Injection site reactions are commonly reported after COVID-19 vaccination. In patients aged 12 years and older receiving Pfizer-BioNTech COVID-19 vaccination during clinical trials, injection site pain (66% to 91%; less than 2% severe), injection site swelling (5% to 12%; less than 1% severe), and injection site redness (5% to 10%; less than 1% severe) were reported. In patients aged 6 months to 11 years receiving the Pfizer-BioNTech COVID-19 vaccine, injection site pain or tenderness (4% to 74%; less than 1% severe), swelling (3% to 16%; less than 1% severe), and redness (7% to 19%; less than 1% severe) were reported. The mean duration of pain at the injection site was 1.1 to 2.3 days (range: 1 to 11 days), for redness 1.3 to 2.2 days (range: 1 to 10 days), and swelling 2.2 to 3 days (range: 1 to 10 days).[67786] [67907] In adult individuals receiving Moderna COVID-19 vaccination or mNexspike vaccine during clinical trials, pain (54.6% to 90%; 0.7% to 5% Grade 3), axillary swelling/tenderness (5% to 25%; less than 1% Grade 3), swelling (2.9% to 13%; less than 2% Grade 3), erythema (2% to 9%; less than 2% Grade 3), and rash (2%) were reported. Grade 3 local adverse reactions were more frequently reported after Dose 2 than after Dose 1. Injection site rash or urticaria, likely related to the vaccination, were reported in 6 adults vs. 0 in individuals receiving placebo. The median duration of adverse reactions was 2 to 3 days. Delayed injection site reactions (occurring more than 7 days after administration), such as pain, erythema, and swelling were reported in 1.4% of adult individuals. In pediatric individuals (age: 6 months to 17 years) who received Moderna COVID-19 vaccine or mNexspike vaccine during clinical trials, pain (37% to 95%; 1% to 6% Grade 3), axillary swelling/tenderness (4% to 40%; 1.2% or less Grade 3), swelling of greater than 25 mm (3% to 21%; less than 1% to 3% Grade 3), erythema greater than 25 mm (1.2% to 20%; less than 1% to 3% Grade 3), and injection site rash or urticaria (0.3%) were reported. Delayed injection site reactions (occurring more than 7 days after administration), such as pain, erythema, and swelling were reported in 1.5% of pediatric individuals.[67339] [67908] [72298]

In individuals 16 years and older receiving Pfizer-BioNTech COVID-19 vaccination, fatigue (34% to 70%; 1% to 5% severe), and headache (25% to 65%; 1% to 3% severe), were reported during clinical trials. Malaise, asthenia, hyperhidrosis, lethargy, and night sweats were unsolicited adverse events reported in less than 1% of individuals 16 years and older. In pediatric individuals (age: 2 to 15 years) who received the Pfizer-BioNTech COVID-19 vaccination, fatigue (26% to 78%; 1% to 2% severe) and headache (3% to 76%; 1% to 2% severe) were reported during clinical trials. Syncope and dizziness have been reported during postmarketing experience with Pfizer-BioNTech COVID-19 vaccine.[67786] [67907] In adult individuals receiving Moderna COVID-19 vaccine or mNexspike vaccine, fatigue (33% to 68%; 1% to 11% Grade 3) and headache (25% to 63%; 1% to 5% Grade 3) were reported during clinical trials. In pediatric individuals (age: 37 months to 17 years) receiving Moderna COVID-19 vaccine or mNexspike vaccine, fatigue (40% to 70%; 1% to 8% Grade 3) and headache (12% to 71%; 1% to 8% Grade 3) were reported during clinical trials. Syncope has been reported during postmarketing experience with Moderna COVID-19 vaccine. Prior to administration, ensure procedures are in place to prevent falls and manage syncopal reactions. Patients should remain seated or lying down during the observation period to decrease the risk for injury. If syncope develops, observe patients until symptoms resolve.[66175] [67339] [67786] [67907] [67908] [72298]

