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From the 1/14/2022 release of VAERS data:

Found 30 cases where Vaccine is 6VAX-F or ADEN or ADEN_4_7 or ANTH or BCG or CEE or CHOL or DF or DPIPV or DPP or DT or DTAP or DTAPH or DTAPHEPBIP or DTAPIPV or DTAPIPVHIB or DTIPV or DTOX or DTP or DTPHEP or DTPHIB or DTPIHI or DTPIPV or DTPPHIB or DTPPVHBHPB or EBZR or 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) or H5N1 or HBHEPB or HBPV or HEP or HEPA or HEPAB or HEPATYP or HIBV or HPV2 or HPV4 or HPV9 or HPVX or IPV or JEV or JEV1 or JEVX or LYME or MEA or MEN or MENB or MENHIB or MER or MM or MMR or MMRV or MNC or MNQ or MNQHIB or MU or MUR or OPV or PER or PLAGUE or PNC or PNC10 or PNC13 or PPV or RAB or RUB or RV or RV1 or RV5 or RVX or SMALL or SSEV or TBE or TD or TDAP or TDAPIPV or TTOX or TYP or UNK or VARCEL or VARZOS or YF and Symptom is Abortion of ectopic pregnancy or Ectopic pregnancy or Ectopic pregnancy termination or Ectopic pregnancy with contraceptive device or Ruptured ectopic pregnancy

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Case Details

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VAERS ID: 384694 (history)  
Form: Version 1.0  
Age: 33.0  
Sex: Female  
Location: Illinois  
Vaccinated:2009-06-03
Onset:0000-00-00
Submitted: 2010-04-07
Entered: 2010-04-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3029A / UNK AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy, Laparotomy, Pregnancy test urine positive, Ruptured ectopic pregnancy
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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; Inhaler
Current Illness:
Preexisting Conditions: The patient had a history of asthma and had been taking Singulair and using an unspecified inhaler at the time of vaccination. The patient had no prior pregnancies.
Allergies:
Diagnostic Lab Data: 08/Jun/2009: Urine pregnancy test - positive; blood serum - positive.
CDC Split Type: 200902480

Write-up: Initial report was received 09 June 2009 from a health care professional. A 33-year-old pregnant female patient with a history of asthma and no prior pregnancies, had received a 0.5 mL intramuscular injection of ADACEL, lot number C3029AA on 03 June 2009. She had also been taking SINGULAIR 10mg and an unspecified inhaler concomitantly for her pre-existing condition of asthma. The patient''s last menstrual period occurred on 12 May 2009 and she had been approximately three weeks pregnant at the time of vaccination. It was further noted that the patient had received ADACEL because she was a health care worker. On 8 June 2009, the patient had urine and blood serum pregnancy tests performed; results for both tests were provided on 09 June 2009 which confirmed a positive pregnancy. The patient''s expected date of confinement was unknown at the time of the report. According to the reporter, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 05 April 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient had a tubal ectopic pregnancy on an unspecified date and was treated with methotrexate. Subsequently, an emergency laparotomy was performed for a ruptured ectopic on an unspecified date. No further information was provided. Documents held by sender: None.


VAERS ID: 387284 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Ohio  
Vaccinated:2010-03-04
Onset:2010-04-20
   Days after vaccination:47
Submitted: 2010-05-10
   Days after onset:20
Entered: 2010-05-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3107 / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Drug exposure during pregnancy, Ruptured ectopic pregnancy
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No known allergies. No medical history.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201001842

Write-up: Initial case was received on 29 March 2010 from a healthcare professional. A 24 year old female received an intramuscular injection of ADACEL (Sanofi Pasteur Inc. lot number UF499BA, Sanofi Pasteur Ltd. Lot number C3107) on 04 March 2010. At the time of the vaccination the patient was pregnant. Her last menstrual period (IMP) and estimated date of confinement (EDC) were unknown. She had no previous pregnancies, no known allergies, no concomitant medications and no medical history. At the time of this report she had no adverse event. Follow-up information was received on 07 May 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient experienced a "ruptured tubal pregnancy" on 20 April 2010. No further information was provided. The patient was reported to recover on an unspecified date. Documents held by sender: None.


