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From the 9/17/2021 release of VAERS data:

Found 17 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) and Symptom is Aborted pregnancy or Abortion or Abortion complete or Abortion early or Abortion incomplete or Abortion induced or Abortion infected or Abortion late or Abortion missed or Abortion of ectopic pregnancy or Abortion spontaneous or Abortion spontaneous complete or Abortion spontaneous incomplete or Foetal cardiac arrest or Foetal death or Premature baby death or Premature delivery or Stillbirth and Vaccination Date from '2020-01-01' to '2021-12-31'

Table

   
AgeCountPercent
17-44 Years1694.12%
Unknown15.88%
TOTAL17100%



Case Details

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VAERS ID: 874218 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-01-08
Onset:2020-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. P100112488 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Foetal disorder, Premature delivery, Pyelocaliectasis
SMQs:, Haematopoietic erythropenia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness: Body mass index high; Pregnancy with young maternal age
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191001; Test Name: First sequential; Result Unstructured Data: No major congenital malformations noted; Test Date: 20191029; Test Name: Second sequential; Result Unstructured Data: No major congenital malformations noted; Test Date: 20191001; Test Name: Nuchal translucency; Result Unstructured Data: No major congenital malformations noted; Test Date: 20191126; Test Name: 20 weeks anatomy ultrasound; Result Unstructured Data: No major congenital malformations noted; Test Date: 20190916; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformations noted
CDC Split Type: USSEQIRUS202002355

Write-up: Delivery at 36.9 weeks of gestation; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 05-Mar-2020, concerning a 19-year-old, pregnant, female subject of body weight: 147 lbs, height: 63 inches and body mass index (BMI): 26, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject''s current condition included increased BMI and adolescent pregnancy. The subject''s concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy. The subject''s obstetrical history noted that the subject had no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject''s last menstrual period (LMP) date was on 15-Jul-2019. The subject''s estimated delivery date (EDD) was reported as 20-Apr-2020, while corrected estimated date of delivery (CEDD) was reported as 11-Apr-2020. The type of pregnancy was singleton. On 16-Sep-2019, the subject underwent ultrasound and no MCMs were noted. On 01-Oct-2019, the subject underwent first sequential and nuchal translucency. No MCMs were noted. On 29-Oct-2019, the subject underwent second sequential and no MCMs were noted. On 26-Nov-2019, the subject underwent 20 weeks anatomy ultrasound and no MCMs were noted. On 08-Jan-2020, at approximately 25 weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as ?Vaccine exposure during pregnancy'') for an influenza immunisation. On the same day, after vaccination, the subject developed anaemia. On 13-Jan-2020, the subject started treatment medication ferrous sulphate at the dose of 325 mg, administered via oral route, once per day. On 25-Feb-2020, the subject stopped with treatment medication ferrous sulphate. At gestational age of 36.9 weeks (reported as), the subject vaginally delivered live birth, female neonate. The neonate''s birth weight was 3204 g, her head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes) and for ten minutes not reported. No MCM was noted on birth. Pregnancy complications included anemia and fetal pylectasis. At the time of this report, the subject did not recover from the event of anaemia, while the outcome of the event ''premature delivery'' was not reported. The event of ''premature delivery'' was assessed as serious due to criterion of medical significance, per company. The reporter did not provide causality assessment to Afluria QIV. The case is linked to 202003815, the corresponding baby case. Follow up received from other health professional on 15-Jun-2020: Pregnancy details updated [date and type of delivery, birth type and foetal outcome populated]. Details regarding neonate added [body weight and APGAR scores added]. The event of vaccine exposure during pregnancy updated [stop date added, outcome changed from ''not reported'' to ''recovered'']. The narrative was amended accordingly. Company comment: A pregnant patient was administered Afluria QIV and anaemia was noted on the same day. Temporal relationship is implausible. Anaemia is common during pregnancy. Causal role of the suspect vaccine is assessed as not related. The neonate was delivered pre-term, however considering unsuggestive temporal relationship causality is assessed as not related as well. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.; Sender''s Comments: A pregnant patient was administered Afluria QIV and anaemia was noted on the same day. Temporal relationship is implausible. Anaemia is common during pregnancy. Causal role of the suspect vaccine is assessed as not related. The neonate was delivered pre-term, however considering unsuggestive temporal relationship causality is assessed as not related as well. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.


