Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (QIV DRESDEN) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
vaccine exposure before pregnancy; Reported Spontaneous Abortion; This is a retrospective pregnancy case. This 28-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu-mRNA vs QIV Dresden or Fluzone (intramuscular, unknown deltoid) on 08-NOV-2023 17:14, for prophylaxis. The subject's past medical history included normal birth (The subject had a history of 3 previous pregnancies with normal birth.). Concomitant products included levonorgestrel (Mirena), norethisterone acetate (Norethisterone) and paracetamol (Tylenol). On 17-FEB-2024, 101 days after receiving Flu-mRNA vs QIV Dresden or Fluzone, the subject developed severe - grade 3 spontaneous abortion (Verbatim: Reported Spontaneous Abortion). Serious criteria included clinically significant/intervention required. Additional event(s) included not applicable vaccine exposure before pregnancy (Verbatim: vaccine exposure before pregnancy). The outcome of spontaneous abortion was resolved on 17-FEB-2024. The outcome(s) of the additional event(s) included vaccine exposure before pregnancy (unknown). Diagnostic results (reference ranges are provided in parenthesis if available): Pregnancy test- 12-FEB-2024 positive and 17-FEB-2024 negative. The investigator considered that there was no reasonable possibility that the spontaneous abortion may have been caused by Flu-mRNA vs QIV Dresden or Fluzone. The company considered that there was no reasonable possibility that the spontaneous abortion and vaccine exposure before pregnancy may have been caused by Flu-mRNA vs QIV Dresden or Fluzone. Pregnancy exposure: Pregnancy Exposure (Flu-mRNA vs QIV Dresden or Fluzone): To mother before conception Last Menstrual Period Date: 06-JAN-2024 Estimated Delivery/Due date: 12-OCT-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 6 weeks Pregnancy Outcome: Spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present Linked case(s) involving the same subject: US2024059635 GSK receipt date: 27-FEB-2024, . The subject stated that despite being on birth control she took a home pregnancy test on 12feb24 and tested positive. starting on 13feb2024 she began experiencing light spotting that lasted through 15feb24. on 16feb24 heavy bleeding began on that same day she took another test and it was negative. she did not ever seek medical attention for this event. Subject weighs 118.2 kg and is 185.4 cm in height with BMI of 34.4. at the initial visit, the subject reported her method of contraception as being the placement of an Intra uterine device (IUD). Mirena on 01MAY2023. The subject also reported starting Norethisterone as another form of birth control on 08NOV2023. She has had 3 live births. This subject was a 29 year old female who reports being a current smoker. She states that she smokes about 6 cigarettes per day. Furtherer, she reports occasionally drinking consuming maybe 1 beer monthly. At the time of her visit, the subject said that she was in the process of moving back into her mother's house Type of conception used was Normal (includes use of fertility drugs). Mother using a method of contraception was mirena iud and oral norethisterone. AE was not related to study treatment SAE was not related to Study Participation Activities other than Study Treatment. Follow up information received on 10-May-2024;17-May-2024,29 MAY2024, 31May2024 Summary of changes: General narrative comments updated. New Event added- Reported Spontaneous Abortion. There is no medical confirmation of pregnancy or spontaneous abortion. On 31-May-2024 the case US2024059635 was identified as duplicate of US2024GSK025890 . The case US2024059635 was prepared for deletion. All future correspondence will be added to the case US2024GSK025890. Follow up information received on 4-Jun-2023 to 5-jun-2024 Summary of change : Event term updated form Reported Spontaneous Abortion. *There is no medical confirmation of pregnancy or of spontaneous abortion. *" to "Reported Spontaneous Abortion and narrative updated. Follow up information received on 06-Feb-2025 End of study Unblinding completed.; Sender's Comments: A case of Abortion spontaneous and Maternal exposure before pregnancy, 101 days and unknown time after receiving the 1st dose of Flu-mRNA vs QIV Dresden or Fluzone in a 28-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. US-GSK-US2024059635:
Medical History/Concurrent Conditions: Normal birth (The subject had a history of 3 previous pregnancies with normal birth.)
MIRENA; Norethisterone; TYLENOL
Test Date: 20240212; Test Name: home pregnancy test; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240217; Test Name: home pregnancy test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)