chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited case received from a nurse on 31 Oct 2017. This case ID linked with 2017SA214850, 2017SA214851, 2017SA214852, 2017SA214853 (same reporter). This case involves a female patient (age reported as from 30 years to 90 years who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number: UT5899LA, expiry date, dose in series and site of administration were not reported) via intramuscular route on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe arm pain and arm pain was so severe that it was difficult to the patient to move her arm. Relevant lab tests were not reported. As a corrective treatment the patient received TYLENOL which did not help reduce the pain and was also given oxycodone. As of 31 Oct 2017, the outcome of the events was reported as recovering. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 31-Oct-2017. This case involves a female patient (age between 30 to 90 years), who was vaccinated once with 0.5 ml FLUZONE QIV) via intramuscular route (batch number: UT5899LA, expiry date, dose in series and site of administration not reported) in arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the experienced severe arm pain following vaccination. Arm pain was so severe that it was difficult to move the arm. Lab test was not reported. It was reported that PARACETAMOL (Tylenol) did not help reduce the pain and were given OXYCODONE (Oxicodone). Patient may also took METHYLPREDNISOLONE ACETATE (DEPO-MEDROL INJECTION) 31-Oct-2017, patient's events were resolving. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited case received from a nurse on 31 Oct 2017. This case is linked with the cases 2017SA214850, 2017SA214851, 2017SA214853, 2017SA214841 same reporter. This case involves a female patient (age reported as from 30 years to 90 years who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number: UT5899LA, expiry date, dose in series and site of administration were not reported) via intramuscular route on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe arm pain and arm pain was so severe that it was difficult to the patient to move her arm. Relevant lab tests were not reported. As a corrective treatment the patient received TYLENOL which did not help reduce the pain and was also given oxycodone. As of 31 Oct 2017, the outcome of the events was reported as recovering. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 31-Oct-2017. This case involves a female patient (age between 30 to 90 years), who was vaccinated once with 0.5 ml FLUZONE QIV via intramuscular route (batch number: UT5899LA, expiry date, dose in series and site of administration not reported) in arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the experienced severe arm pain following vaccination. Arm pain was so severe that it was difficult to move the arm. Lab test was not reported. It was reported that PARACETAMOL (Tylenol) did not help reduce the pain and were given OXYCODONE (Oxicodone). Patient may also took METHYLPREDNISOLONE ACETATE (DEPO-MEDROL INJECTION) 31-Oct-2017, patient's events were resolving. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from nurse on 06-Nov-2017. This case involves four patients (age and gender not reported) who were vaccinated with a dose of QUADRACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patients experienced cellulitis. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Four patients experienced Cellulitis following vaccination with QUADRACEL VACCINE. Time to onset compatibility is unknown. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 30-JUN-2017 from a registered nurse who was reporting on multiple unspecified patients. No medical history or concomitant medications were provided. The nurse reported that the multiple patients were vaccinated with improperly stored GARDASIL 9 (Lot L037554, expires 25-DEC-2017) (dose and site not reported) on unknown dates. No adverse effects reported. The temperature was 9 degrees C to 25 degrees C for 31 minutes. There was a previous excursion that was 9 degrees C to 25 degrees C for 19 minutes, recorded on data logger. No further information was provided. As of 21-NOV-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This case was previously considered valid, but per current process it was determined to be non-valid as there are no patient identifiers, therefore it is being sent to Distribution for the last time to notify all recipients.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received via a company representative from a 45-year-old male patient, who is also a pharmacist and was reporting on himself. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date, reported as "some time on the past", the patient self-administered a dose of PNEUMOVAX 23, injection (dose, route of administration, lot # and expiration date were not reported) for that he could "know what the vaccine felt like". On an unknown date, the patient experienced injection site reaction that was very painful, itchy, red and swollen. No treatment was given for the adverse events. The patient did not seek a medical attention. No laboratory diagnostic studies were performed. The outcome of the events was reported as recovered on an unknown date. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA004883.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-JUN-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot# N000236 and expiration date 24-OCT-2019 (dose and route of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit for 16 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, and refers to a 79 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-SEP-2014, the patient received the first dose of ZOSTAVAX 19400 PFU for prophylaxis (dose, route of administration, lot number and expiration date were not reported, sterile diluent unspecified). On 26-OCT-2017, the patient received inadvertently a second dose of ZOSTAVAX lot number N023002, expiration date 20-NOV-2018 (dose and route of administration were not reported, sterile diluent unspecified). There was not adverse event or product quality complaint involved.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 21-year-old non-pregnant female patient. The patient did not have any pertinent medical history or drug allergies. The patient did not take any concomitant medications. On 21-NOV-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 Microgram in 1 ml, intramuscular, lot # L013051, expiration date 15-APR-2017 for prophylaxis. On 20-JAN-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB 10 Microgram in 1 ml, intramuscular, lot # L025377, expiration date 15-APR-2017 for prophylaxis. On 20-JUL-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB 10 Microgram in 1 ml, intramuscular, lot # M032653, expiration date 31-MAY-2016 for prophylaxis. In approximately 2017 (reported as recently), the patient had a negative hepatitis B antibody titer. The patient sought medical attention and she was not given any treatment for the event. The outcome of the event was reported as not recovered. The relatedness between RECOMBIVAX HB and the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter informed that on an unspecified date, the patient was vaccinated with an improperly stored VARIVAX lot # N008077, expiration date 09-MAR-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was reconstitued with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. The temperature of excursion was reported as 20.5 °F. The time frame was reported as 2 hours. There was not previous temperature excursion. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA002444: US-009507513-1711USA002760: US-009507513-1711USA002762:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 09-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1709USA012767: US-009507513-1711USA003165: US-009507513-1711USA003158:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1709USA012767:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 31-JUL-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1709USA012767: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 5-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 25-JUL-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017 and 20-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017 and 19-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1709USA012767: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1709USA012767: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 5-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012767: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a physician assistant, via company representative, and refers to a 43 year old female patient. No information was provided regarding the patient's medical history or concurrent conditions. On 22-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 in the left deltoid for prophylaxis (route of administration, lot number, and expiration date were not provided). On the same day, the patient was also vaccinated with an unspecified influenza virus vaccine (reported as: flu vaccine)in the right deltoid, and received medroxyprogesterone acetate(DEPO-PROVERA) in the right glute (formulation, dose, strength, indication, frequency, lot number and expiration date were not provided). After receiving the PNEUMOVAX 23, the patient's left arm was red, warm, and painful. The patient also had swollen glands after the administration of the vaccine. At the time of this report it was unknown if the patient had recovered from the events. Causality assessment between therapy with PNEUMOVAX 23 and the events was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from an employee, referring to an adult male "who was 41 or 42" years old patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot # and expiration date were not reported)for prophylaxis (drug administered to patient of inappropriate age).  Other suspect therapies included sterile diluent (STERILE DILUENT).
