chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-DEC-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a county health department, 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 11-MAR-2016, the patient was treated at an urgent care center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, 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. During 2016 (specific date not reported), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) 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 an unspecified date during 2016, the patient was treated at by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, 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. During 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. During 2016, the patient was treated at physician office for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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: Biopsy skin abnormal, Fat necrosis, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from the pharmacist referring to an unknown female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Pharmacist reports that a physician inquired about an unspecified patient who received an unspecified dose of ZOSTAVAX (lot and expiry date not reported) sometime during October 2017. Co-suspect medication included sterile diluent (manufacturer unknown). Pharmacist reported that the physician reported that the patient told him a few days after receiving the vaccine, the patient began to see some bumps in the area, then they became lesions clustered on her back and then her groin too. When the patient stated this had been going on for four months, the physician performed a biopsy of the lesions which came back with a diagnosis of fat necrosis. Outcome of fat necrosis was not recovered and its causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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 15-SEP-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. During 2016, the patient was treated at a hospital for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, 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. During 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 at a Family Medicine facility for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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: PPV
Symptoms: Erythema, Feeling hot, Skin swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a 65 year old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 01-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N025384 with expiration date 19-APR-2019, for prophylaxis (dose and route of administration were not reported). On 02-MAR-2018, the patient experienced redness, warmth and bumpy skin. It was stated that the redness, warmth and bumpy skin spread across the patient's deltoid area. No laboratory diagnostic test was performed. At the time of reporting, the outcome of the events was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, 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. During 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office, 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. During 2016, the patient was treated at a physician's office for the onset of a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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 expense, and pain and suffering, and other damages. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 89 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. In September 2017, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. Subsequently, the physician reported that the same patient received a 2nd dose of PNEUMOVAX 23 on 22-JAN-2018, and that the female patient had no adverse effects after either of the doses.
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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-JUL-2014, the patient was inoculated with ZOSTAVAX at the pharmacy, (by an unspecified health care professional), 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 11-JAN-2016, the patient was treated by a nurse practitioner at a medical group, for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir, lidocaine, and MEDROL 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. The outcome of the events was unknown.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, 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. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-MAR-2016, the patient was treated at a medical office for a blistering vesicular outbreak and decreased immune symptoms which was then 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: Blister, Decreased immune responsiveness, 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 09-DEC-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 04-MAR-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JUN-2016, 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 07-APR-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 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 expense, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information 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. During 2015, the patient was inoculated at Care 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. During 2016, the patient was treated at a clinic for a blistering vesicular outbreak which was diagnosed as 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.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old female patient. The patient's current condition included arthritis. The patient's drug reaction/allergies and concomitant medications were reported as none. On 08-MAR-2018, the patient was administered a dose of PNEUMOVAX 23 (lot: N030847, expiry date: 19-JUN-2019) as a vaccination. On 08-MAR-2018, the patient experienced injection site reaction but she could not give any further description of the event. No further information provided. No PQC. Outcome and causality assessment for the event was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 09-MAR-2018, the patient was inadvertently vaccinated with a pediatric dose of VAQTA for prophylaxis). Dosing details, lot # and expiry date were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling, red, hot to touch, and pain at site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site induration, Injection site swelling, Urticaria
