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 during clinical trials, pain (74% to 90%; 1% to 5% Grade 3), axillary swelling/tenderness (5% to 25%; less than 1% Grade 3), swelling (3% to 13%; 0.5% to 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 during clinical trials, pain (37% to 95%; 1% to 6% Grade 3), axillary swelling/tenderness (4% to 40%; less than 1% Grade 3), swelling of greater than 25 mm (3% to 21%; less than 1% to 3% Grade 3), erythema greater than 25 mm (4% 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]

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, 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, 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.[67339] [67908]

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, 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.[67786] Myalgia (26% to 47%; 1% to 5% 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 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]

During clinical trials, chills (4.6% to 48.7%) and fever (1.3% to 19.6%) occurred after administration of the COVID-19 vaccine. The rates and severity of the reactions were generally higher after the second dose compared to the first dose.[66080] [66120] [66904] [67085] [67339] In patients 5 to 15 years, fever of 101.2 degrees F (38.4 degrees C) or higher was reported in 3 times more patients after the second Pfizer-BioNTech COVID-19 vaccine dose (5 to 11 years: 3.1% after dose 2, 1% after dose 1; 12 to 15 years: 9.9% after dose 2, 3.6% after dose 1). In patients 16 to 55 years, fever of 101.2 degrees F (38.4 degrees C) or higher was reported in 6 times more patients after the second Pfizer-BioNTech COVID-19 vaccine dose (6.9% after dose 2, 1.2% after dose 1). In patients 56 years and older, fever of 101.2 degrees F (38.4 degrees C) or higher was reported in 3.3% of patients after dose 2 compared to 0.1% of patients after dose 1. In patients who received the Pfizer-BioNTech COVID-19 vaccine, chills were more frequently reported in patients 12 to 55 years (16.5% to 41.5%) compared to patients 5 to 11 years (4.6% to 9.8%) and patients 56 years and older (6.5% to 23.4%).[66080] [66904] [67085] After Moderna COVID-19 vaccine administration, fever was reported in more patients 18 to 64 years after dose 2 (17.4%) compared to dose 1 (0.9%). A fever of 102.1 degrees F (38.9 degrees C) or higher was reported by 1.7% of patients after dose 2 compared to less than 0.1% after dose 1. Significantly more patients 65 years and older also reported fever after the second dose (9.9% after dose 2, 0.3% after dose 1). A fever of 102.1 degrees F (38.9 degrees C) or higher was reported by 0.5% of patients after dose 2 compared to less than 0.1% after dose 1. The greatest incidence of chills occurred after dose 2 in patients 18 to 64 years (48.7%).[66120] [67339] The incidence of chills and fever after a booster dose of the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine was similar to that seen after the primary series.[66080] [66120] [67085]

Adverse gastrointestinal (GI) reactions have been reported during COVID-19 vaccine trials.[66080] [66120] [66904] [67085] [67339] Diarrhea (5.3% to 10.7%), nausea (0.4% to 1.2%), and vomiting (0.5% to 2.8%) were reported during Pfizer-BioNTech COVID-19 vaccine clinical trials. Anorexia (decreased appetite) was reported by 0.1% of patients 5 to 11 years old.[66080] [66904] [67085] During Moderna COVID-19 vaccine clinical trials, nausea and/or vomiting was reported in twice as many patients 18 to 64 years after dose 2 (21.4%) compared to dose 1 (9.4%). A similar difference was seen in patients 65 years and older (11.9% after dose 2; 5.2% after dose 1). One case of intractable nausea and vomiting requiring hospitalization was reported as a serious adverse reaction in the vaccine group.[66120] [67339] The incidence of GI adverse reactions after a booster dose of the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine was similar to that seen after the primary series.[66080] [66120] [67085]

Myocarditis and pericarditis have been reported during postmarketing experience with mRNA vaccines. The observed risk is highest in males 12 to 17 years of age (Pfizer-BioNTech COVID-19 vaccine) and in males 18 to 24 years of age (Moderna COVID-19 vaccine). 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. Consider myocarditis and pericarditis in adolescents and young adults with acute 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. Although data from short-term follow-up suggests that most patients have resolution of acute symptoms, information is not yet available about long-term sequelae. 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 was 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 congential heart disease and Kawasaki disease, may receive any currently FDA-approved or FDA-authorized COVID-19 vaccine. In a retrospective study of 139 patients (mostly white male; median age of 15.8 years), suspected myocarditis was reported in 131 (94.2%) patients receiving the Pfizer-BioNTech vaccine, with the majority of cases occurring after the second dose 128 (91.4%). Five cases (3.6%) were reported after the Moderna COVID-19 vaccine, 1 case (0.7%) occurred after the Janssen COVID-19 vaccine, and the brand was unknown in 2 patients. Median onset of symptoms was 2 days after vaccination and the most common symptom was chest pain (99.3%). Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%), or no anti-inflammatory therapies (8.6%). Twenty-six patients (18.7%) were in the ICU, but only 2 patients were treated with inotropic/vasoactive support, and none required ECMO or died. The median hospital stay was 2 days (0 to 10 days).[66175] [66698] [66770] [67172] [67339] [67786] [67907] [67908]

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]

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]

Immunocompromised patients, including patients with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to the COVID-19 vaccine. Patients at increased risk include, but are not limited to, those who have received a solid organ transplant and are taking immunosuppressive therapy, those who are receiving active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 weeks or more), transplant related immunosuppressive drugs, and other biologic agents that are immunosuppressive or immunomodulatory, and patients with moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome). Administration of an additional mRNA COVID-19 vaccine dose at least 2 months after the last dose of COVID-19 vaccine has been authorized for individuals who have undergone solid organ transplantation, or are diagnosed with a condition that is considered to have an equivalent level of immunocompromise.[66175] [67339] [67786] [67907] [67908] Immunosuppressed persons may also include patients with severe combined immunodeficiency (SCID), hypogammaglobulinemia, or agammaglobulinemia. Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.[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 patient'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]