VAERS ID: 893940 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2020-10-30
Onset:2020-10-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gestational diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt is a G1P0, recently diagnosed with gestational diabetes. Gestational age 30 weeks. Intrauterine fetal demise occurred around 24-36 hours after vaccination.


VAERS ID: 901217 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2020-11-16
Onset:2020-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. P100249167 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Exposure during pregnancy, Pyrexia, Subchorionic haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: 2017 convulsions following a Benadryl vaccine
Other Medications: Prenatal Vitamin Promethazine Iron Tablets
Current Illness: N/A
Preexisting Conditions: Low back pain
Allergies: Penicillin Amoxicillin Mango
Diagnostic Lab Data:
CDC Split Type:

Write-up: 14 and 6 weeks pregnant with identical twins. Complications of sub chorionic hemorrhages. Due date May 15, 2021. Following the flu vaccine, I developed a low grade fever at home. Stomach pain was increased. I carried the low grade fever the next three days and miscarried the twins.


VAERS ID: 901252 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Washington  
Vaccinated:2020-10-01
Onset:2020-10-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS Z5N5G / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Foetal hypokinesia, Induced labour, Malaise, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins every day, acyclovir when needed, and unisom when needed
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: On October 1st, 2020 I received the flu shot at my work and I was currently 27 weeks pregnant. A couple hours later, I started to not feel so well but I tried to keep something on my stomach and kept working at the office for the rest of the day. That night I took a bath, and tried getting a video of my baby moving in my belly. That was 7:15 pm that night, and that was the last time I felt my baby move. I went to my doctor''s appointment 5 days later after realizing I hadn''t felt her move in that long, and she had past. I had to be induced that night and my daughter was delivered the next morning at about 10:00 am on October 7th, 2020. She weighed 2 lbs 1 oz.


VAERS ID: 902593 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-09-10
Onset:2020-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER P100230203 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Premature delivery
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; ZOLOFT; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; GABAPENTIN
Current Illness: Anxiety; Body mass index high; Neck pain; Pregnancy with advanced maternal age
Preexisting Conditions: Medical History/Concurrent Conditions: Elective abortion; Live birth; Multigravida; Pre-eclampsia
Allergies:
Diagnostic Lab Data: Test Date: 20200716; Test Name: MSAFP / serum markers; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20200520; Test Name: First trimester screen; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20200518; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20200720; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.
CDC Split Type: USSEQIRUS202007584

