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1.
Am J Trop Med Hyg ; 106(1): 342-344, 2021 10 25.
Article in English | MEDLINE | ID: covidwho-1726464

ABSTRACT

Although rare in Portugal, snakebite envenoming entails severe morbidity and mortality. We present the case of a 65-year-old woman bitten on her leg in a northern coastal region in Portugal, on a walk during the COVID-19 pandemic lockdown. Despite first looking for help at the nearest pharmacy, she developed anaphylactoid shock and was promptly driven to a tertiary hospital, where antivenom was administered in a timely manner under close monitoring. Prophylactic antibiotics were started and maintained based on elevated inflammatory markers and signs of wound inflammation. She evolved favorably, with rapid weaning of vasopressors and resolution of end-organ dysfunction. This case highlights the importance of prompt recognition and describes crucial steps in envenomation management in a country where snakebite is infrequent, but potentially fatal.


Subject(s)
Anaphylaxis/epidemiology , Anaphylaxis/etiology , Snake Bites/complications , Snake Bites/epidemiology , Aged , Anaphylaxis/therapy , Anti-Bacterial Agents/administration & dosage , Antivenins/administration & dosage , Ceftriaxone/administration & dosage , Clindamycin/administration & dosage , Female , Humans , Portugal/epidemiology , Snake Bites/therapy , Tetanus Toxoid/administration & dosage , Treatment Outcome
2.
J Allergy Clin Immunol Pract ; 10(3): 827-836, 2022 03.
Article in English | MEDLINE | ID: covidwho-1587394

ABSTRACT

BACKGROUND: COVID-19 mRNA vaccination-associated acute-onset hypersensitivity reactions have caused anxiety and may be contributing to vaccine hesitancy. OBJECTIVE: To determine the incidence, severity, and risk factors for treated acute-onset COVID-19 mRNA vaccination-associated hypersensitivity reactions in a well-characterized population. METHODS: All Kaiser Permanente Southern California (KPSC) members who received COVID-19 mRNA vaccinations between December 15, 2020, and March 11, 2021, at a KPSC facility were identified and characterized, along with all treated acute-onset vaccination-associated hypersensitivity events. RESULTS: We identified 391,123 unique vaccine recipients (59.18% female, age 64.19 ± 17.86 years); 215,156 received 2 doses (53.54% Moderna), 157,615 only a first dose (50.13% Moderna) (1961 [1.46%] >2 weeks late getting a second dose), and 18,352 (74.43% Moderna) only a second dose. Only 104 (0.028%) (85.58% female, age 53.18 ± 15.96 years) had treated first dose events, 68 (0.030%) Moderna. Only 32 (0.014%) (93.75% female, age 57.28 ± 17.09 years) had treated second dose events, 21 (0.016%) Moderna. Only 2 (0.00033%) vaccinations resulted in anaphylaxis. Only 27 (20.77%) of those with treated first dose reactions failed to get a second dose. Only 6 of 77 (7.8%) with first dose reactions also had second dose reactions. Individuals with treated events were more likely to be female (P < .0001), younger (P < .0001), and had more pre-existing drug "allergies" (2.11 ± 2.12 vs 1.02 ± 1.41 [P < .0001] for average recipients). CONCLUSIONS: Treated acute-onset hypersensitivity events were mostly benign, more common with first COVID-19 mRNA vaccine doses, more likely to occur in younger females with typical risk factors associated with multiple drug intolerance syndrome, and very unlikely to be primarily immunologically mediated.


Subject(s)
Anaphylaxis , COVID-19 , Adult , Aged , Aged, 80 and over , Anaphylaxis/epidemiology , Anaphylaxis/etiology , COVID-19/epidemiology , COVID-19 Vaccines/adverse effects , Female , Humans , Incidence , Male , Middle Aged , RNA, Messenger , Risk Factors , SARS-CoV-2 , Vaccination/adverse effects , Vaccines, Synthetic
3.
Vaccine ; 40(3): 477-482, 2022 01 24.
Article in English | MEDLINE | ID: covidwho-1569120

