Found 25 events with Vaccine as FLU and Symptom is Abortion

Vaccination and miscarriage (spontaneous abortion)
Flu vaccine racket VAERS

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Found 25 events with Vaccine as FLU and Symptom is Abortion

VAERS ID:	128185	Vaccination Date:	1998-10-05
Age:	37.1	Onset Date:	1998-12-01 Days later: 57
Gender:	Female	Submitted:	1999-09-10
State:	New York	Entered:	1999-09-13

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions: mitral valve prolapse (1978); urinary tract infect

CDC 'Split Type': 1998024794

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	UNKNOWN MANUFACTURER		0
HEPA	SMITHKLINE BEECHAM		1

Administered by: Private Purchased by: Other

Symptoms: Abortion

Write-up: p/vax pt could possible be preg, starting 10/4/98; pt devel flu; MD stated that pt had a spontaneous abortion

VAERS ID:	179730	Vaccination Date:	2001-11-06
Age:	48.0	Onset Date:	2001-11-11 Days later: 5
Gender:	Female	Submitted:	2001-12-23
State:	California	Entered:	2002-01-07

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: URI

Diagnostic Lab Data: Sonogram

Previous Vaccinations:

Other Medications: Progestrone,Estrpgen, Folic Acid, ASA

Preexisting Conditions: NONE

CDC 'Split Type':

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	EVANS VACCINES	E73100LA	0		LA

Administered by: Public Purchased by:

Symptoms: Abortion

Write-up: 11/11/2001-Seven weeks into her pregnancy, the patient had a spontaneous abortion.

VAERS ID:	181022	Vaccination Date:	2000-11-28
Age:	41.0	Onset Date:	0000-00-00 Days later:
Gender:	Female	Submitted:	2002-02-05
State:	New Jersey	Entered:	2002-02-07

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: UNK

Diagnostic Lab Data: UNK

Previous Vaccinations:

Other Medications: NONE

Preexisting Conditions: UNK

CDC 'Split Type': 5538604

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	WYETH PHARMACEUTICALS, INC		0	IM

Administered by: Other Purchased by: Other

Symptoms: Abortion spontaneous

Write-up: A 41 year old female reported that she received Flu Shield ('00-'01) on 11/28/00. On that day, she reported being approx. 2 weeks pregnant. Follow-up information has been received on 2/1/02 from the now 42 year old female who reported that she "had a miscarriage". The date of the event was not reported. The event was considered to be an "Other Important Medical Event".

VAERS ID:	214410	Vaccination Date:	2003-10-07
Age:	30.0	Onset Date:	2003-11-10 Days later: 34
Gender:	Female	Submitted:	0000-00-00
State:	Unknown	Entered:	2003-12-24

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: NONE

Preexisting Conditions:

CDC 'Split Type': PJP200300904

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	AVENTIS PASTEUR			IM

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion spontaneous, Drug administration error

Write-up: A report was received from a health care professional on 10/27/03, concerning a 30 year old female vaccinee who was thought to have been pregnant at the time of receiving the Fluvirin vaccine on 10/7/03. On 10/7/03, the vaccinee received Fluvirin but is now thought to have been pregnant, this has yet to be confirmed. There was insufficient info to determine the reporter's causality. Follow up info received from a health care professional indicated that the vaccinee miscarried on 11/10/03. She had a positive pregnantcy test on 10/29/03. Follow-up pending. Upon review of this report was found to be medically significant (OMIC).

VAERS ID:	217805	Vaccination Date:	2001-11-20
Age:	19.0	Onset Date:	2001-11-22 Days later: 2
Gender:	Female	Submitted:	2004-03-12
State:	Alaska	Entered:	2004-03-12

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? Yes, 3 days

Extended hospital stay? No

Current Illness: NONE

Diagnostic Lab Data: WBC elevated, lab test abn

Previous Vaccinations:

Other Medications: NONE

Preexisting Conditions: Group B streptococcus UTI;

CDC 'Split Type': AK200424

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	UNKNOWN MANUFACTURER	Unknown	0		RA

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion, Back pain, Headache, Laboratory test abnormal, Nausea, Vomiting, White blood cell disorder

Write-up: Headache, lower back pain, nausea, vomiting, loss of unborn child. Lasted for two weeks; resulted in hospitalization. Nurse follow up on 05/18/04: spontaneous rupture of membranes.

