chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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. On or about 03-NOV-2015, the patient was inoculated with ZOSTAVAX, at a public health department, (by an unspecified health care professional) 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 condition of herpes zoster. On or about 28-JUN-2016, the patient was treated by a physician at a clinic for a blistering vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed famiciclovir for management of her painful symptoms. As a direct and proximate result of 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, Post herpetic neuralgia, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-MAR-2016, the patient was inoculated at a public health facility (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance 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, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 24-JAN-2017, the patient was treated (by an unspecified health care professional) at a physician office/health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 04-APR-2017, the patient sought subsequent treatment at physician office/health center for ongoing and worsening shingles-related symptoms, which was diagnosed as post-herpetic neuralgia. 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. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 13-APR-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 20-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. On or about 20-JUN-2017, the patient was treated at a health facility for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir, gabapentin, and lidocaine gel for management of her painful symptoms. 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. 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-SEP-2015, 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. 12-DECEMBER-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) for management of his painful symptoms. As a direct and proximate result of 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: 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. During 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. During 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 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: 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 01-NOV-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. On or about 01-APR-2015, the patient was treated by a physician for a vesicular rash, which was diagnosed as herpes zoster or shingles.  On or about 11-DEC-2017, the patient sought subsequent treatment by another physician for ongoing and worsening episodes of shingles outbreaks. 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: 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 22-MAY-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. On or about 26-MAY-2016, a few days after being vaccinated with ZOSTAVAX (conflicting information: it was also reported that the pt. was vaccinated in 2012) the patient was treated by a physician for a vesicular rash, which was diagnosed as 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. On or about 23-MAY-2016, the patient was treated at a medical center, for a vesicular outbreak, which was diagnosed as 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 has 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: Herpes zoster, Pain, Post herpetic neuralgia, 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 (It is unclear from the patient's first name if the patient is a female or male.). Medical history, concurrent conditions, and concomitant medications were not provided. In 2008, the patient was inoculated at a clinic (by an unspecified health care professional) with ZOSTAVAX 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-APR-2016, the patient was treated (by an unspecified health care professional) at the clinic, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. On or about 04-MAY-2016, the patient sought subsequent treatment at the clinic (by an unspecified health care professional) for ongoing and worsening shingles-pain and symptoms, and was then diagnosed with post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient has been prescribed pregabalin (LYRICA) and valacyclovir (VALTREX) for management of his (as reported) 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. The lawyer felt the events were related to ZOSTAVAX. 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. During 2015, the patient was inoculated with ZOSTAVAX 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 23-MAY-2016, she was treated at a treatment center (medical clinic) (by an unspecified health care professional) for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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: Information has been received on 13-APR-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 04-APR-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. On or about 14-JUN-2012, the patient was treated by a health care professional for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed LORTAB for management of her painful symptoms. 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-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 24-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician 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. On or about 20-JUL-2015, the patient was treated by a health care professional in a health clinic for the onset of a severe vesicular rash which was diagnosed as herpes zoster, or shingles. 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-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 01-JUN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. On or about 11-MAY-2016, the patient was treated by a physician at a physician's office for a persistent vesicular rash, which was diagnosed as chronic herpes zoster, or shingles. 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. 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified health care professional)  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. In 2017, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of 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: 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. During 2016, the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified health care professional)  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, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center emergency department (ED) (by an unspecified health care professional) for the onset of a severe vesicular rash, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine was administered by a physician. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician (the same physician who administered the vaccine) for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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: 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 (First name could be female or male). No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2013, the patient was inoculated with ZOSTAVAX at a clinic, 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. During 2013, the patient was treated at clinic /medical facility for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-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 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. Later in 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 13-APR-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 13-JAN-2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. On or about 09-MAY-2016, the patient was treated by a physician at a medical center for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir, cephalexin (KEFLEX) and bacitracin for management of her painful symptoms. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 18-MAR-2015, the patient was inoculated 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 vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-MAY-2016, the patient was treated at a hospital for the  onset of a severe vesicular rash,  which was diagnosed as herpes zoster or shingles. 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown), for prophylaxis (route of administration, lot # and expiration date were not reported). On an unspecified date in April 2018 (also reported as "about a week ago"), the patient developed shingles(herpes zoster). The patient went to see a physician. At the time of reporting, the outcome of the event was reported as recovering. The causality assessment between the event and zoster vaccine live (manufacturer unknown) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2012, the patient was inoculated at a hospital 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 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 blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles with complications. 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or around 03-OCT-2014, the patient was inoculated at a hospital 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 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 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 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, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history, concurrent condition and concomitant medications were reported. On 09-APR-2018, the patient was vaccinated with improperly stored dose of PROQUAD (lot # N025718, expiry date 17-MAR-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (lot number and expiry date unknown). No adverse effects reported. The vaccine was exposed to the temperature of -14 degree Celsius to -10 degree Celsius (-10.5 degree Celsius) for 1 hour. Previous temperature excursion included exposure to -9 degree Celsius to -8 degree Celsius (-6 degree Celsius) for 1 hour. A digital data logger was involved. No product quality complaint was present.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extensive swelling of vaccinated limb, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from Physician on 25-Jan-2018. This case involves a two-month-old male patient, who was vaccinated with 0.5 ml first single dose of PENTACEL (batch number: C5370AA, expiry date was not reported) in left thigh via intramuscular route an unknown date. Patient medical history and concomitant medications were not reported. On unknown date, following the vaccination the patient had extensive swelling at the injection site and the entire left leg. Lab data was not reported. As corrective treatment no medical treatment was prescribed. The event outcome was reported as unknown. Follow-up report received from Physician (pediatrician) on 04-Apr-2018. The patient (age was updated as four-months) was vaccinated with a dose of PENTACEL on 17-Jan-2018. The patient had no history of allergies, underlying disease/immunological disorder, overweight or any history of adverse events reactions to prior vaccines. On an unknown date, following the vaccination, the patient developed injection site cellulitis and circumferential swelling with associated erythema, warmth and pain. The latency for the event "extensive swelling of vaccinated limb" was reported as four-days and duration was reported as one-hour. On an unknown date, the patient recovered from the events (reported as "resolved on one"). No further information was provided. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth
Clinical narrative: Initial unsolicited report received from Physician on 25-Jan-2018. This case involves a two-month-old male patient, who was vaccinated with 0.5 ml first single dose of PENTACEL (batch number: C5370AA, expiry date was not reported) in left thigh via intramuscular route an unknown date. Patient medical history and concomitant medications were not reported. On unknown date, following the vaccination the patient had extensive swelling at the injection site and the entire left leg. Lab data was not reported. As corrective treatment no medical treatment was prescribed. The event outcome was reported as unknown. Follow-up report received from Physician (pediatrician) on 04-Apr-2018. The patient (age was updated as four-months) was vaccinated with a dose of PENTACEL on 17-Jan-2018. The patient had no history of allergies, underlying disease/immunological disorder, overweight or any history of adverse events reactions to prior vaccines. On an unknown date, following the vaccination, the patient developed injection site cellulitis and circumferential swelling with associated erythema, warmth and pain. The latency for the event "extensive swelling of vaccinated limb" was reported as four-days and duration was reported as one-hour. On an unknown date, the patient recovered from the events (reported as "resolved on one"). No further information was provided. List of documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site pain and erythema.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Angioedema, Pharyngeal erythema, Streptococcus test negative, Urticaria
Clinical narrative: Patient developed diffuse urticarial rash, pharynx redness and lip angioedema approximately 45 minutes after injections. Patient was treated with BENADRYL and prednisolone. He was monitored for several hours in the ER and symptoms were completely resolved at discharge.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pyrexia, Rash, Rash vesicular, Scab
Clinical narrative: Rash appeared on stomach/groin on 4/15/2018 and continued to spread from initial appearance to back arms and legs. Rash was vesicular with lesions in various stages of healing, some with crusting. Low grade fever started on 4/15/2018 and progressed to a fever up to 102 F.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Employee was given vaccine at 9:30am on 4/17 and at 2:00pm began notice a rash develop left wrist and also began noticing rash on back. Rash was itching and was relieved by antifungal ointment that was applied to the area.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Blood test, Computerised tomogram, Hypersensitivity, Injection site rash, Peripheral swelling
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, X-ray
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Asthma, Injection site pain, Lymph node pain, Neck pain, Pyrexia
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Rash
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Decreased appetite, Headache, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site swelling, Nausea, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Shaking, chills, headache, fever of 102.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Chills
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 25 year old female patient. The patient had a history of mental disorder. In approximately February 2018 (about 2 months ago), the patient received the first dose of GARDASIL 9 via intramuscular route to prevent HPV (Human Papilloma Virus). Then on 12-APR-2018, the patient was vaccinated with second dose of GARDASIL 9. Later that night (on 12-APR-2018), the patient experienced chills, stomach pain and weakness. On 12-APR-2018 the patient went to an unspecified emergency room, where she received MOTRIN for the pain. The outcome of chills, asthenia and abdominal pain upper was reported as recovered/resolved on 13-APR-2018. Causality assessment was not provided. No product quality complaint was present.
