medically significant. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on 01-FEB-2019 the patient was vaccinated with PROQUAD lot # R012417, expiration date: 28-OCT-2019, for prophylaxis and during the same office visit received a dose of VARIVAX 0.5 ml, once, subcutaneously, lot # N027628, expiration date 04-OCT-2019. Both vaccines were reconstituted with sterile diluent, lot# R006344, expiration date: 13-DEC-2020. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 05-FEB-2019, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis, lot # N023002 and expiration date 20-NOV-2018 (dose, strength, frequency and route of administration were unknown). No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a register nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not provided. Concomitant therapies included sterile diluent. On 14-JAN-2019, the patient was vaccinated with VARIVAX lot # R006753, expiration date 06-MAR-2020 (frequency, dosage, strength were not reported) for prophylaxis. Call was due to a data logger. Temperature/time (47 Fahrenheit to 77 Fahrenheit ) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On the same date, the nurse stated patients received unspecified doses of VARIVAX that were improperly stored (product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not provided. Concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with VARIVAX lot # R020651 for prophylaxis. Call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of VARIVAX that were improperly stored.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 28-JAN-2019, the patient was vaccinated with VARIVAX (frequency, dosage, strength were not reported) for prophylaxis with the respective sterile diluent. Call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit ) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of VARIVAX that were improperly stored (product storage error).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 28-JAN-2019, the patient was vaccinated with PROQUAD lot # R017802, expiration date 19-DEC-2019 (strength, dosage, frequency were not reported) for prophylaxis with the respective diluent, the call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of PROQUAD that were improperly stored.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 31-JAN-2019, the patient was vaccinated with PROQUAD lot # R017803 for prophylaxis with the respective sterile diluent. Call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of PROQUAD that were improperly stored.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma stage III
Clinical narrative: Information has been received from a physician via a company representative referring to a 36 years old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date in 2006 the patient was vaccinated with GARDASIL (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date the patient experienced stage 3 cervical cancer even after receiving GARDASIL. The patient sought unknown type of medical attention. It was unknown if any lab diagnostics were performed or any treatment was given for the events. Outcome of the events was unknown. Causality was not reported. Upon internal review, stage 3 cervical cancer was considered to be medically significant.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 24th January 2019, the patient received SHINGRIX. On 26th January 2019, 2 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were reported as follows: On last Thursday, the patient received a dose of SHINGRIX. Since Saturday, the patient experienced diarrhea. The reporter wanted to know, if this was a possible side effect of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she never had chickenpox but pharmacist recommended SHINGRIX anyway. The patient broke out with an active case of Shingles after she received the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were received as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX in late October 2018. It was stated that, the patient had another occurrence of shingles since the first part of January 2019. The reporter asked if the second schedule of SHINGRIX vaccine be given to the patient. This case was considered as suspected vaccination failure, since the laboratory confirmation for shingles was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that the patient was past the 6 month point for the 2nd dose of the SHINGRIX series, which led to incomplete course of vaccination. The pharmacist consented to follow up. Follow up information was received from the pharmacist on 29th January 2019: The age at vaccination was not reported, however the patient could be 77 or 78 years old at the time of vaccination. On an unknown date, the patient received the 2nd dose of SHINGRIX past the 6 months period from the 1st dose, which led to lengthening of vaccination schedule. Less than a year after receiving SHINGRIX, the patient experienced swollen arm. The patient called the pharmacist for the advice and pharmacist called the GlaxoSmithKline (GSK) to verify that the patient's swollen am was normal. The pharmacist reported that the patient was not his/her patient. The pharmacist did not vaccinate the patient. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. The pharmacist did not consent for follow up. The VAERS information was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced rash, shingles and erythromacular rash. On an unknown date, the outcome of the rash, shingles and erythromacular rash were not recovered/not resolved. The reporter considered the rash, shingles and erythromacular rash to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a rash that the patient considered to be shingles approximately 2 months after a dose of SHINGRIX. The rash consisted of red spots, without blisters in one location, about the size of a half dollar coin. The reporter did not give consent to follow up. The reporter did not consider this to be associated with the dose of SHINGRIX. The reporter was unable to provide specifics of the vaccine or the patient and did not wish to be contacted regarding this case.