chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9, UNK, UNK, UNK
Symptoms: Grip strength decreased, Loss of personal independence in daily activities, Myalgia, Pain, Tremor
Clinical narrative: leg muscle pain; 4 wisdom tooth removals; drug allergy to tylenol, codeine, hydrocodone (all from tooth extraction); fatigue; tremor (in the right arm, the jaw, right leg) / tremor like lower leg shaking; abdominal pain; decreased grip and decresead overall body strength; general lost of entire body strength / decreased overall body strength; This spontaneous report was received from a physician referring to a 14 year old non-pregnant female patient with unspecified respiratory problems.  There was none concomitant medications.  No information was provided regarding patient's pertinent medical history or concurrent conditions.  On an unspecified day in November 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, intramuscular in the left arm, for routine immunisation (dose, lot number and expiration date were not reported).   Two days later in November 2018, the patient began to experience tremors, abdominal pain and fatigue. The tremors started in the right arm then within two to three weeks the patient also experienced tremor in the the jaw and then the right leg as well.   Within that 2 to 3 weeks, on an unspecified date in approximately 2018, the patient also experienced decreased grip (grip strength decreased) and decreased overall body strength (asthenia).   On unspecified dates after initial symptoms began, patient has sought medical attention of one pediatrician and three neurologist.   Between March and July 2019, the patient had transient recovery of tremors.  On an unspecified day in end of June 2019, the patient received acetaminophen (TYLENOL), codeine and hydrocodone due to 4 wisdom tooth removal performed on a single day.  The patient developed drug reaction/allergy to acetaminophen(TYLENOL), codeine and hydrocodone (drug hypersensitivity).  In August  2019 tremors persisted.  On unspecified date in August 2019, jaw tremors resolved.  Abdominal pain and fatigue completely resolved on unspecified date after November 2019.   On an unknown date the patient experienced leg muscle pain (myalgia) that started within seconds of attempted exercise or dance.  It was stated that tremors and muscle pain only occurred with activity and did not present on rest or mild daily routines like walking.  On unspecified date, an electromyography (EMG) was performed and results were normal.  No treatment was given for the events.    At the time of reporting, the patient had not recovered from tremor, asthenia, myalgia and grip strength decreased.  The outcome of wisdom teeth removal and drug hypersensitivity was unknown.   The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events  Physician stated that patient was a dancer that could no longer perform or exercise. Therefore, the events of tremor, asthenia, myalgia and grip strength decreased were considered serious due to disability.
Age: 14.0
Sex: F
Vaccine: HPV9, UNK, UNK, UNK
Symptoms: Wisdom teeth removal
Clinical narrative: leg muscle pain; 4 wisdom tooth removals; drug allergy to tylenol, codeine, hydrocodone (all from tooth extraction); fatigue; tremor (in the right arm, the jaw, right leg) / tremor like lower leg shaking; abdominal pain; decreased grip and decresead overall body strength; general lost of entire body strength / decreased overall body strength; This spontaneous report was received from a physician referring to a 14 year old non-pregnant female patient with unspecified respiratory problems.  There was none concomitant medications.  No information was provided regarding patient's pertinent medical history or concurrent conditions.  On an unspecified day in November 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, intramuscular in the left arm, for routine immunisation (dose, lot number and expiration date were not reported).   Two days later in November 2018, the patient began to experience tremors, abdominal pain and fatigue. The tremors started in the right arm then within two to three weeks the patient also experienced tremor in the the jaw and then the right leg as well.   Within that 2 to 3 weeks, on an unspecified date in approximately 2018, the patient also experienced decreased grip (grip strength decreased) and decreased overall body strength (asthenia).   On unspecified dates after initial symptoms began, patient has sought medical attention of one pediatrician and three neurologist.   Between March and July 2019, the patient had transient recovery of tremors.  On an unspecified day in end of June 2019, the patient received acetaminophen (TYLENOL), codeine and hydrocodone due to 4 wisdom tooth removal performed on a single day.  The patient developed drug reaction/allergy to acetaminophen(TYLENOL), codeine and hydrocodone (drug hypersensitivity).  In August  2019 tremors persisted.  On unspecified date in August 2019, jaw tremors resolved.  Abdominal pain and fatigue completely resolved on unspecified date after November 2019.   On an unknown date the patient experienced leg muscle pain (myalgia) that started within seconds of attempted exercise or dance.  It was stated that tremors and muscle pain only occurred with activity and did not present on rest or mild daily routines like walking.  On unspecified date, an electromyography (EMG) was performed and results were normal.  No treatment was given for the events.    At the time of reporting, the patient had not recovered from tremor, asthenia, myalgia and grip strength decreased.  The outcome of wisdom teeth removal and drug hypersensitivity was unknown.   The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events  Physician stated that patient was a dancer that could no longer perform or exercise. Therefore, the events of tremor, asthenia, myalgia and grip strength decreased were considered serious due to disability.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2007, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: According to pt mother, approx. 2 hours after vaccination pt began to have redness at site of injection as well as a fever. Mother states pt had a fever up to 102 at home. Highest temp in the ER was 100.2. Redness on R arm at time of ER eval extended from R shoulder to R elbow. Pt denied pain and itching.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager referring to a patient of unknown age and gender.      The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not provided.  On 10-MAR-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) that had been improperly stored (dose, frequency, route of administration not reported; lot # S021322 and expiration date 09-JUL-2021), for an unknown indication. It was reported that the lot of vaccine was reconstituted with properly stored Merck's sterile diluent (lot # and expiration date not reported). The storage temperature of the vaccine was -8.3 degrees Celsius and the time frame was 24 minutes. There was digital data logger involved.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005878:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: shingles; neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. Information of the pt's concurrent conditions, medical history or concomitant therapy was not reported.  In or about January 2014, the pt received zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), on an unknown date (reported as shortly after vaccination), the pt suffered from shingles and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitation and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. He suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered.  Causality assessment was related. Herpes zoster and neuropathy peripheral were considered disabling events.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in Urgent Care, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in Urgent Care, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a clinic, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or 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 herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2012, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 28-JUN-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-MAY-2014, the patient was treated in hospital, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated at a hospital, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles/ blistering vesicular outbreak, which was diagnosed as herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 07-APR-2008, he was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at county health department, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-FEB-2017, he was treated by the physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The pt was prescribed hydrocodone and valacyclovir hydrochloride (VALTREX) for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (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, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles by a physician.