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 age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at the Pharmacy for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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 pre-existing conditions and activation of latent conditions; lost wages; loss of earnings capacity, and other losses and damages and pain and suffering, and other damages. 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2012, the patient was inoculated with ZOSTAVAX by a health care provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). Patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine. On or about 27-APR-2015, the patient had physician office visit for treatment of shingles (Herpes zoster). As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On approximately 12-FEB-2013 (reported as on or about 12-FEB-2013), the patient was vaccinated 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). No other suspect or concomitant therapies were reported. 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 latent conditions, lost wages, loss of earning capacity and other losses and damages. On 10-DEC-2016 and on 04-JAN-2017, the patient was treated for shingles and post herpetic neuralgia. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2016, the patient was vaccinated 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. No other suspect or concomitant therapies were reported. 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 latent conditions, lost wages, loss of earning capacity and other losses and damages. On an unknown date in 2016, the patient was treated for shingles. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.
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 17-DEC-2017, the patient was inoculated with ZOSTAVAX by a health care 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 other zoster-related injuries (Herpes zoster) after and despite being inoculated with the ZOSTAVAX. On an unknown date in 2017, 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, the patient had 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. Causality assessment was reported as 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. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX by a physician for routine health maintenance and prevention of shingles (strength, dose, route of administration, lot # and expiry date were not reported). On an unknown date, the patient was diagnosed with shingles (herpes zoster) despite of vaccinating with ZOSTAVAX. On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered serious physical, emotional and economical damages as a result of the patient's injuries. 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 or about 04-APR-2008, 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 an unknown date (reported as on or about 04-JAN-2008), 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
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 24-JUN-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 06-JUN-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
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-APR-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 or about an unknown date in 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; 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. Additional information has been requested.
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 October 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, 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 December 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. The patient's relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date in 2007, the patient was inoculated with ZOSTAVAX for routine health maintenance and prevention of shingles (strength, dose, route of administration, lot # and expiry date was not reported). On an unknown date, the patient was diagnosed with shingles (herpes zoster) despite of vaccinating with ZOSTAVAX. On an unknown date in June 2015, the patient was treated for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
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 age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX by a physician to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2009, the patient was treated by a physician 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 had and would continue suffered 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 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 age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a physician to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2014, the patient was treated by a physician 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 had and would continue suffered 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 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 age and gender.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In July 2014, the patient was inoculated with ZOSTAVAX by a pharmacist to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 14-DEC-2016, the patient was treated by a physician 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 had and would continue suffered 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 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 considered as not recovered. 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 age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 09-DEC-2016, the patient was treated by a physician 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, they had and would continue suffered 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 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 age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 03-DEC-2010, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2016, the patient was treated by a healthcare provider for herpes zoster. 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 had and would continue suffered 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 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 considered as not recovered. 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 age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In February 2010, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On 29-OCT-2016, the patient was treated by a healthcare provider 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 had and would continue suffered 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 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: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a consumer concerning a 5 year old male patient. The patient's had no concomitant medications, pertinent medical history and drug reactions or allergies. On 12-NOV-2018, the patient inadvertently was vaccinated with ZOSTAVAX for prophylaxis (dosing detail, route, lot# and expiry date not reported). On the same day, the patient developed a rash on his stomach and high fever. The patient spoke to the physician and took unspecified dose of ibuprofen on unspecified dates. On 14-NOV-2018, the patient's fever resolved. On 16-NOV-2018, the patient recovered from rash. The reporter's causality assessment was not provided. No product quality complaint was involved.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 77 year old male patient. Information regarding the patient's concurrent condition and concomitant medication was unknown. His historical vaccine included PREVNAR 13 injected in 2017. There were no drug reactions/allergies reported. On 20-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R022249, expiry date: 16-APR-2020) via intramuscular route, for prophylaxis. On the same day after vaccination, the patient developed pain and redness at the injection site and decreased limb mobility. He was treated with TYLENOL and ibuprofen. Outcome of the events was reported as not recovered. Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 12-OCT.2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the pharmacist. On unknown date, the patient experienced shingles and on 03-MAR-2017, the patient was treated for shingles. 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 of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; 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 included 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. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 13-OCT-2016, the patient was treated by a healthcare provider for Shingles. 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 of the patient's injuries. 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 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 event was unknown. Causality assessment was related.
Sex: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a healthcare provider for Shingles. 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 of the patient's injuries. 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 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 event was not recovered/not resolved. Causality assessment was related.
