Initial report received on 17 November 2011 via search of the literature. Published summary of the article was obtained on 23 November 2011. From the literature article received, this case involves an infant born to a 23 year-old female who had been vaccinated at 19 weeks gestation (second trimester) with H1N1 (Trade name, manufacturer name and lot number not reported) on a unspecified date, but sometime between 01 October 2009 through 28 February 2010. The patient's mother may or may not have also received a dose of seasonal influenza vaccine the same day. During a prenatal ultrasound examination at 22 weeks of gestation it was first detected that the patient had congenital anomaly of cleft lip. Outcome was not reported. No other information was provided for the infant. No adverse events were reported for the mother and her information has been captured in case number 2011-11324. The other patients mentioned below from the article, who had been vaccinated during pregnancy with the Pandemic Influenza vaccine, and who had varying reports of adverse events have been captured in case number 2011-1326. The following is verbatim from the published summary of the article: "BACKGROUND AND OBJECTIVE: In April 2009, H1N1 2009 influenza A (H1N1) virus infection (2009 H1N1) was identified. The Advisory Committee on Immunization Practices recommended that pregnant women (in any trimester) be included as an initial target group for 2009 H1N1 vaccination. Monitoring adverse events (AEs) following 2009 H1N1 vaccine administration in pregnant women was a priority for the Centers for Disease Control and Prevention (CDC) in collaboration with the Food and Drug Administration (FDA). Rapid surveillance was conducted for adverse events reported to Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received H1N1 vaccines to assess for potential vaccine safety problems. MATERIALS AND METHODS: The VAERS established in 1990, is jointly administered by CDC and FDA. VAERS generally cannot assess whether a vaccination caused an AE but can identify possible vaccine safety problems for further investigation. Reports are classified as serious, based on the Code of Federal Regulations, if they result in death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly. As part of the federal response to monitor the safety of 2009 H1N1 vaccine, VAERS was enhanced in several ways. VAERS reports received through March 1, 2010, on pregnant women vaccinated with 2009 H1N1 from Oct. 1, 2009, through Feb. 28, 2010 were analyzed. Included were reports of AEs in neonates if the report indicated that their mothers had received the 2009 H1N1 vaccine during pregnancy. All VAERS reports for pregnant cases were manually reviewed. Medical records were requested for all reports that suggested the vaccinee was pregnant at the time of receipt of the 2009 H1N1 vaccine or that concerned infants born to mothers who had received 2009 H1N1 during pregnancy. Reporting rates of AEs in pregnant women were calculated by dividing the number of AEs by the estimated number of 2009 H1N1 doses administered to pregnant women during the time period were covered in this review. RESULTS: From Oct. 1, 2009, through Feb. 28, 2010, VAERS received 294 reports; 288 followed inactivated and 6 followed live vaccines. Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and an infant born with a congenital anomaly. The 2009 H1N1 vaccine was reported as administered mostly during the first (133; 53.9%) or second trimester of pregnancy (67, 27.1%). The most frequent pregnancy-specific AE reported following 2009 H1N1 vaccine administration was spontaneous abortion (SAB) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports). Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported. Risk factors for SAB were identified in 47 of the 95 verified reports (49.5%). The most common risk factor was maternal age 35 years or older in 25 (26.3%) reports. Of 18 stillbirths with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth or a pathological finding that may have contributed to the fetal demise. The overall reporting rate of AEs to VAERS in pregnant women after inactivated 2009 H1N1 was 118.2 reports per 1 million pregnant women vaccinated. The reporting rates for SABs and stillbirths were 49.2 and 7.8 reports, respectively, per 1 million pregnant women vaccinated. Table of adverse events (presented in the article) were based on main diagnosis following medical chart review. The events included: Pregnancy-specific outcomes of SAB (121; 41.2%); Stillbirth (19; 6.5%); preterm delivery (7; 2.4%); threatened abortion (4; 1.4%); preterm labor (3; 1.0%); maternal death (2; 0.7%); preeclampsia (2; 0.7%); intrauterine growth restriction (2; 0.7%); fetal hydronephrosis (1; 0.3%); fetal tachycardia (1; 0.3%); cleft lip (1; 0.3%); neonatal intraparenchymal hemorrhage (1; 0.3%); and intrauterine fetal death (1;0.3%). Non-pregnancy-specific outcomes included allergic reactions other than anaphylaxis (36; 12.2%); general or constitutional symptoms (28; 9.5%); local reactions (10; 3.4%); paresthesias (8; 2.7%); Bell's palsy (5; 1.7%); syncope (5; 1.7%); dizziness (5; 1.7%); hypoesthesia (3; 1.0%); headache (3; 1.0%); Anaphylaxis (1; 0.3%); and other (25; 8.5%). COMMENT: From October 2009 through February 2010, approximately 3% of reports to VAERS after 2009 H1N1 vaccine were of pregnant women who experienced at least 1 AE after vaccination. Among these 294 reports of AEs, no unusual patterns of adverse maternal or fetal outcomes were observed. The most common pregnancy-specific AE reported was SAB. In the review of medical records, more than a third of women who experienced a SAB had at least 1 risk factor, the most common being advanced maternal age. The second most common pregnancy specific AE was stillbirth. Careful review of medical records revealed that 72% of these women had at least 1 risk factor or a pathologic finding in the fetus or placenta, suggesting factors other than vaccination that may have contributed to the fetal demise. SAB is a relatively frequent event in pregnancy, with a rate as high as 22.4% in women aged 34 years or older and 10.4% in women younger than 25 years. Stillbirths occur at a background rate of 0.4% of all pregnancies or 6.22 per 1000 live births and fetal deaths. There is under reporting to VAERS in general and the proportion of AEs following immunization among pregnant women that are reported to VAERS is unknown. Nonetheless, the reporting rates to VAERS for SABs and stillbirths after H1N1 vaccine was several orders of magnitude lower than the expected rates of fetal losses and the general population of pregnant women during a time of heightened awareness about vaccine safety. The VAERS data provided no indication that the occurrence of SAB and stillbirths following influenza vaccination was higher than in the general population. Other AEs observed in pregnant women were mostly non-serious and were similar to those reported in the preliminary review of the safety of 2009 H1N1 vaccines among the general population. VAERS is a passive surveillance system that may be prone to biased reporting (over- or underreporting) and inconsistency in the quality and completeness of reports. VAERS generally cannot determine whether a vaccine caused an AE. Stimulated reporting can occur following publicity around a potential AE. One important limitation of VAERS is that it collects date only on vaccinated individuals who have experienced an AE. The total vaccinated population in not known with certainty and therefore incidence rates of AE cannot be directly calculated. Review of VAERS reports following 2009 H1N1 vaccine had provided a comprehensive and rapid assessment of the safety of inactivated 2009 H1N1 vaccine among pregnant women during a period when influenza vaccine coverage during pregnancy was at its highest levels. CLINICAL IMPLICATIONS: 1) No unusual patterns of adverse maternal or fetal outcomes were observed in pregnant women who received influenza A 2009 monovalent vaccines and who reported to the Vaccine Adverse Event Reporting System (VAERS). 2) The reporting of spontaneous abortion and stillbirth were markedly lower than the expected number of fetal losses in the general population of pregnant women, probably because of underreporting in VAERS. 3) VAERS generally cannot assess whether a vaccination caused an adverse event but can identify possible vaccine safety problems for further investigation. 4) Findings in passive surveillance systems such as VAERS need to be interpreted with caution, given their inherent limitations, such as over- or underreporting, biased reporting, and inconsistency in quality and completeness of reports." Documents held by sender: None.