chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of M-M-R II (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005389: US-009507513-1705USA005390.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005390:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistance referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date,  the patients were vaccinated with improperly stored doses of PROQUAD lot # M043306 with expiration date 24-APR-2018 (dosage and route of administration were not reported) for prophylaxis which were reconstituted with properly stored diluent. This vaccines were exposed to temperature excursion from -14°C to -10°C for an unknown time frame because of data logger. The previous temperature excursion was -14°C to -10°C for 21 hours and 15 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004663:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# M041084, expiration date: 04-APR-2018 and lot# reported as M041509, expiration date: 09-APR-2018) (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.29 degrees Fahrenheit) for 44 hours and for 44 hours and 1 minute. Data logger was involved. There were no previous excursions reported. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006443.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N005096, expiration date 22-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 9 to 25 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, myalgias, nausea, sore throat.
Age: 1.08
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: PROJECTILE VOMITING STARTED AND CONTINUED THRU EARLY MORNING. FEVER OF 100.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Enlarged uvula, Throat tightness
Clinical narrative: Feels throat tightening, swollen uvula.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Numbness and tingling that started in both feet then moved into both legs, ribcage, and eventually both hands/fingers.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Fever, shakes, chills, mottled palms, severe body pains, and swelling, induration, redness, warmth, pain at injection site and over injected arm.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain, Pyrexia, Skin discolouration, Tremor
Clinical narrative: Fever, shakes, chills, mottled palms, severe body pains, and swelling, induration, redness, warmth, pain at injection site and over injected arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included lap band surgery. The patient had an allergy to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine(SULFA). On 10-APR-2017, the patient was routinely vaccinated with a dose of ZOSTAVAX injection, 19400 Plaque-forming units (PFU), subcutaneously in the left arm (lot # reported as M038863; expiration date 12-DEC-2017; dose was not reported) which was reconstituted with Merck sterile diluent (lot # reported as M046371; expiry date 06-JUL-2019). Concomitant therapies included terbinafine (LAMISIL) and vitamin B12. On 11-APR-2017 (reported as 24 hours after the ZOSTAVAX was administered), the patient started to experience pain, swelling and erythema at the injection site. The patient drew a circle around the injection site reaction on the left arm at that time. The patient's swelling grew to about twice the initial size after 24 additional hours (12-APR-2017). The patient sought medical attention and had an appointment with her physician on the morning of 12-APR-2017 and was prescribed oral clindamycin 300 mg, three times a day for 7 days for an unspecified diagnosis. The physician was unsure if the patient had a bacterial infection and left if up to the patient to decide if she should take the antibiotics or not. At the time of the report, it was unknown whether or not the patient took the clindamycin. At the time of report, the patient was experiencing muscle pain in her left arm from her elbow to her shoulder, and was unable to lie on the arm. No lab diagnostic studies were performed. A product quality complaint was not involved. The outcome of all events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of M-M-R II lot# reported as M00166, expiry date: 08-MAR-2018 (dose and route of administration were not provided). Sterile diluent (STERILE DILUENT) (lot #, expiry date were not provided) used to reconstitute improperly stored doses of M-M-R II was stored properly. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. Lot number M00166 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000206: US-009507513-1705USA000207: US-009507513-1705USA000205:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot#: M041213, expiry date: 22-JUN-2018 (dose and route of administration not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was not used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA003082: US-009507513-1705USA003083: US-009507513-1705USA003081.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Loss of personal independence in daily activities, Presyncope, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included coeliac disease. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, via unknown route in the left arm for prophylaxis. On unknown dates, the patient experienced activities of daily living impaired, syncope, presyncope and fatigue (which lasted for 2 months). The outcome of activities of daily living impaired, syncope, presyncope and fatigue was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since September 2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004890 with expiry date 10-NOV-2017) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M004890 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 8 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 16 hours on different days since 29-SEP-2016 to 13-FEB-2017. Maximum individual time frame was reported as 60 minutes. There was no previous temperature excursion. The call was not because of data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005436: US-009507513-1705USA005435: US-009507513-1705USA005437: US-009507513-1705USA005438: US-009507513-1705USA005439: US-009507513-1705USA005462: US-009507513-1705USA005463.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot#: M020926, expiry date: 11-AUG-2018 (dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008154: US-009507513-1705USA000206: US-009507513-1705USA000207:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant th`erapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot#: M018958, expiry date: 03-MAR-2018, orally (dose was not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008154: US-009507513-1705USA000207: US-009507513-1705USA000205:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot# M027882, expiry date: 14-APR-2019 (dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008154: US-009507513-1705USA000206: US-009507513-1705USA000205.