chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 17-NOV-2013, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-FEB-2014, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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: Blister, Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) in 2010, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAY-2016, the patient began to break out with blistering vesicular lesions. The patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient broke out consistently in blistering lesions for more than one year in duration. The patient was further treated at an eye clinic throughout 2016 for shingles interference in the eye. The patient was also treated extensively by a dermatologist for her uncontrolled shingles symptoms, including attempts to treat her shingles with experimental onabotulinumtoxinA (BOTOX) treatments. She was referred to a rigorous chiropractor and acupuncture treatment plan for alternative methods to attempt to curb her terrible symptoms. 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. Upon internal review, shingles interference in the eye was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-MAR-2013, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2013, on a few days after being vaccinated, she was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-MAR-2013, the patient was vaccinated by a physician at office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUN-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful condition. 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: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX injection, lot # M000998 with expiration date on 07-JAN-2018 (dose and route of administration were not reported). No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 08-JUL-2011, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-FEB-2012, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster shingles. On or about 24-FEB-2012, the patient sought subsequent treatment for ongoing pain and new zoster infections. On or about 15-MAR-2012, the patient was treated for continued and uncontrolled herpes zoster outbreaks. On or about 26-MAR-2012, the patient was treated for continued suffering, at which time she was diagnosed with shingles and post-herpetic neuralgia. On or about the dates of 12-JUL-2012 and 10-AUG-2012, the patient sought treatment for her continued neuralgia symptoms that was resistant to treatment attempts. On or about the dates of 29-AUG-2012 and 17-OCT-2012, the patient was treated again for ongoing and worsening symptoms of post-herpetic neuralgia. The patient was prescribed TEGRETOL, TOPAMAX, TRILEPTAL, VALTREX, amitriptyline, gabapentin, and hydrocodone for management of her painful and persistent symptoms. 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: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 08-JUL-2011, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-FEB-2012, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster shingles. On or about 24-FEB-2012, the patient sought subsequent treatment for ongoing pain and new zoster infections. On or about 15-MAR-2012, the patient was treated for continued and uncontrolled herpes zoster outbreaks. On or about 26-MAR-2012, the patient was treated for continued suffering, at which time she was diagnosed with shingles and post-herpetic neuralgia. On or about the dates of 12-JUL-2012 and 10-AUG-2012, the patient sought treatment for her continued neuralgia symptoms that was resistant to treatment attempts. On or about the dates of 29-AUG-2012 and 17-OCT-2012, the patient was treated again for ongoing and worsening symptoms of post-herpetic neuralgia. The patient was prescribed TEGRETOL, TOPAMAX, TRILEPTAL, VALTREX, amitriptyline, gabapentin, and hydrocodone for management of her painful and persistent symptoms. 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: Decreased immune responsiveness, Herpes zoster, Neuropathy peripheral, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 16-JAN-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 13-OCT-2006, administered (by an unspecified person) at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-MAY-2010, the patient was treated by a physician/MD at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 15-JUN-2010, the female was treated again at the same medical center for ongoing and worsening pain at which time the diagnosis of herpes zoster was re-affirmed.  On or about 23-JUL-2010, the female patient was treated at a medical center for shingles with interference to the nervous system.  On or about 03-FEB-2014, the patient sought treatment from a nurse practitioner at a medical center for new outbreaks of herpes zoster. On or about 16-DEC-2016 (date as reported), the patient was treated for recurrent herpes zoster that manifested in persistent cluster outbreaks. On or about 15-DEC-2016 (date as reported), the patient was treated at the physician's office (same office where she received the vaccination on or about 13-OCT-2006) for uncontrolled pain accompanying her herpes zoster, as which time she was diagnosed with neuropathy caused by herpes zoster infections.  The female patient has been prescribed acyclovir, hydrocodone bitartrate (NORCO), prednisone, gabapentin (NEURONTIN), and amitriptyline for management of her painful symptoms. 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. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX.   Upon internal review, the event of treated for Shingles with interference to the nervous system was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Facial paralysis, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 03-AUG-2015, the patient was inoculated with ZOSTAVAX at a family physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-FEB-2016, the patient was treated at the family physician's office for the onset of severe vesicular rash accompanied weakened immune symptoms, which was diagnosed as severe herpes zoster and Bell's palsy, a condition of nerve damage affecting the facial muscles. She was prescribed acyclovir and gabapentin for management of her painful condition. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Upon internal review, Bell's palsy was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-FEB-2016, 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2016, the patient was treated at a hospital for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. She was prescribed antivirals for management of her painful symptoms. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Herpes zoster oticus, Infection, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 30-AUG-2012, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2015 and 13-FEB-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 13-DEC-2015, the patient was treated by another physician for ongoing and worsening symptoms of shingles, and the new diagnosis of secondary infections caused by shingles in the ear. The patient was prescribed LEVAQUIN, prednisone, and acyclovir for management of her painful and persistent symptoms. 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. Upon internal review, secondary infections caused by shingles in the ear was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 30-AUG-2012, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2015 and 13-FEB-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 13-DEC-2015, the patient was treated by another physician for ongoing and worsening symptoms of shingles, and the new diagnosis of secondary infections caused by shingles in the ear. The patient was prescribed LEVAQUIN, prednisone, and acyclovir for management of her painful and persistent symptoms. 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. Upon internal review, secondary infections caused by shingles in the ear was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 07-JUL-2011 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-SEP-2016, the patient was treated by a physician for the onset of a blistering vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful symptoms. 