chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 10-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 13-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.5
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 18-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 08-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.25
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 15-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 19-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 2.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 2-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 24-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 9.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 9-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 29-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.08
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 13-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 23-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Blood immunoglobulin G decreased, Bronchiolitis, Chest X-ray abnormal, Cytomegalovirus test positive
Clinical narrative: No response to PPSV23; Pneumococcal titers: 0/14 protective after vaccination; This literature marketed report was received from the authors in a published article concerning a 34-month-old female patient with Immunodeficiency, centromeric instability and facial anomalies (ICF) syndrome.  The patient presented with fever and respiratory distress at age 3 months. After brief hospitalization for presumed bronchiolitis, she returned with new fever, worsening of respiratory symptoms, hepatosplenomegaly, leukopenia, and diffuse hazy infiltrates on chest radiograph. Further evaluation revealed a whole-blood cytomegalovirus (CMV) PCR (polymerase chain reaction) of 125,257 copies/mL and she was diagnosed with CMV pneumonitis.  She was born full-term and newborn screen was normal, including T-cell receptor excision circles. She had received her 2-month vaccinations including live oral rotavirus vaccine without issue, was formula-fed, and had no allergies. Her parents are first cousins, and she had a healthy older brother. Her family history was significant for "blood cancers" in 2 female cousins and a maternal aunt.  She received intravenous immunoglobulin and valganciclovir. She was discharged on hospital day 32 after CMV PCR was undetectable and continued valganciclovir prophylaxis as an outpatient.  Continued evaluation at age 32 months was significant for low NK (natural killer) cells, low memory B cells, and low pneumococcal titers (0/14 protective). Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was administered shortly thereafter. At age 34 months, she developed fever and respiratory distress. Initial evaluation revealed bilateral infiltrates on chest radiograph respiratory viral panel positive for rhinovirus/enterovirus, and elevated whole-blood EBV PCR of 6500 copies/mL CMV PCR was negative. Immunologic evaluation showed loss of previously protective tetanus and diphtheria titers, no response to PPSV23 (0/14 protective) (therapy non-responder and antibody test negative), low IgG, and additional abnormalities in lymphocyte subsets.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Enterovirus test positive, Epstein-Barr virus test positive, Hepatosplenomegaly, Human rhinovirus test positive, Immunoglobulin therapy
Clinical narrative: No response to PPSV23; Pneumococcal titers: 0/14 protective after vaccination; This literature marketed report was received from the authors in a published article concerning a 34-month-old female patient with Immunodeficiency, centromeric instability and facial anomalies (ICF) syndrome.  The patient presented with fever and respiratory distress at age 3 months. After brief hospitalization for presumed bronchiolitis, she returned with new fever, worsening of respiratory symptoms, hepatosplenomegaly, leukopenia, and diffuse hazy infiltrates on chest radiograph. Further evaluation revealed a whole-blood cytomegalovirus (CMV) PCR (polymerase chain reaction) of 125,257 copies/mL and she was diagnosed with CMV pneumonitis.  She was born full-term and newborn screen was normal, including T-cell receptor excision circles. She had received her 2-month vaccinations including live oral rotavirus vaccine without issue, was formula-fed, and had no allergies. Her parents are first cousins, and she had a healthy older brother. Her family history was significant for "blood cancers" in 2 female cousins and a maternal aunt.  She received intravenous immunoglobulin and valganciclovir. She was discharged on hospital day 32 after CMV PCR was undetectable and continued valganciclovir prophylaxis as an outpatient.  Continued evaluation at age 32 months was significant for low NK (natural killer) cells, low memory B cells, and low pneumococcal titers (0/14 protective). Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was administered shortly thereafter. At age 34 months, she developed fever and respiratory distress. Initial evaluation revealed bilateral infiltrates on chest radiograph respiratory viral panel positive for rhinovirus/enterovirus, and elevated whole-blood EBV PCR of 6500 copies/mL CMV PCR was negative. Immunologic evaluation showed loss of previously protective tetanus and diphtheria titers, no response to PPSV23 (0/14 protective) (therapy non-responder and antibody test negative), low IgG, and additional abnormalities in lymphocyte subsets.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Leukopenia, Lung infiltration, Natural killer cell count decreased, Pneumonia cytomegaloviral, Polymerase chain reaction positive
