chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Kell blood group positive, Neonatal disorder, Pain in extremity
Clinical narrative: Case number PHHY2013US119845, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilaterally deafness. On 01 OCT 2006, during her second trimester she received session influenza vaccine and experienced injection site arm soreness (for mother se case PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient was vaccinated with Seasonal Influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2007. On an unknown date, after vaccination she experienced injection site sore arm. The patient received influenza vaccine in 2006, 2009, 2010 and 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119860, PHHY2013US119861, PHHY2013US119862 and PHHY2013US119863). It was reported that the patient was pregnant at the time of this report and planned to receive influenza vaccine for 2012-13, but had not received it yet. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain, Neonatal disorder
Clinical narrative: Case number PHHY2013US119860, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal Influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient was vaccinated with Seasonal Influenza vaccine in 2007 and experienced sore arm (injection site) (see case: PHHY2013US119845). The patient received Seasonal Influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2008. On an unknown date, after vaccination she experienced sore arm (injection site). She received Influenza vaccine in 2009, 2010 and in 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119862, PHHY2013US119861 and PHHY2013US119863). It was reported that the patient that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive Influenza vaccine, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Case number PHHY2013US119860, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal Influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient was vaccinated with Seasonal Influenza vaccine in 2007 and experienced sore arm (injection site) (see case: PHHY2013US119845). The patient received Seasonal Influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2008. On an unknown date, after vaccination she experienced sore arm (injection site). She received Influenza vaccine in 2009, 2010 and in 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119862, PHHY2013US119861 and PHHY2013US119863). It was reported that the patient that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive Influenza vaccine, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2013US119860, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal Influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient was vaccinated with Seasonal Influenza vaccine in 2007 and experienced sore arm (injection site) (see case: PHHY2013US119845). The patient received Seasonal Influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2008. On an unknown date, after vaccination she experienced sore arm (injection site). She received Influenza vaccine in 2009, 2010 and in 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119862, PHHY2013US119861 and PHHY2013US119863). It was reported that the patient that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive Influenza vaccine, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Kell blood group positive, Neonatal disorder, Pain in extremity
Clinical narrative: Case number PHHY2013US119860, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal Influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient was vaccinated with Seasonal Influenza vaccine in 2007 and experienced sore arm (injection site) (see case: PHHY2013US119845). The patient received Seasonal Influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2008. On an unknown date, after vaccination she experienced sore arm (injection site). She received Influenza vaccine in 2009, 2010 and in 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119862, PHHY2013US119861 and PHHY2013US119863). It was reported that the patient that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive Influenza vaccine, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain, Neonatal disorder
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717)  and Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic )>reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and 2009 and experienced sore arm (injection site) (see cases PHHY2013US119845, PHHY2013US119862 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2010. On an unknown date, she experienced vaccine INN (manufacturer and batch numbered not reported) on an unknown date in 2010. On an unknown date, she experienced sore arm (injection site). At the time of reporting the outcome of the event was resolved. She received influenza vaccine in 2011 and experienced sore arm (injection site) (see case PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to received influenza vaccine for 2012-13, but had not received it. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717)  and Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic )>reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and 2009 and experienced sore arm (injection site) (see cases PHHY2013US119845, PHHY2013US119862 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2010. On an unknown date, she experienced vaccine INN (manufacturer and batch numbered not reported) on an unknown date in 2010. On an unknown date, she experienced sore arm (injection site). At the time of reporting the outcome of the event was resolved. She received influenza vaccine in 2011 and experienced sore arm (injection site) (see case PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to received influenza vaccine for 2012-13, but had not received it. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717)  and Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic )>reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and 2009 and experienced sore arm (injection site) (see cases PHHY2013US119845, PHHY2013US119862 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2010. On an unknown date, she experienced vaccine INN (manufacturer and batch numbered not reported) on an unknown date in 2010. On an unknown date, she experienced sore arm (injection site). At the time of reporting the outcome of the event was resolved. She received influenza vaccine in 2011 and experienced sore arm (injection site) (see case PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to received influenza vaccine for 2012-13, but had not received it. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Kell blood group positive, Neonatal disorder, Pain in extremity