Write-up: Post-partum pre-eclampsia; Delivery at 34.7 week of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received on 07-Dec-2020 from other health professional and concerned a 40-year-old, pregnant, female subject of body weight: 173.5 lbs, height: 65 inches and body mass index (BMI): 28.9, enrolled in, a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject''s concurrent conditions included advanced maternal age, chronic neck pain, anxiety and body mass index high (BMI 28.9). The subject''s concomitant medications included folic acid for pregnancy, Zoloft (sertraline hydrochloride) for anxiety, Prenatal vitamins (unspecified vitamins and mineral) for pregnancy, Flexeril (cyclobenzaprine hydrochloride) and gabapentin for chronic neck pain. The subject had a history of previous pre-eclampsia. The subject''s obstetrical history included three previous pregnancies, with two full term live births and one abortion. The subject did not have a history of offspring with major congenital malformations (MCMs). Also, the subject had no relevant maternal or paternal history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject''s last menstrual period (LMP) date was 09-Mar-2020, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 14-Dec-2020. The type of pregnancy was singleton. On 18-May-2020, the ultrasound revealed no MCMs. On 20-May-2020, the first trimester screen revealed no MCM On 16-Jul-2020, the maternal serum alpha-fetoprotein screening (MSAFP) / serum markers revealed no MCMs. On 20-Jul-2020, the ultrasound revealed no MCMs. On 10-Sep-2020, at approximately 26 weeks of gestation (calculated per LMP) the subject was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV) [influenza vaccine, dose, route of administration, anatomical location: not reported] (explicitly coded as ''Vaccine exposure during pregnancy'') for influenza immunisation. The batch number reported was P100230203. At gestational age of 34.7 weeks (as reported), the subject delivered live birth, male neonate via caesarean method of delivery. The neonate''s birth weight was 2807 g, the body length was 47.6 cm and head circumference 34.5cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 at one minute and 8 at five minutes. APGAR score was not reported for ten minutes. No MCM was identified at birth. On 19-Nov-2020, two months and nine days after receiving Afluria Quadrivalent, the subject experienced post-partum pre-eclampsia. At the time of initial reporting on 07-Dec-2020, the subject had not recovered from the event of ''pre-eclampsia''. The outcome of the event ''premature delivery'' was not reported. The reporter did not provide a causality assessment. The events of ''pre-eclampsia'' and ''premature delivery'' were considered to be medically significant by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. This case is linked with the case 202007585 (the corresponding baby case). Company comment:The pregnant subject experienced pre-eclampsia and premature delivery approximately two months after vaccination with the suspect product, Afluria Quadrivalent. The patient was administered vaccine at approximately 26 weeks of gestation. Chronology is unsuggestive. The subject''s story of previous pre-eclampsia highly confounds causality. Underlying conditions of advanced maternal age, body mass index high and therapy with concomitant drug sertraline also confound causality for the events .Considering all above mentioned, causal relationship for the events of pre-eclampsia and premature delivery is assessed as not related due to due to biological implausibility, unsuggestive chronology and presented confounders. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.; Sender''s Comments: The pregnant subject experienced pre-eclampsia and premature delivery approximately two months after vaccination with the suspect product, Afluria Quadrivalent. The patient was administered vaccine at approximately 26 weeks of gestation. Chronology is unsuggestive. The subject''s history of previous pre-eclampsia highly confounds causality. Underlying conditions of advanced maternal age, body mass index high and therapy with concomitant drug sertraline also confound causality for the events .Considering all above mentioned, causal relationship for the events of pre-eclampsia and premature delivery is assessed as not related due to due to biological implausibility, unsuggestive chronology and presented confounders. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.


VAERS ID: 902596 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-10-27
Onset:2020-10-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER P100265371 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Delivery, Exposure during pregnancy, Premature delivery, Preterm premature rupture of membranes
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; NIFEREX [POLYSACCHARIDE-IRON COMPLEX]
Current Illness: Body mass index increased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200630; Test Name: First trimester screen; Result Unstructured Data: Increased risk for Down''s syndrome. No major congential malformation noted.; Test Date: 20200608; Test Name: Ultrasound; Result Unstructured Data: No major congential malformation noted.; Test Date: 20200630; Test Name: Ultrasound; Result Unstructured Data: No major congential malformation noted.; Test Date: 20200812; Test Name: Ultrasound; Result Unstructured Data: No major congential malformation noted.
CDC Split Type: USSEQIRUS202007590

Write-up: Delivery at 32.6 weeks of gestation; Prolonged premature rupture of membranes; Vaccine exposure during pregnancy; This observational study case, initially received on 07-Dec-2020 from other health professional and concerned a 31-year-old pregnant, female subject of body weight 146 lbs, height 63 inches and body mass index (BMI) 25.9, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject''s concurrent conditions included increased BMI. The subject''s concomitant medications included Niferex (polysaccharide-iron complex) and Prenatal vitamins (unspecified minerals and vitamins) both used for pregnancy. The subject''s obstetrical history included no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject''s last menstrual period (LMP) date was reported as 07-Apr-2020. The subject''s estimated delivery date (EDD) was not reported and corrected estimated date of delivery (CEDD) was reported as 12-Jan-2021. The type of pregnancy was singleton. On 08-Jun-2020, the ultrasound revealed no MCM. On 30-Jun-2020, ultrasound revealed no MCM, but first trimester screen revealed increased risk for Down''s syndrome and no MCM. On 12-Aug-2020, the ultrasound revealed no MCM. On 27-Oct-2020, at approximately 29 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine, route of administration, anatomical location: not reported) (explicitly coded as ''Vaccine exposure during pregnancy'') for an influenza immunisation. The batch number reported was P100265371. On 11-Nov-2020, 15 days after receiving Afluria QIV, the subject developed prolonged premature rupture of membranes. At gestational age of 32.6 weeks (as reported), the subject vaginally delivered a live birth, female neonate. The characteristics of the neonate included birth weight of 1984 grams, head circumference: 30 cm and length: 44.5 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). No data for APGAR score at 10 minutes was provided. No MCM was identified at birth. On the same day, the subject recovered from prolonged premature rupture of membranes. The outcome of ''premature delivery'' was not reported. The events of ''premature delivery'' and ''premature rupture of membranes'' were considered to be medically significant by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. The reporter did not provide causality assessment. This case is linked to the case 202007591 (the corresponding baby case). Company comment: A 31-year-old pregnant subject developed preterm premature rupture of membranes 15 days after vaccination with the suspect product, Afluria QIV. Reportedly, the event of premature delivery emerged 26 days post vaccination, at gestational age of 32.6 weeks. Chronology is unsuggestive. Underlying condition of body mass index high confounds causality for the events. With information presented, causality for both events is assessed as not related due to biological implausibility and presented confounder. Vaccine exposure during pregnancy is assessed as not related per company''s conventions.; Sender''s Comments: A 31-year-old pregnant subject developed preterm premature rupture of membranes 15 days after vaccination with the suspect product, Afluria QIV. Reportedly, the event of premature delivery emerged 26 days post vaccination, at gestational age of 32.6 weeks. Chronology is unsuggestive. Underlying condition of body mass index high confounds causality for the events. With information presented, causality for both events is assessed as not related due to biological implausibility and presented confounder. Vaccine exposure during pregnancy is assessed as not related per company''s conventions.


