chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-SEP-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster.  The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-MAR-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JUL-2013, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-AUG-2016, the patient was treated at an internal medicine and geriatric office for a vesicular outbreak, which was diagnosed as shingles. He was prescribed acyclovir and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 21-OCT-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. 13-JUL-2013. This is a correction. The patient tab was updated with source information. The narrative was updated with minor changes to the wording. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 22-Apr-2009, the patient was inoculated with ZOSTAVAX at a Medical Center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a Nurse Practitioner for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-OCT-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JUN-2014, the patient was treated at a clinic for a blistering vesicular outbreak that was diagnosed as shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2011, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-MAR-2016, the patient was treated by a physician at a dermatology center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-DEC-2015, the patient was treated by a physician, for a blistering vesicular outbreak, which was diagnosed as zoster keratitis. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, zoster keratitis was considered to be medically significant. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Joint range of motion decreased, Joint swelling, Laboratory test normal
Clinical narrative: Left foot and ankle became extremely swollen and burning - looked like a loaf of bread and felt like it was in the toaster. After a month swelling went down enough that I could wiggle my toes. It is now 10 weeks later and still somewhat swollen. July 20, 2018: I had gotten the original several years ago (back when insurance was not paying for it) and I asked my doctor if he thought I should get this new one and he gave me the OK. I got the shot at noon and by 8:00 that night, I was wishing that I hadn't. My left foot became extremely swollen and burning. As I described it...it looked like a loaf of bread and felt like it was stuck in the toaster. It was 2 weeks before I could get an appointment with the doctor. He ordered x ray and a test for possible blood clot. Both tests came back with no evidence of cause. It was a month before the swelling came down enough that I could wiggle my toes. The burning has pretty much stopped, and I think that the discomfort I experience now is caused by the tightness in the top of the foot and ankle, and the fact that the ankle doesn't flex as it should. I have missed 10 weeks of exercise classes and I feel the loss of strength...relying sometimes now on the use of a cane for assistance. I am hoping to get back to class and do just what I can. I would like to learn the cause of this reaction and possible favorable treatment. There was never any rash or redness. If, through your studies, you find any explanation or treatment, I would appreciate hearing from you. Possible some shingles, no rash. I'm assuming that I should not get the follow-up 2nd shot?
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Peripheral swelling, Skin tightness, Walking aid user, X-ray normal
Clinical narrative: Left foot and ankle became extremely swollen and burning - looked like a loaf of bread and felt like it was in the toaster. After a month swelling went down enough that I could wiggle my toes. It is now 10 weeks later and still somewhat swollen. July 20, 2018: I had gotten the original several years ago (back when insurance was not paying for it) and I asked my doctor if he thought I should get this new one and he gave me the OK. I got the shot at noon and by 8:00 that night, I was wishing that I hadn't. My left foot became extremely swollen and burning. As I described it...it looked like a loaf of bread and felt like it was stuck in the toaster. It was 2 weeks before I could get an appointment with the doctor. He ordered x ray and a test for possible blood clot. Both tests came back with no evidence of cause. It was a month before the swelling came down enough that I could wiggle my toes. The burning has pretty much stopped, and I think that the discomfort I experience now is caused by the tightness in the top of the foot and ankle, and the fact that the ankle doesn't flex as it should. I have missed 10 weeks of exercise classes and I feel the loss of strength...relying sometimes now on the use of a cane for assistance. I am hoping to get back to class and do just what I can. I would like to learn the cause of this reaction and possible favorable treatment. There was never any rash or redness. If, through your studies, you find any explanation or treatment, I would appreciate hearing from you. Possible some shingles, no rash. I'm assuming that I should not get the follow-up 2nd shot?