Clinical narrative: No response to PPSV23; Pneumococcal titers: 0/14 protective after vaccination; This literature marketed report was received from the authors in a published article concerning a 34-month-old female patient with Immunodeficiency, centromeric instability and facial anomalies (ICF) syndrome.  The patient presented with fever and respiratory distress at age 3 months. After brief hospitalization for presumed bronchiolitis, she returned with new fever, worsening of respiratory symptoms, hepatosplenomegaly, leukopenia, and diffuse hazy infiltrates on chest radiograph. Further evaluation revealed a whole-blood cytomegalovirus (CMV) PCR (polymerase chain reaction) of 125,257 copies/mL and she was diagnosed with CMV pneumonitis.  She was born full-term and newborn screen was normal, including T-cell receptor excision circles. She had received her 2-month vaccinations including live oral rotavirus vaccine without issue, was formula-fed, and had no allergies. Her parents are first cousins, and she had a healthy older brother. Her family history was significant for "blood cancers" in 2 female cousins and a maternal aunt.  She received intravenous immunoglobulin and valganciclovir. She was discharged on hospital day 32 after CMV PCR was undetectable and continued valganciclovir prophylaxis as an outpatient.  Continued evaluation at age 32 months was significant for low NK (natural killer) cells, low memory B cells, and low pneumococcal titers (0/14 protective). Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was administered shortly thereafter. At age 34 months, she developed fever and respiratory distress. Initial evaluation revealed bilateral infiltrates on chest radiograph respiratory viral panel positive for rhinovirus/enterovirus, and elevated whole-blood EBV PCR of 6500 copies/mL CMV PCR was negative. Immunologic evaluation showed loss of previously protective tetanus and diphtheria titers, no response to PPSV23 (0/14 protective) (therapy non-responder and antibody test negative), low IgG, and additional abnormalities in lymphocyte subsets.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Respiratory distress, Stem cell transplant, Therapy non-responder
Clinical narrative: No response to PPSV23; Pneumococcal titers: 0/14 protective after vaccination; This literature marketed report was received from the authors in a published article concerning a 34-month-old female patient with Immunodeficiency, centromeric instability and facial anomalies (ICF) syndrome.  The patient presented with fever and respiratory distress at age 3 months. After brief hospitalization for presumed bronchiolitis, she returned with new fever, worsening of respiratory symptoms, hepatosplenomegaly, leukopenia, and diffuse hazy infiltrates on chest radiograph. Further evaluation revealed a whole-blood cytomegalovirus (CMV) PCR (polymerase chain reaction) of 125,257 copies/mL and she was diagnosed with CMV pneumonitis.  She was born full-term and newborn screen was normal, including T-cell receptor excision circles. She had received her 2-month vaccinations including live oral rotavirus vaccine without issue, was formula-fed, and had no allergies. Her parents are first cousins, and she had a healthy older brother. Her family history was significant for "blood cancers" in 2 female cousins and a maternal aunt.  She received intravenous immunoglobulin and valganciclovir. She was discharged on hospital day 32 after CMV PCR was undetectable and continued valganciclovir prophylaxis as an outpatient.  Continued evaluation at age 32 months was significant for low NK (natural killer) cells, low memory B cells, and low pneumococcal titers (0/14 protective). Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was administered shortly thereafter. At age 34 months, she developed fever and respiratory distress. Initial evaluation revealed bilateral infiltrates on chest radiograph respiratory viral panel positive for rhinovirus/enterovirus, and elevated whole-blood EBV PCR of 6500 copies/mL CMV PCR was negative. Immunologic evaluation showed loss of previously protective tetanus and diphtheria titers, no response to PPSV23 (0/14 protective) (therapy non-responder and antibody test negative), low IgG, and additional abnormalities in lymphocyte subsets.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: patient was administered an improperly stored dose of MMRII; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 05-MAR-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (albumin status rHA)(Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency and route were not provided; Lot number reported as S006048  has been verified to be valid; expiration date reported and validated as 27-FEB-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).    The vaccine underwent a temperature excursion of 47.3 Fahrenheit (° F) for a period of 14 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Physician reports improperly stored MMR was administered on an unspecified date to an unspecified patient; No additional adverse effects reported; This spontaneous report was received from a physician referring to an unspecified patient of unknown age and gender. There was no information regarding his/her pertinent medical history, past medication, current conditions, drug reactions or allergies provided.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, vaccination scheme and route of administration were not provided) ; lot number 1660945 was determined as not valid for measleas, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R-II), expiration date was reported as 13-FEB-2021) as prophylaxis (product storage error). Concomitant therapies included sterile diluent.   It was reported that the vaccine was stored in a temperature of 9 degrees Celcius (°C) in a timeframe of 48 hours. There was no previous temperature excursion reported, and it was reported that a digital data logger was involved.  This case was considered as non-valid due to the lack of patient's identifiers.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient stated that she had gotten her first dose of GARDASIL in 2012 and her second dose of GARDASIL in 2015; No AE symptoms were reported.; This spontaneous report was received from a female consumer of unknown age.   No information regarding the patient's pertinent medical history, drug reactions or allergies,  concomitant therapies was provided.  In 2012 the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (reported as "HPV 4" vaccination) 0.5 milliliters (ml), as prophylaxis. In 2015, she received the second 0.5 ml dose (inappropriate schedule of product administration) (vaccination scheme frequency, route, and anatomical location of vaccinations were not reported; lot numbers and expiration dates were unknown). No adverse event symptoms were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Office manager reports that nurse administered an expired VAQTA; This spontaneous report was received from a officer manager referring to a 12-month-old patient on unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not reported.  On 28-APR-2020, the patient was vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) by intramuscular route as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location of vaccination were not reported; lot number S002505 and expiration date 04-APR-2020) (expired product administered).
