chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 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 were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 02-JAN-2015 at 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. On or about 03-JUN-2016, the patient was treated by a health care professional for a vesicular outbreak that was diagnosed as severe shingles. On or about 25-JUL-2016, the patient was treated again by a physician for ongoing and worsening symptoms of shingles outbreaks that had lasted several months. At that encounter, the patient was then diagnosed with ongoing herpes zoster and post herpetic neuralgia. The patient was prescribed gabapentin (NEURONTIN) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eye infection, Eyelid infection, Ophthalmic herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 from a lawyer and a male patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 06-NOV-2013 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. On or about 24-JUL-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 17-NOV-2015, the patient was treated by another physician for herpes zoster which caused an infection in the eye and eyelid. On or about 23-NOV-2015, the patient was treated again by his physician for ongoing and worsening symptoms, which the physician then diagnosed as post herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Upon internal review herpes zoster which caused an infection in the eye was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot# M039202 with expiration date on 11-MAR-2018; lot# M032492 with expiration date on 02-MAR-2018; lot# M036458 with expiration date on 02-MAR-2018; lot number reported as M036153 with expiration date on 02-MAR-2018; and lot # M012261with expiration date on 01-FEB-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M037770 with expiration date on 01-JUN-2019; and lot # M017983 with expiration date on 30-MAY-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# M032649 with expiration date on 11-NOV-2018; and lot # L048848 with expiration date on 09-AUG-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Headache, Memory impairment, Pain in extremity, Pain in jaw
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 19-MAY-2017. This case involves a 20-year-old female patient who was vaccinated with a dose of TENIVAC (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 15-MAY-2017. Patient received a previous dose of MENACTRA on an unspecified date in 2015 and had a reaction as headache and memory issues in which she couldn't remember anything. Patient's Illness at time of vaccination was reported as none. Concomitant medications were not reported. On 15-MAY-2017, same day following the vaccination, the patient experienced left arm soreness. On 18-MAY-2017, three days following the vaccination, the patient began experiencing jaw pain. Lab data and corrective treatment were not reported. The outcome of the events was unknown (reported as 'Arm soreness and jaw pain continue to today, 19-MAY-2017'). List of documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: JEV1, MMR, SMALL
Symptoms: Erythema, Musculoskeletal stiffness, Pyrexia, Rash, Swelling
Clinical narrative: Pt presented w/ redness that was hot to the touch, swelling, and rash spreading from deltoid to chest. Pt could not raise arm due to stiffness and stated he had experienced fever the night before but did not have fever at the time he was seen. Pt was given antibiotics and 48 hours quarters.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site- sore to touch.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-05-26.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot # M043987 with expiration date at 30-JUN-2018, also reported as 20-OCT-2018; lot # N003997 with expiration date at 20-OCT-2018, lot # reported as M03997 with expiration date at 20-OCT-2018, lot # reported as M033338 with expiration date at 15-APR-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From16-MAR-2017 to 31-MAR-2017, the doses of PNEUMOVAX 23 with lot numbers: M043987, M03997and M033338 were exposed to a temperature in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). No details were reported regarding the temperature excursion with the doses of PNEUMOVAX 23 with lot # N003997. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015598: US-009507513-1705USA015597: US-009507513-1705USA015599:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates, the multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N003703, expiration date 29-OCT-2019, dose, route and frequency were not provided). No adverse effects were reported. The vaccines were stored in the temperature between 32 and 35 degrees Fahrenheit for 5 days. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA015635: US-009507513-1705USA006154.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates, the multiple unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # N005096, expiration date 22-OCT-2018, dose, route and frequency were not provided). No adverse effects were reported. The vaccines were stored in the temperature between 32 and 35 degrees Fahrenheit for 4 weeks. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source.  Additional information has been requested; Sender's Comments:  US-009507513-1705USA006119: US-009507513-1705USA015635:
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to 2 female patients in their 20' who were siblings. No informations regarding the patients' pertinent medical history, concomitant medications, drug reactions oa allergies was provided. On unknown dates, the patients were vaccinated with 3 doses of GARDASIL injection (doses, route of administration, lot#, and expiration dates were not provided), for prevention of Human Papillomavirus (HPV). On unknown dates, the patients experienced fertility issues. They were told by the physician, that the fertility issues were because they received GARDASIL in the past. The outcome of fertility issues was unknown. The relatedness between the adverse event and GARDASIL was not provided by the nurse. Additional information is not expected, as there was no consent to contact the reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lumbar puncture, Meningitis, Ophthalmic herpes zoster, Seizure