Clinical narrative: Induration and swelling on the left thigh, appeared approximately 2 hours after vaccines administered. Diffuse urticaria appeared approximately 48 hours after vaccines given.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Dizziness, Mobility decreased, Nausea, Pain
Clinical narrative: Patient noted soreness, swelling and difficulty lifting arm on 3/8/18 which persisted. Developed nausea, vomiting, dizziness and diarrhea over the next few days. Symptoms resolved 3/12/18.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Vomiting
Clinical narrative: Patient noted soreness, swelling and difficulty lifting arm on 3/8/18 which persisted. Developed nausea, vomiting, dizziness and diarrhea over the next few days. Symptoms resolved 3/12/18.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Amenorrhoea, Anti-Muellerian hormone level, Antibody test, Antinuclear antibody
Clinical narrative: My daughter was diagnosed with Primary ovarian insufficiency in 2017 after visiting the doctor for amenorrhea and undergoing numerous test and diagnostic imaging to come to the diagnosis. Patient completed the HPV series (9/9/13, 8/9/14, 8/19/15) in2015, she developed undetermined intermittent abdominal pain months after the first dose of GARDASIL but not until after being diagnosed wth POI did I correlate the abdominal pains with the GARDASIL series.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood follicle stimulating hormone, Blood oestrogen, Blood testosterone, Blood thyroid stimulating hormone, DNA test for fragile X
Clinical narrative: My daughter was diagnosed with Primary ovarian insufficiency in 2017 after visiting the doctor for amenorrhea and undergoing numerous test and diagnostic imaging to come to the diagnosis. Patient completed the HPV series (9/9/13, 8/9/14, 8/19/15) in2015, she developed undetermined intermittent abdominal pain months after the first dose of GARDASIL but not until after being diagnosed wth POI did I correlate the abdominal pains with the GARDASIL series.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hysteroscopy, Karyotype analysis, Laboratory test, Nuclear magnetic resonance imaging abdominal, Ovarian failure
Clinical narrative: My daughter was diagnosed with Primary ovarian insufficiency in 2017 after visiting the doctor for amenorrhea and undergoing numerous test and diagnostic imaging to come to the diagnosis. Patient completed the HPV series (9/9/13, 8/9/14, 8/19/15) in2015, she developed undetermined intermittent abdominal pain months after the first dose of GARDASIL but not until after being diagnosed wth POI did I correlate the abdominal pains with the GARDASIL series.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound pelvis
Clinical narrative: My daughter was diagnosed with Primary ovarian insufficiency in 2017 after visiting the doctor for amenorrhea and undergoing numerous test and diagnostic imaging to come to the diagnosis. Patient completed the HPV series (9/9/13, 8/9/14, 8/19/15) in2015, she developed undetermined intermittent abdominal pain months after the first dose of GARDASIL but not until after being diagnosed wth POI did I correlate the abdominal pains with the GARDASIL series.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-APR-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), 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 an unspecified date during 2016, the patient was treated at a hospital by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, 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. On an unknown date during 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) 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 an unspecified date during 2016, the patient was treated at a hospital by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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, 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. On an unknown date during 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) 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 an unspecified date during 2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) 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 29-FEB-2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms, which was then 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: Blister, Herpes zoster, 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 05-MAR-2016, the patient was inoculated with ZOSTAVAX at a pharmacy 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 01-APR-2016, she was treated by a physician for a blistering vesicular outbreak which was diagnosed as 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2013, the patient was inoculated with ZOSTAVAX at a hospital for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster.  During 2016, she was treated at the same hospital for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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. During 2015, the patient was inoculated with ZOSTAVAX at a hospital 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, she was treated by a physician for a blistering vesicular outbreak which was then diagnosed as 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Significant pain and swelling at the site of injection. Pain commands within three hours after the injection and finally completely subsided after about three days. Shivering/chills began in the evening about nine hours after the injection and continued intermittently throughout the night. Fever developed about 24 hours after the injection and continued intermittently through about 48 hours after the injection. The patient's normal temperature is typically around 97.8°F, the fever reached a high of 100°F the day after injection and a high of 99.5°F on the second day after injection.  Acetaminophen (2x500 mg) was taken in response to the fever on the first day And I had limited affect in lowering the temperature to about 99.3°F. The patient?s temperature return completely to normal ( 97.8°F) by 50 hours after the injection. The patient had to limit his activities during the 48 hours after injection
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient was in for their 4 month Well Child Check (WCC). Patient hadn't received the rotavirus vaccine at the 2 month WCC, but received the first dose at the 4 month WCC. The first dose was given beyond the labeled 14 weeks and 6 days. Parents were informed and are willing to complete the series. No adverse event to date.
