chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Headache
Clinical narrative: This spontaneous report was received from a physician, regarding to a currently 11-year-old male patient. As part of his past medical history, the reporter mentioned that the patient was healthy, immunocompetent and fully vaccinated. There was no drug reactions or allergies and no concomitant medications. It was specified that the patient had never chickenpox and had no a prior history of herpes zoster or herpes zoster ophthalmicus. On 27-JUN-2008, 23-AUG-2011, and 09-DEC-2012, the patient was vaccinated with either PROQUAD or VARIVAX lot number reported as "16902Z", for prophylaxis (also reported as vaccine) (strength, dosage schedule, route of administration and anatomical location were not provided). The physician reported that he was uncertain which vaccine was administered. The reporter mentioned that this uncertainty was due to a clerical error from switching from paper documentation to electronic documentation. On an unknown date, the patient experienced meningitis (neck stiffness, photophobia, headache, tremor) and was admitted to hospital on 09-FEB-2019. There were various unspecified studies performed, included a Cerebrospinal fluid (CSF) analysis, which sample was collected on 12-FEB-2019, and the results were: Protein 115 (units not provided), Red Blood Cell (RBC) count 7 (units not provided), Glucose 58 (units not provided) and White Blood Cell count (WBC) 635 (units not provided) and the varicella zoster virus Polymerase Chain Reaction (PCR) test was positive. It was reported that the patient did not experienced a rash at the injection site, following the vaccination; that there was no rash, no encephalitis, no pneumonia; that the patient did not have recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was stated that the physician would like to do a genotyping in order to see if the patient's meningitis was caused by the community or the vaccine strain that he received. At the time of the report, the patient was recovered and receiving valacyclovir hydrochloride (VALTREX) as part of the treatment given. The outcome of varicella virus test positive was not provided. The causality between meningitis and varicella virus test positive, and PROQUAD was not provided. The causality between meningitis and varicella virus test positive, and VARIVAX was not reported. Upon internal review, meningitis was determined to be medically significant.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Meningitis, Musculoskeletal stiffness, Photophobia, Polymerase chain reaction positive, Tremor
Clinical narrative: This spontaneous report was received from a physician, regarding to a currently 11-year-old male patient. As part of his past medical history, the reporter mentioned that the patient was healthy, immunocompetent and fully vaccinated. There was no drug reactions or allergies and no concomitant medications. It was specified that the patient had never chickenpox and had no a prior history of herpes zoster or herpes zoster ophthalmicus. On 27-JUN-2008, 23-AUG-2011, and 09-DEC-2012, the patient was vaccinated with either PROQUAD or VARIVAX lot number reported as "16902Z", for prophylaxis (also reported as vaccine) (strength, dosage schedule, route of administration and anatomical location were not provided). The physician reported that he was uncertain which vaccine was administered. The reporter mentioned that this uncertainty was due to a clerical error from switching from paper documentation to electronic documentation. On an unknown date, the patient experienced meningitis (neck stiffness, photophobia, headache, tremor) and was admitted to hospital on 09-FEB-2019. There were various unspecified studies performed, included a Cerebrospinal fluid (CSF) analysis, which sample was collected on 12-FEB-2019, and the results were: Protein 115 (units not provided), Red Blood Cell (RBC) count 7 (units not provided), Glucose 58 (units not provided) and White Blood Cell count (WBC) 635 (units not provided) and the varicella zoster virus Polymerase Chain Reaction (PCR) test was positive. It was reported that the patient did not experienced a rash at the injection site, following the vaccination; that there was no rash, no encephalitis, no pneumonia; that the patient did not have recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was stated that the physician would like to do a genotyping in order to see if the patient's meningitis was caused by the community or the vaccine strain that he received. At the time of the report, the patient was recovered and receiving valacyclovir hydrochloride (VALTREX) as part of the treatment given. The outcome of varicella virus test positive was not provided. The causality between meningitis and varicella virus test positive, and PROQUAD was not provided. The causality between meningitis and varicella virus test positive, and VARIVAX was not reported. Upon internal review, meningitis was determined to be medically significant.