Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pregnancy test urine positive, Ultrasound abdomen abnormal, Ultrasound pelvis abnormal, Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: Case number PHHO2014US014069, is an initial report received on 17 Oct 2014, from clinical study. This 32-year-old female subject was enrolled in a study. The subject medical history included asthma. The subject did not receive any concomitant vaccinations and concomitant medications. Subject had no history of spontaneous abortions and no significant obstetrics and gynecology history. Subject had no history of allergic reactions to food, drugs and vaccines. The subject's urine pregnancy test showed negative at the time the ICF was signed and at screening/day1. Subject was using condoms and spermicide on a regular basis with for greater than 8 weeks. The subject agreed to continue using birth control throughout the study and for at least 4 weeks post vaccination. Subject's obstetric history included 3 normal pregnancies (vaginal delivery) without any complication. The subject reported that she had irregular menstrual periods (reported that this was normal for her); with time from start of one period to start of the next ranging from 14 days to 52 days. The subject's LMP date was 18 Aug 2014. On 29 Sep 2014 at 15:09 hrs the subject received blinded study vaccine. On 11 Oct 2014, the subject experienced vaginal bleeding and abdominal pain and reported that she had spontaneous abortion. On the same day, the subject went to emergency room. The subject's quantitative blood HCG level was reported as 668 m/u/m2 on 11 Oct 2014 which indicated that the subject was approximately 2-4 weeks of gestation at the time of vaccination. A transabdominal and transvaginal pelvic ultrasound was performed. The ultrasound report showed no intrauterine gestation; the endometrial stripe was abnormally thickened, measure 2.1 cm in AO dimensions and was inhomogeneous in appearance; also no evidence of significant increased vascularity in the endometrial stripe on color imaging. The cervix appeared to be closed and a nabothian cyst was noted in the cervix. Both the right and left ovaries was within normal limits in appearance, containing many follicles (measures 2.7x1.8x2.1 cm and 2.3x2.0x2.1cm respectively). No free fluid was seen in the cul-de-sac. Doppler imaging of the ovaries was not performed. It was reported that findings could represent blood products in the endometrial canal, given the history of vaginal bleeding and may be secondary to spontaneous abortion. It was also reported that an ectopic gestation could not be excluded entirely. On 11 Oct 2014, the subject completely recovered from the event. On 14 Oct 2014, the subject had a follow up visit with her OB/GYN (records were pending). The subject's UPT on 23 Oct 2014 was negative. The subject did not receive any treatment for the event. The investigator considered the event as serious (medically significant). The investigator did suspect a possible causal relationship between the event (spontaneous abortion) and study vaccination. Investigator provides rationale for causality assessment as "there is a possibility to the spontaneous miscarriage was caused by IP (investigational product). "However, unable to state with any degree of confidence that there is a probability of relationship between the two". The investigator also stated that there was no other relationship except temporal relationship. Follow up report received on 22 Oct 2014, prior to the circulation of previous report: Subject's medical history, LMP date, gestational age, laboratory details and subject's clinical information were updated. Follow up report received on 23 Oct 2014, prior to the circulation of previous report: hospital records received. Updated lab data and clinical course related details.