Patients with altered immune states due to generalized neoplastic disease or an immune system compromised by radiation therapy or chemotherapy may not have an adequate immune response to the COVID-19 vaccine. Patients at increased risk include, but are not limited to, those receiving active treatment for solid tumor and hematologic malignancies, receipt of chimeric antigen receptor (CAR) T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppresive therapy), and active treatment with alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory. Administration of an additional mRNA COVID-19 vaccine dose at least 2 months after the last dose of COVID-19 vaccine has been authorized for individuals who have undergone solid organ transplantation, or are diagnosed with a condition that is considered to have an equivalent level of immunocompromise.[66175] [67339] [67786] [67907] [67908] 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 patient'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] Delay vaccination for at least 3 months after hematopoietic cell transplantation (HCT) or engineered cellular therapy (e.g. CAR-T cells) to maximize vaccine efficacy.[66335] Revaccinate patients who received 1 or more doses of COVID-19 vaccine prior to or during HCT or CAR-T-cell therapy for any doses administered before or during treatment starting at least 3 months after transplant or CAR-T-cell therapy. An mRNA COVID-19 vaccine is recommended for revaccination doses. Consider revaccination 6 months after therapy completion for patients who received 1 or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab) that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies). For patients receiving B-cell-depleting therapies on a continuing basis, COVID-19 vaccines should be administered approximately 4 weeks before the next scheduled therapy.[66175] For patients with hematologic malignancies receiving intensive cytotoxic chemotherapy (e.g., cytarabine/anthracycline-based induction regimens for AML), delay vaccination until absolute neutrophile count (ANC) recovery. For patients with solid tumor malignancies undergoing major surgery, separate date of surgery from vaccination by at least a few days to allow symptoms (e.g. fever) to be correctly attributed to surgery vs. vaccination. For more complex surgeries (e.g. splenectomy or surgery that may lead to an immunosuppressive state) surgeons may recommend a wider window (+/- 2 weeks) from the time of surgery.[66335]

Postponing vaccination with the COVID-19 vaccine is recommended in patients with a moderate or severe acute illness or infection, with or without fever. Defer COVID-19 vaccination until the illness has improved. Advise individuals with known current SARS-CoV-2 infection to defer any COVID-19 vaccination at least until recovery from the acute illness and criteria to discontinue isolation have been met. Individuals who recently had SARS-CoV-2 infection may consider delaying a COVID-19 vaccine dose by 3 months from symptom onset or positive test. Increased time between infection and vaccination may result in an improved immune response to vaccination. Additionally, a low risk of reinfection has been observed in the weeks to months after infection. Take into account risks of COVID-19 severe disease or characteristics of the predominant SARS-CoV-2 strain when determining whether to delay a COVID-19 vaccination after infection.[66175]

Although patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) could have a diminished response, the COVID-19 vaccine should be offered to patients with chronic, stable HIV. Administration of an additional mRNA COVID-19 dose at least 2 months after last dose of COVID-19 vaccine has been authorized for individuals who have undergone solid organ transplantation, or are diagnosed with a condition that is considered to have an equivalent level of immunocompromise. Patients at increased risk include, but are not limited to, those with advanced or untreated HIV infection (people with HIV and CD4 counts less than 200/mm³, history of AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV infection).[66175] [67339] [67786] [67907] [67908]

The COVID-19 vaccine is administered by intramuscular (IM) injection only. Carefully consider the risks and benefits in patients at increased risk for bleeding after an intramuscular injection, such as thrombocytopenia, bleeding disorders (e.g., hemophilia), coagulopathy, vitamin K deficiency, and those receiving anticoagulant therapy. Caution and appropriate precautions to minimize the risk of bleeding or hematoma formation are advised.[65107] [66175] [67339] [67786] [67907] [67908]

COVID-19 vaccination is strongly recommended during pregnancy and in recently pregnant individuals (up to 6 weeks postpartum). Vaccination may occur in any trimester and is recommended as soon as possible to maximize maternal and fetal health.[66175] [66179] [66863] A growing body of evidence suggests that benefits of COVID-19 vaccination outweigh any known or potential risk of vaccination during pregnancy. Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination in pregnant patients reduces the risk of COVID-19 hospitalization in infants younger than 6 months.[66175] Data analyzed from 3 vaccine safety-related databases (VAERS, the v-safe active surveillance system, and the v-safe pregnancy registry) did not identify safety concerns for pregnant patients who were vaccinated late in their pregnancy or their infants. 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. There is no current evidence that COVID-19 vaccines cause fertility problems in woman or men.[66175] [66863] [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 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] Encourage pregnant women to enroll in the CDC's V-SAFE program by going to vsafe.cdc.gov.[67339]

COVID-19 vaccination is recommended in all eligible women, 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 breast milk. However, the COVID-19 vaccines cannot cause infection in either the lactating patient or the infant.[66175] Recent reports suggest mothers who have received mRNA COVID-19 vaccines have antibodies in their breast milk, which may help protect their babies.[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 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 breast milk samples. No differences in reactogenicity were noted between the groups.[66558] If a breast-feeding infant experiences an adverse event possibly related to a maternally administered vaccine, health care providers are encouraged to report the adverse event to the FDA.

Injectable vaccines, including the mRNA COVID-19 vaccines, have been associated with episodes of dizziness, syncope, and fainting, especially in adolescents. 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]

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]

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]