Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Bacterial vaginosis, Constipation, Delivery, Exposure during pregnancy
Clinical narrative: Subchorionic hemorrhage; Constipation; Anemia; Bacterial vaginosis; Urinary tract infection/UTI; Vaccine exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 12-Jul-2019, concerning a 19-year-old adult female, pregnant patient, of body weight 165 lbs, height 60 inches and body mass index (BMI) 32.2.  The patient's obstetrical history was noted and the patient had no previous pregnancies. The patient had no history of offspring with major congenital malformation. Also, the patient had no maternal or paternal history with major congenital malformations. The patient did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.       The patient's last menstrual period (LMP) date was 09-Sep-2018. The type of pregnancy was singleton.    The patient's current conditions included headache and asthma (since unspecified dates). The patient's concomitant medication included prenatal vitamins (minerals nos, vitamins nos) for pregnancy.    On 27-Nov-2018, the patient underwent haemoglobin electrophoresis, prenatal profile, cystic fibrosis mutation analysis and spinal muscular atrophy screening and no major congenital malformations were noted.   On 13-Dec-2018, at approximately 13 weeks gestation, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, batch number: 252664, dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 23-Jan-2019, the patient underwent quadruple screening and no major congenital malformations were noted.   On an unspecified date after vaccination, the patient's pregnancy complication included subchorionic haemorrhage. On an unspecified date, the patient experienced constipation and was treated with Colace [docusate sodium, dose: reported as 1, frequency: as needed (prn), from 01-Feb-2019] orally. On 01-Feb-2019, 1 month and 19 days after vaccination, the patient developed bacterial vaginosis and urinary tract infection (UTI). The patient was treated with Metrogel [metronidazole, dose: 0.75 percent, twice daily (bid), from 01-Feb-2019 to 08-Feb-2019] for bacterial vaginosis and Macrobid (nitrofurantoin, dose: reported as 1, from 01-Feb-2019 to 11-Feb-2019) orally for urinary tract infection. On 26-Mar-2019, 3 months and 13 days after vaccination, the patient developed anemia.   The outcome of the event subchorionic haemorrhage' was recovered on an unspecified date (reported as at 13 weeks gestation), anemia was recovered on 29-Jun-2019, bacterial vaginosis and urinary tract infection were recovered on 11-Feb-2019 and the outcome of the event constipation was not reported.    The patient's estimated date of delivery (EDD) was reported as 26-Jun-2019.  at approximately 41 weeks gestation (reported as 38.4 weeks), the patient gave a live birth to a normal female neonate via vaginal method of delivery. The characteristics of the neonate included birth weight: reported as low birth weight [26 grams (as reported)], head circumference: 31.1 cm, length: 49.5 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes). No major congenital malformations (MCMs) were identified at birth.   The patient's corrected estimated date of delivery (CEDD) was reported as 10-Jul-2019.    This case is linked to the case 201904132 (baby case).; Reporter's Comments: A 19-year-old female pregnant patient experienced subchorionic haemorrhage, unspecified period after receipt of Flucelvax QIVc (considered as vaccine exposure during pregnancy). Due to lack of information regarding onset latency of the event, the causality assessed as unassessable. The patient was diagnosed with bacterial vaginosis and urinary tract infection, 1 month 19 days post vaccination. Considering the infective origin of the event (bacterial), the causal role of inactivated suspect vaccine is ruled out. The patient was diagnosed with constipation, unspecified period post vaccination. Despite lack of onset latency, pregnant state of the patient provide more plausible explanation rather than suspect vaccine. Hence, causality of the event constipation assessed as not related. The patient was diagnosed with anaemia, 3 months 14 days post vaccination. Considering implausible temporal relationship between vaccination and reported event anaemia, also the event can be alternately explained by pregnancy state of the patient rather than suspect vaccine, causality of event anaemia assessed as not related to suspect vaccine. The  causality of event vaccine exposure during pregnancy assessed as not related considering the intended use of the suspect vaccine. The company assessed the case as serious (medically significant).