VAERS ID:	231630	Vaccination Date:	2004-10-28
Age:	31.0	Onset Date:	2004-11-02 Days later: 5
Gender:	Female	Submitted:	2004-12-20
State:	Minnesota	Entered:	2004-12-28

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? Yes, 1 days

Extended hospital stay? No

Current Illness: Pregnancy

Diagnostic Lab Data: U/S confirmed fetal demise.

Previous Vaccinations:

Other Medications: Prenatal vitamins.

Preexisting Conditions: NONE

CDC 'Split Type':

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	AVENTIS PASTEUR	U1453FA	1	IM	LA

Administered by: Private Purchased by: Private

Symptoms: Abortion spontaneous

Write-up: Miscarriage at six weeks gestation one week after flu vaccination.

VAERS ID:	249306	Vaccination Date:	2005-11-29
Age:	35.0	Onset Date:	2005-12-09 Days later: 10
Gender:	Female	Submitted:	2005-12-09
State:	Mississippi	Entered:	2005-12-15

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: MORNING SICKNESS

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions: 5-6 WEEKS PREGNANT

CDC 'Split Type': MS05027

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	AVENTIS PASTEUR	U1806AA		IM	LA

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion spontaneous, Asthenia

Write-up: PT STATES: "AFTER FLU SHOT MY BODY WAS WEAK AND I WAS DRAGGING FOR 2 DAYS'. 12/9/2005 PT WENT FOR SONOGRAM M D AND FOUND NO HEARTBEAT OF FETUS.

VAERS ID:	249972	Vaccination Date:	0000-00-00
Age:		Onset Date:	0000-00-00 Days later:
Gender:		Submitted:	2005-12-28
State:	North Carolina	Entered:	2006-01-03

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type': 200502820

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	AVENTIS PASTEUR				UN

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion spontaneous, Unintended pregnancy

Write-up: Seriousness criteria other medically significant (OMIC). This case involves a cluster of five female (no specific identification provided). The patients had all received vaccinations with Fluzone SV 2005-2005 USP on unspecified dates. The vaccines were received at the local health department and were from three different lots. No information on the specific lot numbers was provided. An unspecified amount of time following vaccination, the five women experienced intra-uterine fetal death. Two of the patients were sisters. Of the five total patients, two of the fetuses were at 37 to 40 weeks gestation at the time of fetal death, and three were 20 to 36 weeks. There was no available information on the causes of deaths in the fetuses or if autopsies are planned. It was not reported whether any of the five female patients recovered from the events.

VAERS ID:	276055	Vaccination Date:	2006-10-18
Age:		Onset Date:	2006-10-27 Days later: 9
Gender:		Submitted:	0000-00-00
State:	Unknown	Entered:	2007-04-11

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: UNISOM, NITROFURANTOIN, LEVOXYL, PRE-NATAL VITAMINS WITH DOXALYMINE

Preexisting Conditions: The vaccinee has a history of hypothyroid.

CDC 'Split Type': CVOX200600266

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	CHIRON CORPORATION	70279		IM	LA

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion induced, Drug exposure during pregnancy, Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Spina bifida