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717)  and Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic )>reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and 2009 and experienced sore arm (injection site) (see cases PHHY2013US119845, PHHY2013US119862 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2010. On an unknown date, she experienced vaccine INN (manufacturer and batch numbered not reported) on an unknown date in 2010. On an unknown date, she experienced sore arm (injection site). At the time of reporting the outcome of the event was resolved. She received influenza vaccine in 2011 and experienced sore arm (injection site) (see case PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to received influenza vaccine for 2012-13, but had not received it. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain, Neonatal disorder
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717) Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and experienced sore arm (injection site) (see cases PHHY2013US119845 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2009.  On an unknown date, after vaccination she experienced sore arm (injection site). She received influenza vaccine in 2010 and 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119861 and PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to receive influenza vaccine for 2012-13 but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717) Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and experienced sore arm (injection site) (see cases PHHY2013US119845 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2009.  On an unknown date, after vaccination she experienced sore arm (injection site). She received influenza vaccine in 2010 and 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119861 and PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to receive influenza vaccine for 2012-13 but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717) Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and experienced sore arm (injection site) (see cases PHHY2013US119845 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2009.  On an unknown date, after vaccination she experienced sore arm (injection site). She received influenza vaccine in 2010 and 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119861 and PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to receive influenza vaccine for 2012-13 but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Kell blood group positive, Neonatal disorder, Pain in extremity
Clinical narrative: Case number PHHY2013US119861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 OCT 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 OCT 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case, PHHY2013US116717) Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008 and experienced sore arm (injection site) (see cases PHHY2013US119845 and PHHY2013US119860). The patient received seasonal influenza vaccine INN (manufacturer and batch number not reported) on an unknown date in 2009.  On an unknown date, after vaccination she experienced sore arm (injection site). She received influenza vaccine in 2010 and 2011 and experienced sore arm (injection site) after each vaccination (see cases: PHHY2013US119861 and PHHY2013US119863). It was reported that the patient was pregnant at the time of this report (20 MAR 2013) and planned to receive influenza vaccine for 2012-13 but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain, Neonatal disorder
Clinical narrative: Case number PHHY2013US119863, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008, 2009 and in 2010 and experienced sore arm (injection site) (see cases: PHHY2013US119845, PHHY2013US119860, PHHY2013US119862 and PHHY2013US119861). The patient received Seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2011. On an unknown date, after vaccination she experienced sore arm (injection site). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Case number PHHY2013US119863, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008, 2009 and in 2010 and experienced sore arm (injection site) (see cases: PHHY2013US119845, PHHY2013US119860, PHHY2013US119862 and PHHY2013US119861). The patient received Seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2011. On an unknown date, after vaccination she experienced sore arm (injection site). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2013US119863, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008, 2009 and in 2010 and experienced sore arm (injection site) (see cases: PHHY2013US119845, PHHY2013US119860, PHHY2013US119862 and PHHY2013US119861). The patient received Seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2011. On an unknown date, after vaccination she experienced sore arm (injection site). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Kell blood group positive, Neonatal disorder, Pain in extremity
Clinical narrative: Case number PHHY2013US119863, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to an adult female patient. Her medical history included bilateral deafness. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine and experienced sore arm (injection site) (see case: PHHY2013US116717). Approximately 5 months after vaccination, the patient gave birth to a live infant. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see case: PHHY2013US116871). The patient received seasonal influenza vaccine in 2007, 2008, 2009 and in 2010 and experienced sore arm (injection site) (see cases: PHHY2013US119845, PHHY2013US119860, PHHY2013US119862 and PHHY2013US119861). The patient received Seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date in 2011. On an unknown date, after vaccination she experienced sore arm (injection site). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it. At the time of reporting the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Age: 29.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain, Neonatal disorder
