chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patient was vaccinated with improperly stored GARDASIL 9 (lot # N020139, expiration date 24-FEB-2020; lot # N026812, expiration date 22-JUN-2020; lot # 021475, expiration date 31-JAN-2020; lot # N021572, expiration date 01-MAY-2020; lot # N022583, expiration date 20-JUN-2020), ROTATEQ (lot # N012757, expiration date 27-JAN-2019; lot # N013886, expiration date 19-DEC-2018; lot # 022173, expiration date 15-MAR-2019) and PNEUMOVAX 23 (lot # N023650, expiration date 20-MAY-2019; lot # N024384, expiration date 18-MAY-2019) for prophylaxis. The temperature and time frame was reported as below 32 Fahrenheit (F) (also reported as 29.1 F) for 18 hours. There was no previous temperature excursion. The data logger was involved. No adverse effects reported in any patients.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a female patient of unknown age. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies.  On 09-MAY-2018 (2 days ago), the patient was vaccinated with PNEUMOVAX 23 in the left arm (lot#, expiration date, frequency, dose and route of administration were not provided) for prophylaxis. On 09-MAY-2018 (reported as later that day), the patient's left arm was swollen and warm to touch below the injection site. The pharmacist reported, that on 11-MAY-2018, the swelling has increased and moved towards elbow, was red, hot to touch, and very painful. The patient had no laboratory studies performed. The outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and suspected vaccine was not provided by the reporter.
Sex: F
Vaccine: MMR
Symptoms: Loss of personal independence in daily activities, Rash papular, Sensory disturbance
Clinical narrative: This spontaneous report was received from a female consumer of an unknown age, and refers to herself. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unspecified date in February 2017, the patient was vaccinated with a dose of (wistar ra 27-3) M-M-R II (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis. Subsequently, on an unspecified date in February 2017 also reported as "within 15 minutes of receiving the vaccine", the patient had "outbreaks" on her skin which were described as "raised bumps that travel and run, biting and pinching sensation anywhere on body from seconds to minutes to days then disappear" (rash papular); additionally, she mentioned that her life had been unmanageable, she had dropped out of school and was stuck in her house all day. Consequently, she sought medical attention through a visit to five different specialists who were not able to diagnose her, nor treat her. At the time of reporting, the patient had not recovered from rash papular. The causal relationship between the therapy with (wistar ra 27-3) M-M-R II and the event was not reported. Upon internal review, rash papular was determined to be a disabling event.
Sex: F
Vaccine: RV5
Symptoms: Azotaemia, Dehydration, Gastroenteritis, Gastrointestinal viral infection, Hypokalaemia
Clinical narrative: This spontaneous report as received from a nurse via a company employee refers to a 3 year old female patient. The patient was vaccinated for prophylaxis with ROTATEQ on 21-APR-2015 (lot # K012432; expiration 20-MAY-2016), 23-JUN-2015 (lot # reported as L005751, expiration date reported as 26-JUL-2016) and 25-AUG-2015 (lot # L008578, expiration date 14-DEC-2016). On 06-APR-2018, the patient was diagnosed with viral gastrointestinal infection (reported as viral GI). In April 2018, the patient experienced uremia. On 09-APR-2018, the patient continued to get worse and went to an unknown outside facility. On the same day, the child was sent to hospital, where she was admitted for dehydration with acute gastroenteritis, hypokalemia and uremia. The nurse reported that the patient received an unspecified treatment for the dehydration with acute gastroenteritis, hypokalemia and uremia and was then discharged from the hospital on 10-APR-2018. The outcome of events was reported as recovered/resolved in approximately 2018. Causality assessment was not provided. Lot number L005751 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Asthenia, Blood test abnormal, Borrelia test, C-reactive protein increased
Clinical narrative: This spontaneous report was received from a pharmacy technician who was the patient's mother, referring to her 29 year old daughter. The patient's historical drugs and medical history were not reported. The patient's concurrent conditions included diaphragmatic hernia. The patient's concomitant therapies included unspecified birth control, PROZAC and multivitamins. The patient did not have any drug reactions or allergies. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL for prevention (strength, dose, route, frequency, lot#, expiration date and indication were not reported) (extra dose administered). On an unknown date, after the fourth dose, the patient began to have some nerve problems, described as lost all feeling in her feet, hands and arms, her fingers were always numb (hypoaesthesia), loss of grip, fell down steps from this during college, had so many different issues (adverse event) and she was getting more debilitating (asthenia). On an unknown date (reported as "years ago"), an unspecified test of Lyme's (results not provided), chronic fatigue (results not provided) and Guillain-Barre syndrome were performed from an unspecified healthcare worker; the results for Guillain-Barre syndrome were that some markers came up positive, but not all markers that were needed to be diagnosed. On an unknown date, a neurologist did an unspecified nerve study on an unspecified date (results not provided). On an unknown date, the patient saw an unknown physician to manage her pain. On an unknown date in May 2018 (reported as "in the last month"), the patient had a rheumatoid arthritis (RA) blood test blood work for autoimmune disorder performed by an unspecified healthcare worker, which resulted in very high levels of C-Reactive Protein (CRP) (reported as "went up another 10") and the multibiomarker Disease Activity (VECTRA) test was very high too (blood test abnormal). The patient sought medical attention and received treatment. At the time of reporting, the outcome of hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia and adverse event, Lyme disease and chronic fatigue was reported as not recovered. Additionally, the reporter was unsure if she attributes these events to GARDASIL. Hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia, adverse event, Lyme disease and chronic fatigue were considered disabling events. Upon internal review, Lyme disease was determined to be a medically significant event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA009284.