chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 08-AUG-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Only a few days after being vaccinated, on or about 29-AUG-2014, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-NOV-2014, the patient was inoculated with ZOSTAVAX at a health care center/hospital as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-JAN-2017 the patient was treated at a health care center/hospital for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed lidocaine and valacyclovir for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 21-OCT-2011 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-SEP-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed unspecified pain medication for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-DEC-2012, the patient was inoculated with ZOSTAVAX at a health clinic as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2015, the patient was treated at a medical clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 14-APR-2015, he sought further treatment at a medical clinic for ongoing and worsening symptoms of zoster infections. On or about 27-AUG-2017, the patient was again treated at the medical clinic for ongoing symptoms and persistent pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster outbreaks. The patient was prescribed LIPODERM, gabapentin, acyclovir and LYRICA for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-OCT-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-NOV-2013 the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device, Needle issue
Clinical narrative: After administering a flu vaccination, the needle did not extract into the safety device and my left thumb was pricked as I inserted the syringe into the Sharps container.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Hypersensitivity, Migraine, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had trouble breathing and migraine the morning after vaccination, swelling and pain in vaccinated arm. Patient visited hospital. Initially believed to be cellulitis, but after further investigation was told most likely due to allergic reaction to immunization. Patient given breathing treatment, KEFLEX, prednisone, and medication for migraine pain. All above information per patient.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: A welt formed on his arm.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site bruising
Clinical narrative: Patient reported a yellow and greenish bruise on left arm from injection site to the elbow. He has also been reporting increasing weakness especially in his joints since administration, his doctor could not find any other cause.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus, Psoriasis
Clinical narrative: Within 1 week, Psoriatic lesions appeared on the right side of my head and eventually moved around to the left side of my head. Further, I developed Urticaria on my torso which have not resolved. I was seen by a Physician Assistant last week who said that there was not much we could do since I can't take Prednisone. I received an Rx for triamsinolone acetonide to deal with the itching from my PCP at my first clinic visit on Sept 20. All seem to fault the Adjuvant in the Vaccine. I have not ever had an adverse reaction to any other Flu Vaccine.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient came into pharmacy complaining of nerve pain under injection site since vaccine was given. Second dose of series was given with no complications.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Found out November 18 she is pregnant.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Found out November 18 she is pregnant.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood pressure decreased, Breath holding, Crying, Pallor, Unresponsive to stimuli
Clinical narrative: Patient had a brief crying spell right after first immunization (PEDIARIX) administered. Patient then proceeded to have breath holding spell during second and third shots (S. Pneumo, then Hib). Patient was picked up by MOC and proceeded to intermittently shut eyes and nod off within seconds of shots being administered. Patient lost color in skin. After trying to stimulate patient for a few seconds, Dr. was called in, patient laid back down on table, and blood pressure obtained. BP was low at 58/42.  Patient administered 0.15 ml of Epinephrine and vitals became more stable. Patient's color still very pale. Patient alert and behaving within normal limits at time of transfer to hospital.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Rash
Clinical narrative: Rash under bilateral axila, and cellulitis under right axila. Parent took patient to ER to be evaluated.  Resolved cellulitis on antibiotic.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Patient at first experienced severe arm soreness, fever, chills, rash, breathing issues and headaches. A couple weeks after the vaccine the patient started experiencing chest pains, chest tightness, and more frequent shortness of breath.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient at first experienced severe arm soreness, fever, chills, rash, breathing issues and headaches. A couple weeks after the vaccine the patient started experiencing chest pains, chest tightness, and more frequent shortness of breath.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Respiratory disorder
Clinical narrative: Patient at first experienced severe arm soreness, fever, chills, rash, breathing issues and headaches. A couple weeks after the vaccine the patient started experiencing chest pains, chest tightness, and more frequent shortness of breath.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient feel pain at the injection site.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Swelling
Clinical narrative: Erythema and induration around the site of injection. Patient reported the swelling began about an hour after the injection.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Red, swollen arm from mid-deltoid region down to elbow, warm to touch. Sore. Symptoms started 11/20/17 evening after vaccine administration.