Sex: U
Vaccine: MMRV
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 was vaccinated with an improperly stored dose of PROQUAD (recombinant human albumin) (RHA) lot # N019251 with an expiration date 20-DEC-2018 for prophylaxis, which was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 24 hours. A digital data logger was involved. There was no previous temperature excursion.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Hemiparesis, Injection site hypoaesthesia, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a 70 year old female patient reporting on herself.  The patient's drug reactions/allergies include allergy to penicillin. The patient's pertinent medical history included open heart surgery in 2005. The patient's concomitant medication included medication for "immune system" and an unspecified flu shot. On 02-NOV-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscular in her right arm for prevention of pneumococcal disease (strength, lot number and expiration date were not reported). On 02-NOV-2017, one hour and a half after the patient received the injection, the patient experienced burning sensation on the right side of her face, prickling (injection site paraesthesia) and numbness (injection site hypoaesthesia)/pain where she received the injection and she had no energy on the right side of her body". The patient received treatment for the adverse events; the patient did not seek medical attention and no lab diagnostics/studies were performed. All of the patient's symptoms lasted for about 4-5 days (stop date of the events 06-NOV-2017); they had resolved at the time of the reporting. The causal relationship between the events burning sensation, asthenia, injection site hypoaesthesia, injection site paraesthesia and injection site pain and therapy with PNEUMOVAX 23 were not reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a 70 year old female patient reporting on herself.  The patient's drug reactions/allergies include allergy to penicillin. The patient's pertinent medical history included open heart surgery in 2005. The patient's concomitant medication included medication for "immune system" and an unspecified flu shot. On 02-NOV-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscular in her right arm for prevention of pneumococcal disease (strength, lot number and expiration date were not reported). On 02-NOV-2017, one hour and a half after the patient received the injection, the patient experienced burning sensation on the right side of her face, prickling (injection site paraesthesia) and numbness (injection site hypoaesthesia)/pain where she received the injection and she had no energy on the right side of her body". The patient received treatment for the adverse events; the patient did not seek medical attention and no lab diagnostics/studies were performed. All of the patient's symptoms lasted for about 4-5 days (stop date of the events 06-NOV-2017); they had resolved at the time of the reporting. The causal relationship between the events burning sensation, asthenia, injection site hypoaesthesia, injection site paraesthesia and injection site pain and therapy with PNEUMOVAX 23 were not reported.
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 89 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 1 shot, lot # N022703, expiration date 27-FEB-2019 (route was not reported) for prophylaxis. On an unknown date, the patient experienced swelling after receiving PNEUMOVAX 23. The patient received an unspecified treatment. The outcome of swelling, and the causal relationship between the event and PNEUMOVAX 23 were not reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 30-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. In 2017 (reported as "in the past 2 months" and "within the past month or two"), the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, left arm (dose, lot number and expiration date were not provided) for prophylaxis. In 2017, the patient experienced swelling in his left arm at the injection site and a 102 degree fever for an unspecified period of time. The patient received an antibiotic cefuroxime axetil (CEFTIN) (dose, frequency, route of administration, lot number and expiration date were not provided) for an unspecified period of time as a treatment. The outcome of the events was reported as recovering. The relatedness between PNEUMOVAX 23 and the events was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an immunization official referring to an unspecified number patients of unknown demographics. No information regarding the patients' pertinent medical history and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# M041080, expiration date: 06-OCT-2018; dose, route of administration and anatomical location were not provided) for prophylaxis. A sterile diluent (manufacturer unknown) used to reconstitute the vaccine was stored properly. The vaccine was stored at the temperature of 41.5 degrees Fahrenheit (F) (between 15 F and 46 F) for 18 hours and at 25.5 F for 15 hours and 58 minutes. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, via company representative and refers to a 72 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis. Other suspect therapies included unspecified influenza virus vaccine (strength, dose, route of administration, lot # and expiration date were not provided), administered in the same arm as the PNEUMOVAX 23. On 13-NOV-2017, the patient's arm swelled horribly. The swelling lasted for three days. The patient did not seek medical attention. No treatment was given for the adverse event. The outcome of arm swelling was reported as unknown. The relatedness between PNEUMOVAX 23 and arm swelling was not reported. No product quality complaint was involved.