Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, Haemorrhage in pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Mother case: Case number PHHY2015US018079, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 553318) website on 03 Feb 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 1000071) on 12 May 2015 with the follow-up information received from Quality Assurance Department (reference number: 1000071) on 26 May 2015. This report refers to a 25 years old female pregnant patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 13 Oct 2014. On 23 Oct 2014, she had an ultrasound which indicated strong heartbeat of her baby. On 28 Oct 2014, she started spotting. On 10 Nov 2014, she started to bleed heavily so she had another ultrasound that day and found that the baby's heart was no longer beating. On 12 Nov 2014, she miscarried her baby. She read the FLUVIRIN pamphlet the day after she received the flu shot and noticed that there has been no testing on pregnant women. It's not 100% known to be safe. After reading that she had a feeling that she would miscarry the baby so she did everything right on her behalf to try to counteract this horrible flu vaccine she got. She had a perfect little boy that she gave birth to almost 2 years ago and had no complications with him. She felt that the reason this baby did not make it was because of the shot. Outcome of the events was not reported. The case was assessed as non-serious. Seriousness assessment of miscarriage, absence of baby's heartbeat and bleeding during pregnancy was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: unknown) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000071) on 12 May 2015: Updated QA reference number only. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000071) on 26 May 2015: Updated FLUVIRIN batch review report.    Mother case: Case number PHHY2015US018079, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 553318) website on 03 Feb 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 1000071) on 12 May 2015 with the follow-up information received from Quality Assurance Department (reference number: 1000071) on 26 May 2015. This report refers to a 25 years old female pregnant patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: unknown) intramuscularly into right arm on 13 Oct 2014. On 23 Oct 2014, she had an ultrasound which indicated strong heartbeat of her baby. On 28 Oct 2014, she started spotting. On 10 Nov 2014, she started to bleed heavily so she had another ultrasound that day and found out that the baby's heart was no longer beating. On 12 Nov 2014, she miscarried her baby. She read the FLUVIRIN pamphlet the day after she received the Flu shot and noticed that there has been no testing on pregnant women. It's not 100% known to be safe. After reading that she had a feeling that she would miscarry the baby so she did everything right on her behalf to try to counteract this horrible Flu vaccine she got. She had a perfect little boy that she gave birth to almost 2 years ago and had no complications with him. She felt that the reason this baby did not make it was because of the shot. Outcome of the events was not reported. The case was assessed as non-serious. Seriousness assessment of miscarriage, absence of baby's heartbeat and bleeding during pregnancy was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: unknown) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000071) on 12 May 2015: Updated QA reference number only.