chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to unspecified patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unspecified date since September 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (anatomical route of vaccination was not provided) for prophylaxis. It was reported that on 17-OCT-2016, GARDASIL 9 with lot # M023169 with expiration date on 13-JUN-2018, was exposed to a temperature excursion of 47°F to 77°F for 1 hour time range for 1 cycle. Subsequently on 18-OCT-2016, it was exposed to a temperature excursion of 32°F to 35°F for 30 minutes. On 18-JAN-2017, GARDASIL 9 with lot # L037554 with expiration date on 25-DEC-2017 and lot # M036059 with expiration date on 03-JUN-2019, were exposed to a temperature excursion of 32°F to 35° for 30 minutes. On 20-FEB-2017, the vaccines with lot # L037554, lot # M023169 and also lot # M036059 with expiration date on 03-JUN-2019 were exposed to a temperature excursion of 32°F to 35°F for 1 hour and 30 minutes time frame. On 26-APR-2017, 31-MAY-2017 and 19-JUN-2017, GARDASIL 9 with lot # M043731 with expiration date on 22-JUN-2019 and lot # N002720 with expiration date on 12-MAY-2019 were exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. It was also reported, that the lowest temperature excursion was of 34.3°F and the highest of 46.6°F. Information was provided due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000714: US-009507513-1707USA000715: US-009507513-1707USA000716.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was received from a 63 year old male consumer referring to himself. Medical history, concurrent conditions and concomitant medications were not provided.  He was allergic to penicillin. On an unspecified date, the patient received ZOSTAVAX at a pharmacy (dose, route and lot # not provided) because he did not want to get shingles. On 14-JUN-2017, he was diagnosed with shingles at an urgent care facility. The patient stated the shingles was not an immediate reaction. He received unspecified treatment. The outcome of the shingles was unknown. The patient requested reimbursement for the cost of the ZOSTAVAX and also threatened to get a lawyer and contact his local newspapers. Additional information is not expected as the patient did not provide consent to followup.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 year old patient. On 20-JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M020103 dose 2 for prophylaxis. On 20-JUN-2017 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9. {Additional information has been requested. Additional information is not expected.}
Sex: U
Vaccine: MMRV
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 PROQUAD lot # M048201, subcutaneous for prophylaxis. Concomitant therapies included 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 PROQUAD. {Additional information has been requested. Additional information is not expected}. Sender's Comments: US-009507513-1706USA009372.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 21 year old female patient. On 21-JUN-2017 the patient was vaccinated with an expired dose of GARDASIL 9 lot # M014929, expiration date 27-MAY-2017, dose 2 for prophylaxis. No adverse event or product quality complaint was reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender. The patient received the first dose of GARDASIL 9, lot L007495 expiration date 24-FEB-2017, on 19-JUN-2015 when the patient was 14 years old and the second dose, lot M044717 and expiration date 19-JUL-2019 on 11-APR-2017 (inappropriate schedule of drug administration). No adverse events and no product quality complaint were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUN-2017 the patient was vaccinated with VARIVAX lot # N001528, subcutaneous for prophylaxis. Other suspect therapies included PROQUAD. Concomitant therapies included sterile diluent. On an unknown date the patient experienced accidental overdose and no adverse event. The outcome of accidental overdose is unknown. The reporter considered accidental overdose to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown demographics. Information regarding the patients' pertinent medical history, and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly doses of VARIVAX which had a lot # M042495 and expiration date 19-OCT-2018 (dose, anatomical location and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored DILUENT MRK injection. The doses of VARIVAX were exposure to a temperature excursion from -14 Celsius degree to -10 Celsius degree, during a time frame of 1 hour 19 minutes, which was called by a data logger. There was not previous temperature excursions. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to a patient of unknown gender and age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 19-JUN-2017, the patient was inadvertently vaccinated with one expired dose of GARDASIL 9 lot # L004014 with expiration date on 04-MAR-2017 (strength, anatomical location and administration route were not reported) for prophylaxis, however no adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000704.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9 for prophylaxis (lot#,expiry date, dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unknown number of patients of unknown age and gender. The patients' medical history, concomitant therapies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M037770, expiration date: 01-JUN-2019 and lot # N001533, expiration date: 16-OCT-2019 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 5 minutes. Data logger was used to capture temperature excursions. There were no previous temperature excursions. There were no adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 66 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 22-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscularly, lot # L031459, expiration date on 30-APR-207 (strength, dose number and anatomical location were not provided) for prophylaxis. No adverse event reported. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of patients; names and demographics were unknown to the reporter. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX for prophylaxis, lot #M040144 and expiration date: 26-DEC-2017 (dose, frequency and route of administration were not reported), reconstituted with sterile diluent (manufacturer unknown). The sterile diluent was not involved in the temperature excursions. No adverse effects were reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 15 Farentheit degrees and 46 Farentheit degrees for 1 hour and 18 minutes. The vaccines were also exposed to a temperature between 15 Farentheit degrees and 46 Farentheit degrees for 1 hour, a temperature between 6 Farentheit degrees and 14 Farentheit degrees for 30 minutes and finally, a temperature between -50° Celsius (C) and -15° C for 54 minutes. The medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006803.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date the patient experienced an adverse event (no further details provided). The outcome of adverse event was not reported. Causality assessment was not provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 76 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-NOV-2010, the patient was vaccinated with the first dose of VAQTA 50/1.0 U/ml (lot #, expiration date, dose and route of administration were not reported). On 19-JUN-2017, the patient was vaccinated with the second dose of VAQTA 50/1.0 U/ml, lot # M009786 (dose and route of administration were not reported), which expired on 26-MAY-2017. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
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 M-M-R II lot # L023386, expiration date 25-JUN-2017 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot # L025374, expiration date 27-MAR-2018 (dose and route of administration were not reported). No adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date the patients were vaccinated with VARIVAX lot # L050560, expiration date:14-DEC-2017 (dose, frequency, route and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. There was no adverse effect reported in any patients. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 15.3 degrees Fahrenheit for 1 hour 15 minutes  and 13 degrees Fahrenheit for 8 hour/ 45minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA000696:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses ROTATEQ lot # M040270 with expiration date of 29-APR-2018 and lot# M041184 with expiration date of 31-MAY-2018, for prophylaxis (dose, route and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger". This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008789: US-009507513-1707USA000697: US-009507513-1707USA000699:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses VAQTA  lot # N005274 with expiration date of 03-APR-2018, for prophylaxis (dose, route and frequency were not reported).  No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger".  This is one of several reports from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1706USA008789: US-009507513-1707USA000697: US-009507513-1707USA000698:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to a patient of unknown gender and age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAY-2017, the patient was inadvertently vaccinated with one expired dose of GARDASIL 9 lot # L004014 with expiration date on 04-MAR-2017 (strength, anatomical location and administration route were not reported) for prophylaxis, however no adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1706USA010260.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a multiple unspecified patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose, frequency, route of administration were not provided), lots # M043305 with expiration date of 26-OCT-2018; M041080 with expiration date of 06-OCT-2018 and L027287 with expiration date of 21-JUL-2017 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.8 degrees Fahrenheit) for 60 minutes. Lot # L027287 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (32.5 degrees Fahrenheit) for 5 hours, 50 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.2 degrees Fahrenheit) for 3 hours, 30 minutes and total time in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Lots #  M043305 and M041080 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours,10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000709: US-009507513-1706USA009296.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a multiple unspecified patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (strength, dose, frequency, route of administration were not provided), lots # M037014 with expiration date of 22-NOV-2017 and M038864 with expiration date of 12-DEC-2017 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.8 degrees Fahrenheit) for 60 minutes. Lot # M037014 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (32.5 degrees Fahrenheit) for 5 hours, 50 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.2 degrees Fahrenheit) for 3 hours, 30 minutes and total time in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Lot # M038864 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours,10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA009296: US-009507513-1707USA000708.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 23 year-old female. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, frequency and route of administration were not reported) lot # M043582 with expiration date of 28-OCT-2018, for prophylaxis. The temperature excursion of the VARIVAX was of 41°F for a time frame of 8 hours. No previous temperature excursion occurred. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA009376.