chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 73-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 07-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 79.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 79-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 07-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information abour the availabiity; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 85.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 85-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 11-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 67.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 67-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 22-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005409:
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 76-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 12-FEB-2020, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407 and 2003USA005408.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408:
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Product use in unapproved indication
Clinical narrative: Pneumovax used for pneumonia; This spontaneous report has been received from a lawyer referring to a 69 year old female patient. Historical medications included lidocaine (LIDODERM), zoster vaccine live (ZOSTAVAX), olopatadine hydrochloride (PATANOL), nystatin, alendronate sodium, escitalopram oxalate (LEXAPRO), tramadol hydrochloride, desoximetasone, calcium carbonate (OYSCO) and etodolac. The patient's medical history included carpal tunnel, disability, left shoulder replacement, bone disorder, familial risk factor and arrhythmia. Family history included type 2 diabetes (sister, nephew, daughter), hyperglycemia (sister, nephew, daughter), high cholesterol (mother), hypertension (father, mother, daughter), heart attack (mother, aunt), stroke (mother, aunt), obesity (father, mother, aunt, daughter), loss of vision, blindness, alcoholism. The patient's concurrent conditions included tobacco user, alcohol use, hypertension, drug allergy (penicillin and naproxen sodium (ALEVE)), high cholesterol, depression and diabetes mellitus. Concomitant therapies included simvastatin (manufacturer unknown), omeprazole, gabapentin, metoprolol, lisinopril (manufacturer unknown), escitalopram, lorazepam, fluticasone, amlodipine besylate, hydrochlorothiazide, acetaminophen (+) hydrocodone bitartrate, terconazole and ondansetron.    On 16-OCT-2013 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, strength, batch/lot# and expiration date were unknown) for pneumonia (product use in unapproved indication).        The case is linked to case# US-009507513-2001USA010186 due to the same patient.; Sender's Comments:  US-009507513-2001USA010186:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: received a dose of GARDASIL 9 on an unspecified date while pregnant.; This spontaneous prospective pregnancy report was received from a nurse referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On an unknown date the patient was received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis while pregnant (exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was outcome pending. The fetal outcome was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 2/14/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions and allergies was not provided.  On 14-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error); (therapy type: Digital Data Logger), lot number 1660112 and expiration date 18-OCT-2020 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at a temperature of 2 degree Celsius (1.28 Celsius) for a timeframe of 2 hours and 30 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.  No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered 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 06-MAR-2020, the patient was vaccinated with dose one of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) administered oraly as prophylaxis (lot number 1660942 has been verified to be valid, expiration date reported and validated as 06-FEB-2021). No additional adverse effect reported.  The temperature of multiple excursions was reported below 2 degrees Celsius (1.28 degrees Celsius) for 2 hours and 30 hours. No previous temperature excursions reported, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842: US-009507513-2003USA005829: US-009507513-2003USA005831: US-009507513-2003USA005884: US-009507513-2003USA005892: US-009507513-2003USA005901: US-009507513-2003USA005908: US-009507513-2003USA005910: US-009507513-2003USA005916: US-009507513-2003USA005917: US-009507513-2003USA005942: US-009507513-2003USA005946: US-009507513-2003USA005962: US-009507513-2003USA005967: US-009507513-2003USA005983: US-009507513-2003USA005996:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; one dose of improperly stored VARIVAX was administered to the patient on 3/11/2020.; This spontaneous report has been received from an office manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided. The sterile diluent (MERCK STERILE DILUENT) was considered a concomitant medication.  On 11-MAR-2020, the patient received an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (therapy type: Digital Data Logger), lot number S021322 and expiration date 09-JUL-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided). The sterile diluent (MERCK STERILE DILUENT) used for the reconstitution of the vaccine was properly stored.  