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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-NOV-2012 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-DEC-2014 the patient was treated by a Physician Assistant for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed famciclovir (FAMVIR) 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: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 06-JAN-2012, 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. On or about 30-APR-2015, the patient was treated at a health clinic 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 hydrochloride (VALTREX) and acetaminophen (TYLENOL) for management of his painful and persistent 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, Occipital neuralgia, Pain
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 09-NOV-2015, 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 contact a persistent strain of shingles. On or about 16-OCT-2016, the patient was treated at a medical center for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 21-OCT-2016, the patient received subsequent treatment at a medical center for ongoing and worsening symptoms which was diagnosed as severe herpes zoster accompanied by occipital neuralgia. Occipital neuralgia is a condition characterized by chronic pain in the neck, head and behind the eyes at the occipital nerve and artery and is a secondary condition to herpes zoster infections. The patient has been prescribed tramadol, VOLTAREN EMULGEL topical gel and VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 2016 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016 the patient was treated by a physician for blistering vesicular outbreaks that were diagnosed as severe herpes zoster or shingles. 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 has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-MAY-2012 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-NOV-2016 the patient was treated by a physician for severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was treated with valacyclovir hydrochloride (VALTREX) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. 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: Death, Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and an estate administrator regarding a male patient of unknown age. The patient's prior concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-MAR-2014, 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. On or about 09-JUL-2015, the patient was treated at a medical center 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 VALTREX for management of his painful and persistent symptoms. On 24-FEB-2016, the patient succumbed to death with post-herpetic neuralgia listed a significant factor causing his death. Post-herpetic neuralgia is a chronic condition of intense pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and suffered significant medical expenses, and pain and suffering, and other damages, including his eventual death due to complications of his injuries. Additional information has been requested. Reported Cause(s) of Death: post-herpetic neuralgia.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and an estate administrator regarding a male patient of unknown age. The patient's prior concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-MAR-2014, 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. On or about 09-JUL-2015, the patient was treated at a medical center 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 VALTREX for management of his painful and persistent symptoms. On 24-FEB-2016, the patient succumbed to death with post-herpetic neuralgia listed a significant factor causing his death. Post-herpetic neuralgia is a chronic condition of intense pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and suffered significant medical expenses, and pain and suffering, and other damages, including his eventual death due to complications of his injuries. Additional information has been requested. Reported Cause(s) of Death: post-herpetic neuralgia.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 27-APR-2012, 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. On or about 13-OCT-2013, the patient was treated 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 gabapentin for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment with monetary damages. 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, Eyelid pain, Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, 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 03-SEP-2016, 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 or shingles. On or about 07-SEP-2016, the patient sought subsequent treatment from a physician, a specialist in ophthalmology and medical retina diseases specialist for painful lesions on her eyelids, which were diagnosed as acute shingles facial ophthalmic, a painful condition of zoster infections interfering with the eyes and face. On or about 16-SEP-2016, the patient was treated again by the physician for ongoing symptoms associated with her facial and eye shingles infections. The patient was prescribed VALTREX (in continued and increasing doses) and unspecified artificial tears 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. Upon internal review, acute shingles facial ophthalmic was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, 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 03-SEP-2016, 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 or shingles. On or about 07-SEP-2016, the patient sought subsequent treatment from a physician, a specialist in ophthalmology and medical retina diseases specialist for painful lesions on her eyelids, which were diagnosed as acute shingles facial ophthalmic, a painful condition of zoster infections interfering with the eyes and face. On or about 16-SEP-2016, the patient was treated again by the physician for ongoing symptoms associated with her facial and eye shingles infections. The patient was prescribed VALTREX (in continued and increasing doses) and unspecified artificial tears 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. Upon internal review, acute shingles facial ophthalmic was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 06-AUG-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 28-JAN-2015, the patient was treated by a physician at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed tramadol and acyclovir for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-SEP-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, prescribed by a physician, as recommended for routine adult health maintenance 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, also known as shingles. On or about 10-DEC-2013, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed valacyclovir, gabapentin and tramadol for management of his painful and persistent 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-APR-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-MAY-2016 the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful and persistent 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: Blister, 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-2015, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance 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, also known as shingles. On or about 01-JUL-2016, the patient was treated bat a clinic for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of her painful and persistent 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy 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. On or about 08-FEB-2017, 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. She was prescribed VALTREX and prednisone for management for 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about "11-FEB-2016", the patient was inoculated with ZOSTAVAX at a pharmacy for routine 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. The patient began to experience painful symptoms. On or about "09-FEB-2016" (note this is before date of vaccination), the patient was treated by a Physician's Assistant at the office for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed BENADRYL and VALTREX 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. 