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to unspecified patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unspecified date since September 2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB (anatomical route of vaccination was not provided) for prophylaxis. It was reported that on 17-OCT-2016, PEDVAXHIB with lot # M025192 with expiration date on 21-MAR-2019, was exposed to a temperature excursion of 47°F to 77°F for 1 hour time range for 1 cycle. Subsequently on 18-OCT-2016, lot # M036056 with expiration date on 18-MAY-2019, was exposed to a temperature excursion of 32°F to 35°F for 30 minutes. On 20-FEB-2017, the vaccines with lot # M036056 and lot # M034188 with expiration date on 20-MAY-2019 were exposed to a temperature excursion of 32°F to 35°F for 1 hour and 30 minutes time frame. On 26-APR-2017, PEDVAXHIB with lot # N000231 with expiration date on 25-OCT-was exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. It was also reported, that the lowest temperature excursion was of 34.3°F and the highest of 46.6°F. Information was provided due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000715: US-009507513-1707USA000716: US-009507513-1706USA009543.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with PNEUMOVAX23 for prevention of pneumococcal disease. On unknown dates, the patients experienced erythema, swelling and warmth. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA006827.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced a temperature excursion of 22 Fahrenheit degrees for an unspecified timeframe. It was unknown if there were previous temperature excursions. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA007466: US-009507513-1707USA000722: US-009507513-1707USA000723: US-009507513-1707USA000724.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced a temperature excursion of 22 Fahrenheit degrees for an unspecified timeframe. It was unknown if there were previous temperature excursions. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA007466: US-009507513-1707USA000721: US-009507513-1707USA000723: US-009507513-1707USA000724.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, as prophylaxis (Strength, dose, lot # and expiration date were not reported), which experienced a temperature excursion of 22 Fahrenheit degrees for an unspecified timeframe. It was unknown if there were previous temperature excursions. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1706USA007466: US-009507513-1707USA000721: US-009507513-1707USA000722: US-009507513-1707USA000724:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced an unknown temperature excursion for an unspecified timeframe. It was unknown if there were previous temperature excursions. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA007466: US-009507513-1707USA000721: US-009507513-1707USA000722: US-009507513-1707USA000723. US-009507513-1707USA000721: US-009507513-1707USA000722: US-009507513-1707USA000723:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (strength reported as 5mcg/0.5ml, lot # M031574, expiration date 11-NOV-2018; dose and route of administration were not reported) for prophylaxis. The vaccine was improperly stored in the temperature from 47 Fahrenheit (F) to 77F for a few times, 5 hours in total. No adverse effects were reported. The call was made because of the data logger. Follow up information has been received from the registered nurse on 20-JUN-2017 referring to one of two patients who was vaccinated with improperly stored RECOMBIVAX HB on 17-JUN-2017. The vaccine was improperly stored in the temperature from 47 F to 77F for 1 hour and 30 minutes (previously reported as 5 hours total). There was no (previously reported as yes) previous temperature excursion. Sender's Comments: US-009507513-1703USA010484.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored GARDASIL lot # K011562, expiration date: 08-APR-2017 (dose, route of administration and anatomical location were not reported). It was administered prior to its expiration date. The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000770: US-009507513-1707USA000769: US-009507513-1706USA008487: US-009507513-1707USA000768: US-009507513-1707USA000794.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to four patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were unspecified. On four separate unspecified dates, patients were vaccinated with improperly stored ROTATEQ lot # M038744, expiration date: 26-APR-2018 (administered orally; dose was not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000770: US-009507513-1707USA000769: US-009507513-1706USA008487: US-009507513-1706USA008487: US-009507513-1707USA000794.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB lot # L051123, expiration date: 13-OCT-2018 (dose, route of administration and anatomical location were not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000770: US-009507513-1706USA008487: US-009507513-1707USA000767: US-009507513-1707USA000768: US-009507513-1707USA000794.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to seven patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were unspecified. On seven separate unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB lot # M032148 expiration date: 18-APR-2019 (dose, route of administration and anatomical location were not reported). Vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008487: US-009507513-1707USA000769: US-009507513-1707USA000767: US-009507513-1707USA000768: US-009507513-1707USA000794.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored stored ROTATEQ lot # L013203, expiration date: 28-JAN-2017 (administered orally; dose was not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000768: US-009507513-1707USA000770: US-009507513-1707USA000767: US-009507513-1707USA000769: US-009507513-US-1706USA008487.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Endoscopy normal, Fatigue, Malaise