ABSTRACT

BACKGROUND: Acute adverse events and anaphylaxis were reported after the administration of coronavirus disease (COVID-19) mRNA vaccines. We aim to explore the nature and outcome of adverse events following BNT162B2 vaccine in a community vaccination center, Riyadh, Saudi Arabia. METHOD: Within 30 min post vaccination, all acute adverse events (AAEs) that occurred before March 31st, 2021, and in people older than 16 years were reviewed (AAE group). We used the case definition of Brighton collaboration on vaccine safety to define anaphylaxis. Patients' demographics, comorbidities, allergy history, and outcome at disposition were collected. Observation duration after vaccination was short (<15 min) or extended (<3 h). Statistical analysis was performed to study AAEs association with the study variables and outcomes. RESULTS: Out of 71,221 vaccine recipients, 144 (0.002%) had developed 345 AAEs, at a rate of 48.4 events per 10,000 dose administered. The majority of cases in AAE group were first dose recipients (93.8%) and previously healthy (59%), while the minority had a previous history of allergy (6.3%) or a laboratory-confirmed COVID-19 (4.2%). We found a significant association between female gender and the occurrence of any AAE (p-value = 0.002). Per every 10,000 doses administered, non-anaphylactic AAEs were dizziness (17.8), headache (9.7), nausea (7.1), or syncope (3.2). Only one in every ten AAEs was considered serious and resulted in an extended observation (4.8 per 10,000 doses), but only 1/144 required hospitalization for non-anaphylaxis reasons (0.1 per 10,000 doses). According to the Brighton collaboration definition of anaphylaxis, no single case of high certainty anaphylaxis was recorded. No death was documented in this cohort. CONCLUSION: Acute adverse events due toBNT162b2 vaccinewere rare andmostlynon-seriouswith a tendency to occur more in women. Further prospectivestudieson largervaccine recipientsto evaluatethe incidenceof anaphylaxis in the Saudi population are warranted.


Subject(s)
Anaphylaxis , COVID-19 , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Female , Humans , SARS-CoV-2 , Saudi Arabia/epidemiology
5.
Vaccine ; 40(2): 183-186, 2022 01 21.
Article in English | MEDLINE | ID: covidwho-1537111

ABSTRACT

We retrieved data on 8940 anaphylaxis cases post-COVID-19 vaccination from the US Vaccine Adverse Event Reporting System and the European EudraVigilance from week 52/2020 through week 31/2021 and compared them with those of other vaccines. Overall, 837,830,000 COVID-19 vaccine doses were delivered in the US and Europe during the study period, for which the vaccine name was known. The mean anaphylaxis rate was estimated at 10.67 cases per 106 doses of COVID-19 vaccines (range: 7.99-19.39 cases per 106 doses depending on the vaccine). COVID-19 vaccines ranked fifth in reported anaphylaxis rates, behind rabies, tick-borne encephalitis, measles-mumps-rubella-varicella, and human papillomavirus vaccines (70.77, 20, 19.8, and 13.65 cases per 106 vaccine doses, respectively). COVID-19 vaccines are within the range of anaphylaxis rates reported across several common vaccines in these two passive reporting systems. These data should be communicated to reassure the general population about the safety profile of COVID-19 vaccines.


Subject(s)
Anaphylaxis , COVID-19 , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , COVID-19 Vaccines , Humans , Infant , Measles-Mumps-Rubella Vaccine/adverse effects , Mumps Vaccine , SARS-CoV-2
6.
J Allergy Clin Immunol Pract ; 9(11): 3911-3917, 2021 11.
Article in English | MEDLINE | ID: covidwho-1503461

ABSTRACT

Overdiagnosis of anaphylaxis risk is an underappreciated aspect of anaphylaxis prevention. Whereas the benefits of anaphylaxis-risk prevention are well known, potential harms resulting from preemptive approaches to mitigate anaphylaxis-risk are not insignificant. Still, great progress has been made in recent years to avoid the unintended consequences of anaphylaxis-risk overdiagnosis. Reflection on recent advances in the use of diagnostic testing, as well as the application of diagnostic labels, provides an important perspective to understand how far the specialty of allergy and immunology has come in improving the lives of patients and families. Examples of recent paradigm shifts in anaphylaxis-risk management include approaches to peanut allergy prevention without screening, deferral of corticosteroids to prevent biphasic anaphylaxis reactions, reevaluation of reflex use of emergency medical services for resolved community anaphylaxis, and an approach to penicillin allergy delabeling with direct oral challenge. Routine medical practices to decrease anaphylaxis risk can have lifelong impacts for patients-beyond just preventing anaphylaxis. As our understanding of these trade-offs evolves, it becomes necessary to weigh both the benefits and the harms of past management approaches. Because medicine remains a science of uncertainty and an art of probability, a critical approach to risk mitigation remains necessary to find the often-elusive balance in anaphylaxis prevention.


