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This is VAERS ID 287889

History of Changes from the VAERS Wayback Machine

First Appeared on 12/31/2007

VAERS ID: 287889
VAERS Form:
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other      Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidi
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type':

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism a"nd viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlaf


Changed on 12/8/2009

VAERS ID: 287889 Before After
VAERS Form:
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other      Purchased by: Unknown Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidi
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': (blank) WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism a"nd and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlaf venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 5/14/2017

VAERS ID: 287889 Before After
VAERS Form:
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidi Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 9/14/2017

VAERS ID: 287889 Before After
VAERS Form:(blank) 1
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 1 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 2/14/2018

VAERS ID: 287889 Before After
VAERS Form:1
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 6/14/2018

VAERS ID: 287889 Before After
VAERS Form:1
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 8/14/2018

VAERS ID: 287889 Before After
VAERS Form:1
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 9/14/2018

VAERS ID: 287889 Before After
VAERS Form:1
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


Changed on 10/14/2018

VAERS ID: 287889 Before After
VAERS Form:1
Age:24.0
Sex:Female
Location:Unknown
Vaccinated:2007-03-09
Onset:2007-04-09
Submitted:2007-08-10
Entered:2007-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other      Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Blood human chorionic gonadotropin positive, Uterine dilation and curettage

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC 'Split Type': WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.

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