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: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2015, the patient was vaccinated at health center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-NOV-2016, the patient was treated at health center for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 11-FEB-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 15-JUL-2016, the patient sought subsequent treatment for ongoing and worsening outbreaks of shingles infections, requiring increasing regimens of antivirals to manage his symptoms. The patient was prescribed VALTREX for management of his painful and persistent symptoms, and will need to take VALTREX indefinitely to prevent recurrent outbreaks. 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-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 17-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-APR-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed gabapentin for management of his painful symptoms. 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: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-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 01-DEC-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 18-JUL-2012, 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JAN-2017, the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain
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. On or about 07-OCT-2013, 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2014, she was treated by a physician at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms and eye interference, which was diagnosed as severe herpes zoster that had spread to the retina and optic nerve. Between the dates of 29-DEC-2014 and 05-JUL-2017, the patient received consistent treatment at the clinic for serious complications of zoster infections of the eye including detachment of her retina and permanent vision loss. She was prescribed VALTREX, prednisone, and gabapentin for management of her painful symptoms. 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. The outcome of permanent vision loss was considered not recovered. The outcomes of the other events were unknown at the time of reporting. Causality assessment was related. Upon internal review, zoster infections of the eye, retinal detachment and permanent vision loss were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Retinal detachment
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. On or about 07-OCT-2013, 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2014, she was treated by a physician at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms and eye interference, which was diagnosed as severe herpes zoster that had spread to the retina and optic nerve. Between the dates of 29-DEC-2014 and 05-JUL-2017, the patient received consistent treatment at the clinic for serious complications of zoster infections of the eye including detachment of her retina and permanent vision loss. She was prescribed VALTREX, prednisone, and gabapentin for management of her painful symptoms. 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. The outcome of permanent vision loss was considered not recovered. The outcomes of the other events were unknown at the time of reporting. Causality assessment was related. Upon internal review, zoster infections of the eye, retinal detachment and permanent vision loss were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JAN-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-FEB-2013, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 01-JAN-2016, the patient was again treated by a physician for new and worsening symptoms of zoster outbreaks. The patient was prescribed VALTREX for management of her painful and persistent symptoms. 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: Decreased immune responsiveness, Herpes zoster, Rash vesicular
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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 15-SEP-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-JAN-2018, the patient was vaccinated with an expired dose of GARDASIL 9 intramuscularly, (dose and frequency were not reported) lot # L036301 and expiration date: 20-DEC-2017. No adverse effects were reported. The relatedness between the event and GARDASIL 9 was not reported.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 30-DEC-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml dose, intramuscularly for prophylaxis (lot # N003993, expiration date 13-JAN-2018). Other suspect therapies included ADACEL (received on the same day). On 30-DEC-2017, right after the injection, the site was sore. On 31-DEC-2017 (reported as next day), when the patient woke up, the injection area was swollen and warm to touch. Patient reported that swelling went down her arm, close to her elbow (date unknown). Patient took TYLENOL to relieve symptoms. Patient reported that swelling and soreness were very bad for 3 days but within 5-6 days of receiving injection, most of symptoms were resolved. There was no laboratory diagnostic studies performed. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA006659.
Sex: U
Vaccine: VARCEL
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: This non-valid spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JAN-2018, the patient was vaccinated with VARIVAX (dose, site of administration, route of administration, indication, lot # and expiration date were not reported) for prophylaxis. Upon administration of VARIVAX some of the vaccination got in the patient's eye. No adverse effect were reported. No product quality complaint (PQC) was involved.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse prescriber via a company representative and refers to an 1-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in the middle of December 2017, the patient was vaccinated with a dose of M-M-R II subcutaneously (dose, frequency, lot# and expiration date were note reported) for Vaccination against measles, mumps and rubella. On an unknown date, after the M-M-R II administration, the patient experienced a fever, fatigue and a poor appetite. It could not be confirmed when the fever, fatigue and poor appetite resolved. On an unknown date, 10 days after the M-M-R II administration, the patient experienced a suspicious rash. The rash started at the patient's head and neck and progressed to the trunk. There was "no peeling" associated with the rash. The rash disappeared within 24 hours. The patient did not seek medical attention. At the time of this report, the patient was totally fine, healthy with no concerns. The relatedness between the fever, fatigue, poor appetite and rash and M-M-R II was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 11 year old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N022584, expiry date: 15-JUN-2020) for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA007189: US-009507513-1801USA007190: US-009507513-1801USA007191:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 14 year old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N022584, expiry date: 15-JUN-2020) for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA006754: US-009507513-1801USA007190: US-009507513-1801USA007191:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 4 month year-old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (Lot#N005626, expiry date: 26-NOV-2018) orally, for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA006754: US-009507513-1801USA007189: US-009507513-1801USA007191.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 3 month year-old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (Lot#N005626, expiry date: 26-NOV-2018) orally, for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA006754: US-009507513-1801USA007189: US-009507513-1801USA007190.