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-OCT-2013, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-SEP-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications.  Later in 2014, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 20-AUG-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 03-AUG-2016, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-FEB-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-DEC-2014, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-APR-2016, the patient was treated by the same physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster. She was prescribed FAMVIR for management for her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-JAN-2012, the patient was inoculated with ZOSTAVAX at a medical center (considered a hospital) as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2012, the patient was treated at the same medical center (not specified whether admitted; therefore, considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-AUG-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-NOV-2011, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Facial paralysis, Herpes zoster, Rash vesicular, VIIth nerve injury
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-MAR-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-FEB-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. On or about 19-FEB-2015, the patient sought subsequent treatment for a facial paralysis resulting from damage to the facial nerves diagnosed as Bell's palsy. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, facial paralysis/Bell's palsy was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Physical disability, Quality of life decreased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 30-OCT-2013, the patient received ZOSTAVAX, (lot# and route unknown) as recommended for the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 11-JUL- 2015. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of this condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Herpes zoster was reported to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 30-OCT-2013, the patient received ZOSTAVAX, (lot# and route unknown) as recommended for the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 11-JUL- 2015. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of this condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Herpes zoster was reported to be disabling. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (which had a lot # of R003739 and an expiration date of 16-MAR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: below 32F°/0°C (-1.2C) for 21 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. Sender's Comments: US-009507513-1807USA006219: US-009507513-1807USA006220: US-009507513-1807USA006221: US-009507513-1807USA006217: US-009507513-1807USA000939.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (which had a lot # of R003739 and an expiration date of 16-MAR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: below 32F°/0°C (-1.2C) for 21 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. Sender's Comments: US-009507513-1807USA000939: US-009507513-1807USA006220: US-009507513-1807USA006221: US-009507513-1807USA006217: US-009507513-1807USA006218.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anxiety, Bronchial hyperreactivity, Depression, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: A spontaneous report has been received from a Physician. The report concerns a female patient of unknown ethnic origin (age 55 years, height 62 in, weight 168 lb). The patient's past and current medical history included drug allergies: MACRODANTIN (critical), KEFLEX (critical), ANCEF (critical), FARXIGA (critical), INDOCIN (severe), sulfa (moderate), ORTHOVISC (moderate) (ongoing). Concomitant medication included salbutamol for reactive airway disorder, salbutamol sulfate for reactive airway disorder, spironolactone, ezetimibe for hyperlipidemia, zolpidem tartrate for insomnia, ranitidine for GERD, bupropion hydrochloride, metformin, alprazolam for anxiety, gabapentin, ipratropium bromide for wheezing, epinephrine for allergic reaction, venlafaxine hydrochloride and COOL blood glucose tests strips in vitro strip. The patient received influenza vaccine, via unknown route, on 20-NOV-2014. The patient started treatment with FARXIGA 5 mg daily, oral, on 16-MAR-2018 for type 2 diabetes. On 16-MAR-2018, the patient experienced severe shortness of breath. On an unknown date, the patient experienced tendency to have reactions to meds, reactive airway disease, anxiety, depression, PTSD and GERD. Treatment with FARXIGA was discontinued on 20-MAR-2018. The patient recovered from the event(s) of severe shortness of breath on an unspecified date. The outcome of the event(s) of reactive airway disease, anxiety, depression, PTSD, GERD and tendency to have reactions to meds was unknown. The events were considered non-serious. The reporter considered the following event(s) related to treatment with FARXIGA: severe shortness of breath. Summary of follow up information received by AstraZeneca/Medimmune on 11-Jun-2018 from Physician originating from solicited source: Suspect Influenza vaccine added. Reporter's causality for the event severe shortness of breath added. Concomitant medications and concomitant disease updated. Indication for Alprazolam updated. Patient demographics updated. Narrative updated.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Insomnia, Post-traumatic stress disorder, Type 2 diabetes mellitus, Wheezing