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated in a medical center, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On 04-JAN-2006, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a medicine center.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On 23-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 24-NOV-2015, the patient was treated in a hospital, for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir, naproxen and oxycodone (+) acetaminophen (PERCOCET) for management of her painful symptoms and chronic pain.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a health center.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in the health center, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a hospital.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in a hospital, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 15-MAY-2008, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a health department.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on 01-DEC-2015, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: persistent and severe vesicular rash, which was diagnosed as herpes zoster and neuralgia; persistent and severe vesicular rash, which was diagnosed as herpes zoster and neuralgia; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 12-JUL-2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on 13-JAN-2014, the patient was treated in a Medical Group, for persistent and severe vesicular rash, which was diagnosed as herpes zoster and neuralgia. The patient was prescribed valacyclovir(VALTREX) and Hydrocodone for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2011, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated in Urgent Care, for the onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular outbreak, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 03-OCT-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on or about 12-SEP-2014, the patient was treated for the onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician for the onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular outbreak, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013 and 2015, the patient was treated for severe vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Incomplete course of vaccination, Myalgia
Clinical narrative: muscle pain; tiredness; headache; shivering; low-grade fever to 100.0; I am now due for my second shot; This case was reported by a consumer and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle pain, tiredness, headache, shivering, fever and incomplete course of vaccination. On an unknown date, the outcome of the muscle pain, tiredness, headache, shivering, fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the muscle pain, tiredness, headache, shivering and fever to be related to Shingrix.  Additional detials were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination had muscle pain, tiredness, headache, shivering, lowgrade fever to 100 degree F. The patient was due for 2nd dose and till the time of reporting did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.      Lab Comments: Lab test performed on an unknown date
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: muscle pain; tiredness; headache; shivering; low-grade fever to 100.0; I am now due for my second shot; This case was reported by a consumer and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle pain, tiredness, headache, shivering, fever and incomplete course of vaccination. On an unknown date, the outcome of the muscle pain, tiredness, headache, shivering, fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the muscle pain, tiredness, headache, shivering and fever to be related to Shingrix.  Additional detials were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination had muscle pain, tiredness, headache, shivering, lowgrade fever to 100 degree F. The patient was due for 2nd dose and till the time of reporting did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.      Lab Comments: Lab test performed on an unknown date
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, Irritability
Clinical narrative: received both the Engerix B and Pediarix vaccines; Adult product administered to child; Fussy; This case was reported by a other health professional via call center representative and described the occurrence of irritability in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 31st May 2020) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Pediarix .5 ml and the 2nd dose of Engerix B adult 1 ml. In February 2020, less than a week after receiving Pediarix and Engerix B adult, the patient experienced irritability. On 20th February 2020, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the irritability, overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the irritability to be related to Pediarix and Engerix B adult.  Additional information was provided as follows: The patient received both the Engerix B adult and Pediarix vaccines on same day, which led to overdose for hepatitis B antigen and adult product administered to child for Engerix B adult. The reporter indicated that the parent of the patient was called to follow up and the parent indicated that the child was fussy.   This was not considered to be unusual because the child had received five vaccines the day before. The reporter consented to follow up. The reporter was unable to provide any additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Blood disorder, Inappropriate schedule of product administration
Clinical narrative: he was hospitalized for an unrelated condition having to do with a blood problem; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of blood disorder in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced blood disorder (serious criteria hospitalization) and drug dose administration interval too long. On an unknown date, the outcome of the blood disorder and drug dose administration interval too long were unknown.   The reporter considered the blood disorder to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was hospitalized for an unrelated condition having to do with a blood problem. It was stated that, due to being admitted to the hospital, the patient missed the timeline for the second injection (within 6 months) which led to lengthening of vaccination schedule. The reporter stated that, the patient had a second Shingrix injection with the intention of starting the series over but not had the third injection till the time of reporting. Limited information was provided. This case was linked with case US2019194710, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: spike in blood preasure; This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and experienced spike in blood pressure. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female
Clinical narrative: Breast cancer; This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed with breast cancer after receiving a dose of Shingrix. The patient enquired if it was safe for her to receive 2nd dose of Shingrix since she was due for it. Till the time of reporting, the patient did not start the therapy for breast cancer.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Rash on the medial aspect of the bicep; Erythma at the injection site; This case was reported by a physician via call center representative and described the occurrence of rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a day after receiving Shingrix, the patient experienced rash and injection site erythema. On an unknown date, the outcome of the rash and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rash and injection site erythema to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix on right deltoid and on the same day the patient developed a rash on the medial aspect of the bicep and erythema at the injection site. The events spontaneously resolved after 3 days. The reporter did consented for follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Approximately 12 hours after receiving the shot (at about 2 am) began running a fever.  Fever ran anywhere from 99 to 102 degrees.  Associated muscle aches.  Not sure if it was related, but just as the fever began to spike, I experienced a sharp pain in my right knee which has faded away in the 24 hours since.  Fever lasted for approximately 10-12 hours, fading away by mid-afternoon leaving me with a headache.