In patients receiving Pfizer-BioNTech COVID-19 vaccine, new or worsened myalgia (14% to 46%; 2% or less severe) and new or worsened arthralgia (9% to 28%; 1% or less severe) were reported in patients (age: 12 years or older) during clinical trials.[67786] New or worsened myalgia (9% to 18%; less than 1% severe) and new or worsened arthralgia (3% to 7%; 0 severe) were reported in pediatric patients (age: 5 to 11 years) receiving Pfizer-BioNTech COVID-19 vaccine during clinical trials. New or worsened myalgia (0% to 3%; less than 1% severe) and new or worsened arthralgia (1% to 3%; 0 severe) were reported in pediatric patients (age 2 to 4 years) receiving Pfizer-BioNTech COVID-19 vaccine during clinical trials. Pain in the extremity (arm) has been reported during postmarketing experience with Pfizer-BioNTech COVID-19 vaccination.[67907] In adult patients receiving Moderna COVID-19 vaccination or mNexspike vaccine, myalgia (20% to 62%; 0.5% to 10% Grade 3) and arthralgia (16% to 46%; less than 3% grade 3) were reported in clinical trials. Myalgia (26% to 47%; 1% to 5.6% Grade 3) and arthralgia (14% to 29%; less than 2% Grade 3) were reported in pediatric patients (age: 12 to 17 years) receiving Moderna COVID-19 vaccination or mNexspike vaccine during clinical trials. Myalgia (10% to 30%; 2% or less Grade 3) and arthralgia (6% to 17%; less than 1% Grade 3) were reported in pediatric patients (age: 37 months to 11 years) receiving Moderna COVID-19 vaccination during clinical trials.[67908] [72298]

Chills (7% to 42%; less than 1% to 3% severe) and fever (1% to 18%) were reported in patients (age: 16 years and older) receiving Pfizer-BioNTech COVID-19 vaccination during clinical trials. In patients (age: 12 years and older) receiving a booster dose with Pfizer-BioNTech COVID-19 vaccine, bivalent the following were reported: chills (18%) and fever (5%).[67786] Chills (28% to 49%; less than 2% severe) and fever (10% to 24%) were reported in pediatric patients (age: 12 to 15 years) who received the Pfizer-BioNTech COVID-19 vaccination during clinical trials. Chills (2% to 11%; less than 1% severe) and fever (0% to 7%) were reported in patients (age: 2 to 11 years) who received the Pfizer-BioNTech COVID-19 vaccine. One serious fever event (max temp 40.3 degree C) occurred on Day 3 after Dose 2 in a 4-year-old and was considered possibly related to vaccination. Fever (4% to 7%) was reported in pediatric patients (age: 6 to 23 months) receiving Pfizer-BioNTech COVID-19 vaccine during clinical trials. Febrile seizures have been reported during postmarketing experience with Pfizer-BioNTech COVID-19 vaccine.[67907] Chills (5% to 49%; less than 2% Grade 3) and fever (less than 1% to 17%; less than 2% Grade 3) were reported in adult individuals receiving Moderna COVID-19 vaccine or mNexspike vaccine during clinical trials. Chills (10% to 49%; 1.2% or less Grade 3) and fever (1% to 24%; less than 4% Grade 3) were reported in pediatric individuals (age: 6 to 17 years) receiving Moderna COVID-19 vaccine or mNexspike vaccine during clinical trials. Chills (6% to 12%; less than 1% Grade 3) and fever (8% to 16%; 1% to 3% Grade 3) were reported in pediatric individuals (age: 37 months to 5 years). Fever was reported in less than 1% to 19% of pediatric individuals (age: 6 to 23 months) receiving Moderna COVID-19 vaccination during clinical trials. A 1-year-old female had a Grade 3 fever 6 hours after Dose 1 and febrile convulsions 1 day after Dose 1. Febrile seizures have been reported during postmarketing experience with Moderna COVID-19 booster.[67339] [67908] [72298]