Age: 49.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Erythema, Injection site cellulitis, Injection site rash, Skin warm
Clinical narrative: Patient received Tdap (Left Deltoid), FLUCELVAX, PNEUMOVAX (right deltoid each injection 1-2 inches apart) on 11/13/2017. On 11/15/2017 patient returned to the office with a rash on the her right deltoid. As per MD notes arm was red hot. As per MD rash was off to the side not on the injection site. Patient diagnosed with cellulitis of the right upper extremity. Given course of antibiotics KEFLEX 500 mg by mouth 3 times a day for 10 days.
Age: 75.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Blood test, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, body ache, tiredness, flu-like symptoms.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Abnormal faeces, Aphasia, Autism spectrum disorder, Choking
Clinical narrative: Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Conjunctivitis, Cough, Decreased eye contact, Dysphagia
Clinical narrative: Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Ear infection, Endoscopy upper gastrointestinal tract abnormal, Insomnia, Intentional self-injury, Malaise
Clinical narrative: Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Muscle twitching, Oropharyngeal pain, Otitis media, Poor feeding infant, Pyrexia
Clinical narrative: Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Regressive behaviour, Respiratory tract infection, Retching, Sensory disturbance
Clinical narrative: Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-DEC-2014 the patient was vaccinated with M-M-R II (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 17-DEC-2014, the patient was vaccinated with a dose of VARIVAX and sterile diluent (STERILE DILUENT) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. It was reported sterile diluent(manufacturer unknown ) was used to reconstitute the VARIVAX. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 20-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 13-OCT-2006, administered (by an unspecified person) at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-MAY-2014, the patient was treated by a physician at the same medical center (where she received the vaccination) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about the dates of 06-JUN-2014, 09-JUN-2014, 16-JUN-2014, and 27-JUN-2014 the patient sought subsequent medical treatment at the same medical center for ongoing and worsening symptoms and pain attributable to uncontrolled zoster outbreaks.  The female was further diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. On or about 01-JUL-2014, the patient was treated by the physician/MD for uncontrolled symptoms of zoster. On or about 16-SEP-2014, the patient was treated by the same physician/MD again who observed that the patient's ongoing post-herpetic neuralgia had been persistent for more than three (as reported) duration. On or about the dates of 24-SEP-2014, 25-SEP-2014, 02-OCT-2014 and 13-OCT-2014, the patient underwent continued treatment of extreme pain and secondary complications of post herpetic neuralgia and shingles. The patient was referred to specialist neurologists and pain management physicians to attempt to curb these symptoms. On or about 12-JUL-2017, the female patient was treated by a physician/MD at a pain management center for special therapies to help manage her prolonged and agonizing condition. The patient has been prescribed valacyclovir (VALTREX), prednisone, topical steroid cream, gabapentin, acetaminophen, hydrocodone bitartrate (NORCO), oxycodone, acetaminophen, oxycodone hydrochloride (PERCOCET), onabotulinumtoxinA (BOTOX) therapy and neuromodulation treatment in attempts to manage her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-DEC-2009, the patient was inoculated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-FEB-2013, the patient was treated by a Physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with complications. The patient was prescribed valacyclovir (VALTREX) and tramadol for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information was received from a lawyer concerning a case in litigation involving a female patient. The female was inoculated with ZOSTAVAX vaccine on or about October I, 2015 at a health center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather, caused the patient to contract a persistent strain of herpes zoster and other complications. On or about November 15, 2015, the patient was treated at a Hospital, for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster. On or about November 18, 2015, the was treated by a physician for ongoing and worsening outbreaks of shingle on and near the eye. On or about February 19, 2016, the patient sought additional treatment from another physician for worsening symptoms and pain related to shingles. at which time she was diagnosed with post-herpetic neuralgia; a chronic condition of nerve damage and pain secondary to shingles infections. The patient has also been diagnosed with herpes zoster ophthalmicus, after the shingles spread to her eyes. The patient has been prescribed VALTREX, MOTRIN, acetaminophen and