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest X-ray abnormal, Epstein-Barr virus test positive
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (reporting for himself) reported that a male patient of an unspecified age (currently reported as 63 years old) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), via an unspecified route of administration on an unspecified date at single dose to stop getting bronchitis every year. Medical history included mononucleosis; doctor said he may have had mononucleosis as a teenager, COPD and emphysema. There were no concomitant medications. The patient reported he gets bronchitis every year, his physician recommends it, but he is afraid to get the side effects. Patient was told he needed the pneumococcal shot because his is 63 and the other has worn off and he gets bronchitis every year. To make sure he didn't have pneumonia they did a chest x-ray. It showed COPD, he had emphysema. The doctor saw the COPD, which is a stage of emphysema. When he was diagnosed with emphysema because he was around so many people and it is susceptible to air borne things, it may elevate bronchitis and is the same strain. Patient was advised to not be around the smoke, but he couldn't leave his job. He didn't know it was physically hurting him. He worked in a casino for 35 years, it was a smoke filled environment and he developed COPD. The patient reported that he got a pneumonia shot 10 years ago, not sure it if was pneumococcal. He had a reaction to it and he was in bed for one day with lower back pain on unspecified date. It was also reported that after the pneumonia shot, about 5 years ago, the physical showed the Epstein-Barr levels were high. There are certain numbers that tells if the immune system has suppressed or if it has control; he was on the border. Doctor said he may have had Mononucleosis as a teenager; Epstein-Barr and mononucleosis were the same virus. Since that one time, he was still compromised to certain things. The pharmacist has never run across a patient with a medical situation like his; having Epstein-Barr and COPD with getting the vaccine. Patient would like to know when was the pneumonia shot developed and when was the pneumococcal shot developed. Outcome of the event back pain was recovered while outcome of other events was unknown. Information on lot number, batch number and expiration date has been requested.
Age: 0.67
Sex: M
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional calling on behalf of a physician. An 8 month-old male patient of an unspecified ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified day in Dec2017 (3 or 4 weeks before this report) for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced wheezing on an unspecified date in Dec2017 (3 or 4 weeks before this report). In response to the event Albuterol nebulizer treatment was given. Outcome was unknown.
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Limb injury, Myalgia
Clinical narrative: Initial unsolicited report received from nurse on 16-Nov-2017. This case involves 52 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE (Frequency: once, batch number: U5896DA and expiry date: 30 Jun 2018) intramuscularly in right deltoid on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination patient had shortness of breath, muscle pain in right arm, neck, chest and shoulder. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. Follow up information received from a nurse on 08-Jan-2018. The patient was vaccinated with FLUZONE on 13-Nov-2017. The patient did not receive any other vaccinations within 4 weeks prior to the date of vaccination. On 14-Nov-2017 around 3:00 A.M, one day following the vaccination patient had shortness of breath, muscle pain in right arm, neck, chest and shoulder and muscle pain in right arm which was diagnosed with SIRVA. It was also reported by the patient that the following vaccine was given correctly in the proper area. The patient required emergency room (ER)/ doctor visit. Patient received prednisone, NSAID'S as a corrective treatment. On an unknown date, patient was recovered from all the events. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus
Clinical narrative: Large reddened area to arm with itching and soreness at injection site.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Mid/Upper deltoid pain that still persists over one month after injection combined with weakness and reduced range of motion (difficulty lifting arm over head due to pain).
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: The hospital was giving free flu shots. I received one and it hurt when administered. My arm continues to hurt very badly. It hurts all the time but really badly at night. It wakes me several times each night. It has been almost 4 months since I received the shot.
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: Injection site nodule
Clinical narrative: Baby had all of his 8-week shots administered. He developed a nodule on the left upper thigh that has remained for over a year. The doctor was unwilling to give us the vaccine information and said any injection can cause a long-standing skin nodule.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report was received from a 64 year old male patient referring to himself. The patient's has not drug reactions/allergies. The patient's concurrent conditions included tooth ache. On 19-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, 1 vaccine dose, to prevent pneumonia (route of administration, lot # and expiration date were not reported). Concomitant therapies included amoxicillin. On 20-DEC-2017, the patient experienced a low grade fever, sore joints (arthralgia), and pain at the injection site. The patient also felt "run down" (feeling abnormal). No laboratory diagnostic tests were performed and no treatment was received for the events. At the time of reporting, the outcome of the events was reported as not recovered. The causality assessment between the events and PNEUMOVAX 23 was not provided.