In individuals (age: 2 years and older) receiving the Pfizer-BioNTech COVID-19 vaccine, vomiting (1% to 3%; less than 1% severe) and diarrhea (5% to 11%; less than 1% severe) were reported during clinical trials. In individuals (age: 16 and older) who received the Pfizer-BioNTech COVID-19 vaccine, nausea was reported in 274 individuals receiving the vaccine vs. 87 individuals who received placebo and decreased appetite was reported in 39 individuals receiving the vaccine vs. 9 individuals who received placebo. Nausea (0.3% to 0.7%) and decreased appetite (0.3%) were reported in adult individuals and nausea was reported in 5 pediatric individuals (age: 12 to 15). Decreased appetite (5%; n = 1), which was rated as mild, was reported in an individual (age: 6 to 23 months).[67786] [67907] In individuals receiving the Moderna COVID-19 vaccine, nausea/vomiting (4% to 21%; less than 2% Grade 3) was reported in adult individuals receiving during clinical trials. Nausea/vomiting (5% to 24%; less than 1% Grade 3) was reported in pediatric individuals (age: 37 months to 17 years) receiving Moderna COVID-19 vaccine during clinical trials. Loss of appetite/anorexia (23% to 32%; 1% or less Grade 3) was reported in pediatric individuals (age: 6 to 36 months) receiving Moderna COVID-19 vaccination. During the 28-day follow-up period after any dose of Moderna COVID-19 vaccine, 1% or less of pediatric individuals (age: 2 to 11 years) reported abdominal pain (including upper abdominal pain and lower abdominal pain). There was one serious adverse event of abdominal pain reported 16 days following the booster dose by a 7-year-old patient. Available information is insufficient to determine a causal relationship with the vaccine.[67339] [67908]

Myocarditis and pericarditis have been reported during postmarketing experience with mRNA vaccines. The observed risk is highest in males 12 to 24 years within 7 days after vaccination, occurring more often after the second dose. However, cases have also been observed in females and after other doses. Symptoms include chest pain, shortness of breath, or palpitations; younger children may have more non-specific symptoms such as irritability, vomiting, poor feeding, tachypnea, or lethargy. Most patients require hospitalization but experience resolution of acute symptoms; long-term effects are unknown. In a population-based cohort study of 3,095,414 people aged 18 years and older, a 2 to 3-fold higher incidence of myocarditis/pericarditis was observed in people who received a second mRNA vaccination with the Moderna COVID-19 vaccine compared to the Pfizer-BioNTech vaccine. The higher incidence of myocarditis after the Moderna vaccine was highest among younger men (18 to 39 years) and was not present at older ages (40 years and older). However, the odds of pericarditis were higher with the Moderna vaccine for both younger and older individuals. In a retrospective observational cohort examining cardiovascular outcomes in 307 individuals (age: 5 to 29 years) diagnosed with myocarditis linked to mRNA COVID-19 vaccination, at a median follow-up of about 3 months, 89 individuals reported ongoing cardiac symptoms. Cardiac magnetic resonance imaging (CMR) was performed on 216 patients. Overall, 177 of these had late gadolinium enhancement (LGE), a marker of myocardial injury. Among 161 individuals who had LGE on initial CMR and had a follow-up gadolinium-enhanced CMR at a median of 159 days, 98 individuals had persistent LGE. Overall, the severity of LGE decreased during follow-up. The clinical significance of these MRI findings remains unclear. Development of myocarditis or pericarditis within 3 weeks of COVID-19 vaccination is a precaution against subsequent doses of any COVID-19 vaccine, and subsequent doses should generally be avoided. If the decision is made to receive a subsequent dose, the episode of myocarditis or pericarditis should be resolved. Considerations for subsequent vaccination include myocarditis or pericarditis considered unrelated to mRNA COVID-19 vaccination (e.g., due to SARS-CoV-2 or other viruses, diagnosis was made more than 3 weeks after vaccination), personal risk of severe acute COVID-19 (e.g., age, underlying conditions), or timing of any immunomodulatory therapies. Patients with a history of myocarditis or pericarditis prior to COVID-19 vaccination or more than 3 weeks after a COVID-19 vaccine dose should not receive a mRNA vaccine dose until their episode of myocarditis or pericarditis has completely resolved, which includes no evidence of ongoing heart inflammation or sequelae. Individuals who have a history of other heart disease, including congenital heart disease and Kawasaki disease, may receive any currently FDA-approved or FDA-authorized COVID-19 vaccine.[66175] [66698] [66770] [67339] [67786] [67907] [67908] [71812] [72298]