Write-up: A report was received from a healthcare professional on 20/Oct/2006 concerning a 34 year old pregnant vaccinee. No details of the vaccinees past medical history or details of any concomitant medications were provided. On 13/Oct/2006 the vaccinee was administered Fluvirin 0.5mls by intramuscular injection. By the following day (19/Oct/2006) she had developed a hugh wheal, about 3 inches in diameter, at the injection site, which was also hot, red and itchy. Further information is requested. A follow-up report was received from a healthcare professional concerning a pregnant 34-year-old female vaccinee. The vaccinee has a history of Hypothyroid since 2003 which is on going. The vaccinee's concomitant medications include Levoxyl, 0.05 mg once a day, orally for Hypothyroid, since 2003 and is on going, Pre-natal vitamins with Doxalymine, 1 tablet once a day, orally for pregnancy since Jun/2006 and is on going, Unisom, 1 tablet once a day, orally for nausea from Sep/2006 to Oct/2006 and Nitrofurantoin, as required, orally for bladder infections in 2004. The vaccinee also received an influenza vaccinee (brand unspecified) in Oct/2005. On 18/Oct/2006, the vaccinee received 0.5ml of Fluvirin, once, intramuscularly into her upper left arm. On 19/Oct/2006, the vaccinee experienced a red wheal at the injection site, which resolved on 23/Oct/2006. On 27/Oct/2006, the vaccine had an elective termination of pregnancy, due to Spina Bifida. The infant was a 12 oz male. The reporter dose not considered the red wheal at the injection site to be serious and is unknown if it is related to Fluvirin. No further information is expected.

VAERS ID:	284078	Vaccination Date:	2006-09-25
Age:	33.0	Onset Date:	0000-00-00 Days later:
Gender:	Female	Submitted:	2007-07-05
State:	Texas	Entered:	2007-07-09

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: prenatal testing: serologies done on 25-Oct-2006 - normal: ultrasound 03-Nov-2006 - showed no fetal cardiac activity.

Previous Vaccinations:

Other Medications: PRENATAL

Preexisting Conditions: Past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome. Follow-up information received on 11 May 2007. She did not have any illness at the time of the vaccination. Her previous pregnancy occurred in 2004.

CDC 'Split Type': 200602672

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	SANOFI PASTEUR	U2201AA		IM
TDAP	SANOFI PASTEUR	C2559AA	0	IM	LA

Administered by: Private Purchased by: Private

Symptoms: Abortion missed, Drug exposure during pregnancy, Foetal heart rate abnormal, Serology normal, Ultrasound scan abnormal

Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a physician on 12 October 2006. A 33 year old female patient received on 25 September 2006, intra-muscular, 0.5 ml booster of Adacel (lot number C2559AA, expiry date 12 August 2008), while she was 1 week pregnant (LMP was 10 June 2007). The patient did not receive any concomitant vaccines. The patient's past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome. At the time of the report (12 October 2006), the patient did not have prenatal testing yet. No information about prior exposures to Adacel was provided. The patient did not experience any adverse reactions following receipt of Adacel on 25 September 2006. Follow-up information received on 11 May 2007. The patient received Adacel in the left deltoid and she did not have any illness at that time. The patient's past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome in 2004. The patient's last menstrual period was 04 September 2006 and her expected date of delivery is 11 June 2007. The patient was last seen on 06 October 2006 for confirmation of pregnancy and was lost to follow-up by the reporting physician. She was referred to an OB/GYN for prenatal care. The reporting physician was not aware of the current pregnancy outcome. Follow-up information received on 02 July 2007 from a health care professional, Date of last menstrual periods was 11 September 2006. The estimated date of delivery was 11 June 2007. Past obstetric history included: 1 live birth, previous pregnancy with no pre-term / congenital anomalies. The patient received one intramuscular dose of Fluzone (lot# U2201AA) on 30 October 2006. Prenatal testing included serologies on 25 October 2006, which was normal and ultrasound on 03 November 2006, which showed no fetal cardiac activity. Outcome of the pregnancy was missed abortion on the first trimester with Dilation and curettage (D&C).

