chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Blood bicarbonate decreased, C-reactive protein normal, Infant irritability, Laboratory test, Lip discolouration
Clinical narrative: Suddenly her lips and face became white/ gray; it appeared that she was not breathing; Suddenly her lips and face became white/ gray; febrile to 100.6; She was fussy/ clingy all day/ mother has not been able to put her down; Blood bicarbonate increased; Blood Culture; C-Reactive protein normal; Mother could not feel a heart beat; Laboratory test; Liver function test normal; Metabolic acidosis; Metabolic function test abnormal; Respiratory viral panel; Urine ketone body present; White blood cell count increased; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID: 2413525-1. The original narrative from the sender is as follows:  pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix. Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.  Lab Data: febrile to 100.6, exam reassuring. Due to 4min episode, and fever they did labs. US: 1+leuks, BMP: unremarkable aside from mild metab acid w bicarb 19, WBC: 19k, 14N. LFT: normal. CRP: normal. Blood culture: pending. RVP: pending. +admit for monitoring-to the floor.  History/ Allergies: polydactyly- followed by Ortho/ Hand-f/u 10/2022, ABO incompatibility baby A+ DAT + / IAT +, Fail newborn hearing scree, passed the repeat, Normal newborn metabolic screen.,NKDA  The reporter did not assess the causal relationship between Vaxelis and "Suddenly her lips and face became white/ gray", "it appeared that she was not breathing", "She was fussy/ clingy all day/ mother has not been able to put her down" and "Mother could not feel a heart beat".   The causal relationship between Vaxelis and "febrile to 100.6", "Blood bicarbonate increased", "Blood Culture", "C-Reactive protein normal", "Laboratory test", "Liver function test normal", "Metabolic acidosis", "Metabolic function test abnormal", "Respiratory viral panel", "Urine ketone body present" and "White blood cell count increased" is not applicable due to the nature of the events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Liver function test normal, Metabolic acidosis, Metabolic function test abnormal, Pulse absent, Pyrexia
Clinical narrative: Suddenly her lips and face became white/ gray; it appeared that she was not breathing; Suddenly her lips and face became white/ gray; febrile to 100.6; She was fussy/ clingy all day/ mother has not been able to put her down; Blood bicarbonate increased; Blood Culture; C-Reactive protein normal; Mother could not feel a heart beat; Laboratory test; Liver function test normal; Metabolic acidosis; Metabolic function test abnormal; Respiratory viral panel; Urine ketone body present; White blood cell count increased; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID: 2413525-1. The original narrative from the sender is as follows:  pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix. Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.  Lab Data: febrile to 100.6, exam reassuring. Due to 4min episode, and fever they did labs. US: 1+leuks, BMP: unremarkable aside from mild metab acid w bicarb 19, WBC: 19k, 14N. LFT: normal. CRP: normal. Blood culture: pending. RVP: pending. +admit for monitoring-to the floor.  History/ Allergies: polydactyly- followed by Ortho/ Hand-f/u 10/2022, ABO incompatibility baby A+ DAT + / IAT +, Fail newborn hearing scree, passed the repeat, Normal newborn metabolic screen.,NKDA  The reporter did not assess the causal relationship between Vaxelis and "Suddenly her lips and face became white/ gray", "it appeared that she was not breathing", "She was fussy/ clingy all day/ mother has not been able to put her down" and "Mother could not feel a heart beat".   The causal relationship between Vaxelis and "febrile to 100.6", "Blood bicarbonate increased", "Blood Culture", "C-Reactive protein normal", "Laboratory test", "Liver function test normal", "Metabolic acidosis", "Metabolic function test abnormal", "Respiratory viral panel", "Urine ketone body present" and "White blood cell count increased" is not applicable due to the nature of the events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Respiratory arrest, Skin discolouration, Urine leukocyte esterase positive, White blood cell count increased
