Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Blood sodium decreased, Complication of delivery, Creatinine renal clearance, Exposure during pregnancy
Clinical narrative: vision changes; right upper quadraint pain; edema; headache; blood pressure reading elevated without diagnosis of hypertension; vaccine exposure during pregnancy; developed liver failure post-delivery due to the preeclampsia; after vaccination developed preeclampsia for the last five months of pregnancy; delivery was difficult, and developed liver failure post-delivery due to the preeclampsia; Initial information received on 02-Oct-2014 regarding an unsolicited serious case from physician and consumer/ non-health care professional via Health Authority (under reference number: 0547009).  This case was linked with case number 2014SA136364 (infant case).  This case involves a 32-year old female patient who experienced blood pressure reading elevated without diagnosis of hypertension (blood pressure increased), edema (oedema), headache, vision changes (visual impairment), right upper quadraint pain (abdominal pain), developed liver failure post-delivery due to the preeclampsia (hepatic failure), after vaccination developed preeclampsia for the last five months of pregnancy (pre-eclampsia), delivery was difficult, and developed liver failure post-delivery due to the preeclampsia (complication of delivery) and vaccine exposure during pregnancy (exposure during pregnancy), after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The date of last menstrual period was reported as 18-Oct-2012. The estimated due date is 25-Jul-2013.  Medical history included Pertussis on 21-Feb-2013, mitral valve prolapse, poor personal hygiene, fungal infection, rheumatic fever (age 12, ear infection), treatment noncompliance, oedema peripheral, upper respiratory tract infection, varicella, arthropod sting, tumor excision in 1990 (right groin tumor removed), tooth extraction (age 23-24, all four taken out) and atrial fibrillation.  Past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing gestational diabetes.  Notes: Family history for diabetes, heart attack, melanoma, prostate cancer, stroke and ovarian CA. No known drug, food or latex allergies.  Concomitant medications were not reported.  On 07-May-2013, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C4385AA and expiration date: unknown) via intramuscular route in the right arm for prophylactic vaccination.  On 04-Jun-2013, the patient developed a serious blood pressure reading elevated without diagnosis of hypertension (blood pressure increased), edema (oedema), headache, vision changes (visual impairment), right upper quadrant pain (abdominal pain)  28 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for these events (seriousness)  On an unknown date, the patient developed a serious liver failure post-delivery due to the preeclampsia (hepatic failure), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was considered as medically significant.  On an unknown date, the patient developed non-serious events of preeclampsia for the last five months of pregnancy (Pre-eclampsia), delivery was difficult and developed serious event of liver failure post-delivery due to the preeclampsia (Complication of delivery) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  This was also a case of vaccine exposure during pregnancy (Exposure during pregnancy).  Relevant laboratory test results included: Blood albumin - On 14-May-2013: 3.3 (Low) [Units (Non-UCUM): 3.3 NA] Blood creatinine - On 14-May-2013: 0.46 (Low) [Units (Non-UCUM): 0.46 NA]; on 16-May-2013: 0.48 (Low) [Units (Non-UCUM): 0.48 NA] Blood glucose - On 14-May-2013: 102 (High) [Units (Non-UCUM): 102 NA] Blood pressure measurement - On an unknown date: [Comment: blood pressure ranged from 144/60 TO 100/60 Units (Legacy):] Body temperature - On an unknown date: [Comment: ranged 98.9 TO 97.6 Units (Legacy):] Creatinine renal clearance - On 16-May-2013: 255 (High) [Units (Non-UCUM): 255 NA] Glucose tolerance test - On 07-May-2013: 97 [Comment: FBS 97, 1 HOUR: 211, 2 hours: 173, 3 hours: 75. Units (Non-UCUM): 97 NA] Glycosylated haemoglobin - On 07-Jun-2013: 5.8 UNK [Units (Non-UCUM): 5.8 NA] Heart rate - On 05-Jul-2013: 124 [Units (Non-UCUM): 124 NA] Protein total - On 14-May-2013: 5.7 (Low) [Comment: protein total Units (Non-UCUM): 5.7 NA].  Note: There was no mention of liver failure, pre-eclampsia, or premature delivery in the patient's medical record.  Addendum 02-Mar-2015: Upon second medical examination of case at time of internal review the following has been modified in this case. The event of vaccine exposure during pregnancy was added.   Documents held by sender:  medical records.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was resolved on an unknown date.  There will be no information available regarding batch number in this case.  Follow-up information for this unsolicited report was received from a healthcare professional on 17-Feb-2015.   A 32-year-old pregnant female patient had received on 07-May-2013 (previously reported as February 2013) a 0.5 ml intramuscular right arm injection of Adacel (DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, lot number C4385AA expiration date 17 September 2015) and on 04-Jun-2013 i.e. 28 days later, developed an elevated blood pressure reading without diagnosis of hypertension, vision changes, right upper quadrant pain, edema and headache. The patient was sent to labor and delivery for 24-hour observation.  Laboratory data included on 07-May-2013 a glucose tolerance test: FBS 97 (Fasting blood sugar), 1 hour: 211, 2 hours: 173, 3 hours: 75.  Additional information received on 19-Apr-2021 regarding an unsolicited serious case from physician and consumer/ non-health care professional via Health Authority (under reference number: 0547009).  New events hepatic failure, pre-eclampsia, complication of delivery and vaccine exposure during pregnancy was updated.  Corresponding fields and narrative were updated.; Sender's Comments: Follow up information received on 19-Apr-2021: hepatic failure, pre-eclampsia, complication of delivery and vaccine exposure during pregnancy was updated. This case of vaccine exposure during pregnancy, concerns a 32-year old female patient who was found to have elevated blood pressure reading without diagnosis of hypertension,visual disturbance, abdominal pain, edema, headache 28 days after vaccination with ADACEL. The time to onset is unknown for hepatic failure, pre-eclampsia and complication of delivery. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.