chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 19-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 16-OCT-2018 the patient was vaccinated with an expired dose of ROTATEQ vial (dose and frequency were not reported) (lot # N005080, expiry date: 03-OCT-2018) orally for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse via employee refers to a male patient of an unknown age. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 11-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (lot#, expiry date, route and dosage details were not reported). On 12-OCT-2018, the patient sought medical attention, called the office and reported, "redness, swelling, and warmth at the insertion site. The patient was advised to take TYLENOL and to call back if the symptoms worsened. No product quality complaint (PQC) was involved. It was unknown if the patient's symptoms had resolved. The reporter did not provide any causality assessment.
Age: 44.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Rhinorrhoea
Clinical narrative: A spontaneous report has been received from a consumer concerning a Caucasian male patient of (age 44 years 49 weeks 5 days, height 67 in, weight 170 lb). No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown Concomitant medication included cetirizine hydrochloride for allergies. The patient received FLUMIST QUADRIVALENT  (intranasal) (batch number Unk) 0.25 ml once/single administration (preferred term: Off label use), via nasal route, for flu vaccine on 01-OCT-2018. Patient stated on 02-Oct-2018, when he woke up, he had a really runny or significantly runny nose, he took antihistamine, Zyrtec which seemed to make it go away and most of 02-Oct-2018, he had a dry cough (preferred term: Cough) that was more than typical but he was recovering and also his nose was stuffed up but seemed to be only slight at the time of report (recovering). HCP not aware. The outcome of the event of received 0.25 ml FLUMIST QUADRIVALENT (off label use) was unknown. The events were considered non-serious.
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable Physician. A currently 12-year-old male patient had received 2 doses of PREVNAR 13 when he was a baby. Relevant medical history and concomitant medications were not reported. He had lobar Pneumonia 3 times, the last time was when he was 9 years old. The outcome of the event was unknown. Information on the batch number has been requested. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events drug ineffective and lobar Pneumonia.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves female patient of 13 year who received suspect vaccine was FLUBLOK QIV which was given accidently as it was recommended to 18 years and above old. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medication was none. On 02-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1806 and expiry date: 06-May-2019) (dose and dose in series was not reported) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported that if any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740 and 2018SA279743 (Same reporter). This case involves a 60 years old female patient who received vaccine FLUBLOK QIV which was in shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none reported as no other vaccine was given. On 02-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1829 via intramuscular route in the left deltoid. It was case of actual medication error due to incorrect product storage. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Needle issue
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient who received 0.5 ml dose of TYPHIM VI (lot N1K911M, expiry date: 27-Oct-2019) via unknown route. This is a PTC case as it this involves TYPHIM pre-filled syringes with the tip which having difficulty when attaching a needle to the barrel / attempted to connect the needle to the barrel, it fell apart. This case was reported for two patients, out of which one was immunized. PTC number: 100002476 status: in process. It was reported that, a Product Technical Complaint involving (2) different TYPHIM pre-filled syringes with the tip caps. The first was reported to the pharmacist on 9/21/2018. A nurse reported having difficulty when attaching a needle to the barrel, it fell apart and fell to the floor. No product was leaking. Denied any cracked tips. No reported problem with the plunger. International travel was planned. The patient did not receive the vaccine due this incident. Pharmacist refused to share any patient information for this report citing HIPAA concerns. The second incident occurred today. A nurse reported that when she attempted to connect the needle to the barrel, it fell apart. No vaccine was leaking. Denied that the tip was cracked. No reported problem with the plunger. Nurse did reconnect a new needle and patient did receive this immunization. Patient was preparing for international travel. No information about relevant tests reported. Outcome: not applicable. Follow up information received on 05-Oct-2018 from a pharmacist. No new information received. Follow-up report received from a pharmacist on 08-Oct-2018. The PTC ID updated. Follow up information received on 11-Oct-2018 from a pharmacist. No new information received. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site reaction