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance and refers to a 17-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 20-NOV-2017, the patient was vaccinated with VAQTA 1 ml, intramuscular (lot # and expiration date were not provided for prophylaxis. The patient was given incorrectly an adult dose of  VAQTA. No adverse effect was reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a n adult patient of unknown age and gender. No information about patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications was reported. On 26-OCT-2017, the patient was vaccinated with two separate pediatric doses of VAQTA for prophylaxis (strength, lot # and expiration date were not reported). No adverse effects were reported. This is one of 2 reports received from the same reporter.; Sender's Comments: US-009507513-1710USA014500:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date in July 2017, the patient was vaccinated with an improperly stored dose of M-M-R II  (strength, dose, frequency, dose number and administration route were not reported) lot number M027637, expiration date 02-JUN-2018, for prophylaxis. Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not provided). On an unspecified date in 2017, the vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 47 Fahrenheit (F) and 77 F (54.6 F) for 2 hours. The previous temperature excursion registered was 47 F to 77 F (54.1 F) for 1 hour. No adverse effects were reported. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1711USA009696: US-009507513-1711USA009697: US-009507513-1711USA008021:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date in October 2017, the patient was vaccinated with with an improperly stored dose of M-M-R II (recombinant human albumin (rHA)) (strength, dose, frequency, dose number and administration route were not reported) lot number M027637, expiration date 02-JUN-2018, for prophylaxis. Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not provided). On an unspecified date in 2017, the vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 47 Fahrenheit (F) and 77 F (54.6 F) for 2 hours. The previous temperature excursion registered was 47 F to 77 F (54.1 F) for 1 hour. No adverse effects were reported. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1711USA009695: US-009507513-1711USA009697: US-009507513-1711USA008021:
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Body aches and low grade fever. Became 102 degree fever on second day. Large area of redness around injection site. OUTCOME: I'll be danged if I'm going to get a flu shot again. I never get the flu anyway. This is ridiculous.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLUX, UNK
Symptoms: Ear infection, Injection site erythema, Injection site induration, Injection site mass, Injection site reaction
Clinical narrative: Received 4 shots (flu, & standard 6 month shots), two in the left thigh. Dtap upper L thigh.. large red welt for 5 days with hard lump. Lump persists for 8+days. Low grade temp & double ear infection 5+ days after injection.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLUX, UNK
Symptoms: Urticaria
Clinical narrative: Received 4 shots (flu, & standard 6 month shots), two in the left thigh. Dtap upper L thigh.. large red welt for 5 days with hard lump. Lump persists for 8+days. Low grade temp & double ear infection 5+ days after injection.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient is 64 and was given high dose.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT IS 62 YEARS OLD AND RECEIVED A HIGH DOSE FLU FOR 65 AND OLDER. NO ISSUES.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient came in for her first flu shot and was given Influenza immunization. The recommendation is to administer 0.25ml to a patient 6m-8 years old that has never received a flu shot. Patient was given a full 0.5ml dose.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Polymerase chain reaction, Rash pruritic, Rash vesicular, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician, concerning a 18 month old female patient. The patient's medical history was not reported. The patient did not have concurrent conditions. The patient had not had drug allergies, and was not taking any concomitant medication. The patient had no recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was also reported that the patient had no prior history of herpes zoster, herpes zoster ophtalmicus and that she never had chickenpox.  