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. The male of unknown age was inoculated with ZOSTAVAX vaccine on or about January 16, 2015 at a Clinic 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. On or about June 27, 2016, the patient was treated by a nurse at a Clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as shingles. The patient was prescribed Acyclovir for management of his painful and persistent 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-FEB-2007, the patient was inoculated with ZOSTAVAX at a physician's office 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 severe herpes zoster. On or about 02-APR-2010, the patient was treated by a dermatologist for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed valacyclovir (VALTREX) and acetaminophen (+) oxycodone (PERCOCET) for 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: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-DEC-2017 the patient was vaccinated with one improperly stored dose of PROQUAD (dose, frequency and route of administration were not reported) lot # N015621 and expiration date: 15-NOV-2020). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degrees Celsius (C) to -10 C for 1 hour and 15 minutes and between -9 C to 8 C for 4 hours and 25 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002263:
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pain, Pruritus, Pyrexia
Clinical narrative: 2:30 pm - vaccine, 10:00 pm - fever/chills, 01/05/2018 - fever broke, 01/05/2018 - achy exhausted for the rest of the day, 01/06/2018 - still achy 1:00 pm started itching and continued until 01/08/2018, 01/09/2018 - itching stopped.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Vaccine was administered SQ instead of IM patient sis report pain and redness at the injection site the following day.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Severe arm pain radiating into the axilla without visible ecchymosis or swelling. Symptoms lasted 4-5 days. No treatment and was watched.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersomnia, Induration, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a 57 year old non pregnant female patient reporting on herself with depression, chronic pain, fibromyalgia and drug reactions or allergies to fentalyl and LYRICA. The patient's concomitant therapies included levothyroxine sodium (manufacturer unknown), nabumetone, meclizine, oxybutynin chloride, fluvoxamine maleate, atorvastatin, clonazepam, clomipramine hydrochloride, trazodone hydrochloride (manufacturer unknown), chlorzoxazone, metformin, gabapentin, morphine and multivitamin. On 08-DEC-2017, the patient was vaccinated with a shot of PNEUMOVAX 23 on an unspecified arm for the prevention of pneumonia (dose, route of administration, lot number and expiration date were not reported). On 08-DEC-2017, the patient began to experience identical welts in the area on both arms and those had developed into large, swollen and hard bumps on each arm that felt hot and extended under the arms. The reporter stated that it looked like ringworm or like a burn and both hands and both arms are hot and swollen and appear to be getting worse. It was also reported that the patient experienced so bad pain that she could not get off the couch for 2 days and slept for 2 days straight. Furthermore, the patient seek medical attention and had been treating the affected areas with ice. At the time of the report, the outcome of urticaria, hypersomnia, dysstasia, pain, feeling hot, mass, thermal burn, tinea infection and peripheral swelling was reported as not resolved. Additionally, the reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash, Swelling, Thermal burn, Tinea infection
Clinical narrative: This spontaneous report was received from a 57 year old non pregnant female patient reporting on herself with depression, chronic pain, fibromyalgia and drug reactions or allergies to fentalyl and LYRICA. The patient's concomitant therapies included levothyroxine sodium (manufacturer unknown), nabumetone, meclizine, oxybutynin chloride, fluvoxamine maleate, atorvastatin, clonazepam, clomipramine hydrochloride, trazodone hydrochloride (manufacturer unknown), chlorzoxazone, metformin, gabapentin, morphine and multivitamin. On 08-DEC-2017, the patient was vaccinated with a shot of PNEUMOVAX 23 on an unspecified arm for the prevention of pneumonia (dose, route of administration, lot number and expiration date were not reported). On 08-DEC-2017, the patient began to experience identical welts in the area on both arms and those had developed into large, swollen and hard bumps on each arm that felt hot and extended under the arms. The reporter stated that it looked like ringworm or like a burn and both hands and both arms are hot and swollen and appear to be getting worse. It was also reported that the patient experienced so bad pain that she could not get off the couch for 2 days and slept for 2 days straight. Furthermore, the patient seek medical attention and had been treating the affected areas with ice. At the time of the report, the outcome of urticaria, hypersomnia, dysstasia, pain, feeling hot, mass, thermal burn, tinea infection and peripheral swelling was reported as not resolved. Additionally, the reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a 57 year old non pregnant female patient reporting on herself with depression, chronic pain, fibromyalgia and drug reactions or allergies to fentalyl and LYRICA. The patient's concomitant therapies included levothyroxine sodium (manufacturer unknown), nabumetone, meclizine, oxybutynin chloride, fluvoxamine maleate, atorvastatin, clonazepam, clomipramine hydrochloride, trazodone hydrochloride (manufacturer unknown), chlorzoxazone, metformin, gabapentin, morphine and multivitamin. On 08-DEC-2017, the patient was vaccinated with a shot of PNEUMOVAX 23 on an unspecified arm for the prevention of pneumonia (dose, route of administration, lot number and expiration date were not reported). On 08-DEC-2017, the patient began to experience identical welts in the area on both arms and those had developed into large, swollen and hard bumps on each arm that felt hot and