chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-JAN-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On 07-JAN-2014, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On 10-NOV-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about September 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (lot#, expiration date, dose and route were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an about September 2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster/shingles. The patient continued to suffer ongoing injuries with mental and physical pain and suffering. 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 causality assessment of events was reported to be related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-OCT-2016, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date in October 2016, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure, Herpes zoster) and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 30-OCT-2016, the patient had physician office visit for treatment of shingles. The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2014, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient developed shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 30-NOV-2016, the patient was treated by a physician for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date in 2015, patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) (injury) after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure) and suffered serious physical, emotional and economic damages. On an unknown date in 2015, the patient had physician office visit for treatment of shingles (Herpes zoster). As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUL-2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure). On an unknown date in 2016, the patient was treated by a health care provider for shingles (Herpes zoster). The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, Patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (pain), extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was reported as related for the events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On unknown date in 2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 29-JAN-2015, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-MAR-2014, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, patient developed shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure). On or about 07-JAN-2015, the patient had physician office visit for treatment of shingles. The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, Patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2011, the patient was vaccinated with ZOSTAVAX for permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient developed shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX (Vaccination failure), and suffered serious physical, emotional (emotional distress), and economic damages as a result of patient's injuries (Injury). On or about 09-NOV-2016, the patient was treated by a physician for shingles. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain (Pain) and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2016, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date in 2016, the patient was treated by a health care provider for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-OCT-2007, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On 12-SEP-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
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. In approximately 2014 (reported as: or about 2014), the patient was inoculated with ZOSTAVAX (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries. On an unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. On or about 2016, the patient was treated for shingles. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
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. In approximately 2010 (reported as: on or about 2010), the patient was inoculated with ZOSTAVAX (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries (prophylaxis). On an unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure), and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life (Quality of life decreased); increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions (condition aggravated), lost wages, loss of earning capacity and other losses and damages. On or about 2014, the patient was treated for shingles. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
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. In approximately 2016 (reported as: on or about 2016), the patient was inoculated with ZOSTAVAX (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries. On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. On or about 2016, the patient was treated for shingles. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received a nurse director concerning about a 1-year-old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was vaccinated with PROQUAD and M-M-R II both administered concomitantly as prophylaxis (strength, dose, frequency, route of administration, site of administration, therapy type, lot number and expiration date of both vaccines were not reported) (inappropriate schedule of drug administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine in 2016, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a 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 vesicular
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine on or about 22-SEP-2015, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-JAN-2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine in 2009, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/ordespite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a 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 vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-NOV-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Upon internal review, varicella pneumonia was determined a significant medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 10-JAN-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-FEB-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 29-APR-2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy site unspecified abnormal, Oral surgery, Papilloma, Papilloma excision, Squamous cell carcinoma of the oral cavity
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient had allergy to intravenous (IV) contrast. The patient's concomitant medication included birth control (unspecified). On unspecified date (reported as over 5 years ago), the patient was vaccinated with 3 doses of GARDASIL, 0.5 milliliter (route, lot # and expiry date were not reported) to prevent human papillomavirus (HPV). On unspecified date approximately in 2018 (reported as a few months ago), the patient was diagnosed with an unspecified type of benign oral squamous cell papilloma (squamous cell carcinoma of the oral cavity) by biopsy. The patient sought medical attention and a surgery was done due to an event. The patient verified that, the papilloma was surgically removed and that her current status was recovering. There was no product quality complaint reported. The reporter's causality assessment was not provided. Upon internal review, squamous cell carcinoma of the oral cavity was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-SEP-2013, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-MAY-2016, the patient was treated at a dermatology office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-NOV-2016, the patient was treated by a nurse practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-NOV-2011, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by healthcare providers at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac stress test normal, Chest pain, Chills, Dizziness, Electrocardiogram normal
Clinical narrative: This case was reported by a nurse and described the occurrence of chest pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In November 2018, the patient experienced fatigue, skin warm, pain, headache, malaise and shivering. On 16th November 2018, the patient experienced chest pain, dizziness and ringing in ears. In November 2018, the outcome of the fatigue, headache, malaise, shivering and dizziness were recovered/resolved. On 16th November 2018, the outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, skin warm, pain and ringing in ears were unknown. It was unknown if the reporter considered the chest pain, fatigue, injection site erythema, injection site swelling, skin warm, pain, headache, malaise, shivering, dizziness and ringing in ears to be related to SHINGRIX. Additional details were received as follows: This case was reported by nurse who herself was the patient. After vaccination with SHINGRIX, the patient had many of the common and uncommon side effects. The patient presented with vaccination site redness and swelling which happened within 12 hours after vaccination with SHINGRIX. Within 24 hours after vaccination, a large red streak, measured approximately 3 by 1 inch, developed about 3 inches below the injection site. It was hot, swollen red and painful. The patient presented with headache (HA), malaise, shivering, fatigue which lasted for 36 hours. Four days after vaccination with SHINGRIX, the patient developed pain in chest that lasted for approximately 25 minutes and felt like she was going to faint, dizziness and ringing in her ears. The patient never felt this events before. The patient was taken by ambulance to the emergency department (ED). In ED, the patient had done 2 EKGs (electrocardiogram) and  2 troponins test which showed results stable normal vital signs. Everything was normal and the patient did not have a heart attack. Two days later, the patient had a 100 percent normal stress test. The patient had not told to her coworkers about her chest pain or feelings of faint. The patient asked if GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine and if it was recommended to receive the follow up of SHINGRIX in 2 months. This case was linked with case US2018GSK219275 (master case), reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: This case was reported by a nurse and described the occurrence of chest pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In November 2018, the patient experienced fatigue, skin warm, pain, headache, malaise and shivering. On 16th November 2018, the patient experienced chest pain, dizziness and ringing in ears. In November 2018, the outcome of the fatigue, headache, malaise, shivering and dizziness were recovered/resolved. On 16th November 2018, the outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, skin warm, pain and ringing in ears were unknown. It was unknown if the reporter considered the chest pain, fatigue, injection site erythema, injection site swelling, skin warm, pain, headache, malaise, shivering, dizziness and ringing in ears to be related to SHINGRIX. Additional details were received as follows: This case was reported by nurse who herself was the patient. After vaccination with SHINGRIX, the patient had many of the common and uncommon side effects. The patient presented with vaccination site redness and swelling which happened within 12 hours after vaccination with SHINGRIX. Within 24 hours after vaccination, a large red streak, measured approximately 3 by 1 inch, developed about 3 inches below the injection site. It was hot, swollen red and painful. The patient presented with headache (HA), malaise, shivering, fatigue which lasted for 36 hours. Four days after vaccination with SHINGRIX, the patient developed pain in chest that lasted for approximately 25 minutes and felt like she was going to faint, dizziness and ringing in her ears. The patient never felt this events before. The patient was taken by ambulance to the emergency department (ED). In ED, the patient had done 2 EKGs (electrocardiogram) and  2 troponins test which showed results stable normal vital signs. Everything was normal and the patient did not have a heart attack. Two days later, the patient had a 100 percent normal stress test. The patient had not told to her coworkers about her chest pain or feelings of faint. The patient asked if GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine and if it was recommended to receive the follow up of SHINGRIX in 2 months. This case was linked with case US2018GSK219275 (master case), reported by the same reporter.