Leitlinien & Arzneimittelsicherheit

HOS-099999 · has-adverse-reaction-information · PDF-Seite 76

Summary of safety profile The safety of Comirnaty KP.2 is inferred from safety data of the prior Comirnaty vaccines. Initially approved Comirnaty vaccine Infants 6 to 23 months of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 2 176 infants (1 458 initially approved Comirnaty 3 mcg and 718 placebo) were 6 to 23 months of age. The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%). Children 2 to 4 years of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 3 541 children (2 368 Comirnaty 3 mcg and 1 173 placebo) were 2 to 4 years of age. The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses In Study 3, a total of 3 109 children 5 to 11 years of age received at least 1 dose of the initially approved Comirnaty vaccine 10 mcg and a total of 1 538 children 5 to 11 years of age received placebo. At the time of the analysis of Study 3 Phase 2/3 with data up to the cut-off date of 20 May 2022, 2 206 (1 481 Comirnaty 10 mcg and 725 placebo) children have been followed for ≥ 4 months after the second dose in the placebo-controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing. The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after booster dose In a subset from Study 3, a total of 2 408 children 5 to 11 years of age received a booster dose of Comirnaty 10 mcg at least 5 months (range of 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months). The overall safety profile for the bo

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HOS-100005 · has-adverse-reaction-information · PDF-Seite 113

Summary of safety profile The safety of Comirnaty LP.8.1 is inferred from safety data of the prior Comirnaty vaccines. Initially approved Comirnaty vaccine Infants 6 to 23 months of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 2 176 infants (1 458 initially approved Comirnaty 3 mcg and 718 placebo) were 6 to 23 months of age. The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%). Children 2 to 4 years of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 3 541 children (2 368 Comirnaty 3 mcg and 1 173 placebo) were 2 to 4 years of age. The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses In Study 3, a total of 3 109 children 5 to 11 years of age received at least 1 dose of the initially approved Comirnaty vaccine 10 mcg and a total of 1 538 children 5 to 11 years of age received placebo. At the time of the analysis of Study 3 Phase 2/3 with data up to the cut-off date of 20 May 2022, 2 206 (1 481 Comirnaty 10 mcg and 725 placebo) children have been followed for ≥ 4 months after the second dose in the placebo-controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing. The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after booster dose In a subset from Study 3, a total of 2 408 children 5 to 11 years of age received a booster dose of Comirnaty 10 mcg at least 5 months (range of 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months). The overall safety profile for the

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HOS-099993 · has-adverse-reaction-information · PDF-Seite 43

Summary of safety profile The safety of Comirnaty JN.1 is inferred from safety data of the prior Comirnaty vaccines. Initially approved Comirnaty vaccine Infants 6 to 23 months of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 2 176 infants (1 458 initially approved Comirnaty 3 mcg and 718 placebo) were 6 to 23 months of age. The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%). Children 2 to 4 years of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 3 541 children (2 368 Comirnaty 3 mcg and 1 173 placebo) were 2 to 4 years of age. The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses In Study 3, a total of 3 109 children 5 to 11 years of age received at least 1 dose of the initially approved Comirnaty vaccine and a total of 1 538 children 5 to 11 years of age received placebo. At the time of the analysis of Study 3 Phase 2/3 with data up to the cut-off date of 20 May 2022, 2 206 (1 481 Comirnaty 10 mcg and 725 placebo) children have been followed for ≥ 4 months after the second dose in the placebo-controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing. The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills and diarrhoea (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after booster dose In a subset from Study 3, a total of 2 408 children 5 to 11 years of age received a booster dose of Comirnaty 10 mcg at least 5 months (range of 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months). The overall safety profile for the booster do

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HOS-099987 · has-adverse-reaction-information · PDF-Seite 7