extended under the arms. The reporter stated that it looked like ringworm or like a burn and both hands and both arms are hot and swollen and appear to be getting worse. It was also reported that the patient experienced so bad pain that she could not get off the couch for 2 days and slept for 2 days straight. Furthermore, the patient seek medical attention and had been treating the affected areas with ice. At the time of the report, the outcome of urticaria, hypersomnia, dysstasia, pain, feeling hot, mass, thermal burn, tinea infection and peripheral swelling was reported as not resolved. Additionally, the reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding concurrent conditions, medical history or concomitant medication was not provided. On 22-DEC-2017, the patient was vaccinated with ZOSTAVAX intramuscularly instead of subcutaneously, as prevention of shingles(dosage information, lot number and expiration date were not informed). The patient stated any adverse events as a result of the injection. It was also reported that no treatment was given for adverse event, The patient did not seek medical attention.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 04-JAN-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-JAN-2013, at the pharmacy, the patient was inoculated (by an unspecified person) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date 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 20-MAR-2016, the male was treated (by an unspecified healthcare professional) at an Urgent care clinic, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with ophthalmic complications. The male patient suffered interference when his zoster infections spread into his eyes. 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, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the event of Onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as Severe herpes zoster with ophthalmic complications. Zoster infections spread into his eyes was determined to be medically significant. 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 29-OCT-2014, the patient was inoculated with ZOSTAVAX at a family practice office, as recommended for routine adult health maintenance and for the prevention of shingles (Dose, route of administration, lot # and expiration date 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 04-NOV-2016, the patient was treated (by an unspecified health care professional) at a family practice office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, a chronic condition of nerve pain and permanent damage secondary to shingles. 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. Causality assessment was related. The event of Persistent strain of Herpes Zoster/treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, a chronic condition of nerve pain and permanent damage secondary to shingles was considered to be disabling. 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 17-DEC-2008, the patient was inoculated with ZOSTAVAX at a physician's office, 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 shingles. On or about 21-MAY-2014, she was treated by a dermatologist for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles on her forehead and face. The patient was prescribed valacyclovir (VALTREX) and fluocinide 0.5% ointment for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Hurt more than normal with the injection. Noted hard spot when took BANDAID off when got home same day. Turned red in past 2 days and hard spot same size. May have been flatter before.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red area near immunization site. No fever, discomfort or streaking.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Mother called advice nurse morning after vaccines with report of whelps around injection site that extends form above her buttocks around the waist to below the knee on the L side only.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red bump on right anterior thigh that started approximately 2 days ago after vaccines.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Dizziness, Erythema, Hyperhidrosis
Clinical narrative: 1/2 hour later (R) arm become painful, 1 1/2 hour later at bedtime (R) was red and swollen, hot to tough, very large red rash next AM. Sweat badly for four days; Temp 102 rash travel down my arm=felt faint weak's. Vaccine information statement=states 2 day 12-19-2017 I went back to my doctor's office on 12-22-2017 because rash and swelling pain was no better. The office person once again it would take 8 day to clear up. It was the worse Christmas I ever had. I will not do the second half of PPSV-23 shot.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: 1/2 hour later (R) arm become painful, 1 1/2 hour later at bedtime (R) was red and swollen, hot to tough, very large red rash next AM. Sweat badly for four days; Temp 102 rash travel down my arm=felt faint weak's. Vaccine information statement=states 2 day 12-19-2017 I went back to my doctor's office on 12-22-2017 because rash and swelling pain was no better. The office person once again it would take 8 day to clear up. It was the worse Christmas I ever had. I will not do the second half of PPSV-23 shot.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reports that she broke out in hives on the left side of her face and left arm. She states that they are very itchy. Pt advised to take antihistamine and monitor symptoms.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Loss of personal independence in daily activities, Malaise, Syncope, Vision blurred
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Headache, Loss of personal independence in daily activities, Syncope, Vision blurred
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Laboratory test normal, Muscular weakness, Syncope
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Visual impairment, White blood cell count increased
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Chest X-ray, Condition aggravated
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Confusional state, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Hypertension, Joint injury, Loss of consciousness
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Malaise, Palpitations, Syncope
Clinical narrative: My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle twitching, Pallor, Syncope
Clinical narrative: The patient experienced syncope and some twitching. The episode lasted about 10 seconds or less. The patient looked pale initially.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Persistent headache for approximately 1 week. It was not responsive to any pharmacologic or non-pharmacologic interventions to reduce the pain.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Pt received HPV #2 and Flu vaccine in office. Pt was waiting 15 min after HPV vaccine. Mom reported Pt broke out in rash. Gave 20mL of BENADRYL in office. Before administering BENADRYL Pt complained of itching and headache.
Age: 10.0
Sex: M
Vaccine: FLU4, HEPA, IPV, MMRV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed pain at site in right upper arm, associated with redness. Redness lasted approximately 2 days, pain persisted approximately 14 d.