chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 13-DEC-2014 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 02-MAR-2016, the patient was treated at a hospital medical center for a painful rash that was diagnosed as shingles.  On or about 16-MAR-2016, the patient was treated again at the hospital medical center for a worsening condition, which was determined to be post-herpetic neuralgia.  Post-herpetic neuralgia is a painful and chronic condition caused by the residual nerve damage after the contracting shingles.  While shingles and post-herpetic neuralgia are chronic and incurable conditions, the patient has been prescribed methylprednisolone oral (MEDROL DOSEPAK) and hydrocodone bitartrate (NORCO) to manage her 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, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009733:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information was received on 19-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy was not reported. On 07-JUL-2011 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance 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 17-JUN-2016 the patient was treated for four outbreaks of painful blisters that were diagnosed as shingles that had caused post-herpetic neuralgia. Post-herpetic neuralgia is a painful and chronic condition caused by the residual nerve damage after the contracting shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical treatment. As a further proximate result the patient 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, Rash
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-AUG-2012 at a pharmacy, as recommended for routine adult health maintenance 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 04-MAR-2013, the patient was treated by a physician for a painful rash that was diagnosed as a severe case of shingles. On or about 25-JUN-2013, the patient was treated again by the physician for persistent shingles breakouts. The shingles virus is an incurable condition for which the patient was prescribed acetaminophen (+) hydrocodone bitartrate (VICODIN) and gabapentin (manufacturer unknown) for the management of 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: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 04-DEC-2014, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.On or about 19-SEP-2015, the patient was treated for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient was prescribed valacyclovir (VALTREX) to manage her symptoms and 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information was received on 19-APR-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent condition and concomitant therapy were not reported. On 30-APR-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent 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 30-APR-2009 (date reported as same date vaccine was administered) the patient was treated for a painful rash and persistent nerve pain which was then diagnosed as shingles. Although shingles is an incurable viral condition, the patient was prescribed acyclovir and prednisone for management of her 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 suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that the patient was inoculated with ZOSTAVAX vaccine on or about 26-AUG-2014 at a pharmacy as recommended for routine adult health maintenance 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 08-APR-2016, the patient was treated at a medical facility for an ongoing painful rash which was diagnosed as 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: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 14-JAN-2011 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 08-FEB-2013, the patient was treated by a University medical center for an ongoing painful rash which was diagnosed as shingles and post-herpetic neuralgia.  Although shingles and neuralgia are incurable viral conditions, the patient was prescribed Acyclovir and hydrocodone bitartrate and acetaminophen (NORCO) for management of her 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, pain and suffering and other damages. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009733:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with ZOSTAVAX vaccine on or about 10-APR-2012 at a medical facility, as recommended for routine adult health maintenance 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 24-DEC-2013, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed antivirals to manage her 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 25-JUN-2014, at a medical care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 16-JUN-2016, the patient was treated by a physician at a medical care facility for an ongoing painful rash which was diagnosed as a shingles. Although shingles is an incurable viral condition, the patient was prescribed VALTREX for management of his 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, pain and suffering and other damages. Additional information has been requested. Sender's Comments: US-009507513-1704USA009733.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 07-AUG-2012 at a pharmacy, as recommended for routine adult health maintenance 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 22-JUL-2016, the patient was treated at a medical center for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient was prescribed acyclovir to manage her 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from an attorney in the from of an initial legal complaint regarding a male patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 06-OCT-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent 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 31-AUG-2015 the patient was treated for a painful rash that was diagnosed as a severe case of 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 suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 13-AUG-2014 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 04-MAY-2015, the patient was treated by a health care facility emergency room for an ongoing painful rash that was diagnosed as shingles with post-herpetic neuralgia.  