chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HIBV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 28-AUG-2017 from a Licensed Practical Nurse who was reporting on an unspecified number of patients. No medical history or concomitant medications were provided. The nurse reported that on unspecified dates, an unspecified number of patients were administered improperly stored PEDVAXHIB (lot N003700, expires 01-NOV-2019; lot M014926, expires 17-FEB-2019), RECOMBIVAX (lot M008551, expires 02-JUN-2018; lot M046373, expires 04-NOV-2019) and PNEUMOVAX 23 (lot M040804, expires 20-MAY-2018) vaccines. The temperature was between 32 degrees F and 35 degrees F (32.4 degrees F) for 14 hour and 30 minutes. There was a previous temperature excursion between 32 degrees F and 35 degrees F (34.9 degrees F) for 30 minutes. This was not due to a data logger. No adverse effects were reported. No further information was reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Rash, Scab, Skin lesion
Clinical narrative: This spontaneous report was received from an approximately 61 year old male patient, who was also a pharmacist, referring to himself. The patient's concurrent conditions included hypertension and diabetes mellitus. The patient did not have history of drug reactions or allergies. The patient's medical history and concomitant therapies were not reported. On an unspecified date in October 2015, the patient was vaccinated with a dose of ZOSTAVAX (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. Other suspect therapies included sterile diluent.  On an unspecified date in September 2017, the patient developed a rash on the left temple and scalp area. Then, on an unspecified date in September 2017, he was diagnosed with herpes zoster by a physician, and he was treated with VALTREX. Laboratory tests were not performed. It was also reported that the patient was not able to work for a week (unspecified dates). At the time of reporting, the patient was recovering from the herpes zoster; the patient stated that his lesions were crusted and almost gone. The relatedness between the event and therapy with ZOSTAVAX and sterile diluent was not reported.
Age: 30.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 30 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated at unappropriated age with a dose of GARDASIL 9 for prophylaxis (strength, Lot # and expiration date were not reported). No adverse effects were reported.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health professional refers to a 17 month old male patient. Patient's relevant medical history, concomitant medications and drug history were not reported. On 05-SEP-2017, the patient was vaccinated with VARIVAX (lot # N008829, expiry date: 16-MAR-2019, strength: 0.5 ml, dose: 0.5ml, once) injection that underwent temperature excursion to vaccinate against varicella. No adverse effects were reported after receiving the vaccine. It was reported that the therapy with VARIVAX was ongoing and that the patient would receive a booster of the VARIVAX at the age of 4. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002557: US-009507513-1709USA002643.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse reporting on approximately 10 patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On 06-SEP-2017, the patients received improperly stored doses of ROTATEQ lot # M041770 (expiry date 26-JUN-2018) or lot # M045546 (expiry date 12-JUN-2018), oral for prophylaxis (dose not reported). No symptoms reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 47.8 degrees Fahrenheit for 1 hour. The reported indicated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA005895.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with 1 dose of GARDASIL 9, for prophylaxis, that was improperly stored by being exposed to light (route of administration, expiration date and lot number were not provided) No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N012492, expiration date 17-MAR-2018 subcutaneously (strength and dose number were not provided) for prophylaxis. The vaccine was diluted with an sterile diluent (MRK). On an unspecified date, the vaccine was exposed to temperature ranges between 6° Fahrenheit (F) to 14°F (9.2°F) during a time frame of 10 hours and 15°F to 46°F for 27 hours. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. No information about the patient´s medical history, concomitant medications or concurrent conditions was provided. On 07-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M033219, expiration date 18-AUG-2017), for prophylaxis (dose, frequency and route were not provided).  Concomitant therapies included sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 74-year-old female patient with an allergy to sulfa medications. No information regarding the patient's pertinent medical history or concomitant medications was provided. On 05-SEP-2017, the patient was intramuscularly vaccinated with one unspecified dose of PNEUMOVAX 23 injection (lot # N011305, expiration date: 20-JAN-2019) for the prevention of pneumonia. On an unknown date in September 2017 (reported as a few days later), the patient's arm was really inflamed and red. The patient sought medical attention and went to his doctor. There was an unspecified treatment given for the adverse events. The outcome of the events of "the patient's arm was really inflamed and red" was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. The reporter considered the events of "the patient's arm was really inflamed and red" to be life threatening. This is one of two report received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA004758.
