chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient could have been vaccinated with VARIVAX lot # M045204, expiration date 11-NOV-2018 or PROQUAD lot # M043310, expiration date 24-APR-2018 albumin status rHA or lot # M047303, expiration date 29-MAY-2018, albumin status rHA or lot # M048201, expiration date 05-JUN-2018, albumin status rHA; lot # N000336, expiration date 03-JUL-2018, albumin status rHA or with M-M-R II lot# L026551, expiration date 16-JUL-2017 albumin status HSA or lot # M035935, expiration date 09-AUG-2018, albumin status HSA (dose, route of administration and frequency were not provided for all vaccines). Vaccines were reconstituted with properly stored MERCK STERILE DILUENT. The temperature excursions were not reported for PROQUAD lot # M043310. All other vaccines underwent following temperature excursions: from - 0.9 to 10.6 degrees Farenheit on 02-MAY-2017 for over 38 hours, from -0.4 to 9.6 degrees Farenheit on 03-MAY-2017 for 38 hrs; from -0.9 to 8.1 on 09-MAY-2017 and from -5.6 to 7 on 10-MAY-2017 for 37 hrs; from -5.3 to 6.3 on 15-MAY-2017 for 31.5 hrs; from -6.2 to 8.2 on 19-MAY-2017 for 15 hrs; from -7.1 to 7.2 on 22-MAY-2017 and from -6.5 to 6.4 on 23-MAY-2017 for 64 hrs; from -6.2 to 9.5 on 25-MAY-2017 for 14 hrs; from -7.1 to 6.6 on 30-MAY-2017 for 86hrs. The reporter said that the patient may have received one of the improperly stored suspect therapies, but the reporter was not sure which one. There was no previous temperature excursion. The call was made because of a data logger. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX dose reported as 19400 PFU (plaque forming units) (lot number and expiration date were not reported) for prophylaxis. The dose of ZOSTAVAX was reconstituted with sterile diluent (MERCK) (dose, lot number and expiration date were not reported). On an unknown date, the patient experienced injection site rash and injection site swelling. The outcome of the events was unknown. The relatedness between the events and the suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a three unspecified patients of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # M039453 with expiration date at 19-DEC-2017; for prophylaxis) reconstituted with sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and medical assistant and refers to a patient of unknown age and gender. On 15-JUN-2017, the patient was vaccinated with one dose of expired GARDASIL lot # M014929 (expiration date 27-MAY-2017) for prophylaxis. No adverse effects was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: This spontaneous report was received from a retired physician of unknown age via a company representative, referring to himself. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were unknown to the reporter. On an unknown date, approximately in 2009 (reported as 8 years ago) the patient was vaccinated with ZOSTAVAX (dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) to prevent shingles. On an unknown date, approximately in 2015 (reported as about a year or two ago) the patient experienced "prodrome" of shingles "without rash". The symptoms included pain and numbness. On an unknown date (reported as presently), the patient experienced "prodome" of shingles without "rash". The symptoms included pain and numbness. The patient treated himself with VALTREX (dosing details unspecified). It was unknown if laboratory diagnostics were performed. It was unknown if the patient sought any medical attention. The outcome of the events (first occurrence) was unknown and the outcome of events on second occurrence was not recovered (reported as presently experiencing). The causality assessment was not provided by the reporting physician. There was no product quality complained involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to an unspecified patient (pharmaceutical representative of other company) of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot # and expiration date unknown) for prevention of shingles. Three days later, the patient developed "shingles".  No symptoms were provided. No further patient details captured. The outcome of the event was unknown.  Causality assessment was not provided. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: FLUX, HEP
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a female patient of unknown age, who was a licensed practical nurse. The patient referred to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient received "numerous" booster doses of RECOMBIVAX HB (route and site of administration, lot# and expiration date were not reported) due to unspecified reasons. Other suspect therapies included influenza virus vaccine (unspecified) (route and site of administration, lot# and expiration date were not reported). On an unknown date, after she received an unspecified influenza virus vaccine, she developed "worse than normal flu-like" symptoms. The outcome of the event and the relatedness between the event and RECOMBIVAX HB were not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007288.