Clinical narrative: Suddenly her lips and face became white/ gray; it appeared that she was not breathing; Suddenly her lips and face became white/ gray; febrile to 100.6; She was fussy/ clingy all day/ mother has not been able to put her down; Blood bicarbonate increased; Blood Culture; C-Reactive protein normal; Mother could not feel a heart beat; Laboratory test; Liver function test normal; Metabolic acidosis; Metabolic function test abnormal; Respiratory viral panel; Urine ketone body present; White blood cell count increased; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID: 2413525-1. The original narrative from the sender is as follows:  pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix. Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.  Lab Data: febrile to 100.6, exam reassuring. Due to 4min episode, and fever they did labs. US: 1+leuks, BMP: unremarkable aside from mild metab acid w bicarb 19, WBC: 19k, 14N. LFT: normal. CRP: normal. Blood culture: pending. RVP: pending. +admit for monitoring-to the floor.  History/ Allergies: polydactyly- followed by Ortho/ Hand-f/u 10/2022, ABO incompatibility baby A+ DAT + / IAT +, Fail newborn hearing scree, passed the repeat, Normal newborn metabolic screen.,NKDA  The reporter did not assess the causal relationship between Vaxelis and "Suddenly her lips and face became white/ gray", "it appeared that she was not breathing", "She was fussy/ clingy all day/ mother has not been able to put her down" and "Mother could not feel a heart beat".   The causal relationship between Vaxelis and "febrile to 100.6", "Blood bicarbonate increased", "Blood Culture", "C-Reactive protein normal", "Laboratory test", "Liver function test normal", "Metabolic acidosis", "Metabolic function test abnormal", "Respiratory viral panel", "Urine ketone body present" and "White blood cell count increased" is not applicable due to the nature of the events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: ROTATEQ vaccine expired 09-04-2022; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2464591-1. The original narrative from the sender is the following:  ROTATEQ VACCINE EXPIRED 09-04-2022.  The causal relationship between Vaxelis and the reported event "Expired Product Administered" is assessed as not applicable due to the nature of the event.   No further information is expected.  Note: Based on the available information, the event was not related to Vaxelis but to Rotateq vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from reporting system and information was kept as reported in the form.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Crying, Diarrhoea, Vomiting
Clinical narrative: loose watery stools; Inconsolable crying; Emesis; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2417741-1. The original narrative from the sender is the following:  The day after the vaccines were administered, the infant developed loose watery stools, followed by inconsolable crying and emesis. Parents brought child to the ER, where she was able to eat after taking ondansetron PO and was discharged home. Baby was seen in the office today and appeared happy with a normal abdominal exam. Passed a normal BM today.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Diarrhoea" "Crying" and "Vomiting".  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: 1st dose at 7-years old; A nurse reported that a 7 year old patient was administered Vaxelis; This non-serious spontaneous safety report with reference# 02268150 and interaction# 02268145 was received by a partner on 14-OCT-2022 from a Nurse and forwarded on 14-OCT-2022.  Due to the nature of the event, the causality between Vaxelis and the reported events of "A nurse reported that a 7 year old patient was administered Vaxelis", was not applicable.  Off label use classification added as 1st dose at 7-years old.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients; This non-serious spontaneous safety report, with reference number 02268180 / 02268162, was received by the partner on 14-OCT-2022 and forwarded on 17-OCT-2022, from a non-healthcare professional.   Due to the nature of the event the causal relationship between Vaxelis and the event "unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients" was not applicable.   Further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional in  on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004183, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004181, MCM-004183, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 1.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.83
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004183, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.67