VAERS ID:	40511	Vaccination Date:	1991-11-13
Age:	34.0	Onset Date:	1992-03-18 Days later: 126
Gender:	Female	Submitted:	0000-00-00
State:		Entered:	1992-03-23

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data: 26NOV91 Ultrasound-confirmed 5 1/2 wk fetus; JAN91 Ultrasound-grossly abn fetus;

Previous Vaccinations:

Other Medications:

Preexisting Conditions: hx of irregular menstrual cycles;

CDC 'Split Type': CO4137

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	CONNAUGHT LABORATORIES

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion, Foetal disorder

Write-up: Pt underwent termination of pregnancy; LMP 30SEP91, sl PV bleeding on 10NOV91; Recvd vax on 13NOV91; ultrasound confirmed 5 1/2 wk fetus on 26NOV91; JAN92 ultrasound showed "grossly abn fetus; preg terminated 4FEB92;

VAERS ID:	215224	Vaccination Date:	2003-10-07
Age:	30.0	Onset Date:	2003-11-10 Days later: 34
Gender:	Female	Submitted:	0000-00-00
State:		Entered:	2004-01-20

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: Concomitant drugs not reported.

Preexisting Conditions:

CDC 'Split Type': 200400057

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	EVANS VACCINES			IM

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion spontaneous

Write-up: An Anonymised Single Patient Print (ASPP) report was received from a regulatory authority on 01/05/2004, concerning a 30-year-old female pt who miscarried approximately 1 month after receiving Fluvirin on 10/07/2003. On 11/10/2003 the pt miscarried. The pt had a positive pregnancy test on 10/29/2003. There was insufficient info to determine the reporter's causality. This case is suspected to be a duplicate of case PJP-2003-00904, previously reported on 12/22/2003. We await confirmation as to whether or not this case is a duplicate.

VAERS ID:	225155	Vaccination Date:	2003-10-08
Age:	36.0	Onset Date:	2003-12-04 Days later: 57
Gender:	Female	Submitted:	2004-08-30
State:		Entered:	2004-08-09

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions: Pregnant, LMP date: 9/20/03; No relevant history reported.

CDC 'Split Type': E200303410

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	UNKNOWN MANUFACTURER

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion, Unintended pregnancy

Write-up: Case upgraded to serious on 7/30/04 for other seriousness criteria: Spontaneous abortion. Case reported by a health care professional. Case involves an inadvertent administration of vaccine during pregnancy. It was reported that a 36 year old female received influenza vaccine (batch not reported) at her occupational health department. The patient then discovered that she was pregnant and so contacted the reporter for advise. Further information requested. Case to remain open. Follow up 7/30/04: LMP date 9/20/03. Date of vaccination 8/10/03 but manufacturer not confirmed as not given in reporting surgery. Gestational age therefore reported as 3 weeks, however likely to be 1 week if conception assumed to be 2 weeks post LMP date. Expected delivery date was 6/29/04. However patient experienced a spontaneous abortion commencing on 4/12/03. Case will be followed up. (OMIC) Follow up 25/8/04 ASPP received from HA.

VAERS ID:	299547	Vaccination Date:	0000-00-00
Age:	28.0	Onset Date:	2007-11-10 Days later:
Gender:	Female	Submitted:	2007-12-13
State:	North Carolina	Entered:	2007-12-13

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Unknown

Diagnostic Lab Data: An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107.

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type': A0698182A

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	GLAXOSMITHKLINE BIOLOGICALS			UN	UN

Administered by: Other Purchased by: Other

Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Metrorrhagia, Muscle spasms, Ultrasound abdomen, Vaginal haemorrhage

Write-up: This case was reported by a consumer and described the occurrence of spontaneous abortion in a 28-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). On 10 November 2007, at an unspecified time after vaccination with Flu vaccine, the subject experienced cramping and light vaginal spotting. An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107. Heavy bleeding and passing of material began on 17 November 2007, concluding on 23 November 2007. The reporter referred to the events collectively as a spontaneous abortion beginning on 17 November 2007. This case was assessed as medically serious by manufacturer. The spontaneous abortion with heavy bleeding and passing of material resolved by 23 November 2007. Outcome of other reported symptoms was unspecified.