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age.   On an unknown date in 2010 the, patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On an unknown date, the patient experienced arthritis and was treated with adalimumab (HUMIRA). The outcome of arthritis was unknown. Relatedness between arthritis and ZOSTAVAX was not reported. Additional information is not expected, because reporting patient refused to reveal her physician's contact details.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # M025186 with the expiration date of 18-MAY-2018 and lot # M032486 with the expiration date of 06-JUL-2018 (dose, route and site of administration were not reported), FOR PROPHYLAXIS. The administered doses of M-M-R II underwent a temperature excursion between 9 and 25 Celsius degrees (average 10.8 Celsius degrees) for 20 minutes. Digital Data Logger was involved. No adverse events were reported.  This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-00957513-1705USA005160:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II lot # L020189 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On 08-JUN-2017 the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to M-M-R II. 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 medical assistant refers to four patients of unknown age and gender. There was no information about the patients' concurrent conditions and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M043581 with expiration date on 28-OCT-2018 (dose and route of administration were not reported). Properly stored doses of sterile diluent (MERCK) were used to reconstitute the doses of VARIVAX. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 1702 hours. Data logger was used to record the temperature excursion. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current conditions, medical history, drug history and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with ZOSTAVAX of lot/batch #N012492, expiration date:17-MAR-2017 (strength, dose and route of administration were not reported) for routine vaccination at a time that may have corresponded with a temperature excursion (incorrect product storage). Other suspect therapies included sterile diluent(STERILE DILUENT) (ZOSTAVAX Diluent) of lot/batch#M047667, expiration date: 25-JUL-2017 used for the dilution of ZOSTAVAX. The pharmacist reported that per pharmacy policy, the patient was observed for 15 minutes and did not experience an adverse reaction. The reporter declined to provide relevant laboratory data. It was reported that the patient might have also received prevnar during that visit. As of 21-JUN-2017, it was unknown if the patient continued to receive ZOSTAVAX. The outcome of incorrect product storage and no adverse event was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 67-year-old female patient. No information regarding the patient's medical history and drug reactions or allergies was provided. In April or May 2017, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (lot number and expiration date were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) (reported as "water sterile diluent"). On the same day (reported as "hours after administration"), the patient developed a rash around the injection site, which on the next day spread towards the patient's chest. The events were treated with an unspecified dose of prednisone (manufacturer unknown). The patient recovered from the events on an unspecified date in 2017. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
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 and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # reported as M044030 with expiration date on 13-JUN-2018 (dose was not reported). There was no adverse effect reported. Administered doses of the vaccine experienced the temperature excursion of 70 degrees Fahrenheit for 1 hour. Data logger was not involved in recording of the temperature excursion. There were no previous excursions reported. This is one of the several reports received from the same reporter. Additional information is not expected as there was no permission for further contact. Sender's Comments: US-009507513-1706USA010617: US-009507513-1706USA010618.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # M041990 with expiration date on 28-JUN-2019 and lot # M042853 with expiration date on 17-JUL-2019 (dose was not reported). There was no adverse effect reported. Administered doses of the vaccine experienced the temperature excursion of 70 degrees Fahrenheit for 1 hour. Data logger was not involved in recording of the temperature excursion. There were no previous excursions reported. This is one of the several reports received from the same reporter. Additional information is not expected as there was no permission for further contact. Sender's Comments: US-009507513-1706USA010605: US-009507513-1706USA010618.