The physician reported that on 13-OCT-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously, on the left thigh, lot number lot # M048200  (strength, dose, frequency, and expiration date were not reported) for prevention of chickenpox; and with the first dose of M-M-R II subcutaneously, on the right thigh lot number M000768  (strength, dose, frequency and expiration date were not reported) for prophylaxis. The physician reported that on 22-OCT-2017, nine days after vaccination, the patient developed multiple lesions of an itchy, vesicular rash on her arms legs, chest, abdomen, back and face, on the same date, body temperature was 98.6 (units not reported). It was also reported that the patient was prescribed with an unspecified dose of diphenhydramine hydrochloride (BENADRYL) on 25-OCT-2017 (also reported as no prescription drug treatment for the experience required). The physician also informed that on 25-OCT-2017, the patient was seen at her pediatrician and was given a prescription for lab work for Varicella Zoster Virus (VZV) Immunoglobulin M  Antibodies (IgM) and Immunoglobulin G Antibodies (IgG) levels. The results of this test were 2.95 (unspecified units)for IgM and for IgG 1068 (units unspecified) both assessed as positive. It was also reported that the physician was interested on VZV analysis and wanted to send viral isolates. On 26-OCT-2017, the physician sent a swab of 2 vesicles and a scab, of the abdomen, for a Polymerase Chain Reaction (PCR).  And on 01-NOV-2017, a viral culture was obtained and sent to labcorp.  It was reported, that on 11-NOV-2017 the VZVIP results were Negative (no VZV identified, adequate specimen). The results of the viral culture were still pending. At the time of this report, the outcome of the  itchy, vesicular rash on her arms legs, chest, abdomen, back and face, was reported as recovering. The causal relationship between the vaccination with VARIVAX and M-M-R II and the event was not reported. No temperature excursion occurred as a result of a reading from  a Digital Data Logger.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral test
Clinical narrative: This spontaneous report was received from a physician, concerning a 18 month old female patient. The patient's medical history was not reported. The patient did not have concurrent conditions. The patient had not had drug allergies, and was not taking any concomitant medication. The patient had no recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was also reported that the patient had no prior history of herpes zoster, herpes zoster ophtalmicus and that she never had chickenpox.  The physician reported that on 13-OCT-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously, on the left thigh, lot number lot # M048200  (strength, dose, frequency, and expiration date were not reported) for prevention of chickenpox; and with the first dose of M-M-R II subcutaneously, on the right thigh lot number M000768  (strength, dose, frequency and expiration date were not reported) for prophylaxis. The physician reported that on 22-OCT-2017, nine days after vaccination, the patient developed multiple lesions of an itchy, vesicular rash on her arms legs, chest, abdomen, back and face, on the same date, body temperature was 98.6 (units not reported). It was also reported that the patient was prescribed with an unspecified dose of diphenhydramine hydrochloride (BENADRYL) on 25-OCT-2017 (also reported as no prescription drug treatment for the experience required). The physician also informed that on 25-OCT-2017, the patient was seen at her pediatrician and was given a prescription for lab work for Varicella Zoster Virus (VZV) Immunoglobulin M  Antibodies (IgM) and Immunoglobulin G Antibodies (IgG) levels. The results of this test were 2.95 (unspecified units)for IgM and for IgG 1068 (units unspecified) both assessed as positive. It was also reported that the physician was interested on VZV analysis and wanted to send viral isolates. On 26-OCT-2017, the physician sent a swab of 2 vesicles and a scab, of the abdomen, for a Polymerase Chain Reaction (PCR).  And on 01-NOV-2017, a viral culture was obtained and sent to labcorp.  It was reported, that on 11-NOV-2017 the VZVIP results were Negative (no VZV identified, adequate specimen). The results of the viral culture were still pending. At the time of this report, the outcome of the  itchy, vesicular rash on her arms legs, chest, abdomen, back and face, was reported as recovering. The causal relationship between the vaccination with VARIVAX and M-M-R II and the event was not reported. No temperature excursion occurred as a result of a reading from  a Digital Data Logger.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75-year-old female patient with diabetes mellitus and allergy to sulfonamides (reported as "sulfa"). In approximately 2012 (reported as about 5 years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided), reconstituted with sterile diluent (lot number and expiration date were not provided). Concomitant therapies included insulin and pain pills. On an unknown day (after administration of ZOSTAVAX), the patient might have had herpes zoster. At the time of the report, the patient did not have a rash or herpes zoster. The outcome of the event was reported as recovered on an unknown date. The relatedness between ZOSTAVAX and the event was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to the patient of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 17-OCT-2017 the patient was vaccinated with an expired dose of M-M-R II subcutaneous (lot # L032181, expiration date 25-AUG-2017, dose and route of administration were not reported) for prophylaxis. Reconstituted with sterile diluent (STERILE DILUENT). The patient did not experienced any adverse events. Product quality complaint was not involved.
Age: 0.17
Sex: U
Vaccine: RV5, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 9-week-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017, 29-JUN-2017 and 06-SEP-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017, 26-JUL-2017 and 05-SEP-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1709USA012767: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158: