chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Status epilepticus, Wheelchair user
Clinical narrative: He had status epilepticus, arrested and was intubated on a ventilator. He was then put in an induced coma to control the seizures. But it was too late, the MRI showed encephalitis and brain injury. He never really woke up. He is left with dystonia and corticol blindness. Is wheelchair bound and unable to speak or communicate. My son was a healthy, walking, talking 4 year old before all of this!
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Hallucination
Clinical narrative: pain, redness, and swelling at site of injection. joint and muscle pain. extreme tiredness and weakness . headache. intense shivering. fever, hallucinations. loss of breath  my 1st shot only resulted in a mildly painful arm, the 2nd shot was much more problematic.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: pain, redness, and swelling at site of injection. joint and muscle pain. extreme tiredness and weakness . headache. intense shivering. fever, hallucinations. loss of breath  my 1st shot only resulted in a mildly painful arm, the 2nd shot was much more problematic.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory arrest
Clinical narrative: pain, redness, and swelling at site of injection. joint and muscle pain. extreme tiredness and weakness . headache. intense shivering. fever, hallucinations. loss of breath  my 1st shot only resulted in a mildly painful arm, the 2nd shot was much more problematic.
Age: 64.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Discomfort, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Patient experiences soreness when arm is hanging. No loss of strength. Able to bend arm. Unable to lift or rotate arm. Difficulty dressing self. At night, unable to find comfortable position to sleep.
Age: 64.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injected limb mobility decreased, Insomnia, Pain, Periarthritis
Clinical narrative: Patient experiences soreness when arm is hanging. No loss of strength. Able to bend arm. Unable to lift or rotate arm. Difficulty dressing self. At night, unable to find comfortable position to sleep.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenopia, Headache, Pain in extremity, Pyrexia
Clinical narrative: Got shot on Feb. 28, 2020, and the day after I received the shot, about 23 hours later, I had a fever, eyes got very tired, had a headache.  By March 1, I felt a little better and the fever, eyes and headache were gone.  A few weeks later I started getting headaches but mainly when I am laying down in bed.  When I get up, it seems to get better.  I have not had headaches before.  Had a sore arm after the shot.  Took tynenol.  Sore arm lasted about 4 -5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness, Urticaria
Clinical narrative: 3 welts the size of 1/2 dollar developed on the neck behind the ear 3 days after vacccination.  They were red, swollen and tender but getting better.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Feverish, can't lift arm
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: patient called stating swollen arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sensitive skin
Clinical narrative: About a week later I started having shingles like pain, no rash.  I went to the doctor and he told me I had a hypersensitive skin reaction.  That my body did not have shingles but I was reacting as if I did.  He prescribed me  ValACYclovir 1 GM .  I took all of it but the last days worrth, because pain had gone and I had then  come down with the flu and started taking Tamiflu.  A few days the shingles pain started up worse than ever, but it was worse now on my side.  This has been going on for a month now with no end in sight.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Tic, Toe walking
Clinical narrative: within a 7-10 days of shot developed TICS. Facial and shoulder and neck. They are constant. Also toe-walking.  He is 9 years old and hadn?t had a vaccine since age 1. Never before had he ever exhibited tics or toe walking. It is now four months later and they have not resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Pt says her Arm still is sore 16 days Later. She has "shooting" paiNs and trouble sleeping on Arm. SHe says she is still ABle to Lift ARM and do work
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: vesicular outbreak, which was diagnosed as 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 09-SEP-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. Later on 12-SEP-2015, the patient was treated in a hospital, for vesicular outbreak, which was diagnosed as shingles. The patient was prescribed cephalexin(KEFLEX), acyclovir, sulfamethoxazole(+)trimethoprim(BACTRIM), hydroxyzine(VISTARIL) and hydrocodone bitartrate (+)acetaminophen(NORCO) for management of her painful symptoms and excruciating 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: F
Vaccine: TYP
Symptoms: Asthenia, Hypertension, Palpitations