Sex: U
Vaccine: HEP
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 and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # N002202 with expiration date on 04-NOV-2019 (dose was not reported). There was no adverse effect reported. Administered doses of the vaccine experienced the temperature excursion of 70 degrees Fahrenheit for 1 hour. Data logger was not involved in recording of the temperature excursion. There were no previous excursions reported. This is one of the several reports received from the same reporter. Additional information is not expected as there was no permission for further contact.; Sender's Comments: US-009507513-1706USA010605: US-009507513-1706USA010617:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000439: US-009507513-1707USA000440: US-009507513-1707USA000441: US-009507513-1707USA000442: US-009507513-1707USA000443:
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced antibody test negative. The outcome of antibody test negative was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M035694, expiration date 07-NOV-2017 for prophylaxis (dose, route and site of administration were not reported). The dose experienced a temperature excursion of 6 to 14 degrees Fahrenheit for 22 minutes. There were previous excursions of 6 to 14 degrees Fahrenheit for 25 minutes and 15 to 46 degrees Fahrenheit for 5 minutes. The Data Logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 4 month old male patient. No information on patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2017, the patient was vaccinated with the first dose of ROTATEQ, oral (dose, lot #, expiry date were not provided) for the prevention of rotavirus gastroenteritis and it was well tolerated. On 22-JUN-2017, the patient was vaccinated with the second dose of ROTATEQ lot # M044395, expiry date: 31-MAY-2018 and vomited immediately afterward. The patient did not receive any treatment. No further adverse effects and no product quality issue were reported. The outcome of vomiting was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was 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 an unknown date, the dose of PROQUAD lot # M042501 with expiration date on 17-APR-2018, therapy type, dose, route and site of administration were not reported) was reconstituted with 0.5 ml of sterile water (manufacturer unknown) (lot# reported as 610104P expiration date on 1-JAN-2019) and administered to an unspecified patient. The final volume of PROQUAD administered to the patient was unknown by the reporter. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 75 year old male patient with no pertinent medical history and no drug reactions/allergies. In approximately 2013, reported as 'four to five years ago', the patient was vaccinated with a dose of ZOSTAVAX, dose, route and lot # not reported. Concomitant therapies included sterile diluent. On 24-JUN-2017, the patient had a slight rash and on 25-JUN-2017 the rash was more pronounced. The patient was diagnosed with shingles on 26-JUN-2017. There were no lab tests done. An unspecified treatment was given for the patient. The outcome of shingles was unknown. The relatedness between event and suspect therapy was not reported. Additional information is not expected as the reporter declined to provide demographics for her husband or his physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M016193 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1707USA000601: US-009507513-1707USA000599: US-009507513-1707USA000600.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager 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 26-JUN-2017, the patient was vaccinated with expired dose of GARDASIL lot # K010215, expiration date 05-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000440: US-009507513-1707USA000441: US-009507513-1707USA000442: US-009507513-1707USA000443.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000441: US-009507513-1707USA000442: US-009507513-1707USA000443:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000440: US-009507513-1707USA000442: US-009507513-1707USA000443.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000440: US-009507513-1707USA000441: US-009507513-1707USA000443:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000440: US-009507513-1707USA000441: US-009507513-1707USA000442.
Sex: U
Vaccine: MMR
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. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot M004063 exp 25-JAN-2018, lot M035935 exp 09-AUG-2018) exposed to 47°F to 77°F for 20 hours. No adverse event was reported. No data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002111:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a nurse who reported that on unknown dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot numbers, expiration dates, dosages, and routes of administration unknown). No adverse effects reported. Excursion information: Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit Time frame: 1 hour 40 minutes Previous temperature excursion: No Involved "data logger"? Yes No further information provided. This a one of several reports received from the same source. Telephone call attempt on 22-MAY-2017 to obtain follow-up information was unsuccessful. Follow up information has been received from the reporting nurse (also reported as a certified medical assistant (CMA)) on 12-JUN-2017. It was reported that the temperature on the refrigerator was too cold for 5 days. The minimum temperature was ranging from 34 degrees Fahrenheit to 35 degrees Fahrenheit between these days. The maximum temperature was 42 degrees Fahrenheit. And the temperature when discovered on 25-APR-2017 at 12:45 pm was 40 degrees Fahrenheit. The dating was never notified by an alarm going off