Sex: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-NOV-2011, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 06-OCT-2016, the patient was treated by a healthcare provider for Shingles. 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 of the patient's injuries. 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 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 event was unknown. Causality assessment was related.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. Late in 2014, the patient was treated by a physician for Shingles. 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 of the patient's injuries. 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 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 event was not unknown. Causality assessment was related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of VARIVAX (lot # N022996, expiry 23-AUG-2018) (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute VARIVAX was properly stored. The administered doses of the VARIVAX experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930; US-009507513-1811USA010213: Original Case: 1811USA010211; US-009507513-1811USA010214: US-009507513-1811USA010215.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9, lot # N020353, expiry 28-APR-2020 (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute GARDASIL 9 was properly stored. The administered doses of the GARDASIL 9 experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930; US-009507513-1811USA010211: Original Case: 1811USA010211; US-009507513-1811USA010214: Original Case: 1811USA010213; US-009507513-1811USA010215: Original Case: 1811USA010213.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9, lot # N020353, expiry 28-APR-2020 (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute GARDASIL 9 was properly stored. The administered doses of the GARDASIL 9 experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930; US-009507513-1811USA010211: Original Case: 1811USA010211; US-009507513 1811USA010213: Original Case: 1811USA010213; US-009507513-1811USA010215: Original Case: 1811USA010213.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9, lot # N020353, expiry 28-APR-2020 (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute GARDASIL 9 was properly stored. The administered doses of the GARDASIL 9 experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930 US-009507513-1811USA010211: Original Case: 1811USA010211 US-009507513-1811USA010214: Original Case: 1811USA010213 US-009507513-1811USA010213: Original Case: 1811USA010213.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haematoma, Nodule, Product administered at inappropriate site
Clinical narrative: Mom states that child received a flu shot at the middle school on 10/24/18. Mom states that shot was administered in the back of the arm and he developed a large hematoma. Nurse at the middle school called the child's mom on 10/24/18 and said he had a large knot on his arm and the teacher had sent him to the office. Mom took son to the Dr. and was told to put heat on it 3 times a day until Monday November 19, if not resolved she will schedule an ultrasound and may have to be surgical removed. Called 11/16/18 at 0930 to obtain information for VAERS. No answer. Patient's mom said the knot and bandaid was located more towards the back of the arm in the flabby part instead of the deltoid muscle. Patient's mom stated she was a nurse and worked at hospital. She stated she did not notice any brusing, just the knot. She took the child to Dr.'s office on 11/14/18 saw NP. Mom stated the hematoma was encapsulated. I apologized to the Mother and explained about the VAERS form and she was okay with me completing the VAERS. I also explained about the vaccine compensation program and gave her the phone number and website for more information.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort
Clinical narrative: Patient reports left arm discomfort after influenza shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 101, chills, severe body aches starting 6-8 hours after receiving the vaccine. So far it has lasted 1 day.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Dizziness the evening of the vaccine. Dizzy when head turns. Still some dizziness now (5 days later). 2 days after vaccine noticed slightly raised skin and redness radiating from the injection site. A red circle about 2.5 cm in diameter at the site, 2 elongated red ovals 7 cm long and 1.5 cm wide going from near the injection site towards the underarm, another 1 cm in diameter circle at the end of one of the ovals. Started taking antibiotics 2 days after vaccination in case this was an infection (Doxycycline Monohydrate 100mg twice a day). 5 days later redness has decreased but can still be seen. No new spots or growth of existing ones.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Extreme shoulder pain. Have been prescribed prednisone, HORIZANT and had a cortisone injection in back.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Immunization record showed child due for 2nd HPV 9, 1st MCV4, and 1st Tdap. Father agreed to these vaccines at appointment, unaware that child had received all 3 in another state already roughly 2 months prior. Mother of child called us after appointment to notify us child had already received these vaccines.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: About 8 hours after receiving vaccine, patient we to ED with arm pain, redness, swelling and itching.  Was given Keflex 500mg QID X 10 days and instructed to take Benedryl OTC.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait inability, Mobility decreased, Muscular weakness, Neuralgia, Pain
Clinical narrative: Onset: Quick onset with progressive pain and muscle weakness throughout hip, buttocks, left   lateral Femur and anterior thigh and lateral knee. Within 4 hours extreme nerve pain and throughout all regions- unable to walk, sit or stand or move leg. NO previous strain, or trauma to back or legs. Pain 10/10. Treatment: 2 days after onset. Fascial Distortion Method received. FLEXERIL prescribed. Initial relief for 4 hours only. Pain and immobility returned. 10/10. Treatment 4 days after onset: Stretching and pelvic re-alignment with Prednisone prescribed 10mgx10 days. 2 1/2 week duration of symptoms. Physical therapy initiated 10/31/18.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Nerve compression
Clinical narrative: The shot was given directly into a nerve. I have had limited use of my left arm since the vaccination.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of varicella VARIVAX lot # N022996, expiry 23-AUG-2018; LIQUID PEDVAXHIB, lot # L051123, expiry 13-OCT-2018; GARDASIL 9, lot # N020353, expiry 28-APR-2020 and ROTATEQ, orally, lot # N005617 and expiry 03-OCT-2018. The vaccines were administered for prophylaxis (doses, routes of administration and anatomical locations were not reported); it was reported that the MERCK STERILE DILUENT used to reconstitute VARIVAX was properly stored. The administered doses of the vaccines experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifiers were received. Follow-up information has been received from medical assistant on 14-NOV-2018. On 14-NOV-2018, a call was placed to medical assistant. It was reported that, 5 patients received effected vaccines, out of which 2 patients were vaccinated with VARIVAX and 3 patients with GARDASIL 9. Age range of patients who were administered vaccinations was 6 months to 15 years. This report refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with VARIVAX. It was also reported that, there have been no adverse events reported since the time of administration. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA010211:Original Case : 1808USA005930 US-009507513-1811USA010213: US-009507513-1811USA010215: US-009507513-1811USA010214.