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding 61-year-old female patient with sjogren's (shogren's) disease and hypertension. There was no concomitant medication reported. In approximately November 2016 (reported as six months ago), the patient was vaccinated with a dose of ZOSTAVAX. Other suspect therapy included the sterile diluent (dose, route, anatomical location, lot number and expiration date were not reported) for shingles prevention for both above therapies described. In December 2016, the patient developed "ophthalmic shingles (ophthalmic herpes zoster), seizures and meningitis." It was also reported that the patient was hospitalized in approximately December 2016 due to the ophthalmic shingles, seizures and meningitis and while the patient was hospitalized (date unspecified) a spinal tap (lumbar puncture) was performed (result was not provided). The patient was treated with prednisone (manufacturer unknown) and acyclovir for the ophthalmic shingles. On an unknown date, the patient was discharged from the hospital. At the time of the report, the patient did not recover from the ophthalmic herpes zoster, meningitis and seizure. The relatedness between the events and therapy with ZOSTAVAX and the sterile diluent was not reported. Upon internal review, ophthalmic herpes zoster, meningitis and seizure were determined to be serious due to medically significant events. The reporter considered the events to be serious due to disability and life threatening criterion. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 15 year old female non-pregnant patient. The patient had no medical history, concurrent conditions and drug reactions or allergies. She did not take any concomitant medications. On an unknown date in approximately July 2015, the patient was vaccinated with the first dose of GARDASIL injection (lot#, expiration date, dose ad route of administration were not reported) for HPV prevention. On the same day, couple hours after vaccination, the patient experienced severe headaches that were very permanent and they lasted for about 2 months before the finally subsided and the patient recovered in approximately September 2015. The physician thought that the patient might have had some inflammation occurred in her brain from the vaccine resulting in her bad headaches. No laboratory diagnostic tests were performed. The patient decided not to continue vaccination with GARDASIL due to the event. On an unknown date in March 2017, the patient received the first dose of GARDASIL 9 injection (lot#, expiration date, dose ad route of administration were not reported). The patient had no side effects after GARDASIL 9. The reporter inquired if the patient needed to start the series all over again because she said she's getting mixed advice from 2 different doctors. Product quality complaint was not involved. The causality between the event of brain inflammation and GARDASIL was not reported, the event was not related to GARDASIL 9. Upon internal review, the event of brain inflammation was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M043310 with expiration date: 24-APR-2018, 1 dose also reported as 10 doses) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°C for 15 hours and 40 minutes with previous temperature excursion: temperature greater than -9°C but less than 8°C for 3 hours and 10 minutes; this information was registered in a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014999.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 27-SEP-2012, the patient was vaccinated with ZOSTAVAX (route and lot # not provided) at her primary care physician's office as recommended for routine 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.  On or about 31-JAN-2014, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles.  On or about 08-MAY-2014, she was treated by that same physician for ongoing and worsening symptoms of severe shingles outbreaks.  On or about 30-JUL-2014, the patient required further medical treatment for worsening symptoms.  She was treated for ongoing shingles outbreaks on 17-DEC-2014.  On or about 04-AUG-2016, the patient was treated by another physician for severe herpes zoster conditions.  She was treated again by this same physician for worsening symptoms of this outbreak on or about 11-AUG-2016.  The patient was prescribed valacyclovir (VALTREX), acyclovir and prednisone for management of her painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The persistent strain of herpes zoster/vesicular outbreak that was diagnosed as severe shingles was considered related to ZOSTAVAX. The outcome of the events were not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 14-JUN-2011, the patient was inoculated with ZOSTAVAX (route and lot # not provided) at a family physician's 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.  On or about 30-APR-2016, the patient was treated by a physician for a vesicular oubreak that was diagnosed as herpes zoster "keratis" (shingles in the eye).  