Summary of safety profile The safety of Comirnaty JN.1 is inferred from safety data of the prior Comirnaty vaccines. Initially approved Comirnaty vaccine Infants 6 to 23 months of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 2 176 infants (1 458 initially approved Comirnaty 3 mcg and 718 placebo) were 6 to 23 months of age. The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%). Children 2 to 4 years of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 3 541 children (2 368 Comirnaty 3 mcg and 1 173 placebo) were 2 to 4 years of age. The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses In Study 3, a total of 3 109 children 5 to 11 years of age received at least 1 dose of the initially approved Comirnaty vaccine 10 mcg and a total of 1 538 children 5 to 11 years of age received placebo. At the time of the analysis of Study 3 Phase 2/3 with data up to the cut-off date of 20 May 2022, 2 206 (1 481 Comirnaty 10 mcg and 725 placebo) children have been followed for ≥ 4 months after the second dose in the placebo-controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing. The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after booster dose In a subset from Study 3, a total of 2 408 children 5 to 11 years of age received a booster dose of Comirnaty 10 mcg at least 5 months (range of 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months). The overall safety profile for the bo

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HOS-100011 · has-adverse-reaction-information · PDF-Seite 150

Summary of safety profile The safety of Comirnaty XFG is inferred from safety data of the prior Comirnaty vaccines. Initially approved Comirnaty vaccine Infants 6 to 23 months of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 2 176 infants (1 458 initially approved Comirnaty 3 mcg and 718 placebo) were 6 to 23 months of age. The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%). Children 2 to 4 years of age – after 3 doses of the 3 mcg primary series In an analysis of Study 3 (Phase 2/3), 3 541 children (2 368 Comirnaty 3 mcg and 1 173 placebo) were 2 to 4 years of age. The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses In Study 3, a total of 3 109 children 5 to 11 years of age received at least 1 dose of the initially approved Comirnaty vaccine 10 mcg and a total of 1 538 children 5 to 11 years of age received placebo. At the time of the analysis of Study 3 Phase 2/3 with data up to the cut-off date of 20 May 2022, 2 206 (1 481 Comirnaty 10 mcg and 725 placebo) children have been followed for ≥ 4 months after the second dose in the placebo-controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing. The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (> 10%). Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after booster dose In a subset from Study 3, a total of 2 408 children 5 to 11 years of age received a booster dose of Comirnaty 10 mcg at least 5 months (range of 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months). The overall safety profile for the boo

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HOS-100007 · has-contraindication-information · PDF-Seite 147

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 147

HOS-099983 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4

HOS-099989 · has-contraindication-information · PDF-Seite 41

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099995 · has-contraindication-information · PDF-Seite 73

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 73

HOS-100001 · has-contraindication-information · PDF-Seite 110

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 110

HOS-100000 · has-indication-information · PDF-Seite 109

Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-099988 · has-indication-information · PDF-Seite 39

Comirnaty JN.1 concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in infants and children aged 6 months to 11 years. The use of this vaccine should be in accordance with official recommendations.

HOS-099982 · has-indication-information · PDF-Seite 3

Comirnaty JN.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-100006 · has-indication-information · PDF-Seite 146

Comirnaty XFG dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-099994 · has-indication-information · PDF-Seite 72

Comirnaty KP.2 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-099991 · has-interaction-information · PDF-Seite 42

No interaction studies have been performed. Concomitant administration of Comirnaty JN.1 with other vaccines has not been studied.

HOS-100009 · has-interaction-information · PDF-Seite 149

Comirnaty XFG 30 micrograms/dose dispersion for injection may be administered concomitantly with seasonal influenza vaccine. In individuals 18 years of age and older, Comirnaty XFG may be administered concomitantly with a pneumococcal conjugate vaccine (PCV). In individuals 18 years of age and older, Comirnaty XFG may be administered concomitantly with an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine. In individuals 65 years of age and older, Comirnaty XFG may be administered concomitantly with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine. Different injectable vaccines should be administered at different injection sites. Concomitant administration of Comirnaty XFG 10 micrograms/dose dispersion for injection with other vaccines has not been studied.

HOS-099985 · has-interaction-information · PDF-Seite 6

Comirnaty JN.1 30 micrograms/dose dispersion for injection may be administered concomitantly with seasonal influenza vaccine. In individuals 18 years of age and older, Comirnaty JN.1 may be administered concomitantly with a pneumococcal conjugate vaccine (PCV). In individuals 18 years of age and older, Comirnaty JN.1 may be administered concomitantly with an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine. In individuals 65 years of age and older, Comirnaty JN.1 may be administered concomitantly with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine. Different injectable vaccines should be administered at different injection sites. Concomitant administration of Comirnaty JN.1 10 micrograms/dose dispersion for injection with other vaccines has not been studied.