Age: 0.17
Sex: U
Vaccine: HEPA, DTAPIPVHIB, HEP, HEPA, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning to a 10 week old patient (gender not reported). Current conditions, medical history and concomitant medications were not reported. On 08-SEP-2017, the patient was inadvertently vaccinated with a dose of VAQTA (lot number and expiration date not reported), 0.5 ml, intramuscular for prophylaxis instead of hepatitis b vaccine (manufacturer unknown). No adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HEPA, DTAPIPVHIB, HEP, HEPA, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant concerning to a 10 week old patient (gender not reported). Current conditions, medical history and concomitant medications were not reported. On 08-SEP-2017, the patient was inadvertently vaccinated with a dose of VAQTA (lot number and expiration date not reported), 0.5 ml, intramuscular for prophylaxis instead of hepatitis b vaccine (manufacturer unknown). No adverse event was reported.
Age: 0.08
Sex: M
Vaccine: HEP, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 4 week old male patient. No information about the patient's medical history, concomitant medications or medical history was provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported and no product quality complaint (PQC) was involved.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 14 month old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient was vaccinated with M-M-R II (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, on 19-JUN-2017 and subsequently he was vaccinated with VARIVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, on 29-AUG-2017 and PROQUAD (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, on 05-SEP-2017. No adverse symptoms were reported. No further information was provided. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA005552: US-009507513-1709USA005553.
Sex: U
Vaccine: MMR
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 patient's medical history, concurrent conditions, drug and allergy history were not provided. It was reported that on 17-FEB-2017, 20-MAR-2017, 22-MAR-2017, 28-MAR-2017, 15-MAY-2017, 18-JUL-2017 and 24-AUG-2017, the patients were vaccinated with an unspecified number of improperly stored doses of M-M-R II lot # M000768, expiration date 05-JAN-2018 (dose, frequency and administration route were not reported), for prophylaxis. Concomitant therapies included the sterile diluent used for reconstitution, which did not undergo a temperature excursion. The data logger registered a temperature of 47° Fahrenheit (F) to 77°F (-3.10) for 17 hours 15 minutes. There were not previous temperature excursion. No adverse effects were reported.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to a 2 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 08-FEB-2016, the patient was vaccinated with the first dose of PROQUAD lot # L040415 with expiration date on 13-APR-2017 for prophylaxis.  Other suspect therapies included sterile diluent (STERILE DILUENT). It was reported that the patient was vaccinated at a inappropriate age, however, no adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to several unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and  concomitant medications were not provided. On 11-SEP-2017, three patients were vaccinated with and incorrect stored dose of PROQUAD lot # N010115 with expiration date on 24-SEP-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. other patients were vaccinated in unmentioned dates. It was reported that the vaccines were exposed to temperature of 15 to 46 Farenheit grades range. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a  multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of PROQUAD lot # N014947 with expiration date on 11-SEP-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. Other suspect therapies included sterile diluent (STERILE DILUENT). It was reported that the vaccines were exposed to temperature of 30 Farenheit grades range for a time frame of 4 hours and 40 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1709USA005854:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 12 years. It was also confirmed that on 14-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005738: US-009507513-1709USA005739: US-009507513-1709USA005748: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005747: US-009507513-1709USA005737: US-009507513-1709USA005736: US-009507513-1708USA001768: US-009507513-1709USA005740:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 17 years. It was also confirmed that on 07-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005738: US-009507513-1709USA005739: US-009507513-1709USA005748: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005747: US-009507513-1709USA005737: US-009507513-1708USA001768: US-009507513-1709USA005735: US-009507513-1709USA005740.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis.  It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 16 years. It was also confirmed that on 07-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA005738: US-009507513-1709USA005739: US-009507513-1709USA005748: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005747: US-009507513-1708USA001768: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005740:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 17-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1708USA001768: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 12 years. It was also confirmed that on 17-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1708USA001768.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis.  