chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Psoriasis
Clinical narrative: Injection site swelled up in an area about 3 inches by 3 inches and became extremely itchy, red and warm the day after the injection. I then developed a flare-up of my psoriasis. I had a break out on my right knee about 48 hours after the injection. I also noticed small patches about a half inch circle in size on other spots like my left ankle and under my left knee where I had never had break outs before.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified number of patients of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-JUN-2018, the unspecified patients were inadvertently vaccinated with an expired properly stored dose of PNEUMOVAX 23 injection, lot # M037669, expiry date: 09-MAY-2018 for prophylaxis (strength, dose, route, anatomical location and dosage schedule were not provided) (expired product administered). No adverse effects were reported. No product quality complaint (PQC) was reported. Upon receipt of follow-up information received on 07-SEP-2018 it was determined that this case is now valid because the registered pharmacist confirmed that two patients received the vaccines on 02-JUN-2018 (MARRS: 1809USA006237). On 02-JUN-2018, a 66 year old patient was inadvertently vaccinated with an expired properly stored dose of PNEUMOVAX 23. Sender's Comments: US-009507513-1809USA006237.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. On 21-AUG-2018 the patient received Oka-Merck PROQUAD (lot # R008203, expiration date 16-SEP-2019; indication for prophylaxis; dose was not reported) and MERCK STERILE DILUENT (strength, dose, frequency, route, lot number, expiration date and indication were not provided) via intradermal route (incorrect route of drug administration). No adverse effects reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient (gender and age unknown). Information about medical history, concurrent condition and concomitant therapy was unknown. On 20-AUG-2018, the patient was vaccinated with a dose of Oka-Merck PROQUAD injection (strength, route and frequency unknown; a dose, lot# N000336, expiration date: 30-JUL-2018, therapy type: recombinant Human albumin (rHA)) for unknown indication (expired product administered). No adverse effects were reported. Follow-up information was received on 04-SEP-2018. This spontaneous report is regarding a 5 year old male patient. The patient was vaccinated with Oka-Merck PROQUAD in the left upper arm. Other suspect therapies included KINRIX (Lot # 75153, Expiration date unknown) in the left deltoid arm for prophylaxis.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JUL-2017, the patient was vaccinated with GARDASIL 9 dose 1 (route, dose, frequency, lot number and expiration date were not reported) for prophylaxis. Then, on 16-JUL-2018, the patient was vaccinated with GARDASIL 9 dose 2 (route, dose, frequency, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 1-year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. The patient's concomitant therapy included sterile diluent. On an unknown date (reported as 1 year old), the patient was vaccinated with first dose of Oka/Merck VARIVAX (strength, frequency, route, lot # and expiry date was not reported) for prophylaxis. On an unknown date (reported as 2 years old), the patient was vaccinated with second dose of Oka/Merck VARIVAX (strength, frequency, route, lot # and expiry date was not reported) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 02-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006256: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Pallor
Clinical narrative: This spontaneous report as received from a physician refers to a 20 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 injection (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient complained of not feeling good, was pale and very dizzy, and had to lie down immediately after receiving her first dose of GARDASIL 9. No treatment was received for the events. The outcome of events was reported as recovered/resolved (reported as: symptoms resolved after a minute). The relationship between the events and GARDASIL 9 was not provided. No product quality complaint was involved. This is one of the same report (reported as: different patient, who was also patient's sibling) received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has received from a pharmacist referring to a currently 66 year old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not reported. The patient received PNEUMOVAX 23 (dose, route, strength, batch/lot # and expiration date were not reported) on an unspecified date in 2014 for prophylaxis, PREVNAR 13 (dose, route, strength, batch/lot # and expiration date were not reported) on an unspecified date in 2017 and PNEUMOVAX 23 (dose, route and strength were not reported; lot # N029303, expiration date 21-APR-2019) on 04-SEP-2018 for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-SEP-2018, the patient was vaccinated with and expired dose of RECOMBIVAX HB injection, lot # L016959, expiration date 12-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Mobility decreased
Clinical narrative: This spontaneous report was received from a physician referring to a 50 year old female patient with recurrent sinus infections. The patient's medical history and historical drugs were not reported. Concomitant therapies included BACTRIM. On 04-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular route, in the left deltoid (dose, dose number, frequency were unknown) with lot number R009162 and expiration date 01-JUL-2020 (also reported as 06-JAN-2020). On the same date of vaccination (reported as "within 1 to 2 hours"), the patient developed severe injection site pain, erythema, and muscle tenderness, and the pain was radiating to the patient's neck, deltoid and tricep. The physician reported that as a result of the pain, the patient could not lift her left arm above 90 degrees and was also having difficulty moving her neck, which physician considers a significant disability. The patient's pain lasted all night and she returned to the physician on 05-SEP-2018 (reported as "today"), the physician reported she did not observe any muscle or joint swelling, and that the events were caused maybe because the injection went in the wrong part of her arm. At the time of the report, the outcome of injection site pain, erythema, myalgia, musculoskeletal discomfort, administration site movement impairment and neck pain was reported as not resolved. The physician did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal discomfort, Myalgia, Neck pain
Clinical narrative: This spontaneous report was received from a physician referring to a 50 year old female patient with recurrent sinus infections. The patient's medical history and historical drugs were not reported. Concomitant therapies included BACTRIM. On 04-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular route, in the left deltoid (dose, dose number, frequency were unknown) with lot number R009162 and expiration date 01-JUL-2020 (also reported as 06-JAN-2020). On the same date of vaccination (reported as "within 1 to 2 hours"), the patient developed severe injection site pain, erythema, and muscle tenderness, and the pain was radiating to the patient's neck, deltoid and tricep. The physician reported that as a result of the pain, the patient could not lift her left arm above 90 degrees and was also having difficulty moving her neck, which physician considers a significant disability. The patient's pain lasted all night and she returned to the physician on 05-SEP-2018 (reported as "today"), the physician reported she did not observe any muscle or joint swelling, and that the events were caused maybe because the injection went in the wrong part of her arm. At the time of the report, the outcome of injection site pain, erythema, myalgia, musculoskeletal discomfort, administration site movement impairment and neck pain was reported as not resolved. The physician did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 04-SEP-2018, the patient was vaccinated with a improperly stored dose of LIQUID PEDVAXHIB for prophylaxis (which had a lot # of N012119 and an expiration date 06-FEB-2020 however, route, dosage schedule, anatomical location and dosage number were not reported), The LIQUID PEDVAXHIB was exposed to a temperature between 9 degrees Celsius(C) to 25 degrees C for time frame of 48 minutes.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD for prophylaxis, lot number R007684, expiration date on 11-SEP-2019 (strength, dose number, anatomical location and route of administration were not reported). The temperature excursion was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 58 minutes without a previous temperature excursion and was called because a digital data logger. There was not adverse effect reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA002855.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist refers to a female patient of unknown age. Information on patient's medical history and concurrent conditions were not reported. The patient's concomitant therapy included sterile diluent. On 30-AUG-2018, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot # and expiry date was not reported) for prophylaxis (exposure during pregnancy). The patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to her son of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PROQUAD intramuscular (Incorrect route of drug administration) (dosing details, lot/batch number and expiration date: unspecified) for prophylaxis. No adverse event was reported. Outcome of the events was not reported. Causality assessment was not reported. No product quality complaint was involved.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 3 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 22-AUG-2018, the patient was vaccinated outside the recommended dosing schedule with PROQUAD for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). There was no adverse event involved.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004059: US-009507513-1809USA004060.
Sex: F
Vaccine: VARZOS
Symptoms: Facial nerve disorder, Facial paralysis, Herpes zoster
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 19-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient suffered from a severe right facial nerve axonopathy and was diagnosed with Bell's palsy. 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. Upon internal review, Bell's palsy was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-MAY-2014, the patient was treated by a Physician Assistant for a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-NOV-2013, the patient was treated at a hospital for the onset of severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-MAY-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 06-FEB-2014, the patient was treated by a physician for the onset of severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed famiciclovir and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 04-OCT-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 13-MAY-2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 10-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office from a physician/MD, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 02-SEP-2016, the patient was treated by a certified nurse practitioner (NP-C) at a healthcare facility for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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. In 2009, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 25-JUL-2014, the patient was treated by the hospital (by an unspecified healthcare professional) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 29-SEP-2015, the patient sought subsequent treatment from the hospital (same hospital as the hospital on 25-JUL-2014) (by an unspecified healthcare professional) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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 20-MAY-2014, the patient was inoculated with ZOSTAVAX at Homecare and Hospice Care as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 09-SEP-2016, the patient was treated by Homecare and Hospice Care for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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. In 2011, the patient was inoculated with ZOSTAVAX at a Health Department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, 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, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.   Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Infertility female, Ovarian failure
Clinical narrative: This spontaneous report was posted somewhere on social media and was received from a registered nurse via a company representative concerning a multiple unspecified female patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with some unspecified doses of GARDASIL 9 and GARDASIL (concentration, frequency, route and lot number were not provided) for prophylaxis. On an unknown date, after the administration of the vaccines, the multiple unspecified patients developed ovarian failure and infertility. The outcome of ovarian failure and infertility was unknown. The causal relationship between adverse events and therapies were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-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. On or about 11-JUN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2012, the patient was treated at the same hospital for the onset of a severe a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
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 patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, 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 for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated by a physician/DO at an eye and laser healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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. In 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, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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 25-JUL-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, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient 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 the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 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 16-APR-2012, the patient was inoculated with ZOSTAVAX at a physicians center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-NOV-2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 17-NOV-2014, the patient sought subsequent treatment at a physicians center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from an office manager, referring to a 18 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 03-MAR-2018, the patient was vaccinated with one pediatric dose of VAQTA, (strength: 25/0.5), for prophylaxis (frequency, route of administration, lot number and expiration date were not reported). On 05-SEP-2018, the patient at 19 years old received a second pediatric dose of VAQTA, 0.5 (units not provided) for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported). No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2010 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2010 the patient 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 ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash erythematous, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 13 year old female patient. The patient's medical history included; a past drug reaction with ZITHROMAX. No information was provided regarding the patient's concurrent conditions and concomitant medications. The patient had none laboratories performed. In 2017, (reported as about a year ago) the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular, scheduled at: (0, 2 months and 6 months) for prevention of human papilloma virus infection (HPV), (strength, lot number and expiration date were not reported). Subsequently the patient required medical attention because she broke out in a rash across her entire body. The rash consisted of red, raised bumps and was itchy (rash erythematous, rash papular and rash pruritic) however the rash went away after 3 weeks. The outcome of rash generalised, rash pruritic, rash papular and rash erythematous was reported as resolved, on unspecified date in 2017. At the time of the report, the casual relationship between the aforementioned events and GARDASIL 9 was not reported.
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-DEC-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-MAY-2013, the patient was treated by a physician at a healthcare facility/clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed BACTRIM for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. 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 of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, 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 for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-SEP-2015, the patient was treated by the emergency department at a hospital (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.