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VAQTA on 4/21/2020 that had been improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. This report included one patient and one combination product.    On 21-APR-2020, the patient was inadvertently administered a dose of improperly stored hepatitis A vaccine, inactivated (VAQTA) for prophylaxis lot # S032056, expiry date 09-NOV-2020) (exact dose, route of administration were not provided). No additional adverse event.  The  hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 47.7 degrees Farenheit for 12 minutes. Previous temperature excursion was 58.3 degrees Farenheit for 14 hours. The digital data logger was involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Skin lesion
Clinical narrative: severe and debilitating shingles, consisting of painful blisters and lesions across her body; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 19-MAR-2007, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, pt suffered severe and debilitating shingles, consisting of painful blisters and lesions across her body. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt 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. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The severe and debilitating shingles, consisting of painful blisters and lesions across her body was considered as disability by the reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effects reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-DEC-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot# R028529, expiration date 09-JUN-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis.  The administered doses of the vaccines were stored with the lowest temperature of 34.3 Fahrenheit during 4 hours. There was a digital data logger involved, but there was no previous temperature excursion. No additional adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effects reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 31-DEC-2019, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot# R028529, expiration date 09-JUN-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis.  The administered doses of the vaccines were stored with the lowest temperature of 34.3 Fahrenheit during 4 hours. There was a digital data logger involved, but there was no previous temperature excursion. No additional adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; that patient received improperly stored dose; This spontaneous report was received from a physician, referring to a patient of unknown age and gender.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant therapies was provided.  On 17-MAR-2020 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route of administration, vaccination scheme and  anatomical site of vaccination, were not reported); lot number S025609, expiration date 18-AGU-2020, as prophylaxis.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  The administered dose of the vaccine experienced a temperature excursion -5.48 degrees Celsius for 7 hours, as recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician, referring to a patient of unknown age and gender.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies was provided.  On 11-MAR-2020 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form (route of administration, vaccination scheme and  anatomical site of vaccination, were not reported); lot number S025609, expiration date 18-AGU-2020, as prophylaxis.  The used of a properly stored sterile diluent were reported.   The administered dose of the vaccine experienced a temperature excursion -5.48 degrees Celsius for 7 hours, as recorded by a data logger. There was no adverse effect reported.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Her son missed the second dose of GARDASIL 9 two months later, because of school activities and sports. And had not been able to get the second dose because of pandemic restrictions.; This spontaneous report was received from the patient's mother referring to her 17 year old male son. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     In August 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown)  for prophylaxis.   The patient´s mother reported that her son missed the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) two months later (approximatly October 2019), because of school activities and sports. And  that her son had not been able to get the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) because of pandemic restrictions.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effects reported; patinet received improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 05-MAR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and anatomical location were not reported) via unknown route of lot # S025609, with an expiry date of 18-AUG-2021 for prophylaxis (Product storage error). The concomitant medication included sterile diluent(STERILE DILUENT) which was reported to be stored properly. No additional adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius (C) to 8 degree Celsius (c)) -5.48 C for a time frame of 7 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Rash
Clinical narrative: shingles/pain in her lower back and burning rash in the lower right side and was diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. The patient was prescribed the zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-FEB-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist. She suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live(ZOSTAVAX) vaccine: pain in her lower back and burning rash in the lower right side and was diagnosed with shingles on 06-DEC-2014. She claimed compensatory damages to her for past, present, and future damages, including, but not limited to, pain and suffering for severe and permanent personal injuries sustained by patient, health and medical care costs, together with interest and costs as provided by law. At the reporting time, the outcome of shingles was unknown. The causality between the event and zoster vaccine live(ZOSTAVAX) was considered as related by lawyer and patient.   The event shingles was determined to be disabled by lawyer and patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient received improperly stored dose of varivax; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/ allergies were not reported.   