Clinical narrative: This is a spontaneous report from a contactable retired registered nurse (RN) who reported similar events for herself and for her husband. This is the second of two reports. A 80-year-old male patient received PREVNAR 13 on 12Jun2017 in the morning, at single dose, in the right deltoid, for immunisation. No vaccinations were given within 4 weeks prior. Medical history included ongoing blood pressure high (first diagnosed 8 or more years ago), ongoing atrial fibrillation (diagnosed about 1 1/2 years ago), ongoing Barrett's esophagus (first diagnosed about 1 year ago, he had an endoscopy on 22Jun2017 that showed it was still negative for dysplasia), urinary frequency (diagnosed a couple of years ago) and ongoing cardiac disorder. The patient previously took on unknown date(s) an unspecified pneumococcal vaccine, yellow fever vaccine and influenza vaccine, all for immunization, with no adverse events. Family history was none. Concomitant medications included oral losartan tablets, ongoing from 3 or 4 years, at 25 mg, 1x/day (varying dosages), for blood pressure high, metoprolol, ongoing from about 2 years, at 25 mg, 2x/day, for blood pressure high and atrial fibrillation, omeprazole ongoing, at 40 mg, 1x/day, for Barrett's esophagus, FLOMAX ongoing, 0.4 mg, 1x/day, for urinary frequency and acetylsalicylic acid ongoing, at 81 mg, 1x/day, for cardiac disorder. Since an unspecified date in 2017, the patient has been very fatigued, did not feel well and lost his appetite. The events did not require emergency room or physician office visit or a treatment. All the events worsened and had not yet resolved at the time of report. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017293425 same reporter, different patient, same product, similar events.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Diarrhoea
Clinical narrative: Runny stool, foul-smelling, once daily, for 3 weeks following vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Oedema, Paraesthesia, Pruritus
Clinical narrative: Scarlet blisters in oval 3cm x 2.5 cm with clear exudate, crusting, itching, and sensations of pins and needles lasting x16 da; Larger edematous area 10 cm x 7 cm also 16 da; Headache x 1 da signs and symptoms were self-limiting, no treatment necessary.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Scarlet blisters in oval 3cm x 2.5 cm with clear exudate, crusting, itching, and sensations of pins and needles lasting x16 da; Larger edematous area 10 cm x 7 cm also 16 da; Headache x 1 da signs and symptoms were self-limiting, no treatment necessary.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased
Clinical narrative: 5 hours following vaccine, temp of 101.3, the following morning temp of 102.2.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Received vaccine on 6/21/17 had L hand and arm numbness on 7/7/17 seen doctor on 7/7/17 had noticeable L hand weakness compared to Rt.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Erythema, Injection site swelling
Clinical narrative: Patient's mother called reporting that patient's arm was red and swollen. It started the day after the vaccination was administered. The patient also received dose #2 of MMR in the right arm that same day. The mother denied any systemic reaction such as hives or SOB. The patient complained of discomfort but not having high fevers. She was given tylenol for pain and warm compresses.  The mother described the swelling from her left upper arm extending close to her elbow. Father provided a photo which confirmed this. Patient advised to continue tylenol or motrin. Dispensed benadryl suspension to father. Reviewed allergic reaction red flags. Today, patient's father reports that all is resolved.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No medical history, allergies nor concomitant therapies were provided. On 14-JUN-2017, the patient was vaccinated with ROTATEQ, administered orally, with the lot # L029618, and the expiration date of 20-MAY-2017, for prophylaxis. The patient was vaccinated with an expired dose of the vaccine. No adverse effects or product quality complains were reported and no further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The pharmacist stated that doses of PROQUAD lot# reported as N00291 with an expiration date 24-JUL-2018 were placed in the refrigerator in error because they were mistaken for M-M-R II. No doses of the improperly-stored PROQUAD have been administered to patients. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On 05-JUN-2017, the patient was inadvertently vaccinated with one expired dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with lot number reported as N014310 and expiration date of 26-MAY-2017 (dose, route of administration and anatomical location were unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This information has been received from a billing coordinator concerning an unspecified patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date in June 2017 (reported as since 07-JUN-2017), the patient was vaccinated with an expired dose of PROQUAD with lot number M044720 and expiration date 07-MAY-2017 (dose, strength, dose number, route of administration and anatomical location were not provided), for prophylaxis. The reporter could not provide the lot number and the expiration date for the properly stored sterile diluent used to reconstitute the dose of PROQUAD. No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to unspecified patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unspecified date since September 2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, for prophylaxis. It was reported that on 11-OCT-2016, ROTATEQ with lot # M002254 with expiration date on 15-NOV-2017, was exposed to a temperature excursion of 47°F to 77°F for 1 hour time range for 1 cycle. Subsequently on 18-JAN-2017, lot # M002254, lot # M017518 with expiration date on 15-NOV-2017 and lot # M031807 with expiration date on 02-APR-2018 were exposed to a temperature excursion of 32°F to 35° for 1 hour. On 20-JAN-2017, lot # M002254 and lot # M031807 were exposed to the previously mentioned temperature excursion, but for a 30 minutes time frame. On 20-FEB-2017, the same lot number were exposed to a temperature excursion of 32°F to 35°F for 1 hour and 30 minutes time frame. On 26-APR-2017, ROTATEQ with lot # M040271 with expiration date on 30-APR-2018 was exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. On 31-MAY-2017 and on 19-JUN-2017, ROTATEQ with lot # M0402689 with expiration date on 14-MAY-2018 was exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. It was also reported, that the lowest temperature excursion was of 34.3°F and the highest of 46.6°F. Information was provided due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA009543: US-009507513-1706USA009543: US-009507513-1707USA000714.