Age: 1.08
Sex: M
Vaccine: FLU4, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Provider ordered a MMR and VARIVAX, however what was given was a PROQUAD and VARIVAX. Patient rec'd more than double the dose of varicella. We have tried to reach dad 4 times, he is not returning our calls. We wanted him to give the child ibuprofen and watch for febrile seizures.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Chills, moderate pain, redness at injection site, muscular pain in shoulders and both arms, general malaise, weakness. It felt like I had the flu but with no fever. All subsided, (except some soreness at injection site), by early afternoon of 03/13/18.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: Chills, moderate pain, redness at injection site, muscular pain in shoulders and both arms, general malaise, weakness. It felt like I had the flu but with no fever. All subsided, (except some soreness at injection site), by early afternoon of 03/13/18.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Erythema, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: ARM IS RED WARM TO TOUCH AND HAS BLISTERS SWOLLEN. BENADRYL MOTRIN ICE AND ELEVATE. PT IS THROWING UP.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 5-10 minutes after administration the child developed a localized non-raised red rash around the site of the MMR vaccine on his right arm. It remained localized to the upper arm and edge of the shoulder. He had no difficulty breathing and no swelling of the face or throat. The rash was not raised or swollen. Client advised to wait a while longer before leaving so he could be monitored. Five minutes later the rash had not spread and the child still had no other symptoms. The mother was advised to keep an eye on the rash and to take him in to the hospital if it started spreading, if the rash became swollen, if he developed any swelling of the face or throat, or if he started having any difficulty breathing.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness, redness, warm to touch just below injection site, affecting the bottom half of the R deltoid muscle. Started the day after the vaccine and has persisted x 5 days. Using ibuprofen for discomfort. The primary concern is that the same exact reaction occurred in sibling who received the same vaccine the same day. Question of possible contaminated batch of vaccines?
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe left upper extremity pain, swelling and redness.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness, redness, warm to touch just below injection site, affecting the bottom half of the R deltoid muscle. Started the day after the vaccine and has persisted x 5 days. Using ibuprofen for discomfort. The primary concern is that the same exact reaction occurred in sibling who received the same vaccine the same day. Question of possible contaminated batch of vaccines?
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase BB, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase MM normal, C-reactive protein increased, Chest X-ray normal
Clinical narrative: Patient is a 25-year-old male with no significant past medical history who returns to the clinic for further evaluation and management of chest pain temporally associated with recent smallpox vaccination (given on 9 Jan 2018). Please see my previous notes for complete details. Briefly, patient originally described receiving his smallpox vaccine on 9 Jan18 (Lot # VV03-019C) and did well until approximately 12 days later when he awoke in the early morning hours of 21 Jan with sharp chest pain and chest tightness. He initially went back to sleep, but the pain continued for the next day. He presented to his medic this morning who recommended calling the support center.  Patient described his pain as a 'sharp' midsternal chest pain, though more on the right mid sternal edge. The pain was worsened with deep breathing and associated with some chest tightness. He specifically notes that the pain was worse when leaning forward (not improved). He also stated the pain was somewhat reproducible with palpation, though this was a slightly different quality of pain.  He also endorsed a nonproductive cough during the previous 2 days. He denied any other systemic symptoms.  WAMC ED evaluation included a CXR and ECG that were reportedly within normal limits. Troponin wnl but CRP was elevated.   Interval History: He states he has done well other than 2 episodes of similar chest pain early in his course, but denies any symptoms in last few weeks. He is back to running 4-5 miles and denies any chest pain, dyspnea with this.  Repeat ECG by PCM wnl (early repol).  No new complaints or concerns.  SPV vaccine site with well-healed Jennarian scar.  ETS from the Army in <40 days.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Cough, Electrocardiogram normal, Painful respiration