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, Fall, Fatigue, Grip strength decreased, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a pharmacy technician who was the patient's mother, referring to her 29 year old daughter. The patient's historical drugs and medical history were not reported. The patient's concurrent conditions included diaphragmatic hernia. The patient's concomitant therapies included unspecified birth control, PROZAC and multivitamins. The patient did not have any drug reactions or allergies. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL for prevention (strength, dose, route, frequency, lot#, expiration date and indication were not reported) (extra dose administered). On an unknown date, after the fourth dose, the patient began to have some nerve problems, described as lost all feeling in her feet, hands and arms, her fingers were always numb (hypoaesthesia), loss of grip, fell down steps from this during college, had so many different issues (adverse event) and she was getting more debilitating (asthenia). On an unknown date (reported as "years ago"), an unspecified test of Lyme's (results not provided), chronic fatigue (results not provided) and Guillain-Barre syndrome were performed from an unspecified healthcare worker; the results for Guillain-Barre syndrome were that some markers came up positive, but not all markers that were needed to be diagnosed. On an unknown date, a neurologist did an unspecified nerve study on an unspecified date (results not provided). On an unknown date, the patient saw an unknown physician to manage her pain. On an unknown date in May 2018 (reported as "in the last month"), the patient had a rheumatoid arthritis (RA) blood test blood work for autoimmune disorder performed by an unspecified healthcare worker, which resulted in very high levels of C-Reactive Protein (CRP) (reported as "went up another 10") and the multibiomarker Disease Activity (VECTRA) test was very high too (blood test abnormal). The patient sought medical attention and received treatment. At the time of reporting, the outcome of hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia and adverse event, Lyme disease and chronic fatigue was reported as not recovered. Additionally, the reporter was unsure if she attributes these events to GARDASIL. Hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia, adverse event, Lyme disease and chronic fatigue were considered disabling events. Upon internal review, Lyme disease was determined to be a medically significant event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA009284.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Lyme disease, Pain management, Rheumatoid factor, Sensory loss
Clinical narrative: This spontaneous report was received from a pharmacy technician who was the patient's mother, referring to her 29 year old daughter. The patient's historical drugs and medical history were not reported. The patient's concurrent conditions included diaphragmatic hernia. The patient's concomitant therapies included unspecified birth control, PROZAC and multivitamins. The patient did not have any drug reactions or allergies. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL for prevention (strength, dose, route, frequency, lot#, expiration date and indication were not reported) (extra dose administered). On an unknown date, after the fourth dose, the patient began to have some nerve problems, described as lost all feeling in her feet, hands and arms, her fingers were always numb (hypoaesthesia), loss of grip, fell down steps from this during college, had so many different issues (adverse event) and she was getting more debilitating (asthenia). On an unknown date (reported as "years ago"), an unspecified test of Lyme's (results not provided), chronic fatigue (results not provided) and Guillain-Barre syndrome were performed from an unspecified healthcare worker; the results for Guillain-Barre syndrome were that some markers came up positive, but not all markers that were needed to be diagnosed. On an unknown date, a neurologist did an unspecified nerve study on an unspecified date (results not provided). On an unknown date, the patient saw an unknown physician to manage her pain. On an unknown date in May 2018 (reported as "in the last month"), the patient had a rheumatoid arthritis (RA) blood test blood work for autoimmune disorder performed by an unspecified healthcare worker, which resulted in very high levels of C-Reactive Protein (CRP) (reported as "went up another 10") and the multibiomarker Disease Activity (VECTRA) test was very high too (blood test abnormal). The patient sought medical attention and received treatment. At the time of reporting, the outcome of hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia and adverse event, Lyme disease and chronic fatigue was reported as not recovered. Additionally, the reporter was unsure if she attributes these events to GARDASIL. Hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia, adverse event, Lyme disease and chronic fatigue were considered disabling events. Upon internal review, Lyme disease was determined to be a medically significant event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA009284.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Exposure to communicable disease
Clinical narrative: This spontaneous report was received from a nurse concerning a 3 years and 6 months old patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 01-JUN-2016, the patient was vaccinated with VARIVAX for prophylaxis, non valid lot number L027432 (dose, route of administration, anatomical location and expiration date were not reported). On an unknown date, the patient was exposed to another child with chickenpox (exposure to communicable disease) at an unspecified daycare. The outcome of exposure to communicable disease and the causal relationship between the event and therapy with VARIVAX were not reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to a 12 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, reported as "in the recent past", the patient was inadvertently vaccinated with unspecified doses of VARIVAX concomitantly with PROQUAD for prophylaxis, reported as "well baby vaccination", (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported for any of the vaccines) (overdose). On an unknown date, the patient develop a fever up to 103 (units not provided) (pyrexia). It was reported that the patient did not seek for medical attention and that no treatment was provided for the event. The patient's fever come down on an unknown date. The reporter did not assess the causal relationship between therapy with VARIVAX or PROQUAD and the patient's fever. Additionally, it was stated that this incident was reported to VAERS (number not provided).