HOS-099997 · has-interaction-information · PDF-Seite 75

Comirnaty KP.2 30 micrograms/dose dispersion for injection may be administered concomitantly with seasonal influenza vaccine. In individuals 18 years of age and older, Comirnaty KP.2 may be administered concomitantly with a pneumococcal conjugate vaccine (PCV). In individuals 18 years of age and older, Comirnaty KP.2 may be administered concomitantly with an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine. In individuals 65 years of age and older, Comirnaty KP.2 may be administered concomitantly with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine. Different injectable vaccines should be administered at different injection sites. Concomitant administration of Comirnaty KP.2 10 micrograms/dose dispersion for injection with other vaccines has not been studied.

HOS-100003 · has-interaction-information · PDF-Seite 112

Comirnaty LP.8.1 30 micrograms/dose dispersion for injection may be administered concomitantly with seasonal influenza vaccine. In individuals 18 years of age and older, Comirnaty LP.8.1 may be administered concomitantly with a pneumococcal conjugate vaccine (PCV). In individuals 18 years of age and older, Comirnaty LP.8.1 may be administered concomitantly with an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine. In individuals 65 years of age and older, Comirnaty LP.8.1 may be administered concomitantly with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine. Different injectable vaccines should be administered at different injection sites. Concomitant administration of Comirnaty LP.8.1 10 micrograms/dose dispersion for injection with other vaccines has not been studied.

HOS-099992 · has-pregnancy-information · PDF-Seite 42

Pregnancy No data are available yet regarding the use of Comirnaty JN.1 during pregnancy. However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Based on data available with other vaccine variants, Comirnaty JN.1 can be used during pregnancy. Breast-feeding No data are available yet regarding the use of Comirnaty JN.1 during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the vaccine is negligible. Observational data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty JN.1 can be used during breast-feeding. 42 Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-100010 · has-pregnancy-information · PDF-Seite 149

Pregnancy No data are available yet regarding the use of Comirnaty XFG during pregnancy. However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Based on data available with other vaccine variants, Comirnaty XFG can be used during pregnancy. Breast-feeding No data are available yet regarding the use of Comirnaty XFG during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the vaccine is negligible. Observational data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty XFG can be used during breast-feeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 149

HOS-100004 · has-pregnancy-information · PDF-Seite 112

Pregnancy No data are available yet regarding the use of Comirnaty LP.8.1 during pregnancy. However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Based on data available with other vaccine variants, Comirnaty LP.8.1 can be used during pregnancy. Breast-feeding No data are available yet regarding the use of Comirnaty LP.8.1 during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the vaccine is negligible. Observational data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty LP.8.1 can be used during breast-feeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 112

HOS-099986 · has-pregnancy-information · PDF-Seite 6

Pregnancy No data are available yet regarding the use of Comirnaty JN.1 during pregnancy. However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Based on data available with other vaccine variants, Comirnaty JN.1 can be used during pregnancy. Breast-feeding No data are available yet regarding the use of Comirnaty JN.1 during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the vaccine is negligible. Observational data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty JN.1 can be used during breast-feeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 6

HOS-099998 · has-pregnancy-information · PDF-Seite 75

Pregnancy No data are available yet regarding the use of Comirnaty KP.2 during pregnancy. However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Based on data available with other vaccine variants, Comirnaty KP.2 can be used during pregnancy. Breast-feeding No data are available yet regarding the use of Comirnaty KP.2 during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the vaccine is negligible. Observational data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty KP.2 can be used during breast-feeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 75

HOS-100002 · has-warning-information · PDF-Seite 111

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine sho

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HOS-099996 · has-warning-information · PDF-Seite 74

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine sho

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100008 · has-warning-information · PDF-Seite 148

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine sho

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HOS-099990 · has-warning-information · PDF-Seite 41

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring 41 symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorde

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HOS-099984 · has-warning-information · PDF-Seite 5

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine sho

Auszug; vollständigen Abschnitt im Original lesen.