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In the US the emergency use authorization fact sheets for healthcare providers for the 3 authorized Covid-19 vaccines only require the vaccine providers to report “vaccine administration errors whether or not associated with an
adverse event,
• serious adverse events* (irrespective of attribution to vaccination),
• cases of Multisystem Inflammatory Syndrome (MIS) in adults and
children, and
• cases of COVID-19 that result in hospitalization or death. *Serious adverse events are defined as:
• Death;
• A life-threatening adverse event;
• Inpatient hospitalization or prolongation of existing hospitalization;
• A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;
• A congenital anomaly/birth defect;
• An important medical event that based on appropriate medical judgement may
jeopardize the individual and may require medical or surgical intervention to
prevent one of the outcomes listed above.”The good news is anyone can report any adverse event in the Vaccine Adverse Event Reporting System (VAERS). I also found that after receiving the vaccine recipients are encouraged to enroll in a smart phone text and web based system to report any side effects to the CDC. The CDC monitors this system and follows up if more information is needed.
I found the statement below for pregnant people and will encourage the use of the v-safe system for all of my patients that have been vaccinated.
“Pregnant people who choose to receive COVID-19 vaccine are encouraged to enroll in v-safe. A <strong style=”font-family: inherit; font-size: inherit;”>v-safe pregnancy registry has been established to follow outcomes among pregnant people who are vaccinated. Based on self-reported information, no specific safety signals have been observed among pregnant vaccine recipients included in the <strong style=”font-family: inherit; font-size: inherit;”>v-safe registry. However longitudinal follow-up is needed to fully evaluate pregnancy and birth outcomes.”