Although shingles and post-herpetic neuralgia are incurable conditions, the patient has been prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of his 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, pain and suffering and other damages. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009733:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 10-JAN-2011 at a health clinic, as recommended for routine adult health maintenance 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 06-JUL-2015, the patient was treated by her physician for a painful rash that was diagnosed as shingles that had spread into her eyes. While shingles is an incurable condition, the patient was prescribed acyclovir to manage her symptoms and 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 11-DEC-2014 at a hospital, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 20-APR-2016, patient was treated at a hospital for an ongoing painful rash which was diagnosed as shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, 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
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 ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy on or about 07-NOV-2013, as recommended for routine adult health maintenance 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 12-OCT-2015, the patient was treated for a painful rash that was diagnosed as shingles, an incurable virus, for which the patient was prescribed gabapentin and valacyclovir (manufacturers unknown) to manage her 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: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 13-JUL-2011 by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported that 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 01-NOV-2011, the patient was treated by the physician for an ongoing painful rash which was diagnosed as a 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, pain and suffering and other damages. Additional information has been requested. Sender's Comments: US-009507513-1704USA009733.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative reporting on a 45-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. The pharmacist reported that on an unknown date, the patient was vaccinated with ZOSTAVAX 19400 "PFU" (Inappropriate schedule of drug administration) (dose, frequency, lot number and expiration date were not reported) intramuscularly (product use issue) for prophylaxis. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that that the patient was inoculated with a dose of ZOSTAVAX on or about 09-OCT-2012 at a health facility as recommended for routine adult health maintenance 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 05-DEC-2012, the patient was treated at a health care facility for a painful rash diagnosed as shingles. On or about 10-JAN-2013 the patient was treated at a medical facility for ongoing shingles outbreaks. While shingles is an incurable condition, the patient was prescribed acyclovir  (manufacturer unknown) and valacyclovir (VALTREX) to manage his 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: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 16-FEB-2011 at a health clinic, as recommended for routine adult health maintenance 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 03-JAL-2014, the patient was treated at a hospital emergency department for a painful rash that was diagnosed by a physician as a severe case shingles. Although herpes zoster is an incurable viral condition, the patient was prescribed ZOFRAN and NORCO to manage the painful symptoms of 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: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is being complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 09-JAN-2009 by a physician as recommended for routine adult health maintenance 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 06-FEB-2014, the patient was treated by the physician for a painful rash that was diagnosed as 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 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
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) on or about 23-OCT-2012, at a pharmacy, as recommended for routine adult health maintenance 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 12-APR-2016, the patient was treated for a painful rash that was diagnosed as 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: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a male patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 14-FEB-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent 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 17-JUL-2014 the patient was treated for a painful rash that was diagnosed as 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 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, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 26-SEP-2014 at a health clinic, as recommended for routine adult health maintenance 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-MAY-2015, the patient was treated at the same facility for an ongoing painful rash which was diagnosed by her physician as 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: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information was 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 01-APR-2015, at a pharmacy as recommended for routine adult health maintenance 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  04-MAR-2016, the patient was treated by a physician for a painful rash that was diagnosed as herpes zoster (shingles). On or about 17-MAR-2016, the patient was treated at the same facility for ongoing and worsening symptoms, that were diagnosed as post herpetic neuralgia, a chronic condition involving nerve damage as a residual effect of severe shingles outbreaks. Although shingles and post herpetic neuralgia are incurable conditions, the patient was prescribed valacyclovir hydrochloride (VALTREX) and lidocaine (LIDODERM) for management of her symptoms and 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: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient who was inoculated with ZOSTAVAX on or about 08-JUL-2013 at a Care Center, as recommended for routine adult health maintenance 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 13-DEC-2013, the patient was treated at a clinic for an ongoing painful rash which was diagnosed as shingles and post herpetic neuralgia, a condition involving nerve damage as a residual effect of severe shingles. Although shingles and post herpetic neuralgia are incurable conditions, the patient was prescribed NEURONTIN and amitriptyline, for management his 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