PERCOCET, Valacyclovir, NEURONTIN, and POLYSPORIN ointment for management of her painful and persistent condition. As a direct and proximate result of these malfunctions, the patient has 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. Outbreak of shingles on or near the eye was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer concerning a case in litigation involving a female patient. The female was inoculated with ZOSTAVAX vaccine on or about October I, 2015 at a health center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather, caused the patient to contract a persistent strain of herpes zoster and other complications. On or about November 15, 2015, the patient was treated at a Hospital, for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster. On or about November 18, 2015, the was treated by a physician for ongoing and worsening outbreaks of shingle on and near the eye. On or about February 19, 2016, the patient sought additional treatment from another physician for worsening symptoms and pain related to shingles. at which time she was diagnosed with post-herpetic neuralgia; a chronic condition of nerve damage and pain secondary to shingles infections. The patient has also been diagnosed with herpes zoster ophthalmicus, after the shingles spread to her eyes. The patient has been prescribed VALTREX, MOTRIN, acetaminophen and PERCOCET, Valacyclovir, NEURONTIN, and POLYSPORIN ointment for management of her painful and persistent condition. As a direct and proximate result of these malfunctions, the patient has 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. Outbreak of shingles on or near the eye was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-MAR-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-SEP-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-OCT-2014, the patient was inoculated at a health center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Between the dates of 26-DEC-2014 and 31-JAN-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed prescription topical ointments for management of her painful outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-AUG-2011, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-JUN-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed  hydrocodone bitartrate and acetaminophen (NORCO) and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 05-JUN-2008, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-MAY-2016, the patient was treated at an urgent care center for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: 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 concomitant medications, concurrent conditions or medical history. On or about 06-OCT-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-FEB-2015 the patient was treated by a physician at his medical practice for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came in with his sister for his flu shot this fall. At that time his Mom mentioned that he had a mark from his HPV vaccine. After further examination he did have a raised red area 8 cm round. Patient denied any pain.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Gestational hypertension, Induced labour, Neonatal disorder, Pre-eclampsia
Clinical narrative: I had an uncomplicated, healthy pregnancy prior to being vaccinated at 36 weeks along. My due date was 4/1/2015 but I was induced on 3/18/2015 due to gestational hypertension and pre-eclampia. My son was born on 3/19/2015 weighing only 5lbs 8oz. I was given terbutaline prior to delivery and my son had hypoglycemia. Initial glucose was 55 but repeat glucose around 4 hours of life was 26. He was symptomatic with jitteriness, thus he was given formula and transferred to the Intermediate Special Care Nursery for further management. In the ISCN he did require a tube feeding. He also had jaundice past the mid chest. I was never able to breastfeed again after him being in the ISCN. He has been sick since the day he was born (allergies, ear infections, cough, respiratory issues) and also delayed
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea
Clinical narrative: Patient called to report Asthma flare up and difficulty breathing after receiving vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Swelling, Ultrasound Doppler
Clinical narrative: Pt received vaccine and developed redness and swelling that night. She went to the ER on 11/7/17 after the swelling and redness were becoming concerning to the pt, she also had developed dizziness.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, OPV
Symptoms: Anxiety, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Central auditory processing disorder, Hypermobility syndrome
Clinical narrative: Patient came from another country. He was shrieking and had no speech/babbling. He was hyperactive and could not be held. He had to be moving all the time. He had speech delay identified at 2 years old. He had auditory processing found at age 7. He had sensory processing disorder found at age 3. He has hypermobility. He had many allergies and had a tonsillectomy at 3 years. He had OCD. He was finally diagnosed with autism with psychiatry at age 17. He has anxiety and ADHD. His IQ tests in the lower 30%. His expressive speech is still delayed.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, OPV