Clinical narrative: HEART PALPITATIONS; HYPERTENSION; WEAKNESS; This spontaneous case report was extracted through VAERS database (781110-1) on 01-Feb-2019. The case was reported by a consumer via health authority. The report describes a 68-year-old female consumer who experienced heart palpitations, hypertension, and weakness following the intake of oral Vivotif for an unknown indication.  The consumer had history of mitral valve prolapse with bundle block and she was allergy to sulfonamides.  The consumer's concomitant medication included Vitamin D3 (cholecalciferol) Vitamin B12 (cyanocobalamin) calcium and iodine.  It was reported that the consumer took the first dose of Vivotif on 04-Oct-2018. On 06-Oct-2018, she experienced weakness, heart palpitations and hypertension. The consumer was taken to ER (emergency room) and it was unclear whether her symptoms were a result of the oral vaccine or not. She completed all the doses of Vivotif course.  The action taken with Vivotif with respect to the events heart palpitations, hypertension, and weakness was dosage maintained.  The clinical outcome of the events heart palpitations, hypertension, and weakness was unknown.  Company's Comment: In this case, it was reported that a 68-year-old female consumer experienced "heart palpitations, hypertension, and weakness'' following the intake of oral Vivotif. The consumer's past medical history included mitral valve prolapse with bundle block. In view of above information about the past medical history which gives a plausible explanation of the events, the causality of the events "heart palpitations, hypertension, and weakness" with Vivotif is assessed as unlikely with vivotif.; Sender's Comments: Company's Comment: In this case, it was reported that a 68-year-old female consumer experienced "heart palpitations, hypertension, and weakness" following the intake of oral Vivotif. The consumer's past medical history included mitral valve prolapse with bundle block. In view of above information about the past medical history which gives a plausible explanation of the events, the causality of the events "heart palpitations, hypertension, and weakness" with Vivotif is assessed as unlikely with vivotif.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles; The vaccine did not prevent shingles as intended; persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles; 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 2013, 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 26-DEC-2015, the patient was treated in a clinic, for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles. The patient was prescribed valacyclovir(VALTREX) 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, VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles; The vaccine did not prevent shingles as intended; persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles; 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 2013, 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 26-DEC-2015, the patient was treated in a clinic, for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles. The patient was prescribed valacyclovir(VALTREX) 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.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: When shot was given IM in upper left deltoid, I could not feel the needle penetrate or the release of vaccine into my arm. I watched the practitioner (I don't know her name, black hair, tall, glasses, superior attitude) take the needle out, with my mother being witness. My arm soon after became tingly numb so I slapped it against my leg/thigh to get feeling back. The rest of the day felt fine. Then that night the usual pain started to seep in. I have received a Tdap before long ago and I know they are painful to recover. However the next day my arm didn't have the same mobility as before, and this had never happened before, but thinking it was just the shot I brushed it off, well about a week passed and it wasn't getting better, it felt worse, to the point were the socket felt swollen, loose, almost dislocated and when I would use it my arm would just give out on me. I can't lift it completely over my head, at certain angles I can't put pressure on it, to turn in bed it gives out under my weight, cleaning my hair in the shower it gives out on me, sitting here typing this I feel a stabbing needle pain in my deltoid. When I returned to the physician to get further shots for my medical schooling I brought it up to them and all they said was, "That's weird." and proceeded to not do anything about it and move on with their day. They have not done a VAERS and I have just NOW in this passed week received any care for it. A physical therapy appointment that did nothing. There have been no Xrays, CT scans, or MRIs done to look inside to see what is going on, let alone give me the name of the person who gave me the shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site inflammation, Injection site pain
Clinical narrative: Pain and inflammation around injection site that started immediately following injection and lasted for 7 days. No treatment. Resolved on its own.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information; 2 months old patient was administered a dose of VAQTA; This spontaneous report was received a medical assistant and refers to a 2-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-MAR-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection, 1 dose (strength, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. No additional adverse event was reported. The outcome of product administered to patient of inappropriate age was not provided.