The vaccine was stored at a temperature of -8.3 Celsius for a timeframe of 24 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This is one of the cases from the same reporter.; Sender's Comments:  US-009507513-2003USA005878:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information provided.; patient was administered a dose of Prevnar 13 on 2/11/2020 and was administered a dose of PNEUMOV AX 23 on 3/13/2020.; This spontaneous report was received from a registered nurse and refers to a 41-year-old female patient. The patient's concurrent conditions included lupus, rheumatoid arthritis (RA), hypertension, deep vein thrombosis (DVT), and gastrooesophageal reflux disease (GERD). The patient's medical history, concomitant medications, and drug reactions or allergies were not reported.  On 11-FEB-2020, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, route of administration, lot number, and expiration date were not provided) for an indication not provided.  On 13-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular injection (dose, frequency, lot number, and expiration date not reported), as "preventative" since the patient was at "high risk" because of her concurrent conditions (inappropriate schedule of product administration). No additional adverse event information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose administered; 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, concomitant medications, drug reactions and allergies were unknown. On 03-MAR-2020, the patient received an expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R006220, expiration date 29-FEB-2020 (dose, route, anatomical location were unknown) for prophylaxis. Other suspect therapies included sterile diluent (lot# S005087, expiration date 30-SEP-2021). No adverse events reported. No product quality complaint (PQC) involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; improperly stored vaccine was administered; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 03-MAR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) one dose orally for prophylaxis (lot # 1660942, expiration date reported as 06-FEB-2021, strength was not reported) (product storage error). No adverse effects were reported. The nurse reported that the vaccines underwent multiple temperature excursions below 2 degree Celsius (1.28Celcius) for a time frame of 2 hours and 30 hours as recorded by a data logger. The vaccines had no previous temperature excursion. No product quality complaint was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improper product storage; No adverse event; 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, concomitant medications, drug reactions and allergies were unknown. On 20-FEB-2020, the patient received a dose of improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose with lot # 1660112, expiration date 18-OCT-2020 (anatomical location, route of administration was unknown) for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at multiple temperature excursions of below 2 degrees Celsius (1.28 degree Celsius) for a time frame of 2 hours and 30 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: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; the patient was inadvertently administered a dose of varivax that had been improperly stored; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported.      On 10-MAR-2020, the patient was inadvertently administered an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) lot # S021322 and expiry date 09-JUL-2021 for prophylaxis (strength, route, anatomical location not reported). The vaccine was reconstituted with properly stored sterile diluent (lot # and expiry date not reported). The time frame for multiple temperature excursions was -8.3 degrees celsius (°C) for 24 minutes. It was unknown if any previous temperature excursion was done. Data logger was involved. No adverse effects reported. No product quality complaint was involved in this report.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product; No adverse event; 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, concomitant medications, drug reactions and allergies were unknown. On 06-FEB-2020, the patient received a dose of improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose with lot # 1660112, expiration date 18-OCT-2020 (anatomical location was unknown) via oral route for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at multiple temperature excursions of below 2 degrees Celsius (1.28 degree Celsius) for a time frame of 2 hours and 30 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: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-FEB-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose detail were not reported) (lot # 1660112, expiration date 18-OCT-2020) orally for prophylaxis, which was reported as improperly stored (temperature below 2 degrees Celsius (1.28 degrees Celsius) multiple excursions, time frame was 2 hours and 30 minutes) (product storage error). There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. No PQC was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 05-MAR-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose detail were not reported) (lot # 1660942, expiration date 06-FEB-2020) orally for prophylaxis, which was reported as improperly stored (temperature below 2 degrees Celsius (1.28 degrees Celsius) multiple excursions, time frame was 2 hours and 30 minutes) (product storage error). There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. No PQC was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; a dose of expired PROQUAD was administered to an unspecified patient; Information has been received from an healthcare worker via field representative, referring to a 4 years old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 13-MAR-2020, the patient was vaccinated with a dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route and dose detail were not reported) (lot # R024020, expiration date 19-FEB-2020) for prophylaxis (expired product administered). It was unknown by the field representative if the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and sterile diluent (STERILE DILUENT) used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent any temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 2/21/2020 patient received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 21-FEB-2020, the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660112 and expiration date 18-OCT-2020; strength and dose detail were unknown) orally for prophylaxis. The vaccine was exposed to temperature excursion below 2 degrees Celsius (1.28 degrees Celsius) for 2 hours and 30 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 2/18/2020 patient received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 18-FEB-2020, the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660112 and expiration date 18-OCT-2020; strength and dose detail were unknown) orally for prophylaxis. The vaccine was exposed to temperature excursion below 2 degrees Celsius (1.28 degrees Celsius) for 2 hours and 30 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 14-FEB-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660112, expiration date: 18-OCT-2020, orally for prophylaxis. There was no additional adverse effect reported. Administered dose of vaccine was stored below 2 Celsius degrees (1.28 Celsius degrees) for 2 hours and for 30 hours as recorded by digital data logger.  Previous temperature excursion was not noted.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient was administered an improperly stored dose of ROTATEQ; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported.  On 12-MAR-2020, the patient was vaccinated with improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660958, expiration date: 23-FEB-2021, orally for prophylaxis. Administered dose of vaccine was stored in the lowest temperature below 36 Fahrenheit degrees (31.44 Fahrenheit degrees) for 6 hours and 33 minutes, as recorded by a digital data logger. There was no previous temperature excursion noted. No additional adverse event information provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Nurse referring to a patient of an unknown age and gender. Information on patient's medical history, concurrent condition, drug allergies/reactions and concomitant medications were not reported. On 18-FEB-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (dose: 1 dose, strength, frequency, route not reported) lot # 1660112, expiry date: 18-OCT-2020 for prophylaxis. The vaccine was stored at a temperature of below 2 degree Celsius(1.28 degree Celsius) for 2 hours and 30 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 3/5/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660942, expiration date 06-FEB-2021 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse effect reported. No product quality complaint. The vaccine experienced multiple temperature excursions below 2 degrees Celsius (1.28C) for 2 hours and 30 hours. There was no previous temperature excursion. There was data logger involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effect; patient received a dose of improperly stored rotateq; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 03-JAN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, dose number, lot # and expiration date were not provided) for prophylaxis. On 02-MAR-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660942 with expiration date 06-FEB-2020 (exact dose and dose number were not provided) for prophylaxis.   The multiple temperature excursions were below2 Celsius degrees (C) (1.28 C) for 2 hours and 30 hours. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 2/10/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-FEB-2020 ,the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660112, expiration date 18-OCT-2020 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse effect reported. No product quality complaint. The vaccine experienced multiple temperature excursions below 2 degrees Celsius (1.28C) for 2 hours and 30 hours. There was no previous temperature excursion. There was data logger involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vacine in use; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported.  On 04-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1660942, expiry date: 06-FEB-2021 for prophylaxis (strength, dose number, anatomical location, route was not reported) (product storage error). It was reported that the vaccine was exposed to a multiple temperature excursion of below 2 degree Celsius (1.28 C) for a time frame of 2 hours and 30 hours. There was no previous temperature excursion reported. Data logger was involved. No adverse events reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; fue patient was inadvertently administered a dose of V ARIV AX fuat had been improperly stored; This spontaneous report was received from a practice manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 10-MAR-2020, the patient was vaccinated with a dose of improperly stored dose varicella virus vaccine live (oka/merck)(VARIVAX) ) injection, lot # S021322, expiration date 09-JUL-2021 (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No additional adverse event was reported.  On an unknown date, the temperature excursion was (-8.3) degrees Celsius, for a time frame of 24 minutes. There was not reported if previous temperature excursion occurred. The digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Neuropathy peripheral
