chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (For tolerance to 1st dose please refer case US2018205833). Concurrent medical conditions included drug allergy. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, hives and rash. On an unknown date, the patient experienced erythema, skin discoloration, eyelids pruritus and pruritus. On an unknown date, the outcome of the allergic reaction, skin discoloration, rash, eyelids pruritus and pruritus were unknown and the outcome of the hives was resolved with sequelae and the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the allergic reaction, hives, erythema, skin discoloration, rash, eyelids pruritus and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose SHINGRIX around 2:00 or 3:00 pm on the left arm. Hives started to develop soon after the vaccination. The patient contacted her physician the next day, but was not able to be seen so she went to the Emergency room. The patient was diagnosed with an allergic reaction. The majority of the rash was on her torso but there were hives on her arms and legs. In 2018, less than month after receiving SHINGRIX, the patient said her eyelids itched but did not have hives. She also described there was itching and redness on parts of her body. The hives resolved within 4 to 7 days, however, she still had brownish red discolorations where the hives were located on her skin. The reporter gave consent to follow up. The reporter gave permission for her physician to be contacted and provided contact details of the same. The call center representative was unable to obtain additional information.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eyelids pruritus, Hypersensitivity, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (For tolerance to 1st dose please refer case US2018205833). Concurrent medical conditions included drug allergy. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, hives and rash. On an unknown date, the patient experienced erythema, skin discoloration, eyelids pruritus and pruritus. On an unknown date, the outcome of the allergic reaction, skin discoloration, rash, eyelids pruritus and pruritus were unknown and the outcome of the hives was resolved with sequelae and the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the allergic reaction, hives, erythema, skin discoloration, rash, eyelids pruritus and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose SHINGRIX around 2:00 or 3:00 pm on the left arm. Hives started to develop soon after the vaccination. The patient contacted her physician the next day, but was not able to be seen so she went to the Emergency room. The patient was diagnosed with an allergic reaction. The majority of the rash was on her torso but there were hives on her arms and legs. In 2018, less than month after receiving SHINGRIX, the patient said her eyelids itched but did not have hives. She also described there was itching and redness on parts of her body. The hives resolved within 4 to 7 days, however, she still had brownish red discolorations where the hives were located on her skin. The reporter gave consent to follow up. The reporter gave permission for her physician to be contacted and provided contact details of the same. The call center representative was unable to obtain additional information.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (For tolerance to 1st dose please refer case US2018205833). Concurrent medical conditions included drug allergy. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, hives and rash. On an unknown date, the patient experienced erythema, skin discoloration, eyelids pruritus and pruritus. On an unknown date, the outcome of the allergic reaction, skin discoloration, rash, eyelids pruritus and pruritus were unknown and the outcome of the hives was resolved with sequelae and the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the allergic reaction, hives, erythema, skin discoloration, rash, eyelids pruritus and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose SHINGRIX around 2:00 or 3:00 pm on the left arm. Hives started to develop soon after the vaccination. The patient contacted her physician the next day, but was not able to be seen so she went to the Emergency room. The patient was diagnosed with an allergic reaction. The majority of the rash was on her torso but there were hives on her arms and legs. In 2018, less than month after receiving SHINGRIX, the patient said her eyelids itched but did not have hives. She also described there was itching and redness on parts of her body. The hives resolved within 4 to 7 days, however, she still had brownish red discolorations where the hives were located on her skin. The reporter gave consent to follow up. The reporter gave permission for her physician to be contacted and provided contact details of the same. The call center representative was unable to obtain additional information.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Nerve injury, Pain in extremity, Sleep disorder
Clinical narrative: Immediate pain at injection site - almost fainted from the pain. Increasing pain throughout the day 10/11/2018, and into the night. Pain continued and increased especially at night for 8 days.  Patient returned to Pharmacy to report pain, and was told to see a doctor. Patient saw PA 10/19/2018 and was referred for physical therapy and told to take over the counter pain meds (not working). Continued to try to get PT appointment, seen on 10/29/2018 in severe pain, especially at night - no sleep. Went back to Dr. on 11/5/2018, prescribed prednisone and hydrocodone for pain; referred to shoulder specialist - for diagnosis (11/6/2018). Ordered shoulder x-rays and MRI - determined rotator cuff tear and severe tendonitis.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Immediate pain at injection site - almost fainted from the pain. Increasing pain throughout the day 10/11/2018, and into the night. Pain continued and increased especially at night for 8 days.  Patient returned to Pharmacy to report pain, and was told to see a doctor. Patient saw PA 10/19/2018 and was referred for physical therapy and told to take over the counter pain meds (not working). Continued to try to get PT appointment, seen on 10/29/2018 in severe pain, especially at night - no sleep. Went back to Dr. on 11/5/2018, prescribed prednisone and hydrocodone for pain; referred to shoulder specialist - for diagnosis (11/6/2018). Ordered shoulder x-rays and MRI - determined rotator cuff tear and severe tendonitis.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis, X-ray limb abnormal