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004183, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004186, MCM-004183, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004186, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004186, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004186, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004186, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004186, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional.   Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C" and Vaxelis was not applicable.  Further information is expected.  For reference purposes this case is linked to MCM-004173, MCM-004203 and MCM-004204.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional.   Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients" and Vaxelis was not applicable.  Further information is expected.  For reference purposes this case is linked to MCM-004173, MCM-004202 and MCM-004203.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Crying
Clinical narrative: Had excessive crying at time of the injection; This non-serious spontaneous safety report, with case number 02270452/02270446, was received by partner, on 18Oct2022 and forwarded on 19Oct2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Crying".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Crying
Clinical narrative: Had excessive crying at the time of the injection; This non-serious spontaneous safety report, with case number 02270452/02270446, was received by partner, on 18Oct2022 and forwarded on 19Oct2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Crying".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: VAXELIS was administered to a patient after a non-supported temp excursion. No additional AE details or PQC.; This non-serious spontaneous report with reference numbers 02271074 / 02271042 was received by partner on 19-OCT-2022 and forwarded on 20-OCT-2022 from a health care professional.   The causal relationship between Vaxelis and the reported event "non-supported temp excursion, Temperature 28.2F, 50.7F, Time frame 72 hours 45 minutes and 0 seconds, 19 hours 0 minutes and 0 seconds (RESPECTIVELY)" was assessed as not applicable due to the nature of the event.   Further information is expected.  Non-Significant follow up information was received on 17-NOV-2022 from the other health care professional.  No adverse event was reported.  The causal relationship between Vaxelis and the reported event "non-supported temp excursion, Temperature 28.2F, 50.7F, Time frame 72 hours 45 minutes and 0 seconds, 19 hours 0 minutes and 0 seconds (RESPECTIVELY)" was assessed as not applicable due to the nature of the event.  No further information is expected.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Vaccines administered after temperature excursion (46.2 F). Vaccines involved : VAXELIS U7205AA and VAXELIS U7151AA 7.; This spontaneous safety report, with reference number 02272790, was received by a partner on 21-OCT-2022 and forwarded on 24-OCT-2022, from a Health Professional.   This case was considered non-valid due to no patient identifiers were provided (temperature excursion).  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received on 25-NOV-2022 from the physician.  The case is valid as patient identifiers were provided.  It was reported that the patient did not experience any adverse event.  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004325, MCM-004326 and MCM-004327.  Further information is expected.
Age: 4.0
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 4 year old patient received the product VAXELIS instead of KINRIX; This non-serious spontaneous safety report, with reference number 2022SA439239/ Inquiry# 01335763 was received by a partner on 24-OCT-2022 and forwarded on 27-OCT-2022 from another health professional.   Due to the nature of the event, the causality between the event "a 4-year-old patient received the product VAXELIS instead of KINRIXS." and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Vaxelis and Engerix-B on the same date; This non-serious spontaneous safety report, with reference number 2022SA439355/ Inquiry# 01337995 was received by the partner on 25-OCT-2022 and forwarded on 27-OCT-2022 from another health professional.   Due to the nature of the event, the causality between the event "Giving an extra dose of HEPTITIS B to a 6-month-old patient. The patient received several other vaccines the same day including VAXELIS." and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 28-OCT-2022 and forwarded on 02-NOV-2022, from a HCP. The case is maintained as non-serious. The HCP confirmed that no Adverse Events have been reported.  Due to the nature of the event, the causality between the event "Patient received Vaxelis and Engerix-B on the same date" and Vaxelis remained not applicable.  Further information is expected.