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 06-SEP-2013, as recommended for routine adult health maintenance 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 08-MAY-2014, the patient was treated for a painful rash that was diagnosed as shingles. While shingles is an incurable viral condition, the patient has been prescribed valacyclovir hydrochloride (VALTREX) to manage his 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: Blister, Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy was not reported. On 16-APR-2008 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent 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 29-JUN-2009 the patient was treated for a painful rash and blisters that were diagnosed as shingles. The patient was prescribed acyclovir (ZOVIRAX) to manage her 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 suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Initial unsolicited social media report received from a non-healthcare professional via other company Pfizer (under the manufacturer control number: 2017142378) on 10-Apr-2017. This case involves patient (unknown age and gender), who was vaccinated with INFLUENZA VACCINE (Flushot) (Batch number, expiration date, dose, route dose in series and site of administration were not reported) on an unspecified date. Patient's medical history and cncomittant medication was not reported. On an unknown date, following the vaccination the patient had influenza A. This was a case of suspected vaccination failure as no information regarding confirmatory tests (PCR/serology) was reported). Patient's laboratory data and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review the company considered the event as serious because of important medical event influenza. Documents held by sender: none; Sender's Comments: A patient experienced influenza a after receiving flu shot (MFR UNK). This was a case of suspected vaccination failure as the information regarding confirmatory test (PCR and serology) were not reported). Time to onset was not reported and information regarding patients medical history, tolerance to previous vaccinations, ongoing medical condition and dose number of flu vaccine was also not reported. Additional information regarding PCR/serological tests would be required to further assess the case. Based upon available information the role of the vaccine can not be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of Bell's Palsy in a subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included asthma. On an unknown date, 1 day after receiving Flu seasonal TIV Dresden, the subject developed Bell's Palsy. Serious criteria included GSK medically significant. The outcome of Bell's Palsy was unknown. It was unknown if the investigator considered the Bell's Palsy to be related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's Palsy in a patient aged between 2 and 18 years of unspecified gender who was vaccinated with unspecified inactivated influenza vaccine (manufacturer unknown). The patient was a part of the study that investigated the safety of live attenuated influenza vaccine (LAIV) administered to children and adolescents with history of asthma and evaluated whether its safety profile varied according to asthma severity. It also compared LAIV versus inactivated influenza vaccine (IIV) with respect to asthma exacerbations and other adverse events in children and adolescents with a history of asthma within a particular part of the country. The study also identified all non-asthma outpatient visits as a "negative control", since such visits were not expected to vary between IIV and LAIV recipients. The patient was a negative control in the study. The patient had a history of asthma, prior to immunisation. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date between 1 July 2007 and 31 March 2014, the patient received unspecified inactivated influenza vaccine (administration site and route unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, between 1 and 14 days after vaccination with unspecified inactivated influenza vaccine, the patient developed Bell's Palsy. (In this study, 1-14 days period after immunisation was considered as risk window). (In this study, non-asthmatic events like Bell's Palsy were only counted as event if there was no other event of the same kind in the prior 60 days). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of Bell's palsy and unspecified inactivated influenza vaccine. However, the authors stated "The authors concluded, "Among children and adolescents with a history of asthma, we found no evidence that those who received LAIV were more likely to have an asthma exacerbation than those who received IIV, and we found that incidence of such events following immunization with LAIV was relative low regardless of asthma severity. Our findings indicate that use of LAIV in children equal to or more than 2 years old with asthma did not increase the risk of asthma exacerbations. "
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site swelling, Swelling
Clinical narrative: Reddened raised area noted the size of a silver dollar. Instructions given to FOP to give Beady x  days and to apply cool compresses to site. Dime size raised area noted on R thigh PCM assessed and states Area was fine.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Mouth ulceration, Pyrexia, White blood cell count increased