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse and refers to a 6-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date at 2 months of age, the patient received one dose of ROTARIX and, at 4 months of age, the patient was vaccinated with another dose of ROTARIX. Then, on an unspecified date at 6 months of age, the patient received a dose of ROTATEQ orally, lot # M042172, expiration date 08-JUN-2018 (dose was not reported). No side effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 03-MAY-2017 from a licensed practical nurse regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2017 the patient was inadvertently administered an expired dose of VARIVAX (lot # K018959, expiration 15-OCT-2016) (dose not specified). No adverse effect was reported. Action taken is not applicable and the outcome and causal relationship were not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of VAQTA lot#: M033611 expiry date: 02-MAR-2018 (dose and route of administration not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was NOT used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008219: US-009507513-1705USA003082: US-009507513-1705USA003083.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot#: M031574, expiry date: 11-NOV-2018 (dose and route of administration not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was not used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008219: US-009507513-1705USA003083: US-009507513-1705USA003081.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot#: M025569, expiry date: 18-JAN-2018 (dose not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was not used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008219: US-009507513-1705USA003081: US-009507513-1705USA003082.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since September 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M018625 with expiry date 11-AUG-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M018625 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 11 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 17 hours on different days since 29-SEP-2016 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes. There was no previous temperature excursion. The call was not because of data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005436: US-009507513-1704USA014447: US-009507513-1705USA005439: US-009507513-1705USA005438: US-009507513-1705USA005437: US-009507513-1705USA005462: US-009507513-1705USA005463:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to an unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot # M028131 with expiry date 03-JUN-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M028131 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 4 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 5 hours on different days since 26-JAN-2017 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005435: US-009507513-1705USA005437: US-009507513-1705USA005438: US-009507513-1705USA005439: US-009507513-1704USA014447: US-009507513-1705USA005462: US-009507513-1705USA005463.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to an unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot # M028131 with expiry date 03-JUN-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M028131 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 4 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 5 hours on different days since 26-JAN-2017 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005435: US-009507513-1705USA005436: US-009507513-1704USA014447: US-009507513-1705USA005438: US-009507513-1705USA005439: US-009507513-1705USA005462: US-009507513-1705USA005463.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to an unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 22-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot # M028131 with expiry date 03-JUN-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M028131 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 4 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 5 hours on different days since 26-JAN-2017 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005435: US-009507513-1705USA005437: US-009507513-1705USA005436: US-009507513-1704USA014447: US-009507513-1705USA005439: US-009507513-1705USA005462: US-009507513-1705USA005463.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to an unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On an unknown date in January 2017 (reported as "26 days" before i.e. less than 4 weeks), the patient received properly stored dose of VARIVAX (dose, route, lot # and anatomical location not reported) for prophylaxis. On 02-FEB-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M028131 with expiry date 03-JUN-2018) (dose, route and anatomical location not reported) for prophylaxis (Inappropriate schedule of drug administration). Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the M-M-R II with lot # M028131 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 4 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 5 hours on different days since 26-JAN-2017 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005436: US-009507513-1705USA005435: US-009507513-1705USA005437: US-009507513-1704USA014447: US-009507513-1705USA005438: US-009507513-1705USA005462: US-009507513-1705USA005463.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates in 2017, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M039061 with expiry date 28-APR-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M039061 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 2 hours on 13-MAR-2017 and 27-MAR-2017. Maximum individual time frame was reported as 1 hour for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005439: US-009507513-1705USA005436: US-009507513-1705USA005438: US-009507513-1705USA005437: US-009507513-1705USA005435: US-009507513-1704USA014447: US-009507513-1705USA005463.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since September 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M036156 with expiry date 23-FEB-2019) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M036156 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 2 hours on 13-MAR-2017 and 27-MAR-2017. Maximum individual time frame was reported as 1 hour. There was no previous temperature excursion. The call was not because of data logger. No adverse effect were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005462: US-009507513-1705USA005438: US-009507513-1705USA005436: US-009507513-1705USA005439: US-009507513-1705USA005437: US-009507513-1704USA014447: US-009507513-1705USA005435:
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient's mom alerted me that a red skin rash had appeared on bilateral lower extremities; right leg greater than left. She states the patient wasn't itching the lesions at all and "seemed just fine."
Age: 41.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abdominal pain, Epstein-Barr virus infection, Epstein-Barr virus test positive, Exposure to vaccinated person, Influenza like illness
Clinical narrative: *Important* I was not given shots directly mom given shots 12-18-15 contact was 2nd hand as primary caregiver. Developed flu-like serious sickness 3 days after exposure. Cycle of head/chest cold, heart palpitations, pain in abdomen continued for 9 months, revealed to be Epstein-Barr. Unbearable EMF sensitivity continues now.
Age: 41.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Lower respiratory tract infection, Palpitations, Viral upper respiratory tract infection
Clinical narrative: *Important* I was not given shots directly mom given shots 12-18-15 contact was 2nd hand as primary caregiver. Developed flu-like serious sickness 3 days after exposure. Cycle of head/chest cold, heart palpitations, pain in abdomen continued for 9 months, revealed to be Epstein-Barr. Unbearable EMF sensitivity continues now.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Follow up in office afternoon after receiving Tdap and GARDASIL 9 in left arm. Swelling, redness and induration.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm, raised, red softball-sized area on the upper arm where vaccination was given. Patient reported the reaction appeared yesterday.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' drug reactions or allergies and concomitant medications were not reported. Since December 2016, the patients might have been vaccinated with unknown doses of ROTATEQ orally (lot # M034799, expiry date 01-FEB-2018), that had been improperly stored. Temperature of storage was 33 F for 40 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005756:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, multiple doses of improperly stored PROQUAD lot number reported as M041508, expiration date: 09-APR-2018 (dose and route of administration were not reported) were administered to unspecified patients. It was verified that sterile diluent used to reconstitute vaccines was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 degrees of Celsius for 105 minutes. It was reported that the vaccines experienced previous temperature excursion (not specified). Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005747:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71 year old male patient with allergy to azithromycin. The patient had no medical history. On 18-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot# M038351, expiration date: 06-DEC-2017 (dose and route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) lot# reported as M044950, expiration date: 30-MAY-2019 (dose and route of administration were not reported). The patient's had no concomitant therapies. On 20-APR-2017, the patient experienced spotted blisters throughout his body, but mainly on face and legs. No treatment for the event was commenced. No laboratory diagnostic tests were performed. The outcome of the event was reported as not recovered. The causality between the event and ZOSTAVAX was not provided. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion (temperature and time frame were unspecified). A Digital Data Logger was involved. There were many multiple previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter. Sender's Comments: US-009507513-1705USA005731.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a 23-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-MAR-2017, the patient was vaccinated with the first dose in immunization series of GARDASIL 9 injection (one dose, intramuscularly; lot# reported as LO40164, expiration date: 20-FEB-2018). On 02-MAY-2017, the patient developed shingles. It was reported, that the patient received treatment for the adverse event. She sought medical attention and visited a physician. The outcome of shingles was unknown. The relatedness between shingles and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M043310, expiration date 24-APR-2018; dose, route of administration, and frequency were not reported) for prophylaxis that were reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The vaccine data logger measured a temperature range from 6°F to 14°F for a total time frame of 30 min. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA005229:
Sex: U
Vaccine: HPV9, MMR, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, drug reactions or allergies, medical history and concomitant therapy was reported. On an unknown date in May 2017, the patient might have received one of the improperly stored lots of GARDASIL 9 (lot# M032650, expiration date 31-MAR-2019, dose and route of administration were not reported), PNEUMOVAX23 syringes (lot# M037533, expiration date 17-MAY-2017, dose and route of administration were not reported), M-M-R II (lot# M027637, expiration date 02-JUN-2018, therapy type, dose and route of administration were not reported) or ROTATEQ (lot# M038846, expiration date 26-APR-2018, orally, dose was not reported). The reporter was not sure which of the vaccines the patient received. The vaccines were stored in a temperature range from 9 to 25 degrees Celsius (20.04 degrees Celsius) for a total of 168 hours, from 01-MAY-2017 to 08-MAY-2017. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization official and refers an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23, lot # M038359 with expiry date 13-MAY-2018 and lot # M043424 with expiry date 06-JUN-2018 (exact dose and route of administration were not reported). The administered doses were exposed to the temperature between 9 and 25 degrees Celsius (11.8 degrees Celsius) for a time frame of 12.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M028553, expiration date 07-JUN-2018; dose, route of administration, and frequency were not reported) for prophylaxis that were reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The vaccine data logger measured a temperature range from 6°F to 14°F for a total time frame of 30 min. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA003310:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route of administration, lot# and expiration date were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion (temperature and time frame were unspecified). A Digital Data Logger was involved. There were many multiple previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.; Sender's Comments:  US-009507513-1705USA002847:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified multiple patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, multiple doses of improperly stored VARIVAX lot number L035128, expiration date 14-SEP-2017 and lot number M009766, expiration date 23-FEB-2018 (dose and route of administration were not reported) were administered to unspecified patients. It was verified that sterile diluent used to reconstitute vaccines was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 degrees of Celsius for 105 minutes. It was reported that the vaccines experienced previous temperature excursion (not specified). Data logger was involved.  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015034:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' drug reactions or allergies and concomitant medications were not reported. Since December 2016, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 (lot # M028323, expiry date 26-SEP-2018; route and dose were not reported). Temperature of storage was 33 F for 40 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA005775:
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Rash, Skin warm, Swelling
Clinical narrative: Rash, redness, swelling, warmth, and edema presenting 2 days after PREVNAR-13 injection that worsened over 4 days (affected area extended). Cold compresses used for treatment. Patient refused antibiotics for possible cellulitis. Reaction resolved within 1 week of the injection.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache, dizziness, redness and swelling at injection site.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-05-09.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Cholecystectomy, Fracture, Headache, Hepatomegaly
Clinical narrative: Developed severe upper respiratory systems, nodules on the skin, had a tumor removed, bone fractures, gall bladder removal, chest pains, swollen liver, swollen spleen, chronic pancreatitis.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Pancreatitis chronic, Respiratory symptom, Skin mass, Splenomegaly
Clinical narrative: Developed severe upper respiratory systems, nodules on the skin, had a tumor removed, bone fractures, gall bladder removal, chest pains, swollen liver, swollen spleen, chronic pancreatitis.