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 20-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) 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: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2014, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2007, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On or about 25-AUG-2016, the patient was treated for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the  ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning 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 in 2015, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning 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 in 2016, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles (developed on an unknown date in approximately 2016). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-MAR-2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-AUG-2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. She was prescribed valacyclovir and pregabalin for management of her painful symptoms and chronic pain. On or about 15-AUG-2016, she sought subsequent treatment from a nurse practitioner for another blistering vesicular outbreak, which was diagnosed as severe herpes zoster. She was prescribed pregabalin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 33 year old patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. In April 2018 (reported as 6 months ago), the patient was vaccinated with a dose of M-M-R II (dosing details, lot # and expiry date were unknown) for prophylaxis (drug administered to patient of inappropriate age). Other suspect therapies included Merck Sterile Diluent. No adverse effects were reported. It could not be clarified if the patient was previously vaccinated with M-M-R II.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 08-OCT-2018, the patient was vaccinated with an expired dose of VARIVAX subcutaneously, lot# M038859, expiration date: 14-SEP-2018 (exact dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning 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 in 2013, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 17-JUL-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning 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 in 2012, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 12-DEC-2011 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 26-APR-2016 the patient was treated by a physician for onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
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-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 03-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 22-SEP-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 20-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 06-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  N013863 and expiration date 31-OCT-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 05-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 06-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 11-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  N013863 and expiration date 31-OCT-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 29-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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 30-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  N013863 and expiration date 31-OCT-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 05-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-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.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Muscular weakness, Pain in extremity, Product administered at inappropriate site, Weight bearing difficulty
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle spasm in a 26-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 23rd September 2018, the patient received FLUARIX QUADRIVALENT. In September 2018, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced muscle spasm, pain in arm and weakness of arms. On 23rd September 2018, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the muscle spasm was recovering/resolving and the outcome of the pain in arm and weakness of arms were unchanged and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the muscle spasm, pain in arm and weakness of arms to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by the healthcare professional for herself. The FLUARIX might have been administered too high above the deltoid to the patient, which led to vaccine administered at inappropriate site. Afterward the patient experienced pain and difficulty in lifting anything heavy with affected arm which persists till the time of reporting. Muscle spasms of left side of neck and jaw was also developed after two days. The patient has denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 75 or 76 years. The batch number and expiry date were not reported. After receiving SHINGRIX, the patient experienced redness and swelling at the injection site which swelled to double the normal size. This dose was not administered at the reporter's facility, so no further information was available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, 8 hrs after receiving SHINGRIX, the patient experienced headache, nausea, tingling of extremity, fatigue and fever. On 20th September 2018, the patient experienced elevated sedimentation rate. On an unknown date, the outcome of the headache, nausea, tingling of extremity, fatigue and fever were recovered/resolved and the outcome of the elevated sedimentation rate was unknown. It was unknown if the reporter considered the headache, nausea, tingling of extremity, fatigue, fever and elevated sedimentation rate to be related to SHINGRIX. Additional details were provided as follows: The patient reported that, after receiving SHINGRIX, she experienced headache, fatigue, nausea, fever, tingling in both hands and fingers and after day 3, an intermittent fever that would come and go. The patient saw her physician who did a sedimentation rate, and found that it was 40 mm per hr. On 5th October 2018, a repeat test was done, but results were not yet know. At time of report, all other events had resolved. The physician's contact details were provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, 8 hrs after receiving SHINGRIX, the patient experienced headache, nausea, tingling of extremity, fatigue and fever. On 20th September 2018, the patient experienced elevated sedimentation rate. On an unknown date, the outcome of the headache, nausea, tingling of extremity, fatigue and fever were recovered/resolved and the outcome of the elevated sedimentation rate was unknown. It was unknown if the reporter considered the headache, nausea, tingling of extremity, fatigue, fever and elevated sedimentation rate to be related to SHINGRIX. Additional details were provided as follows: The patient reported that, after receiving SHINGRIX, she experienced headache, fatigue, nausea, fever, tingling in both hands and fingers and after day 3, an intermittent fever that would come and go. The patient saw her physician who did a sedimentation rate, and found that it was 40 mm per hr. On 5th October 2018, a repeat test was done, but results were not yet know. At time of report, all other events had resolved. The physician's contact details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional stated, patient would miss the 6 month window for 2nd dose of SHINGRIX next month due to backorder. This case has been linked with case US2018183699, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 9th October 2018 10:00, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 9th October 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site hives. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching and injection site hives were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching and injection site hives to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. After receiving Flu vaccine, the patient experienced itching, swelling over an 8cm by 8cm by 3cm area and hives at the injection site. The reporter knows it was a GSK product but was unable to provide the name or any other information at the time of the call. The staff member would call back to provide additional information. This case was transferred to medical information. This case has been linked with the case US2018183707, US2018GSK186849 and US2018GSK186850 reported by same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Groin pain, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of groin pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included leg cramps (relieved pressure spot on back /waist / buttock area) and sciatica (10 year before the time of reporting on left due to medical procedure and placement on a medical table caused the pain). On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 1st October 2018, less than a day after receiving SHINGRIX, the patient experienced groin pain and discomfort. On 7th October 2018, the patient experienced sleeplessness. On 8th October 2018, the patient experienced leg pain and knee pain. In October 2018, the patient experienced pain in spine. On an unknown date, the outcome of the groin pain was recovering/resolving and the outcome of the discomfort, knee pain and pain in spine were unknown and the outcome of the leg pain and sleeplessness were not recovered/not resolved. It was unknown if the reporter considered the groin pain, discomfort, leg pain, sleeplessness, knee pain and pain in spine to be related to SHINGRIX. Additional details were provided as follows: The patient previously experienced sciatica pain due to medical procedure and placement on a medical table caused the pain. The patient received SHINGRIX in the left arm. The patient was experiencing pain in his right groin area that began sometime after the injection. He stated the pain had been so uncomfortable that was unable to sleep. From 7th October 2018, 6 days receiving SHINGRIX, he noted that he was unable to sleep beginning. At the time of reporting, he was still not able to sleep at night, but noted the severity of the pain was not as bad. On 8th October 2018, 7 days receiving SHINGRIX, the patient also noted the soreness had traveled down the inner right leg to the knee. He also noted the knee cap was painful. He stated there was an area on his buttocks between the buttocks and waist that he can press on and it is slightly sore. The patient noted that it was to the right of the spine. The patient did not have difficulty walking with these events. He stated the traveling soreness down the leg began 2 days before the time of reporting.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of groin pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included leg cramps (relieved pressure spot on back /waist / buttock area) and sciatica (10 year before the time of reporting on left due to medical procedure and placement on a medical table caused the pain). On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 1st October 2018, less than a day after receiving SHINGRIX, the patient experienced groin pain and discomfort. On 7th October 2018, the patient experienced sleeplessness. On 8th October 2018, the patient experienced leg pain and knee pain. In October 2018, the patient experienced pain in spine. On an unknown date, the outcome of the groin pain was recovering/resolving and the outcome of the discomfort, knee pain and pain in spine were unknown and the outcome of the leg pain and sleeplessness were not recovered/not resolved. It was unknown if the reporter considered the groin pain, discomfort, leg pain, sleeplessness, knee pain and pain in spine to be related to SHINGRIX. Additional details were provided as follows: The patient previously experienced sciatica pain due to medical procedure and placement on a medical table caused the pain. The patient received SHINGRIX in the left arm. The patient was experiencing pain in his right groin area that began sometime after the injection. He stated the pain had been so uncomfortable that was unable to sleep. From 7th October 2018, 6 days receiving SHINGRIX, he noted that he was unable to sleep beginning. At the time of reporting, he was still not able to sleep at night, but noted the severity of the pain was not as bad. On 8th October 2018, 7 days receiving SHINGRIX, the patient also noted the soreness had traveled down the inner right leg to the knee. He also noted the knee cap was painful. He stated there was an area on his buttocks between the buttocks and waist that he can press on and it is slightly sore. The patient noted that it was to the right of the spine. The patient did not have difficulty walking with these events. He stated the traveling soreness down the leg began 2 days before the time of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not  reported. The healthcare professional (HCP )reported that the patient had an anaphylactic reaction to an unknown flu vaccine back in 2014.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Muscular weakness, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 62-year-old female patient who received SHINGRIX (batch number C523T, expiry date unknown) for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, weakness of arms and injected limb mobility decreased. The patient was treated with Physical Therapy (Nos). On an unknown date, the outcome of the muscle pain, weakness of arms and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, weakness of arms and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist had reported adverse event to VAERS a couple of weeks before the reporting date. The pharmacist said that, one of her patient started experiencing muscle pain, limited mobility and weakness in the arm where she received the injection. The pharmacist clarified that it was not only at the injection site, but the whole arm. The patient was doing physical therapy to treat the events.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, chills and localized erythema. On an unknown date, the outcome of the pain in arm, chills and localized erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient reported chills, arm soreness, and significant localized redness expanding up to the shoulder. The symptoms resolved after a few days. This case was linked to the case US2018184661, reported by the same reporter for the different patient who also experienced same symptoms with the same lot number.