VAERS ID: 1073683 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-01-14
Onset:2020-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. P100112488 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Alpha 1 foetoprotein, Exposure during pregnancy, Premature delivery, Prenatal screening test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MULTIVITAMINS [VITAMINS NOS]
Current Illness: Beta thalassaemia minor; Rhesus negative
Preexisting Conditions: Medical History/Concurrent Conditions: Gravida I; Live birth
Allergies:
Diagnostic Lab Data: Test Date: 20200214; Test Name: MSAFP / serum markers; Result Unstructured Data: No major congenital malformation noted; Test Date: 20200114; Test Name: Noninvasive prenatal testing; Result Unstructured Data: No major congenital malformation noted; Test Date: 20191217; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted
CDC Split Type: USSEQIRUS202101500

Write-up: Delivery at 36 weeks of gestation; Vaccine exposure during pregnancy; This observational study case was received from other health professional on 24-Feb-2021 and concerned a 33-year-old, pregnant, female subject of body weight 138 lbs, height 65 inches and body mass index (BMI) 23, enrolled in, a prospective observational safety study on pregnancy outcome in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject''s concurrent conditions included beta thalassaemia (thal) minor and the subject was Rh negative. The subject''s concomitant medication included Multivitamin (unspecified vitamins) for pregnancy. The subject''s obstetrical history included one previous pregnancy with full term live birth. The subject had no offspring with major congenital malformations (MCMs). The subject had no maternal or paternal history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject''s last menstrual period (LMP) date was 17-Oct-2019, the estimated delivery date (EDD) was 23-Jul-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. On 17-Dec-2019, ultrasound revealed no MCM. On 14-Jan-2020, at approximately 12 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, anatomical location and route of administration: not reported] (explicitly coded as ''vaccine exposure during pregnancy'') for influenza immunisation. The batch number was P100112488. On the same day, non-invasive prenatal testing revealed no MCM. On 14-Feb-2020, maternal serum alpha-fetoprotein (MSAFP)/ serum markers revealed no MCM. At 36 weeks of gestation (as reported), the subject vaginally delivered a female neonate. The neonate''s birth weight was 2920 g, head circumference and length were not reported. APGAR (appearance, pulse, grimace, activity and respiration) scores at one minute, at five minutes and at ten minutes were not reported. No MCM was identified at birth. The outcome of the event of ''premature delivery'' was not reported. The reporter did not provide a causality assessment. The event of ''premature delivery'' was considered to be medically significant by a Physician within Seqirus''s Pharmacovigilance and Risk Management Department. This case is linked to 202101501 (the corresponding baby case). Company comment: A 33-year-old pregnant subject was administered Afluria QIV at approximately 12 weeks of gestation. The subject experienced premature delivery 5 months and 12 days after vaccination. Chronology is implausible. The subject''s concurrent conditions included beta thalassaemia minor and the subject was Rh negative. Causal role of the suspect vaccine is assessed as not related. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.; Sender''s Comments: A 33-year-old pregnant subject was administered Afluria QIV at approximately 12 weeks of gestation. The subject experienced premature delivery 5 months and 12 days after vaccination. Chronology is implausible. The subject''s concurrent conditions included beta thalassaemia minor and the subject was Rh negative. Causal role of the suspect vaccine is assessed as not related. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.


VAERS ID: 1073684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2020-01-14
Onset:2020-06-26
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. P100112488 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Foetal exposure during pregnancy, Premature baby, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MULTIVITAMINS [VITAMINS NOS]
Current Illness: Beta thalassaemia minor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS202101501

Write-up: Vaccine fetal exposure during pregnancy; Preterm birth at 36 weeks of gestation; This observational study case was received from other health professional on 24-Feb-2021 and concerned a female neonate, whose mother was a 33-year-old, pregnant, female subject of body weight 138 lbs, height 65 inches and body mass index (BMI) 23, enrolled in, a prospective observational safety study. The maternal concurrent conditions included beta thalassaemia (thal) minor and the neonate''s mother was Rh negative. The maternal concomitant medication included Multivitamin (unspecified vitamins) for pregnancy. The maternal obstetrical history included one previous pregnancy with full them live birth. The neonate''s mother had no offspring with major congenital malformations (MCMs). The neonate''s mother had no maternal or paternal history with MCMs. The neonate''s mother did not use tobacco, alcohol or illicit drugs during pregnancy. The neonate''s mother''s last menstrual period (LMP) date was 17-Oct-2019, the estimated delivery date (EDD) was 23-Jul-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The neonate''s father''s age was not reported. On 17-Dec-2019, ultrasound revealed no MCM. On 14-Jan-2020, at approximately 12 weeks of gestation (calculated per LMP), the neonate''s mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, anatomical location and route of administration: not reported] (explicitly coded as ''fetal exposure during pregnancy'') for influenza immunisation. The batch number was P100112488. On the same day, non-invasive prenatal testing revealed no MCM. On 14-Feb-2020, maternal serum alpha-fetoprotein (MSAFP)/ serum markers revealed no MCM. At 36 weeks of gestation (as reported), the neonate''s mother vaginally delivered a female neonate. The neonate''s birth weight was 2920 g, head circumference and length were not reported. APGAR (appearance, pulse, grimace, activity and respiration) scores at one minute, at five minutes and at ten minutes were not reported. No MCM was identified at birth. The outcome of the event of ''premature baby 33 to 36 weeks'' was not reported. The reporter did not provide a causality assessment. The event of ''premature baby 33 to 36 weeks'' was considered to be medically significant by a Physician within Seqirus''s Pharmacovigilance and Risk Management Department. This case is linked to 202101500 (the corresponding mother case). Company comment: A female neonate was exposed to the suspect product, Afluria QIV. The neonate''s mother was vaccinated with Afluria QIV at approximately 12 weeks of gestation. The neonate experienced premature birth at 36 weeks of gestation (5 months and 12 days after vaccination). The maternal concurrent conditions included beta thalassaemia minor and the neonate''s mother was Rh negative. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company''s conventions.; Sender''s Comments: A female neonate was exposed to the suspect product, Afluria QIV. The neonate''s mother was vaccinated with Afluria QIV at approximately 12 weeks of gestation. The neonate experienced premature birth at 36 weeks of gestation (5 months and 12 days after vaccination). The maternal concurrent conditions included beta thalassaemia minor and the neonate''s mother was Rh negative. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company''s conventions.