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Headache, Herpes zoster, Neuralgia, Ophthalmological examination normal
Clinical narrative: This initial spontaneous report was received from a 76 year old female patient regarding herself.  Concurrent conditions included thyroid problem for 20 years and high blood pressure for 30 years.  Concomitant medications included an unspecified high blood pressure medication. She was allergic to propoxyphene (DARVON), amoxicillin and clavulanate (AUGMENTIN), and oxycodone hydrochloride (OXYCONTIN). On 08-NOV-2017, the patient received ZOSTAVAX in her right arm  to "avoid shingles" (dose, route, and lot # not provided). On 20-NOV-2017, she visited the Emergency Room (ER) for sharp pains on the left side of her head and a rash on her forehead over her left eye. She had a CT scan in the ER (results not provided). She then saw her primary care physician who confirmed she had shingles and prescribed unspecified antivirals, orphenadrine (K-FLEX) for 10 days, Calamine Plus lotion, and unspecified nerve pain medication. The patient also had an eye examination which revealed that the optic nerve was not affected by the shingles. The patient said that the shingles lasted six weeks and she recovered from the rash and nerve pain but she still has scars oh her forehead from the shingles rash. Causality assessment was not provided.  The patient asked to "submit a claim" regarding her report that she received ZOSTAVAX and developed shingles. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scar
Clinical narrative: This initial spontaneous report was received from a 76 year old female patient regarding herself.  Concurrent conditions included thyroid problem for 20 years and high blood pressure for 30 years.  Concomitant medications included an unspecified high blood pressure medication. She was allergic to propoxyphene (DARVON), amoxicillin and clavulanate (AUGMENTIN), and oxycodone hydrochloride (OXYCONTIN). On 08-NOV-2017, the patient received ZOSTAVAX in her right arm  to "avoid shingles" (dose, route, and lot # not provided). On 20-NOV-2017, she visited the Emergency Room (ER) for sharp pains on the left side of her head and a rash on her forehead over her left eye. She had a CT scan in the ER (results not provided). She then saw her primary care physician who confirmed she had shingles and prescribed unspecified antivirals, orphenadrine (K-FLEX) for 10 days, Calamine Plus lotion, and unspecified nerve pain medication. The patient also had an eye examination which revealed that the optic nerve was not affected by the shingles. The patient said that the shingles lasted six weeks and she recovered from the rash and nerve pain but she still has scars oh her forehead from the shingles rash. Causality assessment was not provided.  The patient asked to "submit a claim" regarding her report that she received ZOSTAVAX and developed shingles. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case was received from a medical assistant referring to a 2 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was administered an unspecified dose of ROTATEQ (lot: N021026, expiry date: 24-FEB-2019) that was improperly stored (product storage error). The vaccine was exposed to a temperature of 74F for 5 hours. The call was because of a digital data logger. There was no previous temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case was received from a medical assistant referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was administered an unspecified dose of ROTATEQ (lot: N021026, expiry date: 24-FEB-2019) that was improperly stored (product storage error). The vaccine was exposed to a temperature of 74F for 5 hours. The call was because of a digital data logger. There was no previous temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site mass, Injection site warmth, Pain, Skin warm