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was reporting on himself. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On approximately 2003 (reported as about 15 years ago), the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). Other suspect therapies included (crm197) PREVNAR given about "two years ago", approximately in 2016. On an unspecified date (reported as a few months ago), the patient developed a case of pneumonia. The patient wanted to know if he should get re-vaccinated with the PNEUMOVAX 23 because he was concerned the pneumonia prevention vaccination he had already received previously was losing its effectiveness. The outcome of pneumonia and drug effect decreased was unknown as well as the causal relationship between the events and vaccination with PNEUMOVAX 23. Upon internal review the event pneumonia was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an healthcare worker regarding an 28 years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, it was reported that the 28 years old patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (strength, frequency, lot #, expiration date and route of administration were not reported). No side effect were given. The reporter stated that she would double check that the patient was 28 years old. No Product quality complain was present.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an emergency medical technician and refers to his daughter, a female patient of unknown age. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The reporter informed that on an unspecified date in June 2016, the patient was vaccinated with the first dose of GARDASIL 9 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). Later, on an unspecified date in July 2017, she was vaccinated with the second dose of GARDASIL 9 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). The reporter also informed that the patient attended to the doctor's office on 23-MAY-2018 in order to receive the third dose of GARDASIL 9, however it was not confirmed whether she received the third dose or not. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also knows as shingles. During 2014, the patient was treated by for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also knows as shingles and other complications. Later in 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 08-JUNE-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also knows as shingles and other complications. On or about 27-NOV-2015, the patient was treated at a medical facility for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-APR-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-APR-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a outpatient clinic, (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 05-JUL-2016, the patient was treated by a physician for symptoms of a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reported considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications.  During 2016, the patient was treated (by an unspecified healthcare professional) at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Rash
Clinical narrative: This spontaneous report was received from a 78 year old female patient, referring to herself. The patient was taking unspecified over-the-counter medications as concomitant therapies. There was no pertinent medical history, drug reactions or allergies. On 21-MAY-2018, the patient was vaccinated with a dose of ZOSTAVAX Injection, subcutaneously, for prophylaxis (reported as "prevention of shingles") (strength, lot number and expiration date were not reported). The patient reported that one day after being vaccinated with ZOSTAVAX, on 22-MAY-2018, she experienced an unspecified rash, headache, redness and soreness around the injection site. The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered. The patient did not provide a causal relationship between the events and vaccination with ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a medical office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated (by an unspecified healthcare professional) at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a medical center (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-JUL-2016, the patient was treated (by an unspecified healthcare professional) at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), administered at a medical center (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-JUL-2016, the patient was treated (by an unspecified healthcare professional) at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 19-APR-2017, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. Later in 2017, the patient was treated at a community clinic for a blistering vesicular outbreak, which was diagnosed as severe shingles. The patient has been prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 16-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route administered by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 09-MAY-2015, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient has been prescribed ketorolac tromethamine (TORADOL), prednisone, acetaminophen, hydrocodone bitartrate (NORCO) and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 22-MAY-2018, the patient received a dose of VARIVAX (lot number N031001, expiration date 03-NOV-2019) for prophylaxis (strength, dose number, anatomical location and route of administration were not reported) and a dose of PROQUAD (lot number N028447, expiration date 09-APR-2019), also for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In November 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route administered by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. Later in 2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 01-FEB-2014, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-NOV-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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 of herpes zoster, also known as shingles and other complications. Later in 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 30-JAN-2008, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. During 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-JUL-2018, the patient was inoculated with ZOSTAVAX at a community health center for recommended for routine adult health maintenance and 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 of herpes zoster, also known as shingles.  On or about 28-MAY-2016, he was treated by a Family Nurse Practitioner (FNP) at the same community health center for symptoms of a blistering vesicular outbreak, which was diagnosed as severe shingles with ophthalmic complication (shingles that had spread into the eye). On or about 11-OCT-2016, the patient sought subsequent treatment from the FNP for continued and worsening symptoms of zoster pain, which was diagnosed as post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms. As a direct and proximate result of 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. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-JUL-2018, the patient was inoculated with ZOSTAVAX at a community health center for recommended for routine adult health maintenance and 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 of herpes zoster, also known as shingles.  On or about 28-MAY-2016, he was treated by a Family Nurse Practitioner (FNP) at the same community health center for symptoms of a blistering vesicular outbreak, which was diagnosed as severe shingles with ophthalmic complication (shingles that had spread into the eye). On or about 11-OCT-2016, the patient sought subsequent treatment from the FNP for continued and worsening symptoms of zoster pain, which was diagnosed as post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms. As a direct and proximate result of 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. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.