Clinical narrative: A spontaneous report has been received from a Physician. The report concerns a female patient of unknown ethnic origin (age 55 years, height 62 in, weight 168 lb). The patient's past and current medical history included drug allergies: MACRODANTIN (critical), KEFLEX (critical), ANCEF (critical), FARXIGA (critical), INDOCIN (severe), sulfa (moderate), ORTHOVISC (moderate) (ongoing). Concomitant medication included salbutamol for reactive airway disorder, salbutamol sulfate for reactive airway disorder, spironolactone, ezetimibe for hyperlipidemia, zolpidem tartrate for insomnia, ranitidine for GERD, bupropion hydrochloride, metformin, alprazolam for anxiety, gabapentin, ipratropium bromide for wheezing, epinephrine for allergic reaction, venlafaxine hydrochloride and COOL blood glucose tests strips in vitro strip. The patient received influenza vaccine, via unknown route, on 20-NOV-2014. The patient started treatment with FARXIGA 5 mg daily, oral, on 16-MAR-2018 for type 2 diabetes. On 16-MAR-2018, the patient experienced severe shortness of breath. On an unknown date, the patient experienced tendency to have reactions to meds, reactive airway disease, anxiety, depression, PTSD and GERD. Treatment with FARXIGA was discontinued on 20-MAR-2018. The patient recovered from the event(s) of severe shortness of breath on an unspecified date. The outcome of the event(s) of reactive airway disease, anxiety, depression, PTSD, GERD and tendency to have reactions to meds was unknown. The events were considered non-serious. The reporter considered the following event(s) related to treatment with FARXIGA: severe shortness of breath. Summary of follow up information received by AstraZeneca/Medimmune on 11-Jun-2018 from Physician originating from solicited source: Suspect Influenza vaccine added. Reporter's causality for the event severe shortness of breath added. Concomitant medications and concomitant disease updated. Indication for Alprazolam updated. Patient demographics updated. Narrative updated.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Post-traumatic stress disorder, Type 2 diabetes mellitus
Clinical narrative: A spontaneous report has been received from a Physician. The report concerns a female patient of unknown ethnic origin (age 55 years, height 62 in, weight 168 lb). The patient's past and current medical history included drug allergies: MACRODANTIN (critical), KEFLEX (critical), ANCEF (critical), FARXIGA (critical), INDOCIN (severe), sulfa (moderate), ORTHOVISC (moderate) (ongoing). Concomitant medication included salbutamol for reactive airway disorder, salbutamol sulfate for reactive airway disorder, spironolactone, ezetimibe for hyperlipidemia, zolpidem tartrate for insomnia, ranitidine for GERD, bupropion hydrochloride, metformin, alprazolam for anxiety, gabapentin, ipratropium bromide for wheezing, epinephrine for allergic reaction, venlafaxine hydrochloride and COOL blood glucose tests strips in vitro strip. The patient received influenza vaccine, via unknown route, on 20-NOV-2014. The patient started treatment with FARXIGA 5 mg daily, oral, on 16-MAR-2018 for type 2 diabetes. On 16-MAR-2018, the patient experienced severe shortness of breath. On an unknown date, the patient experienced tendency to have reactions to meds, reactive airway disease, anxiety, depression, PTSD and GERD. Treatment with FARXIGA was discontinued on 20-MAR-2018. The patient recovered from the event(s) of severe shortness of breath on an unspecified date. The outcome of the event(s) of reactive airway disease, anxiety, depression, PTSD, GERD and tendency to have reactions to meds was unknown. The events were considered non-serious. The reporter considered the following event(s) related to treatment with FARXIGA: severe shortness of breath. Summary of follow up information received by AstraZeneca/Medimmune on 11-Jun-2018 from Physician originating from solicited source: Suspect Influenza vaccine added. Reporter's causality for the event severe shortness of breath added. Concomitant medications and concomitant disease updated. Indication for Alprazolam updated. Patient demographics updated. Narrative updated.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old male patient who received SHINGRIX (batch number 29RR4?, expiry date June 2019) for prophylaxis. On 14th June 2018 15:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with VALTREX and Steroid Injection. On an unknown date, the outcome of the shingles and rash were recovered/resolved. The reporter considered the shingles and rash to be possibly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that the patient developed a rash on his right calf and shin the morning after receiving his first dose of SHINGRIX. Four days, after the vaccination, the patient visited his doctor who diagnosed shingles, administered a steroid injection and prescribed VALTREX. On the fifth day after the vaccination, the rash was gone. The healthcare professional stated that the patient was told by his doctor that the vaccination gave the patient shingles.