VAERS ID: 415252 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Missouri  
Vaccinated:2010-10-19
Onset:2010-11-22
   Days after vaccination:34
Submitted: 2011-01-21
   Days after onset:60
Entered: 2011-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy, Pregnancy test positive, Salpingectomy, Smear cervix abnormal, Ultrasound scan
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Family history of cancer
Allergies:
Diagnostic Lab Data: beta-human chorionic, positive; Pap test, abnormal-pre cancerous cells
CDC Split Type: WAES1101USA01034

Write-up: Information has been received from a 26 year old female registered nurse, for GARDASIL, a Pregnancy Registry product, concerning herself with a family history of cervical cancer and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot number not provided) in 2009, and the final dose (lot number not provided) on 19-OCT-2010. Concomitant therapy included methotrexate. On 22-NOV-2010 the patient later discovered she was 1 week pregnant with an ectopic pregnancy. She required surgery to remove her right fallopian tube. The patient sought medical attention by calling physician. Diagnostic laboratory test sonogram performed, no results provided. Pregnancy test was positive (unspecified for which time of pregnancy). On an unspecified date, the patient was hospitalized. At the time of this report, the patient''s outcome was unknown. On 10-DEC-2010 the patient discovered she was pregnant again with another ectopic pregnancy, this time on the left side and had been on methotrexate, (WAES #1101USA01251). Follow-up information has been received from a licensed practical nurse reporting that GARDASIL were not administered by their office; vaccine dates and lot #s not known. No information available regarding any concurrent conditions or personal medical history. No LMP data available. The patient was seen from January 2009 to March 2010 for abnormal Papanicolaou (PAP) smears (pre cancerous cells). On 22-NOV-2010, the patient admitted to hospital; and emergency surgery performed. The patient was last seen on 03-JAN-2011. Methotrexate started with doses given on 07-JAN-2011 and 14-JAN-2011. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot numbers. Follow-up information has been received from the patient reporting that she got her GARDASIL vaccines through a planned parenthood center. The patient''s last normal period was on 23-SEP-2010. The first dose of methotrexate was "not successful in dissolving the ectopic pregnancy" on the left side. She was to see doctor for more blood work on 21-JAN-2011 to see if the second dose of methotrexate was successful. The patient''s status was not recovered. Additional information has been requested.


VAERS ID: 417341 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2010-11-29
Onset:2011-01-27
   Days after vaccination:59
Submitted: 2011-02-21
   Days after onset:25
Entered: 2011-02-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0565Z / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure before pregnancy, Ectopic pregnancy, Muscle spasms, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), 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? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 12/15/2010)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound, 01/27/11, right ectopic pregnancy
CDC Split Type: WAES1101USA03536

Write-up: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient who on 14-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot # 666931/0337Z, dose and route not reported), and on 29-NOV-2010 was vaccinated with a second 0.5ml dose of GARDASIL (Lot # 666162/0565Z, route not reported). It was reported that the patient found out she was pregnant after receiving her second dose of GARDASIL. The patient''s last menstrual period (LMP) was on 15-DEC-2010 and the estimated date of delivery (EDD) is on 21-SEP-2011. No adverse side effects were reported. Follow up information has been received from the registered nurse concerning a female patient with no concurrent medical conditions. It was reported that on 27-JAN-2011, an ultrasound was performed because of cramping, the result showed a right ectopic pregnancy. It was reported that on the same day, the patient experienced spontaneous abortion at 6 weeks from LMP. The products of conception were examined (results not reported). Upon internal review, ectopic pregnancy and spontaneous abortion were considered to be other important medical events. Additional information has been requested.


VAERS ID: 456422 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2011-05-16
Onset:0000-00-00
Submitted: 2012-05-29
Entered: 2012-05-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0768Z / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ectopic pregnancy, Maternal exposure during pregnancy
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA00005

Write-up: Information has been received from a registered nurse for GARDASIL a pregnancy Registry product, concerning a 17 year old female patient who on 16-MAY-2011, was vaccinated with the first dose of GARDASIL (route and lot number not reported) while pregnant. The patient''s last menstrual period was on 11-APR-2011 and estimated delivery date would be 16-JAN-2012. No symptoms reported. The patient sought medical


VAERS ID: 486223 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2012-06-01
Submitted: 2013-03-05
   Days after onset:277
Entered: 2013-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ectopic pregnancy, Ectopic pregnancy termination, Fallopian tube operation, Maternal exposure before pregnancy, Tubal rupture
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? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1303USA000734

Write-up: This spontaneous prospective pregnancy report as received from a consumer refers to her 25 years old daughter. On an unknown date the patient was vaccinated with dose 3 of GARDASIL (Lot# and route not reported). The consumer stated that the patient had suffered (2) ectopic pregnancies after receiving the GARDASIL dosages (3). The first ectopic pregnancy occurred approximately eight months ago (approximately in June 2012) where she stayed at hospital for two days and had had one of her fallopian tubes removed due to a rupture. The LMP and EDD were not known. The pregnancy outcomes were ectopic termination. At the time of reporting, the patient''s outcome was unknown. Upon internal review, the second episode of ectopic pregnancy was considered to be an event of medically significant. Additional information has been requested. The patient was hospitalized.


