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Drug exposure during pregnancy from INFLUENZA (SEASONAL) (FLUZONE) 2010

Vaccine Manufacturer:SANOFI PASTEUR
Vaccine Code:FLU
Vaccine Type:INFLUENZA VIRUS VACCINE
Vaccine Name:INFLUENZA (SEASONAL) (FLUZONE)
Year Reported:2010
Symptom Reported:Drug exposure during pregnancy

INFLUENZA (SEASONAL) (FLUZONE) Side Effects Report #375913
INFLUENZA (SEASONAL) (FLUZONE) vaccine side effect was reported on 12/23/2009. Male patient was vaccinated with INFLUENZA (SEASONAL) (FLUZONE). Patient symptoms: Drug exposure during pregnancy, "Initial information was received from a health care professional on 15 December 2009. A male infant received a transplacental dose of FLUZONE SV (lot not reported) on 30 October 2008 via his 32-year-old mother. His mother's last menstrual period was 29 June 2008, and her medical history included chlamydia (2006), tobacco use (stopped in May 2008), BMI less than 19 and anemia and postpartum hemorrhage requiring blood transfusion in a previous pregnancy. She had a history of one previous full-term birth, and one elective abortion. On 03 November 2008, four days post-vaccination, the patient's mother experienced optic neuritis, for which she was hospitalized and treated with intravenous steroids. On 31 January 2009, at 30.5 weeks gestation, the patient's mother experienced premature rupture of membranes; she was hospitalized and treated with VISTARIL, terbutaline, and betamethasone. At 31 weeks, 1 day gestation the patient's mother developed a fever of 100.3 with mild uterine tenderness. Findings were suspicious for chorioamnionitis, and so the recommendation was made to proceed with a primary C-section. On 03 February 2009 the patient was delivered via uncomplicated cesarean section, with Apgar scores of 8/10 at one minute and 9/10 at 5 minutes. He weighed 3 pounds, 4 ounces, and had no congenital anomalies. The patient's mother was discharged from the hospital on 07 February 2009, and the patient remained in the NICU at that time. Outcome was not reported. This case pertains to the infant; information for the mother can be found in case number 2009-04794. Documents held by sender: Office and hospital records." "The patient's mother had a history of chlamydia (2006), tobacco use (stopped in May 2008), BMI less than 19. Obstetric history included 2 previous pregnancies with 1 live birth (1995) and 1 elective abortion (2000). During a previous pregnancy the patient's mother had developed anemia and postpartum hemorrhage requiring blood transfusion." . During the same period patient was treated with PRENATAL VITAMINS. Patient recovered.

INFLUENZA (SEASONAL) (FLUZONE) Side Effects Report #377731
INFLUENZA (SEASONAL) (FLUZONE) vaccine side effect was reported on 01/21/2010. Female patient, 18.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUZONE). Patient symptoms: Drug exposure during pregnancy, "Itching and rash arms, chest, back 20 mins after seasonal flu vaccination. Treated w/BENADRYL 25 mg PO." NonePt is pregnant - 3rd trimesterPt is pregnant in 3rd trimester . Patient recovered.

INFLUENZA (SEASONAL) (FLUZONE) Side Effects Report #380385
INFLUENZA (SEASONAL) (FLUZONE) vaccine side effect was reported on 02/04/2010. Female patient, 16.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUZONE). Patient symptoms: Drug exposure during pregnancy, Patient pregnant. PregnantUrine HCG + . Patient recovered.

INFLUENZA (SEASONAL) (FLUZONE) Side Effects Report #381020
INFLUENZA (SEASONAL) (FLUZONE) vaccine side effect was reported on 02/22/2010. Female patient, 32.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUZONE). Patient symptoms: Drug exposure during pregnancy, "Went to monthly ob/gyn check-up on 12/17 and no heartbeat was detected...Was 16 weeks pregnant. On 12/18, had D&C procedure done. Went to ER on 1/30/10 and had a D&C procedure done as body still was bleeding and was passing clots...still remaining tissue in uterus." None12 weeks pregnant"As of today 2/22/10, still having high levels of hcg in blood and bleeding. On going lab work and ultrasounds since 12/18/09!" . During the same period patient was treated with Prenate Vitamins. Patient was hospitalized Patient recovered.

INFLUENZA (SEASONAL) (FLUZONE) Side Effects Report #384390
INFLUENZA (SEASONAL) (FLUZONE) vaccine side effect was reported on 03/05/2010. Female patient, 38.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUZONE). Patient symptoms: Drug exposure during pregnancy, "Information has been received from a nurse practitioner concerning a 38 year old pregnant female with allergy to DEMEROL and a history of gastric bypass in 1996 who on 31-OCT-2008 at 08:40 was vaccinated IM into deltoid with the second dose of RECOMBIVAX HB (lot# 660461/0401X). There was no concomitant medication. Dose 1 was administered at a different facility and the date that dose 1 was administered was unspecified. Dose 2 was given as 2 combined pediatric doses of RECOMBIVAX HB. As of 18-DEC-2008, the patient was 7 and 1/2 months pregnant (estimated LMP was 18-MAY-2008 and EDD was 22-FEB-2009). No symptoms reported. The patient sought medical attention in the office. Follow-up information received from a licensed practical nurse indicated that the patient was a female with sun damaged skin who received her first dose of (previously reported by the nurse practitioner as second dose) of RECOMIVAX HB (lot# 66041/0401X) IM into the left deltoid on 31-OCT-2008. Concomitant vaccine included FLUZONE, (lot # UT2882FA) IM into the right deltoid as 2 combined pediatric doses during the same visit. The patient did not seek medical attention (previously reported by the nurse practitioner as sought medical attention). The nurse practitioner's office had not seen patient since injection given on 31-OCT-2008 and could not provide any information regarding the outcome of the pregnancy. Follow-up information has been received from a healthcare professional who reported that the patient had 2 previous pregnancies and 1 live birth. No birth defect but a miscarriage or stillbirth occurred 5-6 weeks from last menstrual period during previous pregnancies. It was reported that the date of LMP was 01-APR-2008. On 31-OCT-2008, 30 weeks after the LMP, the patient went to her primary care physician (PCP) for a flu shot and was given the RECOMIVAX HB instead in error (patient was pregnant at that time). During pregnancy, the patient took FLINSTONES MULTIVITAMINS and 2 doses of injection RHOGAM. No prescription drug was taken. The patie" Pregnancy NOS (LMP = 4/1/2008); Drug hypersensitivity; Skin injuryGastric bypassUnknown . Patient recovered.


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