Clinical narrative: Patient is a 25-year-old male with no significant past medical history who returns to the clinic for further evaluation and management of chest pain temporally associated with recent smallpox vaccination (given on 9 Jan 2018). Please see my previous notes for complete details. Briefly, patient originally described receiving his smallpox vaccine on 9 Jan18 (Lot # VV03-019C) and did well until approximately 12 days later when he awoke in the early morning hours of 21 Jan with sharp chest pain and chest tightness. He initially went back to sleep, but the pain continued for the next day. He presented to his medic this morning who recommended calling the support center.  Patient described his pain as a 'sharp' midsternal chest pain, though more on the right mid sternal edge. The pain was worsened with deep breathing and associated with some chest tightness. He specifically notes that the pain was worse when leaning forward (not improved). He also stated the pain was somewhat reproducible with palpation, though this was a slightly different quality of pain.  He also endorsed a nonproductive cough during the previous 2 days. He denied any other systemic symptoms.  WAMC ED evaluation included a CXR and ECG that were reportedly within normal limits. Troponin wnl but CRP was elevated.   Interval History: He states he has done well other than 2 episodes of similar chest pain early in his course, but denies any symptoms in last few weeks. He is back to running 4-5 miles and denies any chest pain, dyspnea with this.  Repeat ECG by PCM wnl (early repol).  No new complaints or concerns.  SPV vaccine site with well-healed Jennarian scar.  ETS from the Army in <40 days.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Tenderness, Troponin normal
Clinical narrative: Patient is a 25-year-old male with no significant past medical history who returns to the clinic for further evaluation and management of chest pain temporally associated with recent smallpox vaccination (given on 9 Jan 2018). Please see my previous notes for complete details. Briefly, patient originally described receiving his smallpox vaccine on 9 Jan18 (Lot # VV03-019C) and did well until approximately 12 days later when he awoke in the early morning hours of 21 Jan with sharp chest pain and chest tightness. He initially went back to sleep, but the pain continued for the next day. He presented to his medic this morning who recommended calling the support center.  Patient described his pain as a 'sharp' midsternal chest pain, though more on the right mid sternal edge. The pain was worsened with deep breathing and associated with some chest tightness. He specifically notes that the pain was worse when leaning forward (not improved). He also stated the pain was somewhat reproducible with palpation, though this was a slightly different quality of pain.  He also endorsed a nonproductive cough during the previous 2 days. He denied any other systemic symptoms.  WAMC ED evaluation included a CXR and ECG that were reportedly within normal limits. Troponin wnl but CRP was elevated.   Interval History: He states he has done well other than 2 episodes of similar chest pain early in his course, but denies any symptoms in last few weeks. He is back to running 4-5 miles and denies any chest pain, dyspnea with this.  Repeat ECG by PCM wnl (early repol).  No new complaints or concerns.  SPV vaccine site with well-healed Jennarian scar.  ETS from the Army in <40 days.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: Local reaction, treated with BENADRYL and ibuprofen, improved.
Sex: M
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's medical history was not reported. In approximately 2013 (reported as 4 or 5 years ago), the patient was vaccinated with a dose of GARDASIL, intramuscular for prophylaxis (it was unknown if it was first or second dose in series). On an unknown date, the patient experienced facial palsy. The outcome of facial palsy was reported as recovered/resolved on an unspecified date. Causality assessment was not reported. Upon internal review, the event of facial palsy was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, 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. During 2012, 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. During 2015, the patient was treated at physician office for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as 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: HPV9
Symptoms: Menstruation delayed
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient. Information regarding patient's medical history, drug reactions and allergies were reported as unknown. On an unknown date the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis whose dose, route, lot number and expiry date were reported as unknown. It was reported that "patient did not have her period the next month". It was unknown if any medical attention was sought. It was unknown if any treatment was given to the patient or any lab diagnostics or studies performed. The outcome of menstruation delayed was reported as unknown. The reporter did not provide the causal relationship with GARDASIL 9. There was no product quality complaint (PQC) involved.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JAN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), 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. On or about 04-APR-2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms, which was then diagnosed as 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. The outcome of the events is unknown. Additional information has been requested.