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to unspecified patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unspecified date since September 2016, the patients were vaccinated with improperly stored doses of VAQTA (anatomical route of vaccination was not provided) for prophylaxis. It was reported that on 17-OCT-2016, VAQTA with lot # M027879 with expiration date on 24-JAN-2018, was exposed to a temperature excursion of 47°F to 77°F for 1 hour time range for 1 cycle. Subsequently on 31-MAY-2017 and on 19-JUN-2017, lot # M038572 with expiration date on 11-MAR-2018 was exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. It was also reported, that the lowest temperature excursion was of 34.3°F and the highest of 46.6°F. Information was provided due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000715: US-009507513-1706USA009543: US-009507513-1707USA000714.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Chills, Decreased appetite, Fatigue, Hyperventilation
Clinical narrative: This is a spontaneous report from a contactable retired registered nurse (RN) who reported similar events for herself and for her husband. This is the first of two reports. This 78-year-old female patient received PREVNAR 13 on 12Jun2017 in the morning, at single dose, in the right deltoid, for immunisation. No vaccinations were given within 4 weeks prior. Medical history included rheumatoid arthritis (diagnosed in either 2008 or 2009) and Raynaud's. The patient previously took pneumococcal vaccine a couple of years before the report, yellow fever vaccine a few years ago and influenza vaccine regularly, all for immunization, with no adverse events. Family history was none. Concomitant medications included oral hydroxychloroquine tablets, since 2009 and ongoing, at 200 mg, 1x/day, for rheumatoid arthritis and acetylsalicylic acid ongoing since an unknown date, 81 mg, 1x/day, for Raynaud's. A blood work done on an unknown date in 2017 (a month or two prior vaccinations) showed up nothing worth mentioning. Since 29Jun2017 the patient began to feel fatigued and did not feel well. On 01Jul2017 at night the patient experienced fever, chills, hyperventilation. Since an unspecified date in 2017 she was having no appetite, spent 3 days in bed and was not being able to talk right at the time of report. She had been taking ibuprofen for the past couple of days and it had been helping. The events did not require emergency room or physician office visit. Speech disorder had not yet resolved at the time of report. Fever, chills and hyperventilation resolved on an unspecified date in Jul2017 and lasted about 12 hours. When her husband took her temperature on an unspecified date in Jul2017 at night it was only 99 (unspecified unit). The other events were resolving at the time of report. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017293442 same reporter, different patient, same drug, similar events.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pyrexia, Speech disorder
Clinical narrative: This is a spontaneous report from a contactable retired registered nurse (RN) who reported similar events for herself and for her husband. This is the first of two reports. This 78-year-old female patient received PREVNAR 13 on 12Jun2017 in the morning, at single dose, in the right deltoid, for immunisation. No vaccinations were given within 4 weeks prior. Medical history included rheumatoid arthritis (diagnosed in either 2008 or 2009) and Raynaud's. The patient previously took pneumococcal vaccine a couple of years before the report, yellow fever vaccine a few years ago and influenza vaccine regularly, all for immunization, with no adverse events. Family history was none. Concomitant medications included oral hydroxychloroquine tablets, since 2009 and ongoing, at 200 mg, 1x/day, for rheumatoid arthritis and acetylsalicylic acid ongoing since an unknown date, 81 mg, 1x/day, for Raynaud's. A blood work done on an unknown date in 2017 (a month or two prior vaccinations) showed up nothing worth mentioning. Since 29Jun2017 the patient began to feel fatigued and did not feel well. On 01Jul2017 at night the patient experienced fever, chills, hyperventilation. Since an unspecified date in 2017 she was having no appetite, spent 3 days in bed and was not being able to talk right at the time of report. She had been taking ibuprofen for the past couple of days and it had been helping. The events did not require emergency room or physician office visit. Speech disorder had not yet resolved at the time of report. Fever, chills and hyperventilation resolved on an unspecified date in Jul2017 and lasted about 12 hours. When her husband took her temperature on an unspecified date in Jul2017 at night it was only 99 (unspecified unit). The other events were resolving at the time of report. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017293442 same reporter, different patient, same drug, similar events.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (manufacturer control number 00499035). A contactable medical assistant (other healthcare professional) reported a patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date ("over one year ago")  at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "injection site pain, tenderness, and swelling shortly after receiving the vaccine." The outcome of the adverse events was unknown. No follow-up attempts are possible. No further information is expected.