Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Expired product administered, Exposure during pregnancy, Immunisation
Clinical narrative: pregnant patient received expired Fluzone Quad/no adverse event; administered new vaccine as soon as possible. Valid vaccine administered on same day; pregnant patient received expired Fluzone Quad; spontaneous abortion; Based on information previously received on 24 May 2019, the following information [corrections] has been amended to add the event spontaneous abortion and case became serious.  Initial solicited report received on 12 September 2018 from a health care professional.    This is a prospective pregnancy registry case for Study. This case involves a 28-year-old female subject who had vaccine exposure during pregnancy and received expired dose of Influenza Quadrival A-B vaccine [FLUZONE QIV] and had spontaneous abortion (Abortion spontaneous) during the study participation. The date of LMP was reported as 07 July 2018. The estimated date of delivery was reported as 13 March 2019. Mother health status was reported as had a smoking history 0.5 pack, former quit on 2010, drink alcohol one drinks per month, hypertension and anemia Father health status was unknown. There was no current pregnancy complications. The subject received a single 0.5 mL intramuscular dose of Influenza Quadrival A-B vaccine (FLUZONE QIV) in the left arm on 12 September 2018 (lot number: UT5937LA, expiration date: 30-Jun-2018). It was also a case of actual medication error due to expired vaccine used. It was case of medication error with overdose (extra dose administered).  It was reported that there was a box of expired flu vaccine in fridge; expired dose was administered. Practice manager reached out to Sanofi safety was advised that there should be no unusual effects and to administered new vaccine as soon as possible (ASAP). Valid vaccine administered on same day. Subject was accidentally administered an expired flu shot dosage. The subject had no non serious adverse event. On 17 September 2019, the subject leads to spontaneous abortion This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.  Follow up information received on 17 October 2018. Narrative description was updated.  Follow up information received on 24 May 2019. LMP as well as EDD was updated. Mother as well as father health status was updated. Current pregnancy history was updated. Narrative description was updated. Pregnancy outcome was updated.   Addendum: The information has been amended to add the event spontaneous abortion.; Sender's Comments: Follow up information received on 24 May 2019: A 28-year-old female subject received an expired dose of Fluzone QIV during her pregnancy. The subject did not experienced any adverse event. The subject received a valid vaccine on same day, Extra dose of flu vaccine was administered. The subject had spontaneous abortion. The subject was followed as a part of pregnancy registry commitment. Company causality taken as reportable for reporting purpose.