Anaphylactoid reactions, such as anaphylaxis, rash, pruritus, urticaria, and angioedema have been reported during postmarketing experience with Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine.[67339] [67786] [67907] [67908] Angioedema/facial swelling was reported in 3 adults receiving the Moderna COVID-19 vaccine during clinical trials. All 3 individuals have a history of injection of dermatological fillers. The onset of swelling was reported 1 to 2 days after the second dose. One serious adverse event of erythema nodosum occurred 8 days after the Moderna COVID-19 booster dose in a 73-year-old female. The event was considered causally related to the Moderna COVID-19 vaccine and was reported as resolved without treatment on Day 30.[67339] During a 28-day follow-up period, hypersensitivity adverse events (injection site rash, injection site urticaria) were reported in approximately 4% of pediatric patients (age: 6 months to 11 years) and 2% to 5% of individuals receiving placebo. Delayed injection site reactions that began more than 7 days after vaccination were reported in 1% to 3% of patients. Delayed reactions included pain, erythema, and swelling.[67908] Appropriate medication treatment must be immediately available to manage potential anaphylactic reactions.[72298]

Lymphadenopathy was reported in Pfizer-BioNTech COVID-19 vaccine clinical trials in 85 individuals receiving the vaccine vs. 7 receiving placebo (age: 16 years and older), 9 receiving the vaccine vs. 2 receiving placebo (age: 12 to 15 years), 13 individuals (0.9%) receiving Pfizer-BioNTech (10 mcg modRNA) vs. 1 (0.1%) individual in the placebo group (age: 5 to 11 years), 1 individual (0.1%) receiving the vaccine vs 0% in the placebo group (age: 2 to 4 years), and in 2 individuals (0.2%) receiving vaccination vs. 0 individuals in the placebo group (age: 6 to 23 months). In patients receiving a Pfizer-BioNTech COVID-19 vaccine booster dose, lymphadenopathy occurred in 1% to 5% of individuals aged 16 years and older, 1% of individuals aged 12 to 15 years, and 2.5% of individuals aged 5 to 11 years.[67786] [67907] During a 28-day follow-up period following any dose of Moderna COVID-19 vaccine clinical trials, lymphadenopathy-related events were reported in 2% of adults, 6% of pediatric patients (age: 12 to 17 years), 2% of pediatric patients (age: 6 to 11 years), 0.9% of pediatric patients (age: 2 to 5 years), and 1.5% of pediatric patients (age: 6 months to 23 months). These events included lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy, injection-site lymphadenopathy, and axillary mass.[66120] [67339]

During the Pfizer-BioNTech COVID-19 vaccine safety follow-up period, Bell's palsy (facial paralysis) was reported by 4 individuals. The onset of facial paralysis was Day 37 after Dose 1 (individual did not receive Dose 2), Day 3, 9, and 48 after Dose 2. There were 2 cases in the placebo group, occurring on Day 32 and Day 102. The information available is insufficient to determine a causal relationship with the vaccine.[67786] Appendicitis was reported in 8 individuals (age: 16 to 55 years) receiving Pfizer-BioNTech COVID-19 vaccine versus 4 individuals receiving placebo. The data available is insufficient to determine a causal relationship with the vaccine.[67907] During Moderna COVID-19 clinical trials, facial paralysis (including Bell's palsy) was reported during the blinded portion in 8 adult patients receiving Moderna COVID-19 vaccination vs. 3 in the placebo group. In the 28-day follow-up period there were 2 cases of facial paralysis, which occurred on Day 8 and Day 22 after vaccination, and 1 case in the placebo group on Day 17 after vaccination. Herpes zoster was reported in 50 adult patients receiving Moderna COVID-19 vaccination during clinical trials vs. 23 in the placebo group. In the 28-day follow-up period there were 22 cases of herpes zoster in those receiving Moderna COVID-19 vaccination vs. 15 in the placebo group. Currently, available information on facial paralysis and herpes zoster infection is insufficient to determine a causal relationship with the vaccine.[67339]

Menstrual irregularity has been reported after mRNA COVID-19 vaccination. A retrospective cohort analysis of prospectively collected data was performed in 19,622 patients (14,936 in the vaccinated group; 4,686 in the unvaccinated group). The study found that when one vaccine dose was administered per cycle, there was a 0.71 day increase (99.3% CI; 0.47 to 0.96) in cycle length after the first dose and a 0.56 day increase (99.3% CI; 0.28 to 0.84) after the second dose, compared to unvaccinated patients. The difference was greatest among patients who received 2 vaccine doses in a cycle, with an increase of 3.7 days (99.3% CI; 2.98 to 4.42). Menses length was unaffected by vaccination.[68037]

In January 2023, the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) identified a potential risk of ischemic stroke in patients 65 years and older who received the Pfizer-BioNTech COVID-19 bivalent vaccine. The CDC's Vaccine Safety Datalink (VSD), a real-time surveillance system, met the statistical criteria to prompt additional investigation into whether patients 65 and older who received the Pfizer-BioNTech COVID-19 bivalent vaccine were more likely to experience an ischemic stroke in the 21 days following vaccination compared with days 22 to 44 days following vaccination. A potential risk was not identified with the Moderna COVID-19 bivalent vaccine. No other safety systems have shown a similar risk and multiple subsequent analyses have not validated this risk. The CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems, however, no change in vaccination practice is recommended.[68453]

Irritability (18% to 51%; less than 1% severe) and drowsiness (9% to 27%; less than 1% severe) were reported in pediatric patients (age: 6 to 23 months) receiving Pfizer-BioNTech COVID-19 vaccine during clinical trials.[67907] Irritability/crying (53% to 68%; 1% to 2% Grade 3) and drowsiness/sleepiness (27% to 37%; less than 1% Grade 3) were reported in pediatric patients (age: 6 to 36 months) receiving Moderna COVID-19 vaccine during clinical trials.[67908]

The use of the COVID-19 vaccine has resulted in laboratory test interference with the Bio-Rad Laboratories BioPlex 2200 Syphilis Total and Rapid Plasma Reagin (RPR) kit. False reactivity may occur for at least 5 months after COVID-19 vaccination. It is unknown if other RPR tests may also be affected. Treponemal testing for syphilis such as Treponema pallidum particle agglutination (TP-PA) and treponemal immunoassays do not appear to be impacted. Retest patients who receive a positive result using the Bio-Rad BioPlex 2200 Syphilis Total and RPR kit for syphilis with another test to confirm results. For patients with a negative treponemal test, but reactive RPR result using the Bio-Rad BioPlex 2200 Syphilis Total and RPR kit, repeat RPR testing is not necessary unless otherwise clinically indicated. For patients previously treated for syphilis, whose treponemal testing will remain persistently positive, and are being evaluated for a possible new syphilis infection, interpret a reactive RPR in the context of the patient's medical history, risk factors, and clinical presentation. If the Bio-Rad BioPlex 2200 Syphilis Total and RPR kit was used and the clinical presentation does not support syphilis reinfection, then confirm reactive results with a RPR test from another manufacturer.[67201]

Immunocompromised individuals, including individuals with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to the COVID-19 vaccine.[67339] [67786] [72298] Immunosuppressed persons may include individuals with congential or acquired immunodeficiencies, whether due to concurrent disease (e.g., HIV infection, leukemia, lymphoma), cancer therapy (e.g., cytotoxic drugs, radiation), or immunosupressive therapy (e.g., corticosteroids). Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. COVID-19 vaccines may be administered without regard to timing of corticosteroid treatment, including topical or intra-articular treatment, bursal, or tendon injection.[65107] [66175] Ideally, complete COVID-19 vaccination at least 2 weeks before initiation or resumption of immunosuppressive therapies, but timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies and optimization of both the individual's medical condition and response to vaccine. Serologic testing or cellular immune testing to assess for immunity after COVID-19 vaccination, outside the context of research studies, is not recommended.[66175]

Data suggest immune response to COVID-19 vaccination may be reduced in patients with renal failure receiving dialysis. Counsel dialysis patients about the potential for reduced immune responses and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus.[69469]