VAERS ID: 1076922 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-09-04
Onset:2020-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. P100239705 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Amniocentesis normal, Bacterial vaginosis, Delivery, Exposure during pregnancy, Live birth, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Body mass index increased
Preexisting Conditions: Medical History/Concurrent Conditions: Bacterial vaginosis; Live birth; Multigravida; Spontaneous abortion
Allergies:
Diagnostic Lab Data: Test Date: 20200806; Test Name: Amniocentesis; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20200807; Test Name: Amniocentesis; Result Unstructured Data: The whole genome chromosome single-nucleotide polymorphism (SNP) microarray analysis was normal. No significant DNA copy number changes or copy neutral regions within the 2.695 million region specific SNP.; Test Date: 20200706; Test Name: First trimester screen; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20200727; Test Name: Second trimester screen; Result Unstructured Data: Increased risk of Down syndrome. No major congenital malformation noted.
CDC Split Type: USSEQIRUS202007444

Write-up: Delivery at 36,7 weeks of gestation; Vaccine exposure during pregnancy; Bacterial vaginosis; This observational study case, initially received on 30-Nov-2020 from other health professional and concerned a 33-year-old, female, pregnant subject of body weight: 148 lbs, height: 62 inches and body mass index (BMI): 27.1, enrolled in, a prospective observational study. The subject''s concurrent condition included body mass index high. The subject''s past medical history included bacterial vaginosis. The subject''s concomitant medications included OB complete one (fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide, and cupric sulfate capsule, liquid filled) for healthy pregnancy. The subject''s past medications included Metrogel (metronidazole) and terconazole, both used for bacterial vaginosis. The subject''s obstetrical history included two previous pregnancies with one full term live birth, and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject''s last menstrual period (LMP) date was on 13-Apr-2020. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 18-Jan-2021 and corrected estimated date of delivery (CEDD) was not reported. On 06-Jul-2020, first trimester screen revealed no MCMs. On 27-Jul-2020, second trimester screen revealed increased risk of Down syndrome, but no MCM was noted. On 06-Aug-2020, amniocentesis revealed no MCMs. On 07-Aug-2020, amniocentesis revealed no MCMs. The whole genome chromosome single-nucleotide polymorphism (SNP) microarray analysis was normal. No significant deoxyribonucleic acid (DNA) copy number changes or copy neutral regions within the 2.695 million region specific SNP. On 04-Sep-2020, at approximately of 20 weeks of gestational age (calculated per LMP), the subject was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV) (influenza vaccine, dose, route of administration, anatomical location: not reported) (explicitly coded as ''Vaccine exposure during pregnancy'') for influenza immunisation. The batch number reported was P100239705. On an unknown date in 2020, unknown amount of time after receiving Afluria Quadrivalent, the subject developed bacterial vaginosis. On 02-Oct-2020, the subject started therapy with Metrogel 0.75 % cream (metronidazole), once at night, vaginally for bacterial vaginosis. On 07-Oct-2020, the subject stopped treatment with Metrogel. At gestational age of 36.7 weeks (as reported), the subject vaginally delivered, live birth female neonate. The characteristics of the neonate included birth weight of 2745 grams, head circumference was 33.5 centimeters (cm) and length 47.6 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores at one and five minutes was 9. APGAR score for ten minutes was not reported. No MCM was identified at birth. The outcome of events was not reported. The reporter did not provide a causality assessment. The event of ''premature delivery'' was considered to be medically significant by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. This case is linked with 202101525 (the corresponding baby case). Additional information received on 11-Dec-2020 from other health professional: Amniocentesis test results were provided. The narrative was amended accordingly. Additional information received on 15-Jan-2021 from other health professional: The subject was enrolled in study upon data query resolution. Report type was changed. Subject''s age was changed from 34 to 33 years. New amniocentesis test added in laboratory data. The narrative was amended accordingly. Additional information received on 25-Feb-2021 from other health professional: Pregnancy outcome received, and pregnancy information updated. Stop date added and outcome changed from not reported to resolved for the event of ''vaccine exposure during pregnancy''. Premature delivery added as a new event and therefore, the case was upgraded from non-serious to serious. Link for baby case added. Narrative was amended accordingly. Company comment: Premature delivery in a 33-year-old female subject was reported after vaccine exposure during pregnancy to the suspect product Afluria Quadrivalent. Vaccine was administered at approximately 20 weeks of gestational age, while the neonate was delivered at gestational age of 36.7 weeks. On an unknown date in 2020, the patient developed bacterial vaginosis. The patient''s past medical history included bacterial vaginosis. The subject''s obstetrical history included two previous pregnancies with one full term live birth, and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions. Bacterial vaginosis is assessed as not related due to biological implausibility and strong confounder (medical history). Causality for the event premature delivery is assessed as not related due to presence of significant confounding factor (bacterial vaginosis).; Sender''s Comments: Premature delivery in a 33-year-old female subject was reported after vaccine exposure during pregnancy to the suspect product Afluria Quadrivalent. Vaccine was administered at approximately 20 weeks of gestational age, while the neonate was delivered at gestational age of 36.7 weeks. On an unknown date in 2020, the patient developed bacterial vaginosis. The patient''s past medical history included bacterial vaginosis. The subject''s obstetrical history included two previous pregnancies with one full term live birth, and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions. Bacterial vaginosis is assessed as not related due to biological implausibility and strong confounder (medical history). Causality for the event premature delivery is assessed as not related due to presence of significant confounding factor (bacterial vaginosis).


