Portal:Centers for Disease Control and Prevention

“ It might be difficult to contact pregnant and postpartum persons by phone, and to obtain medical records on all pregnant persons and infants. Furthermore, vaccinated pregnant persons who choose to participate in v-safe might be different from those who decline; therefore, rates of side effects and adverse events generated from v-safe might not be generalizable to the full population of pregnant vaccine recipients. Similarly, pregnant persons who choose to participate in the pregnancy registry might be those who are more likely to have concerns or have experienced adverse events. ”

“ Estimates are based on household interviews of a sample of the civilian noninstitutionalized population. This table is based on responses about all persons in the family. Data came from the Person file and the Injury and Poisoning Episode file and were weighted using the Person weight. Unknowns for the column were not included in the frequencies, but they were included in the "All persons" column. "Total" includes other races not shown separately and persons with unknown education, family income, poverty status, health insurance characteristics, and current health status. ”

“ Safety data from infants exposed during pregnancy is not available because of the short length of follow up.
On December 1, 2020, the Advisory Committee on Immunization Practices (ACIP) voted that, when a COVID-19 vaccine is authorized by the FDA and recommended by ACIP, healthcare personnel should be offered vaccination in the initial phase of the COVID-19 vaccination program (phase 1a) (3) . The healthcare workforce is predominantly female, and women account for 75% of full-time year-round healthcare personnel (4) . ”

“ Persons with more than one type of health insurance were assigned to the first appropriate category in the hierarchy. "Uninsured" includes persons who had no coverage as well as those who had only Indian Health Service coverage or had only a private plan that paid for one type of service such as accidents or dental care.
10MSA is metropolitan statistical area. Large MSAs have a population of 1 million or more; small MSAs have a population of less than 1 million. "Not in MSA" consists of persons not living in a metropolitan statistical area. ”

“ In some cases, people have ingested ivermectin-containing products purchased without a prescription, including topical formulations and veterinary products. Veterinary formulations intended for use in large animals such as horses, sheep, and cattle (e.g., “sheep drench,” injection formulations, and “pour-on” products for cattle) can be highly concentrated and result in overdoses when used by humans. Animal products may also contain inactive ingredients that have not been evaluated for use in humans. ”

“ The call center staff will be trained to conduct phone interviews with the pregnant participants, including: confirmation of the identity of the v-safe participant and whether the person was pregnant at the time of vaccination or within 30 days after vaccination, informing the pregnant person about the pregnancy registry, including risks, benefits, and alternatives, requesting consent for participation in the registry and for release of medical records from healthcare providers, and asking specific survey questions relevant to pregnancy. ”

“ Because the v-safe active surveillance program will also collect information on health impact events among participants that will result in a follow-up call and submission of a VAERS report, there is the potential for duplicative efforts among pregnant persons within v-safe and between the v-safe and VAERS pregnancy surveillance systems. V-safe and VAERS ISO staff will work closely together in order to minimize these duplicative efforts and to minimize the potential burden on pregnant persons and their healthcare providers. ”

“ This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare. ”

“ Consultation with a health professional includes in-person or by telephone. Injury episode refers to a traumatic event that resulted in one or more injuries due to an external cause such as a fall down a flight of stairs or a motor vehicle traffic accident. ”

“ If the person does not respond to phone calls or text messages despite two separate attempts, performed 3 days apart at a different time of day, the pregnant person will be considered as unreachable and will no longer be included in the phone survey component of the registry. Any pregnant participant in the call center and registry may opt of out of the phone surveys or medical record release at any time. Opting out of the pregnancy phone surveys and/or medical record release does not preclude continued participation in v-safe. ”

“ Persons will be contacted once each trimester during pregnancy and at two time points in the postpartum period, once after delivery and once after the infant is 3 months old. Information collected from the v-safe pregnancy call center survey and medical records will include demographics, pre-pregnancy and gestational conditions, pregnancy history, COVID-19 vaccine information, pregnancy complications, pregnancy outcome and infant outcomes. ”

“ References
1 Lind JN, Lovegrove MC, Geller AI, Uyeki TM, Datta SD, Budnitz DS. Increase in Outpatient Ivermectin Dispensing in the US During the COVID-19 Pandemic: A Cross-Sectional Analysis. J Gen Intern Med. 2021 Jun 18:1–3. doi: 10.1007/s11606-021-06948-6.
The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues ”

“ Only two combinations of multiple race groups are shown due to small sample sizes for other combinations.
4Refers to persons who are of Hispanic or Latino origin and may be of any race or combination of races. "Not Hispanic or Latino" refers to persons who are not of Hispanic or Latino origin, regardless of race. ”

“ Females also dominate the largest healthcare occupations, comprising 88% of registered nurses and 86% of healthcare support workers, which includes nursing, psychiatric, and personal and home health aides. ”

“ At this postpartum contact, the call center will also request consent from the person for release of her infant’s medical records. A brief, final call center follow up will occur when the infant is 3 months old to inquire about any adverse events, including the diagnosis of any birth defects. ”