Myocarditis and pericarditis have been reported during postmarketing experience with mRNA vaccines. Development of myocarditis or pericarditis within 3 weeks of COVID-19 vaccination is a precaution for subsequent doses of any COVID-19 vaccine, and subsequent doses should generally be avoided. If the decision is made to receive a subsequent dose, the episode of myocarditis or pericarditis should be resolved. Considerations for subsequent vaccination include myocarditis or pericarditis considered unrelated to mRNA COVID-19 vaccination (e.g., due to SARS-CoV-2 or other viruses, diagnosis was made more than 3 weeks after vaccination), personal risk of severe acute COVID-19 (e.g., age, underlying conditions), or timing of any immunomodulatory therapies. Patients with a history of myocarditis or pericarditis prior to COVID-19 vaccination or more than 3 weeks after a COVID-19 vaccine dose should not receive a mRNA vaccine dose until their episode of myocarditis or pericarditis has completely resolved, which includes no evidence of ongoing heart inflammation or sequelae. The observed risk is highest in males 12 to 24 years. Based on claims data after the administration of the 2023-2024 formulation of mRNA COVID-19 vaccines, there were approximately 8 cases per million in individuals 6 months to 64 years and approximately 27 cases per million doses in males 12 to 24 years. The onset of myocarditis and pericarditis is usually within 7 days after vaccination, occurring more often after the second dose. However, cases have also been observed in females and after other doses. Although some individuals with myocarditis and/or pericarditis after administration of mRNA COVID-19 vaccines have required intensive care support, available data suggest that individuals typically have resolution of symptoms within a few days with conservative management. Persistence of abnormal cardiac magnetic resonance imaging (CMR) findings, which is a marker for myocardial injury, has been found in individuals with COVID-19 vaccine-associated myocarditis. The clinical and prognostic significance of these CMR findings are not known. Individuals who have a history of other heart disease, including congential heart disease and Kawasaki disease, may receive any currently FDA-approved or FDA-authorized COVID-19 vaccine.[66175] [66698] [66770] [67339] [67786] [67907] [67908] [72298]

COVID-19 vaccination is strongly recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine. It is recommended as soon as possible, regardless of trimester, to optimize maternal and fetal health. There is no preferential recommendation for the use of any one COVID-19 vaccine over another.[66179] [72307] Currently, the CDC does not have the COVID-19 vaccine listed on its Adult Immunization Schedule for pregnant individuals.[72295] Analysis of current data from the V-SAFE pregnancy registry did not find an increased risk of miscarriage among approximately 2,500 pregnant women who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy. Miscarriage rates in this population were 13%, compared to 11% to 16% of pregnancies in the general population.[72308] A systematic review and meta-analysis that included 71 clinical and preclinical studies involving pregnant individuals (n = 17,719,495) found no evidence of safety concerns associated with COVID-19 vaccination during pregnancy, with adverse outcomes not exceeding background rates. Most studies involved mRNA vaccines and showed no increased risk of adverse pregnancy outcomes.[72309] In a prospective cohort study of 131 mRNA COVID-19 vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant), vaccine-induced antibody titers were equivalent in pregnant and lactating women compared to non-pregnant women. All titers were significantly higher than those induced during SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood samples; neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although statistical significance was not reached. No differences in reactogenicity were noted between the groups.[66558] COVID-19 mRNA vaccines are not associated with infertility. ACOG recommends vaccination for all eligible individuals who may consider future pregnancy.[66179]

COVID-19 vaccination is recommended in all eligible individuals, including those who are breast-feeding.[66179] [66864] There are limited data regarding use of the COVID-19 vaccine during breast-feeding, its effect on milk production, and its excretion in human milk.[67339] However, the COVID-19 vaccines cannot cause infection in either the lactating patient or the exposed child.[66175] Recent reports suggest lactating people who have received mRNA COVID-19 vaccines have antibodies in their milk, which may help protect neonates and infants.[66864] In a prospective cohort study of 131 mRNA COVID-19 vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant), vaccine-induced antibody titers were equivalent in pregnant and lactating individuals compared to non-pregnant people. All titers were significantly higher than those induced during SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all milk samples. No differences in reactogenicity were noted between the groups.[66558]