He was prescribed valacyclovir (VALTREX) for management of his painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  Persistent strain of herpes zoster/vesicular oubreak that was diagnosed as herpes zoster "keratis" (shingles in the eye) was considered related to ZOSTAVAX. The outcome of the events was not recovered. Upon internal review, opthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 20-APR-2011 at a health care facility, by a licensed practical nurse (LPN) as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 29-MAR-2016, the male patient was treated by a certified occupational therapist assistant (COTA)(Also reported (O.T.A.)), for a vesicular outbreak that was diagnosed as herpes zoster (shingles) causing secondary fatigue syndrome. On or about 27-APR-2016, the male patient was treated by physician for herpes zoster dermatitis. The male was prescribed valacyclovir (VALTREX) and acyclovir (ZORIVAX) for management of his painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 from a lawyer and a male patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 05-JUN-2012 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. On or about 18-DEC-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 15-DEC-2014 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. On or about 06-JUL-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient has been prescribed valacyclovir (VALTREX) and  methylprednisolone acetate (DEPO-MEDROL) injections for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 15-DEC-2011 at a pharmacy as prescribed by a physician and 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. On or about 19-DEC-2014, the patient was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles. On or about 26-JAN-2015, the patient was treated by a physician for ongoing symptoms of shingles and chronic nerve pain. The patient was then diagnosed with post herpetic neuralgia. The patient was prescribed valacyclovir, gabapentin, and hydrocodone-acetaminophen for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 22-MAY-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 02-JUN-2015, the female patient was treated at a health facility for a vesicular outbreak that was diagnosed as severe shingles. On or about 27-AUG-2015, the female patient reported her reaction and illness caused by ZOSTAVAX to the VAERS database. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot # M035688 with expiration date: 10-AUG-2018, 1 dose and lot# M041080 with expiration date 06-OCT-2018, 17 doses) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°C for 15 hours and 40 minutes with previous temperature excursion: temperature greater than -9°C but less than 8°C for 3 hours and 10 minutes; this information was registered in a digital data logger. No adverse effects were reported.   This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA013899:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # M040269 with expiration date at 28-APR-2018 and lot # M033338 with expiration date at 15-APR-2018; dose was not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From16-MAR-2017 to 31-MAR-2017, the doses of ROTATEQ with lot numbers: M040269 and M033338 were exposed to a temperature in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015598: US-009507513-1705USA000770:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # M036156 with expiration date at 23-FEB-2019 and lot # N002913 with expiration date at 23-FEB-2019; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From16-MAR-2017 to 31-MAR-2017, the doses of RECOMBIVAX HB with lot numbers: M036156 and N002913 were exposed to a temperatures in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015597: US-009507513-1705USA000770:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M041990 with expiration date at 28-JUN-2019 and lot # M037770 with expiration date at 01-JUN-2019; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From 16-MAR-2017 to 31-MAR-2017, the doses of GARDASIL 9 with lot numbers: M041990 and M037770 were exposed to a temperature in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA000770: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015597: US-009507513-1705USA015598.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # M047658 with expiration date at 28-OCT-2017, lot # M033611 with expiration date at 02-MAR-2018, lot # M034893 with expiration date at 26-MAY-2017, lot # M039202 with expiration date at 11-MAR-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From 16-MAR-2017 to 31-MAR-2017, the doses of VAQTA with lot numbers: M047658, M033611 and M039202 were exposed to a temperatures in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). No details were reported regarding the temperature excursion with the doses of VAQTA with lot # M034893. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments:  US-009507513-1705USA015599: US-009507513-1705USA000770: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015597: US-009507513-1705USA015598:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates, the multiple unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # N003700, expiration date 11-NOV-2019, dose, route and frequency were not provided). No adverse effects were reported. The vaccines were stored in the temperature between 32 and 35 degrees Fahrenheit for 5 days. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA006119: Original Case : 1705USA006119 US-009507513-1705USA006154:
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for herself via a sales representative. This female patient of unknown age received on 02Sep2015 PREVNAR 13 at 0.5 ml single dose intramuscular for immunization. Medical history and concomitant medications were not reported. On 02Sep2015 the patient was painful. The patient got the shot that day and that same night it started getting very painful. The pain lasted for about 3 days. Additionally it was reported that on an unspecified date the patient had redness and swollen at the injection site. Final outcome was unknown.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy muscle, Biopsy peripheral nerve, Constipation, Electromyogram, Fall
Clinical narrative: Muscle weakness in arms and legs, falling down, numbness, tingling, muscle twitching, constipation, tiredness, finger stiffness EMG, 2x Lumbar Puncture, Muscle and Nerve Biopsy.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Hypoaesthesia, Lumbar puncture, Muscle twitching, Muscular weakness
