Sex: U
Vaccine: FLU3, TDAP
Symptoms: Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of birth defects in a infant. The infant's mother was exposed to dTpa vaccine and Flu seasonal TIV Dresden during the second trimester of pregnancy (between 14-27 gestational weeks). The pregnancy resulted in a live neonate with a congenital anomaly. On an unknown gestation weeks, the infant was born via unknown delivery method. The mother's last menstrual period was unknown and estimated date of delivery was unknown. Less than a year after the mother's vaccination with dTpa vaccine and Flu seasonal TIV Dresden, the infant was diagnosed with birth defects. Serious criteria included congenital anomaly. Additional event(s) included maternal exposure during pregnancy, second trimester. The outcome of birth defects was unknown. The outcome(s) of the additional event(s) included maternal exposure during pregnancy, second trimester (unknown). The investigator considered that there was a reasonable possibility that the birth defects may have been caused by dTpa vaccine and Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of unspecified major birth defect in an infant of unspecified age and gender whose mother was vaccinated with unspecified trivalent inactivated influenza (IIV3) vaccine and unspecified Tdap vaccine (manufacturer unknown for both) during pregnancy. The patient was reported in a study that aimed to examine the number and type of major birth defects reported in the Vaccine Adverse Event Reporting System (VAERS) after selected maternal vaccinations administered. The study searched the VAERS database for reports of birth defects in pregnant women who received a vaccine during pregnancy from January 1, 1990 through December 31, 2014. No information on patient's family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, between 1 January 1990 and 31 December 2014, the patient's mother had received unspecified IIV3 vaccine and unspecified Tdap vaccine (administration site and route; dosages unknown; batch number not provided for both) in the second trimester (14-27 weeks). (In this study, gestational ages at the time of vaccination and at the time of the adverse event were calculated based on the information provided in the VAERS form or medical record). Subsequently, the patient was exposed to the vaccine in utero. The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was reported for unspecified major birth defect. (In this study, a medical officer with expertise in birth defects was consulted to assist in the assessment of those reports where it was not clear if a birth defect was present and to classify them as major or minor defects. The definition for birth defect was that from the Congenital Defects Program. This includes birth defects detected at birth but also fetal products from stillbirths or spontaneous abortion that underwent an autopsy and/or genetic study documenting a birth defect/genetic abnormality). This case was considered serious due to congenital abnormality. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between unspecified major birth defect and unspecified IIV3 and unspecified Tdap vaccines. The authors concluded "This review of the VAERS database for selected vaccines administered during pregnancy found no increased reporting for any birth defect. Further studies evaluating rates of birth defects following Tdap and influenza vaccinations will provide more specific information on the occurrence of these events after recommended vaccines during pregnancy. Additionally further studies on vaccines not recommended in pregnancy are important as well because many birth defects occur before a woman realizes she is pregnant". This is 1 of the 12 valid cases from the same literature article.                           Adjudication Data Entry        Select All radio buttons in this column Select the radio button next to any fields that need editing and enter data.    Box 7  Describe Adverse Event   (and treatment if any)   This retrospective pregnancy case was reported in a literature article and described the occurrence of birth defects in a infant. The infant's mother was exposed to dTpa vaccine and Flu seasonal TIV Dresden during the second trimester of pregnancy (between 14-27 gestational weeks). The pregnancy resulted in a live neonate with a congenital anomaly. On an unknown gestation weeks, the infant was born via unknown delivery method. The mother's last menstrual period was unknown and estimated date of delivery was unknown. Less than a year after the mother's vaccination with TDaP vaccine and Flu seasonal TIV Dresden, the infant was diagnosed with birth defects. Serious criteria included congenital anomaly. Additional event(s) included maternal exposure during pregnancy, second trimester. The outcome of birth defects was unknown. The outcome(s) of the additional event(s) included maternal exposure during pregnancy, second trimester (unknown). The investigator considered that there was a reasonable possibly that the birth defects may have been caused by TDaP vaccine and Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of unspecified major birth defect in an infant of unspecified age and gender whose mother was vaccinated with unspecified trivalent influenza (IIV3) vaccine and unspecified tetanus  toxoid,  reduced  diphtheria  toxoid  acellular  pertussis  vaccine,  absorbed  (Tdap) vaccine (manufacturer unknown for both) during pregnancy. The patient was reported in a study that aimed to examine the number and type of major birth defects reported in the Vaccine  Adverse  Event  Reporting  System  (VAERS) after selected maternal vaccinations administered. The study searched the VAERS database for reports of birth defects in pregnant women who received a vaccine during pregnancy from January 1, 1990, through December 31, 2014. No information on patient's family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, between 1 January 1990 