Clinical narrative: Case number PHHY2013US116717, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to a 29-year-old female pregnant patient. Her medical history included bilateral deafness. It was reported that the patient's husband had Kell antigen in his blood. Her current conditions included gestational diabetes and Kell antibody in her blood (Kell antibody transfusion). Her last menstrual date was reported as Jun 2006 and expected date of delivery was 13 Mar 2007. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine INN (manufacturer and batch number: not reported) in the left arm. Approximately 5 months after vaccination, the patient gave birth to a live infant with no apparent congenital anomaly due to the influenza vaccine. The patient's pregnancy was full term and the baby was hospitalized with juandice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see baby case: PHHY2013US116871). It was reported that the mother was aware of the Kell antibody issues, gestational diabetes and genetic link prior to the influenza vaccination. On an unknown date, less than one year after vaccination, she experienced sore arm. The patient was vaccinated with Seasonal influenza vaccine in 2007, 2008, 2009, 2010 and 2011 and experienced sore arm after each vaccination (see cases: PHHY2013US119845, PHHY2013US119862, PHHY2013US119861, PHHY2013US119863 and PHHY2013US119860). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it yet. At the time of reporting, the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Age: 29.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Case number PHHY2013US116717, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to a 29-year-old female pregnant patient. Her medical history included bilateral deafness. It was reported that the patient's husband had Kell antigen in his blood. Her current conditions included gestational diabetes and Kell antibody in her blood (Kell antibody transfusion). Her last menstrual date was reported as Jun 2006 and expected date of delivery was 13 Mar 2007. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine INN (manufacturer and batch number: not reported) in the left arm. Approximately 5 months after vaccination, the patient gave birth to a live infant with no apparent congenital anomaly due to the influenza vaccine. The patient's pregnancy was full term and the baby was hospitalized with juandice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see baby case: PHHY2013US116871). It was reported that the mother was aware of the Kell antibody issues, gestational diabetes and genetic link prior to the influenza vaccination. On an unknown date, less than one year after vaccination, she experienced sore arm. The patient was vaccinated with Seasonal influenza vaccine in 2007, 2008, 2009, 2010 and 2011 and experienced sore arm after each vaccination (see cases: PHHY2013US119845, PHHY2013US119862, PHHY2013US119861, PHHY2013US119863 and PHHY2013US119860). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it yet. At the time of reporting, the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Age: 29.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2013US116717, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to a 29-year-old female pregnant patient. Her medical history included bilateral deafness. It was reported that the patient's husband had Kell antigen in his blood. Her current conditions included gestational diabetes and Kell antibody in her blood (Kell antibody transfusion). Her last menstrual date was reported as Jun 2006 and expected date of delivery was 13 Mar 2007. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine INN (manufacturer and batch number: not reported) in the left arm. Approximately 5 months after vaccination, the patient gave birth to a live infant with no apparent congenital anomaly due to the influenza vaccine. The patient's pregnancy was full term and the baby was hospitalized with juandice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see baby case: PHHY2013US116871). It was reported that the mother was aware of the Kell antibody issues, gestational diabetes and genetic link prior to the influenza vaccination. On an unknown date, less than one year after vaccination, she experienced sore arm. The patient was vaccinated with Seasonal influenza vaccine in 2007, 2008, 2009, 2010 and 2011 and experienced sore arm after each vaccination (see cases: PHHY2013US119845, PHHY2013US119862, PHHY2013US119861, PHHY2013US119863 and PHHY2013US119860). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it yet. At the time of reporting, the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Age: 29.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Exposure during pregnancy, Kell blood group positive, Neonatal disorder, Pain in extremity
Clinical narrative: Case number PHHY2013US116717, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496589) website on 15 Oct 2013. This report refers to a 29-year-old female pregnant patient. Her medical history included bilateral deafness. It was reported that the patient's husband had Kell antigen in his blood. Her current conditions included gestational diabetes and Kell antibody in her blood (Kell antibody transfusion). Her last menstrual date was reported as Jun 2006 and expected date of delivery was 13 Mar 2007. On 01 Oct 2006, during her second trimester she received seasonal influenza vaccine INN (manufacturer and batch number: not reported) in the left arm. Approximately 5 months after vaccination, the patient gave birth to a live infant with no apparent congenital anomaly due to the influenza vaccine. The patient's pregnancy was full term and the baby was hospitalized with juandice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason and not due to the vaccine (see baby case: PHHY2013US116871). It was reported that the mother was aware of the Kell antibody issues, gestational diabetes and genetic link prior to the influenza vaccination. On an unknown date, less than one year after vaccination, she experienced sore arm. The patient was vaccinated with Seasonal influenza vaccine in 2007, 2008, 2009, 2010 and 2011 and experienced sore arm after each vaccination (see cases: PHHY2013US119845, PHHY2013US119862, PHHY2013US119861, PHHY2013US119863 and PHHY2013US119860). It was reported that the patient was pregnant at the time of this report (20 Mar 2013) and planned to receive influenza vaccine for 2012-13, but had not received it yet. At the time of reporting, the outcome of the event was resolved. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHHY2013US116727, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496600) website on 15 Oct 2013. This report refers to a female patient of an unknown age. She was vaccinated with seasonal Influenza INN (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced an allergic reaction. She received another Influenza vaccination with FLULAVAL (batch number: AFLLA741AA) on an unknown date and experienced the same event. At the time of reporting the outcome of the event was not reported. No other information was available.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Case number PHHY2013US116775 is an initial spontaneous report received from pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 499249) web site on 15 Oct 2013. This report refers to a female patient of unknown age. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) and ZOSTAVAX (batch number: not reported, other manufacturer) on an unspecified date. On an unknown date, after her vaccinations, the patient developed rash and redness at the injection site and beyond. The patient sought medical attention via phone call to unspecified physician. The outcome of events was reported as recovered/resolved. The seriousness and causality of events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Compartment syndrome, Discomfort, Muscle rigidity, Musculoskeletal stiffness, Myalgia
Clinical narrative: Upon follow-up information received on 23 January 2015, the case was upgraded from non-serious to serious. Initial misuse report received from Healthcare professional on 15 October 2014. A 56-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI158AB, expiry date 30 Jun 2015 and dose number was not reported) in to the deltoid right on 25 September 2014. The patient had experienced muscle pain and stiffness in the right arm with certain movements on 26 September 2014. Lab investigations were not reported. The corrective treatment included as patient self-treated with ADVIL and heat application as well as range of motion exercises. The patient illness at the time of vaccination includes both arms sore from workout at gym, and pre-existing diagnosed allergies and birth defects includes allergies to CIPRO, sulfa and morphine sulphate. At the time of this report the outcome of the event was unknown. Follow-up information for this unsolicited report received on 23 January 2015 from the patient who is also a registered nurse. The patient described that the right arm was still having symptoms of nerve damage and that some compartment syndrome had occurred under the deltoid muscle (unspecified dates). The stiffness was described as absolute rigidity; all tissues through to the wrist were "hard as rock". She reported that she was assuming that the injection went into the bursa. At the time of the report, pain/discomfort felt like "funny bone", 2 out of 10. She also reported that "nerves take time to heal". List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nerve injury
Clinical narrative: Upon follow-up information received on 23 January 2015, the case was upgraded from non-serious to serious. Initial misuse report received from Healthcare professional on 15 October 2014. A 56-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI158AB, expiry date 30 Jun 2015 and dose number was not reported) in to the deltoid right on 25 September 2014. The patient had experienced muscle pain and stiffness in the right arm with certain movements on 26 September 2014. Lab investigations were not reported. The corrective treatment included as patient self-treated with ADVIL and heat application as well as range of motion exercises. The patient illness at the time of vaccination includes both arms sore from workout at gym, and pre-existing diagnosed allergies and birth defects includes allergies to CIPRO, sulfa and morphine sulphate. At the time of this report the outcome of the event was unknown. Follow-up information for this unsolicited report received on 23 January 2015 from the patient who is also a registered nurse. The patient described that the right arm was still having symptoms of nerve damage and that some compartment syndrome had occurred under the deltoid muscle (unspecified dates). The stiffness was described as absolute rigidity; all tissues through to the wrist were "hard as rock". She reported that she was assuming that the injection went into the bursa. At the time of the report, pain/discomfort felt like "funny bone", 2 out of 10. She also reported that "nerves take time to heal". List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Upon follow-up information received on 23 January 2015, the case was upgraded from non-serious to serious. Initial misuse report received from Healthcare professional on 15 October 2014. A 56-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI158AB, expiry date 30 Jun 2015 and dose number was not reported) in to the deltoid right on 25 September 2014. The patient had experienced muscle pain and stiffness in the right arm with certain movements on 26 September 2014. Lab investigations were not reported. The corrective treatment included as patient self-treated with ADVIL and heat application as well as range of motion exercises. The patient illness at the time of vaccination includes both arms sore from workout at gym, and pre-existing diagnosed allergies and birth defects includes allergies to CIPRO, sulfa and morphine sulphate. At the time of this report the outcome of the event was unknown. Follow-up information for this unsolicited report received on 23 January 2015 from the patient who is also a registered nurse. The patient described that the right arm was still having symptoms of nerve damage and that some compartment syndrome had occurred under the deltoid muscle (unspecified dates). The stiffness was described as absolute rigidity; all tissues through to the wrist were "hard as rock". She reported that she was assuming that the injection went into the bursa. At the time of the report, pain/discomfort felt like "funny bone", 2 out of 10. She also reported that "nerves take time to heal". List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Hypoaesthesia, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging brain
