Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Delivery, Exposure during pregnancy, Haemorrhoids, Premature delivery, Premature labour
Clinical narrative: This is a spontaneous case initially received from other health professional on 25-Mar-2019, concerning a 21-year-old adult pregnant female patient of height: 66-inch, weight: 389 lbs, body mass index (BMI): 42.8. The patient had 2 previous pregnancy reported with 1 full-term live birth and 1 preterm live birth. There was no history of maternal or paternal congenital malformation. The patient had a prior history of use of marijuana during current pregnancy. The patient's historical conditions included nausea, vomiting, chlamydia, vaginitis and candidiasis. The patient's historical drugs included Phenergan (promethazine) and Zofran (ondansetron) for nausea and vomiting, Azithromycin for chlamydia, Metrogel for vaginitis and Terazol (terconazole) for candidiasis. The patient's current conditions included hypertension and anaemia. The patient's concomitant medications included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy and ferrous sulfate for anaemia. The last menstrual period (LMP) date of the patient was 18-Apr-2018. The type of pregnancy was multiple (twins). The pregnancy status of the patient was collected, and no pregnancy complications were noted. On 19-Jun-2018, the patient had undergone spinal muscular atrophy, cystic fibrosis and haemoglobin electrophoresis and no major congenital malformations were noted. On 05-Jul-2018, the patient had undergone ultrasound scanning and no major congenital malformations were noted. On 31-Jul-2018, the patient had undergone ultrasound scanning and quadruple screening and no major congenital malformations were noted. On 01-Oct-2018, at the gestational age of 23 weeks, the patient was administered FLUCELVAX QIVc (batch number: 252664, dose, route of administration, anatomical location, expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 16-Nov-2018, the patient had undergone ultrasound scanning and no major congenital malformations were noted. On 28-Nov-2018, 1 month and 27 days after vaccination, the patient developed haemorrhoids. On 05-Dec-2018, 2 months and 4 days after vaccination, the patient developed cutaneous abscess. The patient was treated with Anusol HC [hydrocortisone acetate, dose: 25 mg, frequency: twice a day (bid), route of administration: rectal, from 29-Nov-2018 to 14-Dec-2018], Colace [docusate sodium, dose: 100 mg, frequency: thrice a day (tid), route of administration: oral, from 28-Nov-2018 to 28-Dec-2018] and Proctofoam [pramocaine hydrochloride, dose; 1-1 percent, route of administration: rectal, from 28-Nov-2018 to 29-Nov-2018] for haemorrhoids and Keflex [cefalexin, dose: 500 mg, frequency: twice a day (bid), route of administration: oral, from 05-Dec-2018 to 19-Dec-2018] for cutaneous abscess. 2 months and 13 days after vaccination (at 35.5 gestational week), the patient gave birth to two male neonates vaginally. The gestational age at outcome was 35.5 (explicitly coded as premature labour). The characteristics of first infant included weight 2270 grams, length 41.9 cm and head circumference 31.1 cm. The 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 characteristics of second infant included weight 2545 grams, length 44.5 cm and head circumference 33 cm. The 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 had recovered from the event abscesses of skin on 19-Dec-2018 and from hemorrhoids on 28-Dec-2018. This case was cross-linked to the cases: 201902718 and 201902718 (twin baby case).; Reporter's Comments: A 21-year-old pregnant patient experienced Haemorrhoids, 1 month 27 days after receipt of FLUCELVAX QIVc at 23 weeks of gestation (considered as vaccine exposure during pregnancy). The patient also experienced cutaneous abscess, 2 months 4 days post vaccination and premature labour, 2 months 13 days post vaccination at 35.5 weeks of gestation. The event haemorrhoids assessed as not related, as the pregnant state (second trimester) of the patient provide more plausible explanation rather than suspect vaccine. The event cutaneous abscess assessed as not related considering the implausible temporal relationship and infectious aetiology of the event. Considering the obstetric history of the patient (1 preterm live birth), concurrent medical conditions (hypertension and anaemia), the event premature labour assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).