VAERS ID:	303221	Vaccination Date:	2007-11-14
Age:	28.0	Onset Date:	2008-01-08 Days later: 55
Gender:	Female	Submitted:	2008-01-23
State:	Unknown	Entered:	2008-01-22

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Unknown

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: No other medications

Preexisting Conditions:

CDC 'Split Type': MA20080051

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	NOVARTIS VACCINES AND DIAGNOSTICS			IM	UN

Administered by: Other Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: We received on 16 JAN 2008 via agency from a consumer the following information: A 28-year-old female patient, born on 22 JAN 1979, was vaccinated IM with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 12-13 weeks gestational age caller discovered via ultrasound that she had miscarried on 08 JAN 2008. Company assessment: seriousness criterion: medically significant. Causality: insufficient date (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to product information: Miscarriage is unexpected, drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. No.: NA08-00183.

VAERS ID:	303222	Vaccination Date:	2007-11-14
Age:	31.0	Onset Date:	2007-11-29 Days later: 15
Gender:	Female	Submitted:	2008-01-23
State:	Unknown	Entered:	2008-01-22

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Unknown

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: No other medications

Preexisting Conditions:

CDC 'Split Type': MA20080052

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	NOVARTIS VACCINES AND DIAGNOSTICS			IM	UN

Administered by: Other Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: We received on 16 JAN 2008 via local agency, from a consumer the following information: Consumer left voice mail stating that she received vaccine in November. She wants to report an adverse event that she had her colleague (see case no. MA2008-0051) experienced. No additional information left with message. Addendum: On 16 JAN 2008 we received the following information: A 31-year-old female patient, born on 02 APR 1976 was vaccinated i.m. with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 9 weeks gestational age caller discovered that she had miscarried on 29 NOV 2007. Company assessment: Seriousness criterion: medically significant. Causality: insufficient data (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to agency and local product information: Miscarriage is unexpected drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Local agency no.: NA08-00160

VAERS ID:	308327	Vaccination Date:	2008-01-30
Age:	31.0	Onset Date:	2008-01-30 Days later: 0
Gender:	Female	Submitted:	2008-03-26
State:	Unknown	Entered:	2008-03-27

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: Pregnancy NOS (LMP = 1/20/2008)

Diagnostic Lab Data: beta-human chorionic 02/27/08

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type': WAES0803USA01753

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	UNKNOWN MANUFACTURER			UN	UN
HEPAB	GLAXOSMITHKLINE BIOLOGICALS			UN	UN
IPV	SANOFI PASTEUR			UN	UN
MMR	MERCK & CO. INC.			UN	UN
TDAP	UNKNOWN MANUFACTURER			UN	UN
TYP	UNKNOWN MANUFACTURER			UN	UN

Administered by: Other Purchased by: Other

Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test

Write-up: Information has been received from a certified nurse practitioner concerning a 31 year old female with no pertinent medical history reported. The patient had her last menstrual period on 20-JAN-2008. On 30-JAN-2008, the patient was vaccainted with MMR II (lot # 1312U). Concomitant therapy also administered on 30-JAN-2008 included TWINRIX, influenza virus vaccine (unspecified) (manufacturer unspecified). poliovirus vaccine inactivated (Vero) (manufacturer unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and typhoid vaccine live oral (Ty21a) (manufacturer unspecified). Concomitant therapy administered on 06-FEB-2008 included Japanese encephalitis virus vaccine (manufacturer unspecified), and rabies vaccine (unspecified) (manufacturer unspecified). Subsequently, she became pregnant. Her estimated date of delivery was 26-OCT-2008. On 27-FEB-2008, the patient had a pregnancy test. On 28-FEB-2008, the patient miscarried. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the spontaneous miscarriage was determined to be an Other Important Medical Event. Additional information has been requested.

VAERS ID:	321028	Vaccination Date:	2007-10-24
Age:	35.0	Onset Date:	2007-12-01 Days later: 38
Gender:	Female	Submitted:	2008-07-28
State:	Wisconsin	Entered:	2008-08-01

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data: "None"

Previous Vaccinations:

Other Medications: NASONEX

Preexisting Conditions: The patient had one prior pregnancy that resulted in a full term, normal outcome. Past medical history was denied. From new information received on 25 July 2008, the patient experienced no illnesses during her current pregnancy. The patient had no other vaccinations within four weeks of 24 October 2007.

CDC 'Split Type': 200704125

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	SANOFI PASTEUR	U2437AA	4	IM	UN
TDAP	SANOFI PASTEUR	C2842AA	0	IM	UN

Administered by: Private Purchased by: Unknown

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Initial report received on 30 November 2007 from a health care professional. A 35-year-old female patient had received an intramuscular injection of ADACEL, lot number C2842AA, on 24 October 2007. Site of administration was not provided. The patient's last menstrual period was 20 October 2007. It was determined that the patient was pregnant. The estimated date of delivery was uncertain at the time of this report. Current medications included Nasonex. Per the reporter, the patient did not experience any adverse event. Follow-up information was received from the health professional on 16 June 2008. In addition to ADACEL, the patient also received an intramuscular injection of FLUZONE (lot number U2437AA) on 24 October 2007. The reporter did not consider the patient to be pregnant at the time of vaccination, as the date of last menstrual was 20 October 2007 and the patient received the vaccines on 24 October 2007. No additional information was provided. Follow-up information received on 25 July 2008 from the original reporter who is a health care professional. The ADACEL and FLUZONE SV 2007-2008 administered to the patient on 24 October 2007 were the first, and fifth doses the patient had received of these vaccines respectively. The patient's estimated date of delivery was on July 28, 2008; however the patient experienced a spontaneous abortion (also reported as miscarriage) approximately two months post-vaccination of one single fetus beginning in December 2007 that was confirmed on 02 January 2008. The patient was less than 20 weeks gestation. The reason for the spontaneous abortion was not known, but the patient's Beta HCG's levels had been decreasing in value that indicated a "miscarriage." The patient had not received any prior treatments for infertility, and had not experienced any illnesses during the pregnancy. No prenatal testing had been completed. At the time of this report, it was "unknown" if the patient had recovered. After review of this new information, this case was upgraded to serious.

VAERS ID:	327527	Vaccination Date:	2008-10-06
Age:	29.0	Onset Date:	2008-10-07 Days later: 1
Gender:	Female	Submitted:	2008-10-08
State:	Georga	Entered:	2008-10-08

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: none

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: not known

Preexisting Conditions: 10 weeks pregnant

CDC 'Split Type':

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	SANOFI PASTEUR	U2784KA		IM	LA

Administered by: Private Purchased by: Private

Symptoms: Abortion spontaneous, Drug exposure during pregnancy

Write-up: Miscarriage at 10 weeks gestation within 48 hours of administration

VAERS ID:	352240	Vaccination Date:	2008-11-20
Age:	15.0	Onset Date:	2008-12-17 Days later: 27
Gender:	Female	Submitted:	2009-07-22
State:	Texas	Entered:	2009-07-23

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type': 200903043

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	SANOFI PASTEUR	U2849A		UN	UN

Administered by: Unknown Purchased by: Unknown

Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan vagina abnormal, Urinary tract infection, Vaginal haemorrhage

Write-up: This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. Subject ID: 1-08-08925. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE SV 2008-2009 (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at the os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.