Clinical narrative: Muscle weakness in arms and legs, falling down, numbness, tingling, muscle twitching, constipation, tiredness, finger stiffness EMG, 2x Lumbar Puncture, Muscle and Nerve Biopsy.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Muscle weakness in arms and legs, falling down, numbness, tingling, muscle twitching, constipation, tiredness, finger stiffness EMG, 2x Lumbar Puncture, Muscle and Nerve Biopsy.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Back pain, Blood chloride normal, Blood lactic acid, Blood sodium decreased
Clinical narrative: Started out with high fevers, sore throat, and extreme tiredness and body aches Vaginal ulcers triggered by autoimmune response in June 2013. She kept having issues and ended up having inflammatory response in her back which started January 2014. Complained of increasing back pain. Xrays and MRI completed in 9/2014. Her condition has become worse and currently she's in and out of wheelchair due to inflammation of her back. 2nd MRI 2017 continues to show inflammation. She is experiencing severe back pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood urine present, Fatigue, Genital pain, Inflammation, Neutrophil percentage increased
Clinical narrative: Started out with high fevers, sore throat, and extreme tiredness and body aches Vaginal ulcers triggered by autoimmune response in June 2013. She kept having issues and ended up having inflammatory response in her back which started January 2014. Complained of increasing back pain. Xrays and MRI completed in 9/2014. Her condition has become worse and currently she's in and out of wheelchair due to inflammation of her back. 2nd MRI 2017 continues to show inflammation. She is experiencing severe back pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nitrite urine absent, Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Started out with high fevers, sore throat, and extreme tiredness and body aches Vaginal ulcers triggered by autoimmune response in June 2013. She kept having issues and ended up having inflammatory response in her back which started January 2014. Complained of increasing back pain. Xrays and MRI completed in 9/2014. Her condition has become worse and currently she's in and out of wheelchair due to inflammation of her back. 2nd MRI 2017 continues to show inflammation. She is experiencing severe back pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate increased, Red blood cells urine positive, Urine abnormality, Urine leukocyte esterase positive, Vaginal ulceration
Clinical narrative: Started out with high fevers, sore throat, and extreme tiredness and body aches Vaginal ulcers triggered by autoimmune response in June 2013. She kept having issues and ended up having inflammatory response in her back which started January 2014. Complained of increasing back pain. Xrays and MRI completed in 9/2014. Her condition has become worse and currently she's in and out of wheelchair due to inflammation of her back. 2nd MRI 2017 continues to show inflammation. She is experiencing severe back pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal swelling, Wheelchair user, White blood cell count increased, White blood cells urine positive, X-ray
Clinical narrative: Started out with high fevers, sore throat, and extreme tiredness and body aches Vaginal ulcers triggered by autoimmune response in June 2013. She kept having issues and ended up having inflammatory response in her back which started January 2014. Complained of increasing back pain. Xrays and MRI completed in 9/2014. Her condition has become worse and currently she's in and out of wheelchair due to inflammation of her back. 2nd MRI 2017 continues to show inflammation. She is experiencing severe back pain.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Cellulitis diagnosed by Dr. redness, warmth and tenderness on left arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Throat tightness
Clinical narrative: A few minutes after the injection pt complained of her throat feeling tight. Pt was observed by the provider for 30 minutes with another set of vitals completed on her. No hives, no swelling. Pt felt fine and after being monitored for 30 minutes with no other reaction other than her throat tightness, which resolved before pt left the clinic, was release. Administration of vaccine was at 3:45 and pt was cleared and released at about 4:05pm.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further temperature excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908:
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 14 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908: Original Case : 1608USA012908.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 month old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further temperature excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908: Original Case : 1608USA012908.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 2 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further excursions. Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Exposure via skin contact, No adverse event
Clinical narrative: Information was received on 11-MAY-2017 from a pharmacist who is the patient, a female patient of unknown age. No concomitant medications or medical history was reported. The pharmacist reported that on an unknown date, while drawing up a dose of VARIVAX (lot, expiration and dose not reported), "a droplet touched my skin". The pharmacist reported that she is pregnant (gestational age not reported). No adverse effects reported. Additional information is not expected. No consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. On 15-MAY-2017, the patients were vaccinated with VARIVAX lot # M046005, expiration date 18-NOV-2018 that might have underwent temperature excursions of -14 to -10 degrees Celsius for 1 hour and -9 to 8 degrees Celsius for 2 hours reconstituted in sterile diluent. No adverse experience was reported. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA015663: