chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9, MMRV, PPV, RV5, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD, GARDASIL 9, ROTATEQ, PNEUMOVAX 23, all for prophylaxis (lots# and expiration dates were not provided). PROQUAD was reconstituted with improperly stored sterile diluent (manufacturer unknown). No adverse effects were reported. Temperature and time frame of the excursion were not provided and there was no previous excursion. The digital data logger was involved. Follow up information has been received from the nurse on 16-JAN-2019. Lots# and expiration dates for the improperly stored vaccines were provided. PROQUAD lot# non valid reported as N55860, expiration date reported as 02-MAR-2018, excursion date: from 05-JUL-2017 till 29-JUL-2017) (temperature of excursion (T) ranged from 36 to 46 degree Celsius for 1.5 to 12 hours (h)), lot# R008196, expiration date: 16-SEP-2019 and lot# R012416, expiration date: 28-OCT-2019, excursion dates: from 02-JUL-2018 to 03-OCT-2018, T 9-10 degree Fahrenheit for 2-25 h), lot # non valid reported as E98765, expiration date reported as 01-JAN-20XX (T 6-14 degree Fahrenheit for 3 days, and 47 to 77 degree Fahrenheit for 2 h) administered on an unknown dates. GARDASIL 9 (lot# non valid reported as H12345, expiration date reported as 04-JUL-20xx, T 68 Fahrenheit for 1 month), lot# non valid reported as K08421, expiration date reported as 12-SEP-2018, excursion date: from 01-JUN-2017 to 18-JUL-2017, T range from 28 to 33 degree Celsius, for 0.5 to 8 h) vaccinated on 05-JUN-2017, 08-JUL-2017 and 22-JUL-2017, lot# R017134, expiration date: 29-APR-2021 (excursion date: 31-OCT-2018, T 34 degree Fahrenheit, 8 h), lot# R020947, expiration date: 04-MAY-2021 (excursion date: 31-OCT-2018, T 34 degree Fahrenheit, 8 h) and lot# R017457, expiration date: 10-APR-2021 (excursion dates: from 02-NOV-2018 to 19-DEC-2018, T 33-47 degree Fahrenheit, 5-8 h). ROTATEQ (lot# N030996, expiration date: 08-SEP-2019, and lot# R012957, expiration date: 11-JUN-2019, excursion dates: from 31-OCT-2018, to 19-DEC-2018, T 33-47 degree Fahrenheit, 5-8 h. PNEUMOVAX 23 (lot# non valid reported as G67891, expiration date reported as 31-DEC-20xx, T 22 degree Fahrenheit for 3 h), (lot# R027299, expiration date: 09-APR-2020, excursion date: 19-DEC-2018, T 47 degree Fahrenheit, 8 h), (lot# R011632, expiration date: 02-FEB-2020, excursion dates: 02-NOV-2018, T 33 T 33-47 degree Fahrenheit, 5-8 h, 5h and 28-NOV-2018, 47 T 33-47 degree Fahrenheit, 5-8 h, 8h). The patients were also vaccinated with improperly stored ZOSTAVAX, lot # non valid reported as E34567, expiration date reported as 28-FEB-20XXm T 6-14 degree Fahrenheit, for 120 h) on an unknown dates. The primary reporter nurse confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored (considered as concomitant therapy).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse of unknown age reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 14-JAN-2019, the patient was inadvertently vaccinated with M-M-R II (lot number and expiration date not reported), intramuscularly. No adverse effecters were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided. On 07-DEC-2018, the patient was inadvertently administered a dose of PROQUAD (lot # R015738, expiration date 02-DEC-2019; strength and dose were not provided) that was reconstituted with sterile diluent by intramuscular rather than subcutaneous (incorrect route of product administration) for prophylaxis. No adverse effect reported.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dry mouth, Erythema, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a medical clinic supervisor referring to a 26 year old female patient. The patient's concomitant medications included ibuprofen(IBUPROFEN), valacyclovir hydrochloride and atovaquone, chloroguanide hydrochloride(MALARONE). The patient had none pertinent medical history or drug reactions/allergies. On 14-JAN-2019, the patient received a dose of PNEUMOVAX 23 (lot # R018735 with expiration date 06-APR-2020; strength and dose were not provided) intramuscularly and AFLURIA during the same office visit for prophylaxis. Since 14-JAN-2019 (reported as since receiving the vaccinations), the patient reported that she had developed dry mouth. On an unknown date in January 2019 (reported as now),  the patient's arm (right deltoid) was red and swollen. The patient had also developed a fever on an unknown date in January 2019, but no pus had drained from the injection site. The physician suggested going to an unidentified emergency room, but the patient declined. Sulfamethoxazole, trimethoprim(BACTRIM DS) and cephalexin were prescribed. The patient performed none lab diagnostics/studies. The outcome of the events was reported as not recovered. The causality between PNEUMOVAX 23 and the events was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R023736 with expiration date on 20-AUG-2020 (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -6 degrees Fahrenheit (°F) to 14°F for the time frame of 30 minutes, and another temperature range of 15°F to 46°F for the time frame of 1 hour. There was no previous temperature excursion and the call was because of a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 25-JAN-2019, the patient was vaccinated with an improperly VARIVAX (the dosage regimen information was not reported) lot # N035937 (expiration date: 18-DEC-2019) for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature of -8.16 and -10.96 Celsius degrees for a timeframe of 50 minutes and 13 hours respectively. It was found because of a digital data logger. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1902USA005476: US-009507513-1902USA005477.
Sex: U
Vaccine: HEP, HIBV, MMR, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to multiple, unspecified patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not provided. From 18-JAN-2019 to 30-JAN-2019, these patients was vaccinated with improperly stored doses of M-M-R II (strength, dose and frequency were not reported) lot # N025891/ N024698, expiration date 19-SEP-2019/08-SEP-2019. RECOMBIVAX HB (lot # R004185, expiration date 06-NOV-2020), LIQUID PEDVAXHIB (lot # R005118/ R013571, expiration date 28-NOV-2020/19-MAR-2021) and ROTATEQ (lot # R002521/ R013861, expiration date 18-SEP-2019/04-DEC-2019) for prophylaxis. The sterile diluent used to reconstitute M-M-R II was properly stored. The vaccines were exposed to temperature of 47.3 Fahrenheit (F) for 15 minutes and the data logger was involved. There was no previous temperature excursion. This is a non-valid report with no patient identifiers.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-JAN-2019, the patient was vaccinated with a dose of M-M-R II subcutaneous injection, via intramuscular route (lot # R022423, expiry date: 06-AUG-2020) for prophylaxis which was reconstituted with Merck sterile diluent (lot # N003192, expiry date: 05-JUL-2019). No adverse effects were reported. Product quality complaint was not involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 04-FEB-2019 from a lawyer and an approximately 67 year old  male consumer regarding a case in litigation. In 2015 the patient was administered the ZOSTAVAX (lot number and expiration not reported) by a pharmacist for the long term prevention of shingles and zoster related conditions. Later in 2015 the patient was treated by a physician for the following injuries resulting from use of ZOSTAVAX: shingles. Outcome of shingles was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 5-year-old male patient. There was no information about the patient's concurrent conditions and concomitant therapies. Historical vaccines included M-M-R II and medical history included seizure on 08-JUN-2016. On the same day, the patient was vaccinated with PROQUAD (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same day, in the evening, the patient experienced fever of 99.5 degrees. The outcome of fever was unknown. There was no causality assessment between PROQUAD and fever provided. Sender's Comments: US-009507513-1902USA001268.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 05-JUN-2013 at a medical clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated by a nurse practitioner for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine 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. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an 1-year-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapies were not reported. On 04-FEB-2019, the patient was vaccinated with a dose of improperly stored MMR II, therapy type rHA (recombinant human albumin), lot# N032750, expiration date 20-NOV-2019, (dose, route of administration were not reported) for prophylaxis. MMR II was improperly stored above 47 degrees Fahrenheit (54.1 F) for 5 hours. Data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA002311.
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer via company representative refers to her daughter, a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or past medical history provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (dose, concentration, exact route of administration, albumin status, lot # and expiration date were not provided) and (unspecified) DTap (dose, concentration, exact route of administration, lot # and expiration date were not provided), both for prophylaxis. On an unknown date (reported as 24-48 hours post vaccination), the patient had a fever with a maximum temperature of 103.5 (unit not provided) which lasted approximately 36 hours. No other associated symptoms were reported. The outcome of fever was unknown. The relatedness between the event and the suspected vaccines was not provided.