VAERS ID:	249031	Vaccination Date:	2005-10-25
Age:	18.0	Onset Date:	2005-10-25 Days later: 0
Gender:	Female	Submitted:	2005-12-06
State:		Entered:	2005-12-09

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications: Insulatard (insulin human, Isophane)

Preexisting Conditions: Phantom pregnancy

CDC 'Split Type': WAES0511USA03922

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	UNKNOWN MANUFACTURER	UNK			UN
PPV	MERCK & CO. INC.	1128P			UN

Administered by: Unknown Purchased by: Unknown

Symptoms: Abortion spontaneous

Write-up: Information had been received from a health professional concerning a 18 year old female with a history of a phantom pregnancy who on Oct 25 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650914/1128P), batch # NB14100). Suspect vaccination on the same day included a dose of influenza virus sAg 3v vaccine inactivated (Agrippal). Concomitant medication on Nov 2 2005 included insulin human, isophane (insulatard). On Nov 17 2005, the patient received insulin aspart (Novorapid). Following vaccination, the patient discovered she was pregnant. Her LMP was Sept 17 2005, therefore it was in approximately week four of pregnancy at the time of vaccination. The patient did not experience any adverse events following vaccination. Follow up information indicated that on Nov 24 2005, the patient experienced a spontaneous abortion. Spontaneous abortion was considered to be an other important medical event (OMIC). File to be completed. Other business partner numbers included E200504600.

VAERS ID:	249983	Vaccination Date:	2005-11-13
Age:	18.0	Onset Date:	0000-00-00 Days later:
Gender:	Female	Submitted:	2006-01-03
State:		Entered:	2006-01-03

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness:

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type': B0402636A

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	GLAXOSMITHKLINE BIOLOGICALS	U1202		SC	UN

Administered by: Other Purchased by: Other

Symptoms: Abortion spontaneous, Unintended pregnancy

Write-up: This case was reported by a physician and was a prospective case of pregnancy in a 18 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On Nov 13 2005 the subject, who was two weeks pregnant, received unspecified dose of Fluarix (subcutaneous). The last menstrual period and estimated date of delivery were not reported. At the time of reporting, the subject was 6 weeks into her pregnancy. Verbatim text: The subject received Fluarix four weeks ago. At the time she was 2 weeks pregnant but was unaware of this. On Follow up received Dec 20 2005, it was reported that the subject had a complete miscarriage 22 days later, on Dec 5 2005. the subject's last menstrual period occurred on Oct 13 2005. The subjects estimated date of delivery was July 21 2006. This case was considered serious by manufacturer (OMIC).

VAERS ID:	332613	Vaccination Date:	2007-01-31
Age:	39.0	Onset Date:	0000-00-00 Days later:
Gender:	Female	Submitted:	2008-11-17
State:		Entered:	2008-11-17

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? No

Hospitalized? No

Current Illness: Unknown

Diagnostic Lab Data: Diagnostic ultrasound, hydrops feta

Previous Vaccinations:

Other Medications:

Preexisting Conditions:

CDC 'Split Type': B0545228A

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	UNKNOWN MANUFACTURER			UN	LA

Administered by: Other Purchased by: Other

Symptoms: Abortion induced, Drug exposure during pregnancy, Hydrops foetalis, Ultrasound scan abnormal

Write-up: This case was reported by a regulatory authority (foreign Medicines Control Agency # NO-NOMAADVRE-FHI-2008-6654) and described the occurrence of induced abortion in a 39-year-old female subject who was vaccinated with Influenza vaccine unspecified, manufacturer unspecified. On 31 January 2007, the subject received unspecified dose of Influenza vaccine unspecified (parenteral, unknown injection site, unknown lot number). The vaccine was administered 13 days after her last menstrual period. At unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced hydrops fetalis diagnosed by ultrasound at 12 weeks pregnancy. The patient experienced induced abortion. The regulatory authority reported that the event was a congenital anomaly. The regulatory authority reported that the events were possibly related to vaccination with Influenza vaccine unspecified. No additional information has been requested; the case has been closed.

