Age: 29.0
Sex: F
Vaccine: DTAPIPV, FLUX
Symptoms: Exposure during pregnancy, Pain in extremity, Premature labour, Wrong drug administered
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of sore arm in a 29-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), Influenza vaccine during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included live birth. The subject had 2 previous full-term pregnancies with outcomes of 2 normal births. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. The mother was not using contraception and the type of conception was normal. There was no evidence of defect from prenatal testing. On 22 November 2013 the subject received a dose of KINRIX (unknown details), unspecified dose of Influenza vaccine (unknown details) and experienced wrong vaccine administered and vaccine exposure during the 3rd trimester of pregnancy. The subject reported that she was "supposed to be getting the pertussis vaccine and was accidentally administered a KINRIX vaccine instead." The gestational age at the time of vaccination was calculated to be 30 weeks. The date of last menstrual period was not reported. Per the subject, the estimated date of delivery was reported as 26 January 2014. Relevant test results included ultrasound examinations on 28 June 2013, 16 August 2013, and 4 September 2013 with results showing no evidence of defect from prenatal testing. The subject also had laboratory tests and an amniocentesis in 2013 with results as normal. At the time of reporting, the pregnancy was unknown. On 22 November 2013, less than one day after vaccination with Influenza vaccine and KINRIX, the subject experienced sore arm. At the time of reporting the event was improved. The subject also described an event of increased fetal movement with onset of 22 November 2013 and end date of 23 November 2013. Please see report A1053782B for details regarding the baby case. Follow-up information was received on 08 January 2014 via consumer who reported she "started trying have preterm labor one week after receiving the shot, never had this problem with any other pregnancies". The preterm labor started approximately on 29 November 2013, the outcome was unknown. Follow-up information was received on 27 January 2014 via nurse phone conversation. The nurse called the GSK response center on 17 January 2014 asking for a call back regarding the Pregnancy Initial Notification form. On 27 January 2014 during the phone conversation with the nurse , she stated the subject delivered on 15 January 2014 but she had no details regarding the pregnancy, delivery or vaccinations and suggested GSK obtain this information from Hospital Medical records. At the time of the report no other information was provided. The outcome of the pregnancy was live birth with no apparent congenital anomaly until further detail can be obtained from Hospital Medical records. Follow up was received on 28 January 2014 from the nurse at the facility where the vaccine was administered. The case is considered by GSK to be medically confirmed. The nurse did not consider this case serious and stated no suspect product identified. The nurse documented that the events onset were not life-threatening, did not involve severe or permanent disability, did not involve hospitalization, did not involve a congenital anomaly, and did not jeopardize the subject or require intervention. Per the nurse, the subject's experience was related to erroneous administration. The subject "received KINRIX DTAP" when "she should have gotten BOOSTRIX Tdap.". The co-suspect product's lot number was provided on follow up. The lot number was not a GSK lot number so the product has been changed to reflect that the subject received Seasonal influenza vaccine (Non-GSK) as a co-suspect. The nurse noted that the subject had received the suspect products previously then clarified by stating that the subject "should have already received booster shot before. Unknown on influenza vaccine." The immunization series were not discontinued or delayed. It was unknown if symptoms recurred following subsequent administration with respect to the suspect products; however, the nurse also documented that symptoms did not recur following subsequent administration with respect to seasonal influenza. It was unknown if the subject experienced adverse events following previous vaccinations. Tobacco use and alcohol use were unknown. Follow up was received from the physician on 31 January 2014. The physician reported the date of last menstrual period was 4 April 2013. The physician documented that the connection was not normal; however, also documented that in-vitro fertilization was not used. Concurrent medications included RhoGAM, SYNTHROID, REGLAN and Iron. Betamethasone was administered as treatment for preterm labor. The physician did not consider the events as serious. The physician documented that the outcome of preterm labor was unresolved and unrelated to the GSK product. The outcome of the sore arm was unknown. The physician documented that the subject delivered on 15 January 2014 after 38 weeks and 3 days gestation with no known complications. Details of the delivery were available through the medical center and not available to the physician at the time of reporting. Follow up information was received on 27 March 2014 via healthcare professional who reported the subject "received KINRIX DTaP. She should have gotten BOOSTRIX Tdap. It was erroneous administration." The subject received 0.5ml of KINRIX and 0.5ml of Flu vaccine. The healthcare professional considered the events unrelated to vaccine administration. The events were noted to have resolved completely on 15 January 2014. Therapy with KINRIX and Flu vaccine was not withdrawn, reintroduce or reduced. 19 May 2014 - No further information was provided; patient lost to follow-up.