Clinical narrative: This spontaneous report as received from a 52 year old female registered nurse reporting on herself with asthma and allergy to sulfa drugs who on 19-SEP-2014 was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and route were not reported). Concomitant therapy included SYNTHROID. Since unspecified date in 2014, the nurse experienced severe constipation for two months after receiving ZOSTAVAX, which she did not related to ZOSTAVAX. Then on 20-NOV-2014 the patient experienced numbness which started in her right shoulder and then progressed down through her arm and hand. An nuclear magnetic resonance imaging (MRI) of her cervical spine was performed and showed a herniated disc, so the patient was treated with DECADRON 3 mg daily but she did not feel better and considered that it did not work (MARRS # 1501USA012450) and the numbness in her hand and progressed to the point she was unable to use her hand. As a result, the patient was hospitalized on 13-JAN-2015, here, another nuclear magnetic resonance imaging (MRI) was performed and showed swelling of the spine below the location of the herniated disc. Also lumbar puncture, unspecified "ocular studies", an (MRI) of brain and unspecified bloodwork were performed, all of which ruled out an infection. Ultimately the patient was diagnosed with myelitis transverse. The patient was treated with SOLU-MEDROL 1000mg, intravenous for 5 days and prednisone (manufacturer unknown), 100mg, oral, which had since been tapered down to 80 mg. On 18-JAN-2015 the patient was discharged from the hospital. At this moment her right hand was still "100 percent" numb and she was unable to feel anything in that hand. Also the numbness had progressed down to her right side and leg, and was occasionally causing her to lose her balance. At the time of the report the patient had not recovered from the intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder. On an unknown date the patient recovered from constipation. The registered nurse considered intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder to be disabling and life threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal, Ophthalmological examination, Scan with contrast
Clinical narrative: This spontaneous report as received from a 52 year old female registered nurse reporting on herself with asthma and allergy to sulfa drugs who on 19-SEP-2014 was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and route were not reported). Concomitant therapy included SYNTHROID. Since unspecified date in 2014, the nurse experienced severe constipation for two months after receiving ZOSTAVAX, which she did not related to ZOSTAVAX. Then on 20-NOV-2014 the patient experienced numbness which started in her right shoulder and then progressed down through her arm and hand. An nuclear magnetic resonance imaging (MRI) of her cervical spine was performed and showed a herniated disc, so the patient was treated with DECADRON 3 mg daily but she did not feel better and considered that it did not work (MARRS # 1501USA012450) and the numbness in her hand and progressed to the point she was unable to use her hand. As a result, the patient was hospitalized on 13-JAN-2015, here, another nuclear magnetic resonance imaging (MRI) was performed and showed swelling of the spine below the location of the herniated disc. Also lumbar puncture, unspecified "ocular studies", an (MRI) of brain and unspecified bloodwork were performed, all of which ruled out an infection. Ultimately the patient was diagnosed with myelitis transverse. The patient was treated with SOLU-MEDROL 1000mg, intravenous for 5 days and prednisone (manufacturer unknown), 100mg, oral, which had since been tapered down to 80 mg. On 18-JAN-2015 the patient was discharged from the hospital. At this moment her right hand was still "100 percent" numb and she was unable to feel anything in that hand. Also the numbness had progressed down to her right side and leg, and was occasionally causing her to lose her balance. At the time of the report the patient had not recovered from the intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder. On an unknown date the patient recovered from constipation. The registered nurse considered intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder to be disabling and life threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Blood test normal, Constipation, Hypoaesthesia, Intervertebral disc protrusion
Clinical narrative: This spontaneous report as received from a 52 year old female registered nurse reporting on herself with asthma and allergy to sulfa drugs who on 19-SEP-2014 was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and route were not reported). Concomitant therapy included SYNTHROID. Since unspecified date in 2014, the nurse experienced severe constipation for two months after receiving ZOSTAVAX, which she did not related to ZOSTAVAX. Then on 20-NOV-2014 the patient experienced numbness which started in her right shoulder and then progressed down through her arm and hand. An nuclear magnetic resonance imaging (MRI) of her cervical spine was performed and showed a herniated disc, so the patient was treated with DECADRON 3 mg daily but she did not feel better and considered that it did not work (MARRS # 1501USA012450) and the numbness in her hand and progressed to the point she was unable to use her hand. As a result, the patient was hospitalized on 13-JAN-2015, here, another nuclear magnetic resonance imaging (MRI) was performed and showed swelling of the spine below the location of the herniated disc. Also lumbar puncture, unspecified "ocular studies", an (MRI) of brain and unspecified bloodwork were performed, all of which ruled out an infection. Ultimately the patient was diagnosed with myelitis transverse. The patient was treated with SOLU-MEDROL 1000mg, intravenous for 5 days and prednisone (manufacturer unknown), 100mg, oral, which had since been tapered down to 80 mg. On 18-JAN-2015 the patient was discharged from the hospital. At this moment her right hand was still "100 percent" numb and she was unable to feel anything in that hand. Also the numbness had progressed down to her right side and leg, and was occasionally causing her to lose her balance. At the time of the report the patient had not recovered from the intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder. On an unknown date the patient recovered from constipation. The registered nurse considered intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder to be disabling and life threatening. Additional information has been requested.