VAERS ID: 616909 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Texas  
Vaccinated:2008-07-05
Onset:2008-07-05
   Days after vaccination:0
Submitted: 2015-12-31
   Days after onset:2735
Entered: 2015-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Abortion spontaneous, Anxiety, Arthralgia, Depression, Ectopic pregnancy, Fatigue, High risk pregnancy, Incomplete course of vaccination, Infertility female, Laboratory test, Loss of consciousness, Malaise, Myalgia, Palpitations, Presyncope, Seizure, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: I was not taking any prescription or non-prescription medication at the time.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Numerous laboratory tests and ultrasounds, to determine causes of illnesses and fertility problems.
CDC Split Type:

Write-up: Multiple seizures, blackouts, near fainting episodes, frequent heart palpitations, multiple miscarriages, ectopic pregnancy and high risk pregnancies, chronic fatigue, muscle and joint pain, susceptible to illnesses (possible immune system problems), depression and anxiety resulting from illness and pregnancy loss. All of these presented after two rounds of the vaccine. I was afraid of taking the third dose because of the adverse reactions. My health has been poor since, and my fertility has been permanently affected. Many tests were done to determine the cause of my miscarriages, with no findings as to the cause. But I was very healthy and fertile until injection of the Gardasil Vaccine. I strongly suspect it is to blame.


VAERS ID: 730867 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-18
Entered: 2017-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ectopic pregnancy, Exposure during pregnancy
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017GSK192951

Write-up: This retrospective pregnancy case was reported in a literature article and described the occurrence of ectopic pregnancy in a female subject who received Hepatitis B vaccine. The subject''s last menstrual period was unknown and estimated date of delivery was unknown. The subject received the Hepatitis B vaccine during pregnancy (trimester unknown). On an unknown date, less than a year after receiving Hepatitis B vaccine, the subject developed ectopic pregnancy. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of ectopic pregnancy was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy resulted in an ectopic pregnancy. The investigator considered that there was a reasonable possibility that the ectopic pregnancy may have been caused by Hepatitis B vaccine. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of ectopic pregnancy in a pregnant female aged between 14 and 41 years who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) during pregnancy (trimester unknown). The patient was part of the study, aimed to characterize the adverse events (AEs) after hepatitis B vaccination (approved for use in women of reproductive age) of pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. The authors searched the VAERS for reports of pregnant women vaccinated in a specific country with hepatitis B vaccine from 01 January 1990 through to 30 June 2016. The authors included reports of women vaccinated with hepatitis B vaccine during pregnancy where the primary AE being reported (or the focus of the report) was in the live born infant. The authors excluded the reports where upon review they determined the subject was not pregnant or that hepatitis B vaccine was administered prior to the last menstrual period. All reports and available medical records were reviewed by physicians from the Food and Drug Administration and the Centers for Disease Control and Prevention to ascertain pregnancy status at time of vaccination, calculated the gestational age, and characterized the AEs. (In this study, VAERS received 192 reports involving hepatitis B vaccination of pregnant women. No maternal deaths were reported. Gestational age at the time of vaccination and at the time of the AE were calculated based on: clinical determination by the health care provider as stated in the report, earliest ultrasound assessment (if the former was not available), or last menstrual period, estimated delivery date, or estimated date of conception (if the first two options were unavailable) in the VAERS report and/or medical records. The authors used the following definition for trimesters: first (0-13 weeks), second (14-27 weeks), and third (greater than and equal to 8 weeks). The patient''s last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date from 01 January 1990 through to 30 June 2016, the patient received unspecified HBV vaccine (administration site and route unspecified; dosages unknown; batch number not provided) during pregnancy (trimester unknown) at an unknown gestation week. The age of vaccination was not provided. On an unspecified date from 01 January 1990 through to 30 June 2016, an unknown period after vaccination, the patient had ectopic pregnancy. Treatment was unknown. The authors stated "Strengths of VAERS include its broad national scope and ability to rapidly detect rare AEs and safety signals. However, as a spontaneous reporting system, it has important limitations, including reporting biases (over- or underreporting) and inconsistent quality and completeness of reports. Pregnant women who experience adverse outcomes in their fetuses or infants might be particularly susceptible to recall bias that influences decisions to report. Events that occur close to the time of vaccination and medically serious events are more likely to be reported. In addition, VAERS does not collect data on the number of individuals vaccinated: therefore, it is not possible to calculate the incidence or prevalence of AEs. Due to these limitations, we generally cannot determine from VAERS data alone whether a vaccine caused an AE". The authors concluded "Our analysis of VAERS reports involving hepatitis B vaccination during pregnancy did not identify any new or unexpected safety concerns. Additional data on the safety of maternal hepatitis B vaccination will be provided by an ongoing study of maternal and fetal adverse events after hepatitis B vaccine in the Vaccine Safety Datalink. Using data in VAERS, our safety review did not find any unusual or unexpected AE reporting patterns associated with hepatitis B vaccination in pregnancy". This is 1 of the 50 valid cases reported in the same literature article.