Symptoms: Hypersensitivity, Mental impairment, Obsessive-compulsive disorder, Psychomotor hyperactivity, Sensory integrative dysfunction
Clinical narrative: Patient came from another country. He was shrieking and had no speech/babbling. He was hyperactive and could not be held. He had to be moving all the time. He had speech delay identified at 2 years old. He had auditory processing found at age 7. He had sensory processing disorder found at age 3. He has hypermobility. He had many allergies and had a tonsillectomy at 3 years. He had OCD. He was finally diagnosed with autism with psychiatry at age 17. He has anxiety and ADHD. His IQ tests in the lower 30%. His expressive speech is still delayed.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, OPV
Symptoms: Sensory processing disorder, Speech disorder, Speech disorder developmental, Tonsillectomy
Clinical narrative: Patient came from another country. He was shrieking and had no speech/babbling. He was hyperactive and could not be held. He had to be moving all the time. He had speech delay identified at 2 years old. He had auditory processing found at age 7. He had sensory processing disorder found at age 3. He has hypermobility. He had many allergies and had a tonsillectomy at 3 years. He had OCD. He was finally diagnosed with autism with psychiatry at age 17. He has anxiety and ADHD. His IQ tests in the lower 30%. His expressive speech is still delayed.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Irritability, Rash, Urticaria
Clinical narrative: 10-month-old who presents 1 day after her first influenza vaccination with a rash. Patient was fussy yesterday and had difficulty sleeping last night. This morning at 10 AM the day care staff noticed welts on her wrists and knees. Mom went to evaluate her at lunch time and noted that her wrists and knees were hard and hot. Patient was increasingly fussy today. There are no known ill contacts. There is strep in some of the other classrooms at the child's daycare. Mom brought her directly from the daycare to the ED.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Pyrexia
Clinical narrative: Extremely painful when nurse was giving the shot. The nurse stated that it was difficult to push in the serum. The arm site was sore and had  pain in the right shoulder joint. Also had fever the day after her shot. She complained of loss of range of motion in the right arm and pain the was waking her up at night.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Headache, Nasal congestion
Clinical narrative: Began experiencing chills, fatigue, generalized body aches and weakness, nasal and sinus congestion, and headaches.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Sinus congestion
Clinical narrative: Began experiencing chills, fatigue, generalized body aches and weakness, nasal and sinus congestion, and headaches.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Syncope
Clinical narrative: Patient had syncopal like episode with movement of all 4 limbs, lasted less than 10 seconds, afterwards completely normal exam and vitals.
Age: 5.0
Sex: M
Vaccine: FLUX, MMRV, TDAP
Symptoms: Generalised tonic-clonic seizure, Moaning, Muscle twitching, Poor quality sleep
Clinical narrative: At 5:15 AM child had a Grand mail seizure lasting 6 minutes. Temperature taken when convulsions stopped was recorded at 98.9 F. No history of seizures. Continued to twitch, moan, and have restless sleep for 4 hours (til 9:30am) afterwards. Took 12 hours to return to normal demeanor, energy and activity level.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient stated that her arm is inflamed, hot, swelling and sore. Reported on 11/20/2017. Stated it is getting worse.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Blood creatine phosphokinase, C-reactive protein, Injection site erythema, Injection site irritation, Red blood cell sedimentation rate
Clinical narrative: Redness/irritation at injection site.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased
Clinical narrative: I could not even lift my arm starting about 4 days after injection and continuing for 3-4 days.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Blister, Insomnia, Irritability, Pyrexia, Rash generalised
Clinical narrative: 11/4/17 1:00 AM until ~11:00AM 11/5/17 Fever between 100.2-102.6. ~1:00PM on 11/5/17, measles like rash appeared and remained until 11/13/17. Rash covered head, neck torso, buttocks, all extremities, and dorsum surfaces of feet and hands. Tylenol was given on 11/4/17 at 12:00 PM, 5:00PM, and 8:00PM. Fever between 99.0-99.8 came and went from 12:00PM 11/5/17 until 9:00PM 11/6/17. Patient was examined by Dr. on 11/7/17 and as per Dr., patient had vesicles in his throat. As per Dr., patient's symptoms were possibly caused by a reaction to the MMR vaccine that patient received on 10/26/17. Pt refused to eat acidic foods such as oranges and tomatoes from 11/5/17 until 11/10/17. Patient also presented with symptoms of irritability, avoidance of firm foods (bread, meat, apples), and difficulty sleeping.