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA279494 and 2018SA279808.(same reporter). This case involves a male patient (patient: 02) who experienced reactions between the injection site and elbow, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medication were not provided. On 10-Mar-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB via intramuscular route. On an unknown date, The patient developed a non-serious reactions between the injection site and elbow (vaccination site reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab tests reported.) Final diagnosis was reactions between the injection site and elbow. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for reactions between the injection site and elbow.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to cases 2018SA281637, 2018SA279973, 2018SA279979, 2018SA281635 and 2018SA281634. This case involves a 12 years old male patient who received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported via unknown route. It was a case of actual medication error due to product storage error. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Induration, Inflammation, Peripheral swelling
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 9 years old female patient who experienced inflammation, induration and flushing, while she received vaccine influenza vaccine. The patient had past vaccination with flu shot and experienced same reaction (inflammation, induration and flushing). On 04-Oct-2018 (07:00 PM thursday), the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date (Friday AM), the patient developed a non-serious arms swollen and arm to touch (inflammation) (Unknown latency), hard to touch (induration) (Unknown latency) and arms swollen (flushing) (Unknown latency) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was arms swollen, hard to touch and arms swollen and arm to touch. Doctor recommended cool compresses, zyrtec or Claritin/ Benadryl if needed. The event outcome was reported as Recovered / Resolved (on Sunday PM) for inflammation, induration and flushing. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 11 years old patient who (gender not reported) was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven years old female patient who was vaccinated with a 0.5 ml first dose of QUADRACEL (Batch number: C5222AA, expiration date: 20-Jun-2019, route: intramuscular and site of administration: right gluteus medius, frequency: once) on 09-Oct-2018. The patient's medical history was not reported. The patient received concomitant vaccines HepB and MMR (both by Merck). It was an actual medication error due to inappropriate age at vaccine administration (seven-year-old received QUADRACEL vaccine/No AE). The patient did not experience any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from Consumer/Non-HCP (office staff). This case involves a 55 years old female patient who experienced 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU with every year. The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided. On 05-Oct-2018, the patient received a 0.5 ml standard dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA expiry date 30-Jun-2018 via unknown route in the left deltoid. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (urticaria) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (inflammation) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (vaccination site reaction) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not reported. Final diagnosis was 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain. It was not reported if the patient received a corrective treatment. The event of injection site swelling was ongoing at the time of reporting and outcome of other event was not reported. Documents held by sender: none
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from Consumer/Non-HCP (office staff). This case involves a 55 years old female patient who experienced 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU with every year. The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided. On 05-Oct-2018, the patient received a 0.5 ml standard dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA expiry date 30-Jun-2018 via unknown route in the left deltoid. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (urticaria) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (inflammation) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (vaccination site reaction) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not reported. Final diagnosis was 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain. It was not reported if the patient received a corrective treatment. The event of injection site swelling was ongoing at the time of reporting and outcome of other event was not reported. Documents held by sender: none
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 14 months old female patient who was vaccinated with a 0.5 ml instead of 0.25ml dose of FLUZONE QUADRIVALENT (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. It was reported that the patient was given 0.5ml of FLUZONE QUADRIVALENT instead of 0.25ml for her first vaccine of the 2 part series. It was an actual medication error due to overdose. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received 0.5 ml vaccine FLUZONE HIGH DOSE (lot UJ022AA) via unknown route in the left arm on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants were reported. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Incorrect route of product administration, Underdose, Wrong product administered
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four years old female patient who received a dose of FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 10-Oct-2018, the patient received a 0.1 ml dose of suspect FLUZONE (lot number: UI998AC and expiry date: 03-June-2019) (dose in series and route was not reported) via intradermal route in the left forearm. It was a case of actual medication error due to inappropriate route of vaccination and vaccine underdose. It was reported that the child was administered FLUZONE QUAD intradermally yesterday because the MA thought she grabbed a PPD vial. Only 0.1 mL was administered. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.