as the reporter was assuming the average time the temperature was cold was no longer the 20 min for each occasion (due to delay limit on "Tempguard" system (20 min delay), it was received from the system, all excursions were 20 minutes). Refrigerator was taped that no one was allowed to use any vaccines until each manufacturer was called to make sure. The reporter called the manufacturers seeking information about use the vaccines in the refrigerator. All companies stated vaccines were okay to still be used, with exception of opened vials, which were discarded.; Sender's Comments: US-009507513-1707USA000473: US-009507513-1707USA000474: US-009507513-1704USA013562:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a nurse who reported that on unknown dates, multiple unspecified patients were vaccinated with improperly stored VAQTA (lot numbers, expiration dates, dosages, and routes of administration unknown). No adverse effects reported. Excursion information: Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit Time frame: 1 hour 40 minutes Previous temperature excursion: No Involved "data logger"? Yes No further information provided. This a one of several reports received from the same source. Telephone call attempt on 22-MAY-2017 to obtain follow-up information was unsuccessful. Follow up information has been received from the reporting nurse (also reported as a certified medical assistant (CMA)) on 12-JUN-2017. It was reported that the temperature on the refrigerator was too cold for 5 days. The minimum temperature was ranging from 34 degrees Fahrenheit to 35 degrees Fahrenheit between these days. The maximum temperature was 42 degrees Fahrenheit. And the temperature when discovered on 25-APR-2017 at 12:45 pm was 40 degrees Fahrenheit. The dating was never notified by an alarm going off as the reporter was assuming the average time the temperature was cold was no longer the 20 min for each occasion (due to delay limit on "Tempguard" system (20 min delay), it was received from the system, all excursions were 20 minutes). Refrigerator was taped that no one was allowed to use any vaccines until each manufacturer was called to make sure. The reporter called the manufacturers seeking information about use the vaccines in the refrigerator. All companies stated vaccines were okay to still be used, with exception of opened vials, which were discarded.; Sender's Comments: US-009507513-1704USA013562: US-009507513-1707USA000474: US-009507513-1707USA000472:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a nurse who reported that on unknown dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ (lot numbers, expiration dates, dosages, and routes of administration unknown). No adverse effects reported. Excursion information: Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit Time frame: 1 hour 40 minutes Previous temperature excursion: No Involved "data logger"? Yes No further information provided. This a one of several reports received from the same source. Telephone call attempt on 22-MAY-2017 to obtain follow-up information was unsuccessful. Follow up information has been received from the reporting nurse (also reported as a certified medical assistant (CMA)) on 12-JUN-2017. It was reported that the temperature on the refrigerator was too cold for 5 days. The minimum temperature was ranging from 34 degrees Fahrenheit to 35 degrees Fahrenheit between these days. The maximum temperature was 42 degrees Fahrenheit. And the temperature when discovered on 25-APR-2017 at 12:45 pm was 40 degrees Fahrenheit. The dating was never notified by an alarm going off as the reporter was assuming the average time the temperature was cold was no longer the 20 min for each occasion (due to delay limit on "Tempguard" system (20 min delay), it was received from the system, all excursions were 20 minutes). Refrigerator was taped that no one was allowed to use any vaccines until each manufacturer was called to make sure. The reporter called the manufacturers seeking information about use the vaccines in the refrigerator. All companies stated vaccines were okay to still be used, with exception of opened vials, which were discarded.; Sender's Comments:  US-009507513-1707USA000473: US-009507513-1704USA013562: US-009507513-1707USA000472:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX lot # M045204, expiration date 11-NOV-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the VARIVAX underwent a temperature excursion between 15 to 46 Fahrenheit degrees for 24 hours. The temperature excursion was captured using a digital data logger. No previous temperature excursion was reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1705USA013050:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered no adverse event to be not related to GARDASIL 9, PNEUMOVAX 23, VAQTA and RECOMBIVAX HB. The reporter considered incorrect product storage to be not related to VAQTA, RECOMBIVAX HB, GARDASIL 9 and PNEUMOVAX 23. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000480: US-009507513-1707USA000481: US-009507513-1706USA005951:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005951: US-009507513-1707USA000481: US-009507513-1707USA000479.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.    Additional information has been requested.; Sender's Comments: US-009507513-1707USA000480: US-009507513-1706USA005951: US-009507513-1707USA000479:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA000509: US-009507513-1707USA000510: US-009507513-1707USA000511: US-009507513-1705USA009596.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA000510: US-009507513-1705USA009596: US-009507513-1707USA000511: US-009507513-1707USA000508.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patient of unknown age and gender. On an unknown date the patient was vaccinated with hepatitis a vaccine, inactivated(HEPATITIS A VACCINE, INACTIVATED) for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to Hepatitis A Vaccine, Inactivated(HEPATITIS A VACCINE, INACTIVATED).    This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA000508: US-009507513-1707USA000509: US-009507513-1705USA009596: US-009507513-1707USA000511:
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with hepatitis b vaccine (recombinant)(HEPATITIS B VACCINE (RECOMBINANT)) for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown.  The reporter considered incorrect product storage and no adverse event to be not related to Hepatitis B Vaccine (Recombinant)(HEPATITIS B VACCINE (RECOMBINANT)). This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1707USA000510: US-009507513-1707USA000509: US-009507513-1705USA009596: US-009507513-1707USA000508:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event, Poor quality drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # L039660 for prophylaxis. On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB).; Sender's Comments:  US-009507513-1706USA005754: US-009507513-1707USA000534: US-009507513-1707USA000535: US-009507513-1707USA000536:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1707USA000533: US-009507513-1706USA005754: US-009507513-1707USA000535: US-009507513-1707USA000536.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event, Poor quality drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II lot # M008588 for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to M-M-R II.; Sender's Comments: US-009507513-1707USA000533: US-009507513-1707USA000534: US-009507513-1706USA005754:  US-009507513-1707USA000536:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event, Poor quality drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age.  On an unknown date the patient was vaccinated with ROTATEQ lot # M040270 for prophylaxis.     On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to ROTATEQ.; Sender's Comments:  US-009507513-1707USA000533: US-009507513-1707USA000534: US-009507513-1707USA000535: US-009507513-1706USA005754:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M010212 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1707USA000600: US-009507513-1707USA000601: US-009507513-1707USA000155.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # M038846, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.  Additional information has been requested.; Sender's Comments: US-009507513-1707USA000155: US-009507513-1707USA000601: US-009507513-1707USA000599:
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 63 year old patient of an unknown gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided. On 21-JUN-2017, the patient was vaccinated with an expired first dose of PNEUMOVAX 23 lot # L048265 exp. 10-JUN-2017 for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # L038669 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.    Additional information has been requested.; Sender's Comments: US-009507513-1707USA000600: US-009507513-1707USA000155: US-009507513-1707USA000599:
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Axillary pain, Hypoaesthesia, Swelling
Clinical narrative: Underarm pain, swelling, r hip pain and r foot numbness.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Are is red and warm, tender to touch, approx.  8.5 cm in diameter with moderate elevation.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report ws received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 19-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis Lot number M001746 and expiration date 07-APR-2017 (dose and route of administration, were not reported) . Concomitant therapies included sterile diluent(STERILE DILUENT).   No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. The patients concurrent conditions, medical history and concomitant medication were not reported. On 15-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 as prophylaxis, lot number reported as L033707 and expiration date 18-MAY-2017 (dose, frequency, route and anatomical location were not reported). No adverse events were reported. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a public health nurse referring to an ubnknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with incorrect storage dose of LIQUID PEDVAXHIB for prophylaxis (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). The reporter had no knowledge of whether any patients had any adverse effects after receiving the vaccine. It was stated that the vaccines underwent a temperature excursion of 12.5  degrees Celsius for 6 hours 54 minutes. Previous temperature excursion were not reported. The call was because of a "data logger". No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This spontaneous report was received from a nurse referring to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis (strength, route, frequency, lot/batch # and expiration date were not reported). Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age. No information was provided regarding the patient's medical history. Concurrent conditions included anxiety, for which she was being treated with an unspecified anxiety medication. On 20-JUN-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramsucularly, for prophylaxis (dose, lot number and expiration date were not provided). On the same date, the patient experienced dizziness. The patient sought medical attention and the physician had the patient lay down. The patient recovered from the event on 20-JUN-2017. The reporter did not provide a causal relationship between the event dizziness and therapy with GARDASIL 9. No product quality complaint was filed.