Clinical narrative: This is a spontaneous report from a contactable RN reported for herself. A 65-years-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration on 05Apr2018 08:00 at single dose in deltoid left for immunisation. Medical history included allergy to sulfa and nitrofurantoin (MACRODANTIN). The patient previously took PNEUMOVAX and influenza vaccine given into bursa both for immunization. The patient's concomitant medications were not reported. The patient experienced still sore 8 days later/she can't put weight on it, or roll over onto it, because it hurts on 05Apr2018 with outcome of recovering, lump over injection site on 09Apr2018 with outcome of unknown, fatigue and a little warm to touch on an unspecified date with outcome of unknown. The patient clarify that she never had a fever, but she was more fatigued. The site never got hot or red, just a little warm to touch. The information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: This is a spontaneous report from a contactable RN reported for herself. A 65-years-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration on 05Apr2018 08:00 at single dose in deltoid left for immunisation. Medical history included allergy to sulfa and nitrofurantoin (MACRODANTIN). The patient previously took PNEUMOVAX and influenza vaccine given into bursa both for immunization. The patient's concomitant medications were not reported. The patient experienced still sore 8 days later/she can't put weight on it, or roll over onto it, because it hurts on 05Apr2018 with outcome of recovering, lump over injection site on 09Apr2018 with outcome of unknown, fatigue and a little warm to touch on an unspecified date with outcome of unknown. The patient clarify that she never had a fever, but she was more fatigued. The site never got hot or red, just a little warm to touch. The information on the batch number has been requested.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dysstasia, Vomiting
Clinical narrative: Dizziness, couldn't stand, and was throwing up. Lasted 3 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Patient developed shingles affecting her left thigh. Pain in thigh (not the injection site) started approximately 1 day after vaccine. Rash broke out 1 day after that. Patient reported to office on Day #3.
Age: 54.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Arthralgia, Chills, Decreased immune responsiveness, Headache, Impaired work ability
Clinical narrative: S/O Note Written @ 19 Mar 2018 1243 EDT Chief complaint: The Chief Complaint is: Hx AE after IIV. History of present illness. The Patient is a 54 year old male. The patient is a 54 yo male with a history of adverse effects after receipt of IIV characterized by fever, chills, malaise, arthralgias & myalgias of 5-7 duration. POC was to trial FLUCELVAX, which is a different manufacturing process and premedicating with ibuprofen 800 and continuing for 2-3 days to decrease immune response symptoms. He received vaccine on 27 FEB 2018, and writer telephoned him on 01 MAR, at which time he reported malaise, headache, nausea, and rhinorrhea and missed several days of work. Today I telephoned to review POC. He reports symptoms fully resolved.
Age: 54.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: S/O Note Written @ 19 Mar 2018 1243 EDT Chief complaint: The Chief Complaint is: Hx AE after IIV. History of present illness. The Patient is a 54 year old male. The patient is a 54 yo male with a history of adverse effects after receipt of IIV characterized by fever, chills, malaise, arthralgias & myalgias of 5-7 duration. POC was to trial FLUCELVAX, which is a different manufacturing process and premedicating with ibuprofen 800 and continuing for 2-3 days to decrease immune response symptoms. He received vaccine on 27 FEB 2018, and writer telephoned him on 01 MAR, at which time he reported malaise, headache, nausea, and rhinorrhea and missed several days of work. Today I telephoned to review POC. He reports symptoms fully resolved.
Age: 54.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Arthralgia, Chills, Headache, Impaired work ability, Malaise
Clinical narrative: S/O Note Written @ 19 Mar 2018 1243 EDT Chief complaint: The Chief Complaint is: Hx AE after IIV. History of present illness. The Patient is a 54 year old male. The patient is a 54 yo male with a history of adverse effects after receipt of IIV characterized by fever, chills, malaise, arthralgias & myalgias of 5-7 duration. POC was to trial FLUCELVAX, which is a different manufacturing process and premedicating with ibuprofen 800 and continuing for 2-3 days to decrease immune response symptoms. He received vaccine on 27 FEB 2018, and writer telephoned him on 01 MAR, at which time he reported malaise, headache, nausea, and rhinorrhea and missed several days of work. Today I telephoned to review POC. He reports symptoms fully resolved.