Sex: M
Vaccine: HPV9, UNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient moved his arm while given a dose of GARDASIL-9, which resulted in administration of a partial dose; This initial spontaneous report was received from a medical assistant, regarding a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported. This case concerns one patient and one combination product.  On 11-MAR-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), pre-filled syringe (dose, route of administration, site of administration and vaccination scheme were not reported; lot number 1614897, expiration date 20-SEP-2021) as prophylaxis. During the administration, the patient moved his arm, which resulted in administration of a partial dose (incorrect dose administered). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614897; expirationdate: 20-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; one dose of improperly stored VARN AX was administered to the patient; This spontaneous report has been received from an office manager and refers to a patient of an unknown age and gender. Information about concomitant medications, pertinent medical history and drug reactions or allergies was not provided. On 11-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot# S028926 was verified to be a valid number, expiration date reported and validated as 16-SEP-2021 (strength, dose, vaccination scheme and route of administration were not provided) as prophylaxis. Sterile diluent (STERILE DILUENT) which was used to reconstitute the vaccine had been properly stored. The administered dose of vaccine had temperature excursion of -8.3 degrees Celsius (C) for 24 minutes. There was no previous temperature excursion. Digital data logger was involved. No additional adverse event was reported. The outcome of the events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test, Myalgia, Rheumatoid factor negative
Clinical narrative: severe joint and muscle pain/ it feels like someone is pulling her tendons and bones apart; severe joint and muscle pain/ it feels like someone is pulling her tendons and bones apart; This spontaneous report was received from a consumer referring to her daughter of unknown age. The patient was allergic to penicillin. The patient's concomitant medication and pertinent medical history were not provided.  On an unknown date in July 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in August 2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiration date were not reported).    On an unknown date in  August 2019, after about a week to 10 days, the patient experienced severe joint and muscle pain. The patient said it felt like someone was pulling her tendons and bones apart. The patient sought for medical attention. Over the counter medication and physical therapy were given for the events. On an unknown date the patient had some blood tests done and a rheumatoid arthritis test but that was negative. The doctors had not been able to give any answers. The outcome of severe joint and muscle pain was not recovered. The causality assessment was not provided.
Age: 35.0
Sex: U
Vaccine: HPV9, HPV9, UNK, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; A 35 year old patient received a dose ofGARDASIL 9 on 09/27/2019 and on 03/17/2020; A 35 year old patient received a dose ofGARDASIL 9 on 09/27/2019 and on 03/17/2020; This spontaneous report as received from a pharmacist concerning a 35-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, concurrent conditions, and concomitant medications were not reported.  On 27-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination schedule, and anatomical location was not provided) with lot # 1602284 which was confirmed to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) and with expiration date reported and upon internal review established as 26-SEP-2021 for prophylaxis (product administered to patient of inappropriate age).  On 17-MAR-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination schedule, and anatomical location was not provided) with lot # 1602284 which was confirmed to be valid for for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) and with expiration date reported and upon internal review established as 26-SEP-2021 (same lot # and expiration date for both doses) for prophylaxis (inappropriate schedule of product administration). No known adverse effects were reported. No further information provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; patient received unspecified dose of either a VARIAVX or a PROQUAD dose that was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not provided.        On 05-FEB-2020, the patient was vaccinated with an unspecified improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S025610 had been verified to be a valid number; expiration date 18-AUG-2021) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S017250 had been verified to be a valid number; expiration date 01-DEC-2020); both vaccines for prophylaxis (strengths, frequencies, route of administrations, and anatomical locations were not reported). It was reported the use of properly stored sterile diluent (DILUENT MRK). It was reported the temperature excursion was at 7.5 Fahrenheit (F), for a time frame of 15 minutes, not had previous temperature excursion. It was reported that the call was due to a data logger. No symptoms reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA007010: US-009507513-2003USA007093: US-009507513-2003USA007189:
Sex: U
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: Children over the age of 9 getting GARDASIL 9 vaccination and the physician has noticed a decrease in common warts; Children over the age of 9 getting GARDASIL 9 vaccination and the physician has noticed a decrease in common warts; This spontaneous report was received from a physician and refers to unspecified children over the age of 9 with common warts. The patients' drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.     On an unknown date, the patients were vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and indication were not reported).   On unknown date, the physician noticed decrease in common warts the children had in his practice (therapeutic response unexpected).       At the time of the report, action taken regarding therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the outcome of therapeutic response unexpected and the relationship between therapeutic response unexpected and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) were not reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient experienced no symptoms; there was no diluent available for use; the patient was unable to receive the dose of M-M-R II; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2020, the patient came into the pharmacy for administration of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (strength, dose detail and route were not reported) (lot # S009753, expiration date 31-MAR-2021) and sterile diluent (STERILE DILUENT) for prophylaxis.  