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician, regarding to a currently 11-year-old male patient. As part of his past medical history, the reporter mentioned that the patient was healthy, immunocompetent and fully vaccinated. There was no drug reactions or allergies and no concomitant medications. It was specified that the patient had never chickenpox and had no a prior history of herpes zoster or herpes zoster ophthalmicus. On 27-JUN-2008, 23-AUG-2011, and 09-DEC-2012, the patient was vaccinated with either PROQUAD or VARIVAX lot number reported as "16902Z", for prophylaxis (also reported as vaccine) (strength, dosage schedule, route of administration and anatomical location were not provided). The physician reported that he was uncertain which vaccine was administered. The reporter mentioned that this uncertainty was due to a clerical error from switching from paper documentation to electronic documentation. On an unknown date, the patient experienced meningitis (neck stiffness, photophobia, headache, tremor) and was admitted to hospital on 09-FEB-2019. There were various unspecified studies performed, included a Cerebrospinal fluid (CSF) analysis, which sample was collected on 12-FEB-2019, and the results were: Protein 115 (units not provided), Red Blood Cell (RBC) count 7 (units not provided), Glucose 58 (units not provided) and White Blood Cell count (WBC) 635 (units not provided) and the varicella zoster virus Polymerase Chain Reaction (PCR) test was positive. It was reported that the patient did not experienced a rash at the injection site, following the vaccination; that there was no rash, no encephalitis, no pneumonia; that the patient did not have recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was stated that the physician would like to do a genotyping in order to see if the patient's meningitis was caused by the community or the vaccine strain that he received. At the time of the report, the patient was recovered and receiving valacyclovir hydrochloride (VALTREX) as part of the treatment given. The outcome of varicella virus test positive was not provided. The causality between meningitis and varicella virus test positive, and PROQUAD was not provided. The causality between meningitis and varicella virus test positive, and VARIVAX was not reported. Upon internal review, meningitis was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a male patient of unknown age referring to himself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-MAR-2014, the approximately 67 year old patient was administered the ZOSTAVAX by a physician at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a physician's office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, at approximately 66 years old, the patient was administered the ZOSTAVAX by pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a male patient of unknown age referring to himself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 29-AUG-2012, the approximately 78-year-old patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at an emergency room (ER) at a hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-MAR-2016, the patient was administered the ZOSTAVAX by a healthcare provider at a family medicine office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a family medicine office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-FEB-2011, the patient was administered the ZOSTAVAX by a healthcare provider at a public health facility (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a physician's office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of services, loss of consortium, and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) at a community health center. On an unknown date, the patient was treated by a healthcare provider at a hospital emergency room for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 30-AUG-2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a clinic. On an unknown date, the patient was treated by a healthcare provider at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 64 year old male patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-DEC-2015, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On or about 18-AUG-2016, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a 81-year-old patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-NOV-2014, the patient was administered the ZOSTAVAX by pharmacist at a pharmacy (lot number, dosage and route of administration not provided). In MARCH 2017, the patient was treated by a physician at an ophthalmology office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and an approximately 54-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a healthcare provider at a medical center/hospital (lot number, dosage and route of administration not provided). Later in 2013, the patient was treated by a healthcare provider at a medical center/hospital, for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 66-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-FEB-2011, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided) at a medical office. On or about 24-SEP-2016, the patient was treated by a physician at a medical center/hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of services, loss of consortium, and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-OCT-2012, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a clinic for the following injury resulting from the patient's ZOSTAVAX use: Post-herpetic neuralgia. The patient claims damages including: injury to herself and economic losses. The outcome of post-herpetic neuralgia was unknown. Post-herpetic neuralgia was reported as related to ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 69-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-JAN-2012, the patient was administered the ZOSTAVAX by a healthcare provider at a clinic (lot number, dosage and route of administration