VAERS ID:	336502	Vaccination Date:	2008-09-24
Age:	21.0	Onset Date:	2008-11-11 Days later: 48
Gender:	Female	Submitted:	2009-01-05
State:		Entered:	2009-01-05

Life Threatening Illness? No

Died? No

Disability? No

Recovered? No

ER or Doctor Visit? Yes

Hospitalized? No

Current Illness: none

Diagnostic Lab Data: 10/10/2008, negative urine HCG; 11/12/2008, positive urine HCG

Previous Vaccinations:

Other Medications: none

Preexisting Conditions: none

CDC 'Split Type':

Vaccination	Manufacturer	Lot	Dose	Route	Site
ANTH	UNKNOWN MANUFACTURER	FAV173		SC	UN
FLU	UNKNOWN MANUFACTURER	500550P		IN

Administered by: Military Purchased by: Military

Symptoms: Abdominal pain, Abortion threatened, Amenorrhoea, Anaemia, Chlamydia identification test negative, Drug exposure during pregnancy, Genital haemorrhage, Haematocrit normal, Haemoglobin increased, Red blood cell count decreased, Ultrasound scan normal, Urine human chorionic gonadotropin positive

Write-up: Received AVA #2 on 10/28/08. Reported to clinic 2 weeks later (11/11/08) for AVA #3 and showed positive HCG test. Third AVA held. Symptoms: Amenorrhea. First OB visit was 12/11/08 and placed on Iron supplements. Iron panel and 2nd trimester US ordered. PT seen in ER in other country X 2 with vaginal spotting and abd cramping. Diagnosed w/threatened AB and anemia (12/19 and 12/27). Email from pt on 12/27/08 4:38 AM stated preg and baby were well, then in ER that evening 1903 with 5 minutes of vag spotting. No active bleeding noted but test results showed decreasing Quant hcg: 12/19 = 56,337 and 12/27 = 39,133.68 and anemic: RBC 3.56, hgb 33.5 and hct 35.8. Current GC/KOH/wet prep and chlymadia all negative. TV 12/19/08 = IUP w/active fetus.

VAERS ID:	344300	Vaccination Date:	2008-09-16
Age:	28.0	Onset Date:	2008-11-01 Days later: 46
Gender:	Female	Submitted:	2009-04-10
State:	Florida	Entered:	2009-04-16

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: None Clinical Research Trial

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions: None

CDC 'Split Type':

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	SANOFI PASTEUR	U2532AA	1	IM	LA

Administered by: Other Purchased by: Private

Symptoms: Abdominal pain, Abortion spontaneous, Vaginal haemorrhage

Write-up: Received FLUZONE vaccine on 9/16/08. November (date unknown) patient developed abdominal cramps & vaginal bleeding. OB/GYN evaluation revealed a spontaneous miscarriage.

trimester US ordered. PT seen in ER in other country X 2 with vaginal spotting and abd cramping. Diagnosed w/threatened AB and anemia (12/19 and 12/27). Email from pt on 12/27/08 4:38 AM stated preg and baby were well, then in ER that evening 1903 with 5 minutes of vag spotting. No active bleeding noted but test results showed decreasing Quant hcg: 12/19 = 56,337 and 12/27 = 39,133.68 and anemic: RBC 3.56, hgb 33.5 and hct 35.8. Current GC/KOH/wet prep and chlymadia all negative. TV 12/19/08 = IUP w/active fetus.

VAERS ID:	344300	Vaccination Date:	2008-09-16
Age:	28.0	Onset Date:	2008-11-01 Days later: 46
Gender:	Female	Submitted:	2009-04-10
State:	Florida	Entered:	2009-04-16

Life Threatening Illness? No

Died? No

Disability? No

Recovered? Yes

ER or Doctor Visit? No

Hospitalized? No

Current Illness: None Clinical Research Trial

Diagnostic Lab Data:

Previous Vaccinations:

Other Medications:

Preexisting Conditions: None

CDC 'Split Type':

Vaccination	Manufacturer	Lot	Dose	Route	Site
FLU	SANOFI PASTEUR	U2532AA	1	IM	LA

Administered by: Other Purchased by: Private

Symptoms: Abdominal pain, Abortion spontaneous, Vaginal haemorrhage

Write-up: Received FLUZONE vaccine on 9/16/08. November (date unknown) patient developed abdominal cramps & vaginal bleeding. OB/GYN evaluation revealed a spontaneous miscarriage.