Clinical narrative: Oral ulcer of unknown etiology occurring within 10 days of ROTATEQ, however also a/w fever. Pt referred to local pediatric emergency dept due to associated fever and elevated WBC. Pt made full recovery. Oral ulcer resolved without obvious sequelae.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant and a nurse and refers to a 23-year-old female patient with no concomitant therapies. It was reported that the patient visited made some contraceptive consultation visits and in November 2016, she visited her provider due to an abdominal pain. Other medical history included headaches. There was no information about the patient's drug reactions or allergies. On 23-MAR-2017, the patient was vaccinated with an expired second dose of VARIVAX 0.5 mL, lot number: L008269, expiration date: 11-MAR-2017 (strength, route of administration, and anatomical location were not provided) as routine vaccination. Other suspect therapies included sterile diluent(STERILE VARIVAX DILUENT) (lot number and expiration date unknown). It was reported by the medical assistant that on the same date, the patient experienced a "normal soreness at injection site" (injection site pain); however, it was reported by the nurse that the patient did not have an adverse reaction. No laboratory tests or diagnostic procedures were performed to the patient. On 27-MAR-2017, reported as "today", the patient was following up in the clinic. At the time of reporting, it was unknown whether the patient recovered or not from the event of injection site pain. There was no product quality complaint involved. The causal relationship between the therapy with VARIVAX and the event of injection site pain was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's son, who was also the physician via a company representative and refers to a female patient of an unknown age. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis reported as prevention of shingles. After two months of the vaccination, at an unknown date, the patient experienced a "shingles outbreak". At the time of reporting, it was unknown whether the patient recovered or not from the adverse event. The causal relationship between the adverse event and the therapy with ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Malaise, Vaccination complication
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a male patient in his late 60's. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date (reported as " a couple of months back"), the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prevention of pneumococcal disease, at an unspecified pharmacy. On an unknown date, within a few hours of being vaccinated, the patient had a "general reaction" to the PNEUMOVAX23. The patient felt generally ill and was sick for about a week to a week and one half after being vaccinated. On an unknown date, the patient sought medical attention and visited the physician's office. Product quality complaint (PQC) was not involved. The outcome of the event was reported as fully recovered on an unspecified date. The reporter considered the event to be related to the PNEUMOVAX23. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N002720, expiration date 12-MAY-2019, third dose in series, one shot for prophylaxis (dose was not reported). The vaccine underwent a total of two separate excursions, but individual times and temperatures for each excursion were not available during the time of the initial call. The vaccine reached an "excursion high of 49.6 degrees" (however the reporter did not specify whether this was in Celsius or Fahrenheit). Between the two excursions, the vaccine was out of range for "a total of 40 hours and 22 minutes". The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006396.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Incorrect route of drug administration, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, at pharmacy, the patient was vaccinated with ZOSTAVAX, intramuscularly (incorrect route of drug administration) (dose, lot number expiration date were not reported) instead of VARIVAX, for prophylaxis. On an unknown date, the patient experienced cellulitis on an unknown area of deltoid. The outcome of cellulitis was not reported. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review cellulitis on an unknown area of deltoid was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 19-JAN-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-APR-2014, patient was treated by physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, patient had been prescribed valacyclovir (VALTREX) to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, 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, Neuralgia, Post herpetic neuralgia, Rash
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) at a clinic on or about 29-APR-2014, as recommended for routine adult health maintenance 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 04-APR-2016, the patient was treated by a physician at the clinic for an ongoing painful rash and persistent nerve pain which was then diagnosed as shingles and post herpetic neuralgia, a painful and chronic condition. As a direct and proximate result of these malfunction, 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: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an Office Supervisor referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with PROQUAD lot # M036295 and expiration date 13-FEB-2018 for prophylaxis (route of administration, dose and anatomical location were not provided) with properly stored sterile diluent (lot number and expiration date were unknown). Additionally, it was reported, that the vaccine was exposed to a temperature between 15 Fahrenheit degrees to 36 Fahrenheit degrees for 4 hours. There was no previous temperature excursion. The call was not placed because of a Digital Data logger report. It was no reported product quality complaint involved. Additional information has been requested.