not provided). On or about 29-FEB-2016, the patient was treated by a physician at a physician's office for the following injury resulting from the patient's ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to himself, loss of services, loss of consortium, and economic losses. The outcome of Herpes zoster was unknown. Herpes zoster was reported as related to ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 74-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-MAY-2012, the patient was administered the ZOSTAVAX by a healthcare provider at a physician's office (lot number, dosage and route of administration not provided). On or about 20-APR-2017, the patient was treated by a healthcare provider (not further specified) at a dermatology office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 61-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-JUN-2011, the patient was administered the ZOSTAVAX by a healthcare provider at a facility (lot number, dosage and route of administration not provided). In MARCH 2017, the patient was treated by a healthcare provider (not further specified) at a medical center/hospital for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 77-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2011, the patient was administered the ZOSTAVAX by a healthcare provider (not further specified) at a facility (lot number, dosage and route of administration not provided). On or about 24-MAY-2013, the patient was treated by a physician at the facility for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 73-year-old patient with unknown gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 21-FEB-2017, the patient was treated by a physician at healthcare facility/hospital for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 67-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-JUL-2014, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 27-APR-2016, the patient was treated by a physician at a medical office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself, loss of services, loss of consortium and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 68-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-SEP-2012, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 02-MAR-2017, the patient was treated by a certified medical assistant (CMA) at a health clinic for the following injury resulting from the patient's ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to herself and economic losses. The outcome of Herpes zoster was unknown. Causality assessment for Herpes zoster was considered as related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and an 85-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the ZOSTAVAX by a healthcare provider (not further specified) at a clinic (lot number, dosage and route of administration not provided). On or about 28-FEB-2017, the patient was treated by a physician at a medical office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 64 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-JUL-2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On or about 21-JAN-2016, 04-APR-2016 and 23-FEB-2017, the patient was treated by a healthcare provider at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 26-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with PROQUAD (dose, units, frequency, lot # and expiration date unknown) subcutaneously instead of M-M-R II due to human error (interchange of vaccine products and wrong product administered). No adverse effects were reported. No product quality issue was reported.
Age: 1.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323; US-009507513-1902USA009445: Original Case: 1902USA009323; US-009507513-1902USA009446: Original Case: 1902USA009323; US-009507513-1902USA009447: Original Case: 1902USA009323; US-009507513-1902USA009448: Original Case: 1902USA009323; US-009507513-1902USA009449: Original Case: 1902USA009323; US-009507513-1902USA009450: Original Case: 1902USA009323; US-009507513-1902USA009451: Original Case: 1902USA009323; US-009507513-1902USA009452: Original Case: 1902USA009323; US-009507513-1902USA009453: Original Case: 1902USA009323; US-009507513-1902USA009454: Original Case: 1902USA009323; US-009507513-1902USA009455: Original Case: 1902USA009323; US-009507513-1902USA009456: Original Case: 1902USA009323; US-009507513-1902USA009457: Original Case: 1902USA009323; US-009507513-1902USA009458: Original Case: 1902USA009323; US-009507513-1902USA009459: Original Case: 1902USA009323; US-009507513-1902USA009460: Original Case: 1902USA009323; US-009507513-1902USA009461: Original Case: 1902USA009323; US-009507513-1902USA009462: Original Case: 1902USA009323; US-009507513-1902USA009463: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009444: Original Case: 1902USA009323; US-009507513-1902USA009443: Original Case: 1902USA009323; US-009507513-1902USA009442: Original Case: 1902USA009323; US-009507513-1902USA009441: Original Case: 1902USA009323; US-009507513-1902USA009440: Original Case: 1902USA009323; US-009507513-1902USA009437: Original Case: 1902USA009323; US-009507513-1902USA009438: Original Case: 1902USA009323; US-009507513-1902USA009439: Original Case: 1902USA009323.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513- 902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 18-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 08-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 03-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.