VAERS ID: 864677 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Missouri  
Vaccinated:2019-10-08
Onset:2019-11-05
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2020-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 425T2 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ectopic pregnancy, Exposure during pregnancy, Human chorionic gonadotropin increased, Mass, Muscle spasms, Pain, Surgery, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Dystonia (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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: No known
Diagnostic Lab Data: Blood test (11/06/19), ultrasound (11/07/19), surgery (11/07/19)
CDC Split Type:

Write-up: I obviously didn''t know I was just a few days pregnant at the time of my work-required flu shot. (Date of last period was Sept. 15, conception somewhere the first week of October.) In late October I found out I was pregnant. Just days after finding out, I started spotting and cramping. I spotted a little with my first child so I wasn?t immediately alarmed. I just kept my 8-week appointment as scheduled. The bleeding increased so I called Dr. who ordered a blood test that day and ultrasound the next morning. Blood test showed an HCG level of around 4,000 and we were planning a follow-up blood draw at the end the next day. I went to the ultrasound the next morning and within 20 minutes my doctor called to have me come in right away. The ultrasound showed a small mass in my tube. The doctor was willing to let me wait for the follow-up blood test, but said if I had any pain, to go to the emergency department because if the tube ruptured, I was at high risk of bleeding to death. That night the pain became severe so my husband and I headed to the ED. Within an hour I was in surgery to remove the ectopic pregnancy. My first pregnancy had no complications whatsoever and I had no risk factors for having an ectopic pregnancy. Even in line to get the flu shot I told I co-worker I was nervous to get the shot because I had seen the study where you are more likely to miscarry if you get consecutive flu shots, which I?m required to do for work. She knew we were trying for our second child. I know it?s hard to prove that the shot caused the loss, but the dates work out and I have no other reason to have had complications.


VAERS ID: 877623 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
Vaccinated:2019-11-18
Onset:2019-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 261218 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Complication of pregnancy, Exposure during pregnancy, Gene mutation identification test negative, Laboratory test normal, Laparotomy, Ruptured ectopic pregnancy
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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ectopic pregnancy termination
Allergies:
Diagnostic Lab Data: Test Date: 20191118; Test Name: Cystic fibrosis mutation analysis; Result Unstructured Data: No major congenital malformations noted.; Test Date: 20191118; Test Name: Spinal muscular atrophy; Result Unstructured Data: No major congenital malformations noted.
CDC Split Type: USSEQIRUS202003950

Write-up: Ruptured ectopic pregnancy; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Jul-2020 with an additional document received on 28-Jul-2020 (being processed together), concerning a 24-year-old, pregnant, female subject of body weight 168 lbs, height 71 inches and body mass index (BMI) 23.4, enrolled in a prospective observational safety study. The subject''s relevant medical history was not reported. The subject''s concomitant medication 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 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 on 30-Sep-2019. The subject''s estimated date of delivery (EDD) was reported as 07-Jul-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. On an unspecified date in 2019, the pregnancy status was collected, and ectopic pregnancy was noted as pregnancy complication. On 18-Nov-2019, at approximately seven weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as ''Vaccine exposure during pregnancy'') for an influenza immunization. On the same day, the subject underwent spinal muscular atrophy and cystic fibrosis mutation analysis and no MCMs were noted. On 19-Nov-2019, one day after vaccination, the subject experienced ruptured of ectopic pregnancy. On the same day, the subject underwent laparotomy with removal of ectopic pregnancy. At the time of this report, the outcome for the event of �ruptured ectopic pregnancy'' was not reported. The event of �ruptured ectopic pregnancy'' was considered as serious due to criterion of medical significance, per company. The reporter did not provide causality assessment. Company comment: A pregnant subject was administered Flucelvax QIV at approximately seven weeks of gestation. On an unspecified date in 2019, the pregnancy status was collected, and ectopic pregnancy was noted as pregnancy complication. One day after vaccination, the subject experienced ruptured of ectopic pregnancy. The subject''s relevant medical history was not reported. More information of diagnostic findings and medical history is needed. However, rupture is expected outcome in untreated ectopic pregnancy. Causal role of the suspect vaccine is assessed as not related due to biological implausibility. Vaccine exposure during pregnancy assessed as not related per company''s conventions.; Sender''s Comments: A pregnant subject was administered Flucelvax QIV at approximately seven weeks of gestation. On an unspecified date in 2019, the pregnancy status was collected, and ectopic pregnancy was noted as pregnancy complication. One day after vaccination, the subject experienced ruptured of ectopic pregnancy. The subject''s relevant medical history was not reported. More information of diagnostic findings and medical history is needed. However, rupture is expected outcome in untreated ectopic pregnancy. Causal role of the suspect vaccine is assessed as not related due to biological implausibility. Vaccine exposure during pregnancy assessed as not related per company''s conventions.


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