It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 28-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1708USA001768: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis.  It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 14 years. It was also confirmed that on 07-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1708USA001768: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 18-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1708USA001768: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 14 years. It was also confirmed that on 25-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1708USA001768: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 13 years. It was also confirmed that on 02-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1708USA001768: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with an incorrect stored dose of PROQUAD lot # N014947 with expiration date on 11-SEP-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. Other suspect therapies included VARIVAX and sterile diluent. 2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 30 Fahrenheit grades range for a time frame of 4 hours and 40 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005671.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse reporting on approximately 10 patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On 06-SEP-2017, the patients received improperly stored doses of M-M-R II lot # M045391 (expiry date 14-NOV-2018) or lot # M040558 (expiry date 03-OCT-2018) for prophylaxis (dose and route of administration were not reported), that were reconstituted with properly stored sterile diluent (MRK). No symptoms reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 47.8 degrees Fahrenheit for 1 hour. The reported indicated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004130.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, the patients administered improperly stored doses of ROTATEQ (dose, frequency, route and expiration were unknown, lot #M005732, lot#M031651, lot# M039434, lot# M042821) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006063: US-009507513-1709USA006065: US-009507513-1708USA010866: US-009507513-1709USA006064.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, the patients administered improperly stored doses of VAQTA (dose, frequency, route and expiration were unknown, lot #M039202, lot#N005274) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006062: US-009507513-1709USA006065: US-009507513-1708USA010866: US-009507513-1709USA006064.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, the patients administered improperly stored doses of M-M-R II (dose, frequency, route and expiration were unknown, lot # M020073) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006062: US-009507513-1709USA006065: US-009507513-1708USA010866: US-009507513-1709USA006063.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). Since 22-MAY-2017 to 23-AUG-2017, the patients administered improperly stored doses of RECOMBIVAX HB (dose, frequency and route were unknown, lot # L048848, expiration date: 09-AUG-2018) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006062: US-009507513-1709USA006064: US-009507513-1708USA010866: US-009507513-1709USA006063.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: The initial case was missing the following minimum criteria: identifiable patient. Upon receipt of follow-up information on 06Sep2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP via Pfizer sales representative. A 16-year-old male patient of an unspecified race received TRUMENBA (lot S26985, exp. date 31Jan2019) at single dose on 14Aug2017 via an unspecified route of administration. Relevant medical history and concomitant medication were not specified. On 14Aug2017 the patient experienced swelling and cellulitis at injection site. The outcome of the event cellulitis at injection site was reported as recovered while the outcome of the other adverse event was unknown.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Pyrexia
Clinical narrative: Patient had fever over 102 for greater than 24 hours, also had malaise and weakness the next day.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Haematochezia, Screaming, Vomiting
Clinical narrative: ON THE EARLY MORNING OF 09/11/2017 PATIENT BEGAN TO HAVE INTERMITTENT BOUTS OF SCREAMING, ABDOMINAL PAIN AND NON BILIOUS VOMITTING AND THEN ONE EPISODE OF BLOODY CURRANT JELLY STOOL. MOM IS A NURSE PRACTIONER AND CONTACTED ME AT 0730. AT THIS POINT, PATIENT WAS IMPROVED AND TOLERATING MORNING FEEDS WITHOUT VOMITTING OR ABDOMINAL PAIN, I DID NOT INSTRUCT HER TO GO TO ER AS PATIENTS SYMPTOMS RESOLVED. MOM INSTRUCTED TO OBSERVE CLOSELY AND PRESENT TO ER ASAP IF SYMPTOMS RETURNED. MOM OBSERVED ALL DAY AND PATEINT HAS CONTINUED TO HAVE NO FURTHER SYMPTOMS OF INTUSSUSCEPTION.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin mass
Clinical narrative: Red patch on arm with a knot under the skin. Has been that way for a few days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood glucose normal, Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: DTaP+ IPV WAS ADMINISTERED IN LVL. PT PRESENTED TO THE ER ON 09/12/2017 WITH FEBRILE SEIZURE, ACUTE VOMITING, AND UNSPECIFIED CAUSE OF FEVER.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Rash macular, Sunburn, Throat irritation
Clinical narrative: Red and swollen on left upper arm at injection site. Both arms reddened and itching. Itching on arms, head and trunk of body. Throat felt funny and scratchy. Took Benadryl 50 mg po with good results at home. (Both arms looked sun burned, red and blotchy).