Sex: F
Vaccine: PPV
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report was received from a field representative concerning to a female patient of unknown age who is also a physician. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were unknown by the reporter. In approximately February 2004 (reported as "10-15 years ago"), the patient was vaccinated with PNEUMOVAX 23 injection, to prevent pneumonia (dose, dose number, route of administration, anatomical location, lot/batch # and expiration date were unknown by the reporter). On an unknown date, the patient experienced an upper respiratory infection. It was unknown by the reporter if the patient sought medical attention or if any laboratory diagnostics, studies, intervention to prevent serious criteria, or treatment was given for the adverse event. No additional information was provided. The outcome of upper respiratory tract infection was reported as recovered. The reporter did not provide a causal relationship between the event and vaccination with PNEUMOVAX 23.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
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 14-NOV-2014, 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 on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. 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 considered to be not recovered. Upon internal review, varicella pneumonia was determined to be medically significant. 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 an adult female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2010, the patient was inoculated with ZOSTAVAX at a medical office 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, also known as shingles and other complications. On an unspecified date, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-MAR-2017, the patient was inoculated with ZOSTAVAX at a medical office 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, also known as shingles and other complications. On an unspecified date, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-FEB-2012, the patient was inoculated with ZOSTAVAX at a grocery store 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, also known as shingles and other complications. On an unspecified date, the patient was treated at a corporation (presumed to be patient's place of work) for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-MAR-2017, the patient was inoculated with ZOSTAVAX 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, also known as shingles and other complications. On an unspecified date, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
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 17-MAR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications such as varicella pneumonia. The patient was treated by a physician at a medical office for a blistering vesicular outbreak that 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 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 were considered to be not recovered. Varicella pneumonia were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe 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 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 considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a Nurse Prescriber referring to a 49 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unspecified date, (reported as when the patient was child), the patient might have had vaccination with the series of M-M-R II (doses, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. Recently (unspecified date) the patient had titers drawn which showed she was "not immune to mumps" (Mumps antibody test negative). The nurse indicated that as a treatment (also reported as treatment no) the patient was administered a dose of M-M-R II on 04-FEB-2019, while the patient was also on therapy with XELJANZ. The nurse also reported that there was no adverse effects to report. At the reporting time the outcome of the event Mumps antibody test negative was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
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. In 2016 the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended, and on an unknown date the patient subsequently contracted zoster-related vision loss and other complications. The patient was treated at a medical center for vision loss. 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 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 considered to be not recovered.  Zoster-related vision loss was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient 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 vaccine 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 20-JUN-2016 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. The patient was treated at a medical center for a blistering vesicular outbreak which was diagnosed as severe varicella pneumonia.  As a direct and proximate result of the vaccine 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. Upon internal review, severe varicella pneumonia was determined to be a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a male patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2012 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. The patient was treated by a healthcare provider at a medical center for a blistering vesicular outbreak which was diagnoses as herpes zoster or shingles. As a direct and proximate result of the vaccine 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a male patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2015 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on 02-FEB-2009 at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2009 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated at a medical center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2013 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient 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 vaccine ZOSTAVAX and/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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-AUG-2011, 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 on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe 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 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 suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of the events were considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for eyes for a blistering vesicular outbreak that was diagnosed as severe 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 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 were considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In September 2014, 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 on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe 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 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 suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of the events were considered to be not recovered. Additional information has been requested.
Sex: M
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 an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-DEC-2016, the patient was inoculated with ZOSTAVAX 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, also known as shingles and other complications. On an unspecified date, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles or zoster-related injuries as intended and the patient subsequently developed zoster-related vision loss and other complications. On an unspecified date, the patient was treated at a hospital for vision loss. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, zoster-related vision loss was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In September 2016, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles or zoster-related injuries as intended and the patient subsequently developed zoster-related vision loss and other complications. In 2017, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, zoster-related vision loss was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Strabismus
Clinical narrative: Information was received on 06-FEB-2019 from a lawyer and a female consumer regarding a case in litigation. On 14-JUN-2016 the patient was inoculated at a pharmacy with ZOSTAVAX (lot number and expiration not reported) for its intended purpose: the prevention of shingles. Shortly after receiving the vaccine the patient suffered intermittent horizontal diplopia and was later diagnosed with diplopia and esotropia. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages and required extensive medical care and treatment. The patient suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX.   Dlplopia and esotropia were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, FLU3, TD
Symptoms: Burning sensation, Erythema, Herpes zoster, Pain, Pruritus
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 23-JAN-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. Shortly after receiving the ZOSTAVAX, the patient developed burning, itching, redness and broke out in a rash. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from herpes zoster. As a result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct result of the ZOSTAVAX, the patient symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. Herpes zoster and vaccination failure were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, FLU3, TD
Symptoms: Rash, Vaccination failure
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 23-JAN-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. Shortly after receiving the ZOSTAVAX, the patient developed burning, itching, redness and broke out in a rash. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from herpes zoster. As a result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct result of the ZOSTAVAX, the patient symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. Herpes zoster and vaccination failure were considered to be disabling. Additional information has been requested.