and 31 December 2014, the patient's mother had received unspecified IIV3 vaccine and unspecified Tdap vaccine (administration site and route; dosages unknown; batch number not provided for both) in the second trimester (14-27 weeks). (In this study, gestational ages at the time of vaccination and at the time of the adverse event were calculated based on the information provided in the VAERS form or medical record). Subsequently, the patient was exposed to the vaccine in utero. The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was reported for unspecified major birth defect. (In this study, a medical officer with expertise in birth defects was consulted to assist in the assessment of those reports where it was not clear if a birth defect was present and to classify them as major or minor defects. The definition for birth defects was that from the program. This includes birth defects detected at birth but also fetal products from stillbirths or spontaneous abortion that underwent an autopsy and/or genetic study documenting a birth defect/genetic abnormality). This case was considered serious due to congenital abnormality. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between unspecified major birth defect and unspecified IIV3 and unspecified Tdap vaccines. The authors concluded "This review of the VAERS database for selected vaccines administered during pregnancy found no increased reporting for any birth defect. Further studies evaluating rates of birth defects following Tdap and influenza vaccinations will provide more specific information on the occurrence of these events after recommended vaccines during pregnancy. Additionally further studies on vaccines not recommended in pregnancy are important as well because many birth defects occur before a woman realizes she is pregnant". This is 1 of the 12 valid cases from the same literature article.                           Adjudication Data Entry        Select All radio buttons in this column Select the radio button next to any fields that need editing and enter data.    Box 7  Describe Adverse Event   (and treatment if any)   This retrospective pregnancy case was reported in a literature article and described the occurrence of birth defects in a infant. The infant's mother was exposed to dTpa vaccine and Flu seasonal TIV Dresden during the second trimester of pregnancy (between 14-27 gestational weeks). The pregnancy resulted in a live neonate with a congenital anomaly. On an unknown gestation weeks, the infant was born via unknown delivery method. The mother's last menstrual period was unknown and estimated date of delivery was unknown. Less than a year after the mother's vaccination with TDaP vaccine and Flu seasonal TIV Dresden, the infant was diagnosed with birth defects. Serious criteria included congenital anomaly. Additional event(s) included maternal exposure during pregnancy, second trimester. The outcome of birth defects was unknown. The outcome(s) of the additional event(s) included maternal exposure during pregnancy, second trimester (unknown). The investigator considered that there was a reasonable possibly that the birth defects may have been caused by TDaP vaccine and Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of unspecified major birth defect in an infant of unspecified age and gender whose mother was vaccinated with unspecified trivalent influenza (IIV3) vaccine and unspecified tetanus  toxoid,  reduced  diphtheria  toxoid  acellular  pertussis  vaccine,  absorbed  (Tdap) vaccine (manufacturer unknown for both) during pregnancy. The patient was reported in a study that aimed to examine the number and type of major birth defects reported in the Vaccine  Adverse  Event  Reporting  System  (VAERS) after selected maternal vaccinations administered. The study searched the VAERS database for reports of birth defects in pregnant women who received a vaccine during pregnancy from January 1, 1990, through December 31, 2014. No information on patient's family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, between 1 January 1990 and 31 December 2014, the patient's mother had received unspecified IIV3 vaccine and unspecified Tdap vaccine (administration site and route; dosages unknown; batch number not provided for both) in the second trimester (14-27 weeks). (In this study, gestational ages at the time of vaccination and at the time of the adverse event were calculated based on the information provided in the VAERS form or medical record). Subsequently, the patient was exposed to the vaccine in utero. The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was reported for unspecified major birth defect. (In this study, a medical officer with expertise in birth defects was consulted to assist in the assessment of those reports where it was not clear if a birth defect was present and to classify them as major or minor defects. The definition for birth defects was that from the program. This includes birth defects detected at birth but also fetal products from stillbirths or spontaneous abortion that underwent an autopsy and/or genetic study documenting a birth defect/genetic abnormality). This case was considered serious due to congenital abnormality. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between unspecified major birth defect and unspecified IIV3 and unspecified Tdap vaccines. The authors concluded "This review of the VAERS database for selected vaccines administered during pregnancy found no increased reporting for any birth defect. Further studies evaluating rates of birth defects following Tdap and influenza vaccinations will provide more specific information on the occurrence of these events after recommended vaccines during pregnancy. Additionally further studies on vaccines not recommended in pregnancy are important as well because many birth defects occur before a woman realizes she is pregnant". This is 1 of the 12 valid cases from the same literature article.