Clinical narrative: Immediate pain at injection site - almost fainted from the pain. Increasing pain throughout the day 10/11/2018, and into the night. Pain continued and increased especially at night for 8 days.  Patient returned to Pharmacy to report pain, and was told to see a doctor. Patient saw PA 10/19/2018 and was referred for physical therapy and told to take over the counter pain meds (not working). Continued to try to get PT appointment, seen on 10/29/2018 in severe pain, especially at night - no sleep. Went back to Dr. on 11/5/2018, prescribed prednisone and hydrocodone for pain; referred to shoulder specialist - for diagnosis (11/6/2018). Ordered shoulder x-rays and MRI - determined rotator cuff tear and severe tendonitis.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Information has been received from a consumer (the patient's father) referring to a 14 year old female patient. There was no concurrent condition, concomitant medication or drug reactions/allergies. On 03-MAY-2017, at age 13 years old, the patient was vaccinated with the first dose of GARDASIL 9 (dosage, strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dosage, strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient experienced a seizure. On an unspecified date in 2018, the patient had an electroencephalogram (EEG) and a magnetic resonance imaging (MRI) without results and KEPPRA prescribed by an unspecified neurologist. The outcome of the event was unknown. The causality between the event and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be medically significant. Follow up information was received from the consumer (patient's father) on 19-NOV-2018. In November 2017, the patient received the "final" dose of GARDASIL 9, however it was not specified if it was referring to the second or third dose. After the patient's seizure, and thorough electroencephalogram (EEG) and neurology testing performed on an unknown date in 2018, the patient was diagnosed with juvenile epilepsy (the event was updated from seizure to epilepsy Juvenile myoclonic epilepsy). The outcome of Juvenile myoclonic epilepsy was unknown. The causality assessment between the adverse event and the suspect therapy was not provided. Upon internal review, Juvenile myoclonic epilepsy was determined to be medically significant. This is one of two reports received from the same reporter.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Juvenile myoclonic epilepsy, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Information has been received from a consumer (the patient's father) referring to a 14 year old female patient. There was no concurrent condition, concomitant medication or drug reactions/allergies. On 03-MAY-2017, at age 13 years old, the patient was vaccinated with the first dose of GARDASIL 9 (dosage, strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dosage, strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient experienced a seizure. On an unspecified date in 2018, the patient had an electroencephalogram (EEG) and a magnetic resonance imaging (MRI) without results and KEPPRA prescribed by an unspecified neurologist. The outcome of the event was unknown. The causality between the event and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be medically significant. Follow up information was received from the consumer (patient's father) on 19-NOV-2018. In November 2017, the patient received the "final" dose of GARDASIL 9, however it was not specified if it was referring to the second or third dose. After the patient's seizure, and thorough electroencephalogram (EEG) and neurology testing performed on an unknown date in 2018, the patient was diagnosed with juvenile epilepsy (the event was updated from seizure to epilepsy Juvenile myoclonic epilepsy). The outcome of Juvenile myoclonic epilepsy was unknown. The causality assessment between the adverse event and the suspect therapy was not provided. Upon internal review, Juvenile myoclonic epilepsy was determined to be medically significant. This is one of two reports received from the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Joint swelling, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 13th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was received by a physician who reported for himself via online chat. The reporter did not have a lot number of the SHINGRIX vaccine. At the time of reporting, the patient was still experiencing fever. The reporter did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 13th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was received by a physician who reported for himself via online chat. The reporter did not have a lot number of the SHINGRIX vaccine. At the time of reporting, the patient was still experiencing fever. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever for 24 hours with Tmax 101.5 F, myalgias, lethargy.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Headache, severe nausea, fatigue, extreme arm pain all lasting for about 72 hours.