On 14-MAR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) with lot # S025609 and expiry date 18-AUG-2021, 1 dosage form for prophylaxis (strength, route, anatomical location not reported) which was reconstituted with properly stored sterile diluent. No additional adverse events reported. Doses of suspect vaccines experienced temperature excursion from 15 degrees Fahrenheit (°F) to 46 °F (also reported as -9 °C to 8 °C (-5.48C)) for 7 hours. It was reported that no previous temperature excursion was done. Digital data logger was involved. No product quality complaint was involved in this report. No further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patient received improperly stored dose of VARIVAX which was administered via unspecified route.; This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, or medical history was provided. The concomitant therapy included sterile diluent. On 13-MAR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025609 and expiration date 18-AUG-2021, for prophylaxis (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent. The administered doses of the vaccine experienced a temperature excursion of -9 degree C to 8 degree C (-5.48 degree C) for 7 hours as recorded by a data logger. The vaccine did not have any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 05-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (therapy type: digital data logger) (VARIVAX), first dose, lot # S025609, expiry date reported as 18-AUG-2021 for prophylaxis (strength, frequency, route were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion, total time in the range 15 degree Fahrenheit to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) -5.48 Celsius for a time frame of 7 hours as recorded by a data logger. The vaccines had no previous temperature excursion. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patient received improperly stored dose of VARIVAX which was administered via unspecified route.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/ allergies were not reported.  On 17-MAR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) with lot # S025609 and expiry date 18-AUG-2021, 1 dosage form for prophylaxis (strength, route, anatomical location not reported) which was reconstituted with properly stored sterile diluent. No additional adverse events reported. Doses of suspect vaccines experienced temperature excursion from 15 degrees Fahrenheit (°F) to 46 °F (also reported as -9 °C to 8 °C (-5.48C)) for 7 hours. It was reported that no previous temperature excursion was done. Digital data logger was involved. No product quality complaint was involved in this report. No further information was provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: unspecified number of patients may have been administered an improperly stored dose of VARIVAX or PROQUAD on unspecified dates.; This spontaneous report was received from a Medical assistant referring to an unspecified number of patients of unknown age and gender. Information on patients' medical history, concurrent conditions and drug reactions/ allergies were not reported.      On an unknown date, the patients were vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route, anatomical location, lot # and expiration date were not reported for both the vaccines) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent. Digital data logger was involved in this report. No additional adverse event information was provided. No product quality complaint was involved in this report.  This is a non-valid report due to lack of patient identifiers and unspecified number of patients.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patient received improperly stored dose of VARIVAX which was administered via unspecified route.; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. The patient's concomitant therapy included sterile diluent. Information about pertinent medical history, concurrent condition and drug reaction/allergy was not provided.    On 20-MAR-2020, the patient was vaccinated with improperly stored 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025609, expiration date 18-AUG-2021; strength, dose detail and route was not reported) for prophylaxis (improper storage of product in use). The vaccine was exposed to temperature excursion of  15 Fahrenheit degree to 46 Fahrenheit degree (also reported as -9 Celsius degree to 8 Celsius degree) (also reported as -5.48 Celsius degree) for 7 hours. No previous temperature excursion. No additional adverse effects was reported. The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly. Data logger was involved. The outcome of the event improper storage of product in use was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patient received improperly stored dose of VARIVAX on 3/5/2020 which was administered via unspecified route.; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. On 05-MAR-2020, the patient was vaccinated with improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) therapy type : digital data logger, (lot # S025609 exp.date: 18-AUG-2021) which was reconstituted with properly stored sterile diluent via unspecified route for prophylaxis. No adverse event was reported. It was reported that the vaccine was stored at a temperature of 15 degree Fahrenheit to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) -5.48 Celsius for a time frame of 7 hours. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose; No adverse effect; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. On an unknown date, the patient received improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S025609, expiration date 18-AUG-2021 (strength, dose number, anatomical location, route of administration were unknown) for prophylaxis. Concomitant medications included sterile diluent (lot number and expiry date was unknown). The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent at a temperature of 15 degrees Fahrenheit to 46 degrees Fahrenheit or minus 5.48 degrees Celsius for a time frame of 7 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: VARZOS
Symptoms: Abscess, Blister, Cardiovascular disorder, Herpes zoster, Myocardial ischaemia
Clinical narrative: severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids; ischemia in the lateral wall of the heart; other acute cardiovascular events; severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids; The pt was vaccinated with Zostavax on or around 14-MAY-2013 and 30-SEP-2013; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 14-MAY-2013 and 30-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids. She also developed ischemia in lateral wall of the heart, as well as other acute cardiovascular events, as a result of zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (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, injury and extensive medical treatment. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the events of severe and debilitating shingles including blisters on the inside of her eyelids and ischemia in lateral wall of the heart were determined to be medically significant.