Age: 76.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Inadvertently received a dose of Vaxelis instead of the ordered Fluzone high Dose Q/V; Vaccine administered to a 76years old; This non serious spontaneous safety report was received by the partner on 08-Nov-2022 and forwarded on 09-Nov-2022 with the following reference number 2022SA460825 from other health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received on 23-NOV-2022 from a health care professional.  The reporter confirmed that the patient did not experience any adverse event. Dose, batch number and expiration date of Vaxelis dose were provided.  The causal relationship between Vaxelis and the reported events were not applicable.  The case is maintained as non-serious.  No further information is expected
Age: 73.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently received a dose of VAXELIS instead of the ordered FLUZONE HIGH DOSE QIV; Vaccine administered to a 73yr old; This non serious spontaneous safety report with reference #2022SA461540 was received by the partner on 08-NOV-2022 and forwarded on 09-NOV-2022 from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  Further information is expected.  Case is linked to MCM-004263 (same reporter link)  SIGNIFICANT FOLLOW-UP INFORMATION was received on 23-NOV-2022 from a health care professional.  The reporter confirmed that the patient did not experience any adverse event. Patient history, dose, batch number and expiration date of Vaxelis dose were provided.  The causal relationship between Vaxelis and the reported events were not applicable.  The case is maintained as non-serious.  No further information is expected
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Vaccines administered after temperature excursion (46.2 F). Vaccines involved :VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician.   The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233)  It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004233, MCM-004326 and MCM-004327.  Further information is expected.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician.   The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233) (Temperature excursion case)  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004233, MCM-004325 and MCM-004327.  Further information is expected.  FOLLOW-UP INFORMATION was received on 12-DEC-2022, from a HCP. The case is maintained as non-serious.   The HCP confirmed that there were no adverse events following Vaxelis administration..  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA" and Vaxelis remained not applicable.  Further information is expected..
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician.   The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233)  It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004233, MCM-004326 and MCM-004325.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nurse is calling to report the VAXELIS vaccine was given to an 11-year-old, she was given the infant dose.; The VAXELIS is off-label due to the patient's age, she was intended to receive DTaP; This non-serious spontaneous safety report, with reference number 2022SA497140 / Inquiry# 01396040 was received by a partner on 06-DEC-2022 and forwarded to Agency on 07-DEC-2022 from a health care professional.   Due to the nature of the event, the causality between Vaxelis and reported events "Nurse is calling to report the VAXELIS vaccine was given to an 11-year-old, she was given the infant dose", and "The VAXELIS is off-label due to the patient's age, she was intended to receive DTaP" was not applicable.  OFF LABEL classification has been added to the case.  Further information is expected.
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: Patient also received first dose of VAXELIS and HAVRIX at same visit/ child received first dose at 6 months/use is outside; This non-serious spontaneous safety report, with reference number 02299227/ 02299222 was received by a partner on 08-DEC-2022 and forwarded to Agency on 08-DEC-2022 from a health care professional.   Due to the nature of the event, the causality between the event "Patient also received first dose of VAXELIS and HAVRIX at same visit/ child received first dose at 6 months/use is outside of PI" and Vaxelis was not applicable.  The case is considered as off label due to inappropriate schedule of vaccine administration.  Further information is expected.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Patient was administered VAXELIS on 22NOV2022 and the excursion occurred on 09NOV2022/ Temperature it reached was 10.1C; This spontaneous safety report, with reference number 2022SA509263 (Inquiry Number 01407148) was received by the partner on 14-DEC-2022 and forwarded to Agency on 16-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "Patient was administered VAXELIS on 22NOV2022 and the excursion occurred on 09NOV2022/ Temperature it reached was 10.1C" and Vaxelis was not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Overdose, Wrong product administered
Clinical narrative: Vaccine overdose; Office manager calling to report that a dose of VAXELIS and an unspecified hepatitis B vaccine were accidently concomitantly administered to a 2 month old patient.; This spontaneous safety report with reference number 02305666 (02305660) was received by the partner on 20-Dec-2022 and forwarded to Agency on 20-Dec-2022 from a Nurse Practitioner.  Due to the nature of the events, the causality between Wrong product administered, and Overdose and Vaxelis was not applicable.  Further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Covid after 4 Pfizer Covid vaccines; got Covid after 4 Pfizer Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; ATORVASTATIN; EZETIMIBE taken for blood cholesterol abnormal; MONTELUKAST; MUCINEX; SYNTHROID; VITAMINS NOS. Patient also reported that she was taking another blood pressure medication but doesn't know name for it.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after 4 Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got Covid. It was further reported that in May, patient had her 2nd booster and 2 weeks later flew to (City name) and they (patient and her husband) both got Covid. Hers was a home test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.