Clinical narrative: hearing loss; neuropathy; shingles; Information has been received from a lawyer, concerning a case in litigation and refers to patient of an unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. In or around March 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss, neuropathy and shingles. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's 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 of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.   The reporter considered the events of hearing loss, neuropathy and shingles were considered to be disabling. Upon internal review, the events of hearing loss and neuropathy were determined to be medically significant.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; One female patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a vaccine coordinator, concerning a 6 months-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 05-MAR-2020, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (product storage error) (lot number 1658255 has been verified to be a valid number; expiration date reported and validated as 07-FEB-2021) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The reporter stated that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius.  On 02-MAR-2020, the temperature was 0.8 degrees Celsius for a time frame of 5 hours and 9 minutes, on 04-MAR-2020, the temperature was 0.9 degrees Celsius for 11 hours; and on 05-MAR-2020, the temperature was minus 1.3 degrees Celsius for 9 hours and 29 minutes as recorded by the data logger.  Other temperature excursions occurred on 25-FEB-2020 and the temperature was above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours and 33 minutes and on 03-MAR-2020, the temperature was below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours and 39 minutes, also recorded by the data logger.   No adverse effects were reported.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA006325: US-009507513- 2003USA006317:
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; One male patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a vaccine coordinator, concerning a 7 months-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 27-FEB-2020, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (product storage error) (lot number 1658255 has been verified to be a valid number; expiration date reported and validated as 07-FEB-2021) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The reporter stated that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius.  On 02-MAR-2020, the temperature was 0.8 degrees Celsius for a time frame of 5 hours and 9 minutes, on 04-MAR-2020, the temperature was 0.9 degrees Celsius for 11 hours; and on 05-MAR-2020, the temperature was minus 1.3 degrees Celsius for 9 hours and 29 minutes as recorded by the data logger .   Other temperature excursions occurred on 25-FEB-2020 and the temperature was above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours and 33 minutes and on 03-MAR-2020, the temperature was below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours and 39 minutes, also recorded by the data logger.   No adverse effects were reported.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA006325: US-009507513- 2003USA006305:
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; one male patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a vaccine coordinator, concerning a 7 months-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 02-MAR-2020, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (product storage error) (lot number 1658255 has been verified to be a valid number; expiration date reported and validated as 07-FEB-2021) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The reporter stated that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius.  On 02-MAR-2020, the temperature was 0.8 degrees Celsius for a time frame of 5 hours and 9 minutes, on 04-MAR-2020, the temperature was 0.9 degrees Celsius for 11 hours; and on 05-MAR-2020, the temperature was minus 1.3 degrees Celsius for 9 hours and 29 minutes as recorded by the data logger.    Other temperature excursions occurred on 25-FEB-2020 and the temperature was above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours and 33 minutes and on 03-MAR-2020, the temperature was below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours and 39 minutes, also recorded by the data logger.   No adverse effects were reported.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513- 2003USA006305: US-009507513- 2003USA006317:
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; a dose of PNEUMOVAX was given to a patient via the intravenous route; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 16-MAR-2020, an unknown dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot number R030140 and expiration date 07-AUG-2020) was administered to the patient via the intravenous route. No known adverse effects.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reports; one male patient was administered improperly stored ROTATEQ; Information has been received from a vaccine coordinator referring to a 7 months old male patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 25-FEB-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral; lot number 1658255, expiration date 07-FEB-2021; strength, dose and frequency unknown) for prophylaxis (product storage error).   The storage temperature of the vaccine was above 9 degree Celsius (9.3 degree Celsius) for a time frame of 3 hours 33 minutes on 25-FEB-2020. It was also reported that the storage temperature was below 2 degree Celsius (0.8 degree Celsius) for 5 hours 9 minutes on 02-MAR-2020, below 2 degree Celsius (0.8 degree Celsius) for 11 hours 39 minutes on 03-MAR-2020, below 2 degree Celsius (0.9 degree Celsius) for 11 hours on 04-MAR-2020 and below 2 degree Celsius (-1.3 degree Celsius) for 9 hours and 29 minutes on 05-MAR-2020. The call was because of a data logger. No additional adverse effects were reported.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm. This case is link with case US2020028073, reported by same reporter. Reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: I have all the not severe' side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient had all the not severe side effects. The patient enquired how long did the Shingrix side effects last. The permission to follow up was denied.