The patient was unable to receive the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 17-MAR-2020 because the sterile diluent (STERILE DILUENT) used for administration of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose had expired and there was no sterile diluent (STERILE DILUENT) available for use at that time (circumstance or information capable of leading to medication error and product availability issue). The patient experienced no symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: persistent vesicular rash, which was diagnosed as herpes zoster or shingle; 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 2013, 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 2014, the patient was treated in a clinic, for a persistent 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 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.   On or about 29-MAR-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 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 2010, the patient was treated by a physician, for 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 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 2009, 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 or about 23-MAY-2016, the patient was treated by a physician assistant, for a severe 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: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles; 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 27-AUG-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.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 02-FEB-2015, the patient was treated by a physician, for a persistent vesicular outbreak accompanied by weakened immune symptoms, 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 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 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 in 2013, the patient was treated for 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 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 2013, 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 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 25-JAN-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 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 on 20-MAY-2012, the patient was treated in a hospital, for 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: a vesicular outbreak, which was diagnosed as herpes zoster; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 01-APR-2013, 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 30-NOV-2015, the patient was treated by a nurse practitioner, for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed famciclovir(FAMVIR) 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: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 25-MAY-2016, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe, painful burning rash on the right side of her back and was diagnosed with shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Therefore, the outcome for herpes zoster was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the singles to be a disabling event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or about 31-JUL-2007, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) 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 or shingles. On or about 09-MAY-2014, she was treated by a physician at the same medical center, for a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX), triamcinolone and mupirocin for management of her painful symptoms and chronic pain. As a direct and proximate result of 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, she had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Persistent strain condition of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) 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 or shingles. In 2015, the patient was treated in a clinic for a blistering 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, patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of this report, the patient had not recovered from herpes zoster. The reporter assessed that herpes zoster was related to zoster vaccine live (ZOSTAVAX). Herpes zoster and vaccination failure were considered to be disabling by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Blistering vesicular outbreak, which was diagnosed as shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-NOV-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) 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 or shingles. On or about 10-FEB-2012, pt was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles, therefore, the patient was prescribed with acetaminophen for management of his painful symptoms and chronic. On or about 24-APR-2014, the patient sought subsequent treatment from the physician for a blistering vesicular outbreak, which was diagnosed as 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, patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of this report, the patient had not recovered from herpes zoster. The reporter assessed that herpes zoster was related to zoster vaccine live (ZOSTAVAX). Herpes zoster and vaccination failure were considered to be disabling by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: Pt subsequent contracted a persistent strain condtition of herpes zoster or shingles/for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance for the prevention of shingles in a clinic. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, pt was treated in a clinic for a blistering 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, patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of this report, the patient had not recovered from herpes zoster. The reporter assessed that herpes zoster was related to zoster vaccine live (ZOSTAVAX). Herpes zoster and vaccination failure were considered to be disabling by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In 2013, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) 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 or shingles. In 2016, he was treated at a clinic, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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, he had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).