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 29th January 2019, 1 days after receiving SHINGRIX, the patient experienced headache, pain, tiredness and chills. On an unknown date, the outcome of the headache, pain, tiredness and chills were unknown. It was unknown if the reporter considered the headache, pain, tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, achiness, tiredness and chills. The reporter did not give consent to follow up. No further details were provided.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 71-year-old male patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 1 day after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: On 30th January 2019, the patient was diagnosed with shingles. Emergency room visit was required and the pharmacist did not have any further details. The pharmacist consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) 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 injection site lump and injection site rash. On an unknown date, the outcome of the injection site lump and injection site rash were unknown. It was unknown if the reporter considered the injection site lump and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 60 or 61 years. The patient developed a knot and slight rash at the injection site area one week after receipt of her SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The field representative calling to report that physician was the patient. The field representative stated that physician had the SHINGRIX shot in the last thirty days and had pain at the injection site and flu like symptoms that lasted 2 to 3 days. No further details reported.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Itching, swelling, redness and warm and tenderness to touch down her injection arm to her wrist.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Ageusia, Headache
Clinical narrative: Patient woke up at 8:00 am with a headache and complaining he was not able to taste anything. No problems chewing or swallowing. No swelling of tongue or difficulty breathing. Grandmother was instructed to give him some Tylenol and seek medical treatment if he is not better or worsens by our nurse.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a day after receiving SHINGRIX, the patient experienced shivering, fever and sleeplessness. The patient was treated with TYLENOL. On an unknown date, the outcome of the shivering, fever and sleeplessness were unknown. It was unknown if the reporter considered the shivering, fever and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The patient felt as if he had a fever, extreme shivering but no sweating. The patient took a couple of TYLENOL and the chills subsided but he got no sleep. In the morning of reporting day, felt more or less but was okay, but hammered (almost no sleep).
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Red, warm, itchy and painful to touch.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red, warm, itchy and painful to touch.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Aphasia, Flushing, Lethargy, Pyrexia, Regressive behaviour
Clinical narrative: High fever of 105.0. Lethargic. Flush face. Stopped babbling and saying words. Slight regression.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 28th January 2019, less than an hour after receiving SHINGRIX, the patient experienced tiredness, muscle pain, injection site muscle pain and influenza-like symptoms. On an unknown date, the outcome of the tiredness, muscle pain, injection site muscle pain and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the tiredness, muscle pain, injection site muscle pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 years or 56 years. The patient received 1st dose of SHINGRIX in an unknown deltoid and within 1 hour ended up in bed for 4 hours. The patient experienced tiredness, muscle ache, pain in vaccinated deltoid, massive flu symptoms, and pain was worse after waking up from sleep. The reporter gave consent to follow up. The nurse did not want to give address or date of birth.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Takotsubo Syndrome - chest pain, nausea and weakness. ER for Tx.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Stress cardiomyopathy
Clinical narrative: Takotsubo Syndrome - chest pain, nausea and weakness. ER for Tx.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Given at Dr. office Left upper arm red, swollen and painful for about 2 weeks. headaches and nausea for 1 day. After that there was and still is a deficit between triceps and deltoid muscles that looks like and indentation between the muscles. Strength and range of motion are intact. 2nd injection given 2/5/2019. Arm soreness, light headed and facial flushing that next morning 2/6/19 at pharmacy. Right deltoid. Lot#353S5. Exp:5-29-21.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is 30 weeks pregnant. Her EDD is 4/17/19. She is a G2P0.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Flushing, Hypertension, Palpitations
Clinical narrative: Patient said felt flushed after immunization. Has had high blood pressure and racing heart beat since immunization.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Constipation, Myalgia, Oral herpes
Clinical narrative: Joint and muscle pain, no bowel movement all week (since 2/4/19), vomiting, chills and today (2/8/19) is developing fever blisters.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Joint and muscle pain, no bowel movement all week (since 2/4/19), vomiting, chills and today (2/8/19) is developing fever blisters.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Redness warmth, streaking, treated with cephalosporin.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hives large all over her body. The reporter wanted to know was this considered as hypersensitivity. The reporter wanted to know should she not get the second dose. The patient was in the pharmacy now because she did not want to get the second dose.