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and Swelling of right arm. Redness spreading to other side of arm.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Patient has redness around the arm, very warm and hard. Patient states it is very painful to touch.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: My granddaughter kept complaining about pain in her right arm from the vaccination, and when I looked at her arm this morning, it's all swollen, red and welped up like a bee sting.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant 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 patient may have received an improperly stored dose of one of the following vaccines PROQUAD therapy type: rHA, lot # N009773 with expiration date on 29-NOV-2018 or N009773 with expiration date on 20-SEP-2018 (dose, route and site of administration were not reported) or VARIVAX lot # N017397 with expiration date on 07-JUN-2019, lot # N014368 with expiration date on 09-MAY-2019, lot # N009768 with expiration date on 24-MAR-2019 or lot # N008829  with expiration date on 16-MAR-2019 (dose, route and site of administration were not reported). Concomitant therapies included sterile diluent (MRK). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 25 hours and 50 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, therapy type recombinant human albumin (RHA), lot # N009773, expiration date 20-SEP-2018 (dose, route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 2 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved (PQC).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 57 year old female patient with rheumatoid arthritis, blood pressure, depression, hot flashes, anxiety and attention deficit/hyperactivity disorder. The patient's historical drug included ACTEMRA. On 03-AUG-2017, the patient was vaccinated with ZOSTAVAX, vial#10 (strength, dose, lot/batch# and expiration date were not reported) subcutaneously for prophylaxis. Concomitant therapies included methotrexate, prednisone (manufacturer unknown), diltiazem hydrochloride, venlafaxine hydrochloride, guanfacine hydrochloride, clonazepam, ergocalciferol and Rheumate (medical food prescription containing folic acid). On an unknown date in August 2017, the patient experienced severe injection site reaction. It was about 2 inches 'by' 6 inches and was taking antiviral VALTREX, 1gm tablet, as treatment. It was reported that the patient was prescribed ZOSTAVAX before start taking XELJANZ. It was confirmed by the patient that she did not start therapy with XELJANZ at the time of the report. There was no lab work reported. There was no product complaint to report. The outcome of the event severe injection site reaction was unknown. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N007931 and expiration date 17-NOV-2019 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005382: US-009507513-1709USA005380: US-009507513-1709USA005379: US-009507513-1709USA005381.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, it could not be could out that the patients were vaccinated with improperly stored ROTATEQ orally, lot # M040270 with expiration date: 29-APR-2018 (dose was not reported). Temperature ranged to 1.6 degrees Celsius for the time frame of 8 hours and 30 minutes. There was previous temperature excursion with temperature of 1.3 degrees Celsius for 8 hours and 20 minutes. Digital data logger was not used. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA006252.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, it could not be could out that the patients were vaccinated with improperly stored VAQTA, lot # N005796 with expiration date: 26-MAY-2018 (dose and route of administration were not reported). Temperature ranged to 1.6 degrees Celsius for the time frame of 8 hours and 30 minutes. There was previous temperature excursion with temperature of 1.3 degrees Celsius for 8 hours and 20 minutes. Digital data logger was not used. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA003124.