VAERS ID: 1076924 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-09-25
Onset:2020-09-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER P100239705 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Gastrooesophageal reflux disease, Premature delivery
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZOFRAN [ONDANSETRON]
Current Illness: Body mass index high; Nausea
Preexisting Conditions: Medical History/Concurrent Conditions: Elective abortion; Live birth; Multigravida
Allergies:
Diagnostic Lab Data: Test Date: 20200828; Test Name: MSAFP/serum markers; Result Unstructured Data: No major congenital malformation noted.
CDC Split Type: USSEQIRUS202101522

Write-up: GERD; Delivery at 36.7 weeks of gestation; Vaccine exposure during pregnancy; This observational study case was received on 25-Feb-2021 from other health professional and concerned a 30-year-old, pregnant female subject of body weight: 147 lbs, height: 64 inches and body mass index (BMI): 25.2, enrolled, a prospective observational safety study. The subject''s concurrent conditions included body mass index high and nausea. The subject''s concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for healthy pregnancy and Zofran (ondansetron) for nausea. The subject''s obstetrical history included three previous pregnancies with one full term live birth and two elective abortions. The subject had no history offspring with major congenital malformations MCMs) and maternal or paternal history with MCMs. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject''s last menstrual period (LMP) date was 08-May-2020, the estimated delivery date (EDD) was reported as 21-Feb-2021, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. On 28-Aug-2020, maternal serum alpha 1 fetoprotein (MSAFT) revealed no MCM. On 25-Sep-2020, at gestation age of 20 weeks (calculated per LMP), the subject was administered with Alfuria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly considered as ''Vaccine exposure during pregnancy'') for influenza immunisation. The batch number reported was P100239705. On an unspecified date, unknown amount of time after receiving Afluria QIV, the subject developed gastroesophageal reflux disease (GERD). On 08-Jan-2021, the subject commenced treatment with Pepcid Ac (famotidine), 20 mg three times a day, via oral route of administration for GERD. At gestational age of 36.7 weeks (as reported), the subject vaginally delivered premature, live male neonate. The birth weight of the neonate was 2727 g, head circumference 33.5 cm and length 50.2 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and at ten minutes was not reported. No pregnancy complications noted. No MCM was identified at birth. On the same day, treatment with Pepcid Ac (famotidine) was stopped. The outcome of ''premature delivery'' and GERD was not reported. The reporter did not provide causality assessment. The event of ''premature delivery'' was considered to be medically significant by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. This case is linked to 202101523 (baby case). Company comment: A 30-year-old subject was administered Afluria QIV at gestational age of 20 weeks. On an unspecified date, unknown amount of time after receiving Afluria QIV, the subject developed gastroesophageal reflux disease (GERD). At gestational age of 36.7 weeks, the subject vaginally delivered premature, live male neonate. Causal role of the suspect vaccine is assessed as not related, due to unsuggestive temporal relationship with premature delivery, biological implausibility and pregnancy as a strong confounder for GERD (reported in up to 80% of pregnancies). Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.; Sender''s Comments: A 30-year-old subject was administered Afluria QIV at gestational age of 20 weeks. On an unspecified date, unknown amount of time after receiving Afluria QIV, the subject developed gastroesophageal reflux disease (GERD). At gestational age of 36.7 weeks, the subject vaginally delivered premature, live male neonate. Causal role of the suspect vaccine is assessed as not related, due to unsuggestive temporal relationship with premature delivery, biological implausibility and pregnancy as a strong confounder for GERD (reported in up to 80% of pregnancies). Vaccine exposure during pregnancy is assessed as unrelated per company''s conventions.


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