Sex: M
Vaccine: HEP
Symptoms: Blood creatinine increased, Hepatic enzyme increased, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concmitant medications were not provided. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis (strength, dose, frequency, anatomical location, route of administration, lot # and expiration date were not reported). On an unknown date, an unspecified laboratory study was performed to measure the Hepatitis B titer and the patient had negative Hepatitis B titers (hepatitis b antibody negative). Additionally, the physician reported the patient had elevated liver enzymes (hepatic enzyme increased) and elevated creatinine level (blood creatinine increased). The patient sought the physician for medical attention, but no treatment was given to him for the adverse experiences. At the reporting time, the patient was not recovered from hepatitis b antibody negative, hepatic enzyme increased and blood creatinine increased. The causality assessment between the aforementioned adverse events and RECOMBIVAX HB was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored ROTATEQ (lot# R003111, expiration date: 12-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored ROTATEQ (lot# R003111, expiration date: 12-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes. Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse referring to a 16 year old female patient. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. On unknown dates in 2002 and 2003 the patient received the doses of the hepatitis B vaccine (recombinant) (manufacturer unknown) vaccination series (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. In 2018 (reported as "now"), the patient had negative titers for hepatitis B. It was not known if treatment was given for the event. The outcome of the event was not recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown ages and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 15-NOV-2018, the patient received ROTATEQ (lot# N005619 expiration date 29-OCT-2018) (strength, dose and frequency were not reported) orally for prophylaxis. It was confirmed the ROTATEQ did not have any temperature excursions prior to administration. No adverse symptoms reported.
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 medical history, concurrent conditions and concomitant medications were not reported. On or about 28-APR-2009, the patient was inoculated with ZOSTAVAX (strength, dose, route, lot # and expiry date were not provided) by a physician as recommended for routine adult health maintenance for the prevention of shingles (prophylaxis). On an unknown date, the patient was diagnosed with shingles (herpes zoster) despite of vaccinating with ZOSTAVAX (vaccination failure). On or about 30-DEC-2014, 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. On 29-MAY-2015, the patient was inoculated with ZOSTAVAX at a Clinic 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: 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. In September 2015, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and in December 2015, 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: 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 an unspecified date in October 2016, also reported as, on or about October 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 as recommended by the healthcare professional. On or about 08-OCT-2016, the patient experienced shingles and was treated by a physician assistant at a medical associate. 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 on unknown dates. The patient had and would 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 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 relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically 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. On or about 20-JAN-2015, 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 healthcare professional. On or about 03-OCT-2016, the patient experienced shingles (Herpes zoster) and was treated by a healthcare provider at a clinic. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (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 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 (Condition aggravated); 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 relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
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. In 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 (herpes zoster) and in 2016, 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 (vaccination failure) 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 (emotional distress, 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 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 (quality of life decreased and condition aggravated); 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine. On 07-DEC-2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient 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. 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 the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 25-JAN-2017, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient 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; 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. 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 the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
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 15-DEC-2015 (reported as on or about 15-DEC-2015), 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 health provider. On unknown date, the patient experienced shingles (herpes zoster) and on 11-DEC-2016 (reported as on or about 11-DEC-2016), 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 (vaccination failure) 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 (emotional distress, 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 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 (quality of life decreased and condition aggravated); 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: 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 14-SEP-2016, 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. On 20-SEP-2016, the patient was treated by a healthcare professional 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
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 21-MAY-2013, 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. On 28-AUG-2016, the patient was treated by a healthcare professional 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: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Seizure
Clinical narrative: This spontaneous report was received from the patient's father, concerning to his daughter a 17 year old female patient. The patient's concurrent condition included type I diabetes since 6 years old. Other pertinent medical history and patient's concomitant therapies were not reported. Last year in 2017, the patient was administered GARDASIL 9 (dosage schedule, route, anatomical location, lot number and expiration date were not reported) for prophylaxis, with the final dose administered in December 2017. In September 2018, the patient experienced a seizure, which the patient's father attributed it to a blood sugar low. In November 2018, the patient experienced another seizure, additionally, at this time, the patient was wearing a continuous glucose monitor that showed the blood sugar was in range during the seizure, in effect; the patient's father discarded the relationship between the seizure and type 1 diabetes. The patient was pending to an electroencephalogram (EEG) (schedule for November 20). Additionally it was stated that the patient never exhibited seizure prior to GARDASIL 9 therapy. The outcome of both seizures events was unknown. The outcome of blood sugar low was recovered. The reporter did not provided the causality between GARDASIL 9 and the adverse events. Upon internal review, seizure was determined to be medically significant. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1811USA004645.
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 18-OCT-2007, 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 07-FEB-2008, the patient was treated for herpes zoster. 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
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 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 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. On or about 20-MAR-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 conditions. On or about 10-OCT-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, 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 events was unknown. Causality assessment was related.