Subject(s)
Anaphylaxis , Drug Hypersensitivity , Peanut Hypersensitivity , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , Anaphylaxis/prevention & control , Arachis , Humans , Penicillins
7.
JAMA ; 326(14): 1390-1399, 2021 10 12.
Article in English | MEDLINE | ID: covidwho-1490611

ABSTRACT

Importance: Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy. Objectives: To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population. Design, Setting, and Participants: This study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021. Exposures: Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2. Main Outcomes and Measures: Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted. Results: A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273. Conclusions and Relevance: In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.


Subject(s)
COVID-19 Vaccines/adverse effects , Adolescent , Adult , Aged , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Child , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocarditis/epidemiology , Myocarditis/etiology , Public Health Surveillance , Time Factors , Vaccines, Synthetic/adverse effects , Young Adult
8.
Am J Trop Med Hyg ; 106(1): 342-344, 2021 10 25.
Article in English | MEDLINE | ID: covidwho-1485312

ABSTRACT

Although rare in Portugal, snakebite envenoming entails severe morbidity and mortality. We present the case of a 65-year-old woman bitten on her leg in a northern coastal region in Portugal, on a walk during the COVID-19 pandemic lockdown. Despite first looking for help at the nearest pharmacy, she developed anaphylactoid shock and was promptly driven to a tertiary hospital, where antivenom was administered in a timely manner under close monitoring. Prophylactic antibiotics were started and maintained based on elevated inflammatory markers and signs of wound inflammation. She evolved favorably, with rapid weaning of vasopressors and resolution of end-organ dysfunction. This case highlights the importance of prompt recognition and describes crucial steps in envenomation management in a country where snakebite is infrequent, but potentially fatal.


Subject(s)
Anaphylaxis/epidemiology , Anaphylaxis/etiology , Snake Bites/complications , Snake Bites/epidemiology , Aged , Anaphylaxis/therapy , Anti-Bacterial Agents/administration & dosage , Antivenins/administration & dosage , Ceftriaxone/administration & dosage , Clindamycin/administration & dosage , Female , Humans , Portugal/epidemiology , Snake Bites/therapy , Tetanus Toxoid/administration & dosage , Treatment Outcome
10.
Vaccine ; 39(44): 6464-6469, 2021 10 22.
Article in English | MEDLINE | ID: covidwho-1440395

ABSTRACT

Among 6146 hospital employees, 118 subjects with severe allergic background were identified through a screening questionnaire and stratified into 3 groups (Low-risk (LR), Intermediate (IR) and High-risk (HR) group), based on their allergic anamnesis. Data reports on hypersensitivity reactions (HypR) have been collected in both allergic and non-allergic subjects. Seventeen patients (14%) in the allergic population had a HypR after the first, the second or both doses. Skin manifestations were the most frequent ones. Allergic events were more frequent in HR (35%) than IR (10%; p = 0.005) or LR (0%; p = 0.074) subjects. No patient had anaphylaxis. All patients completed the vaccination schedule. 13 HypR occurred in patients without severe allergic background (13/6028, 0,2%) including one (1/6148, 0.016% of total population) WAO grade-4 anaphylaxis. Our data suggest that BNT162b2 mRNA Covid-19 vaccine is relatively safe also in patients with severe allergic background; however, some precautions are required for high-risk patients.


Subject(s)
Anaphylaxis , COVID-19 , Vaccines , Algorithms , Anaphylaxis/chemically induced , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , COVID-19 Vaccines , Humans , SARS-CoV-2 , Vaccines/adverse effects
11.
JAMA ; 326(14): 1390-1399, 2021 10 12.
Article in English | MEDLINE | ID: covidwho-1391514

ABSTRACT

Importance: Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy. Objectives: To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population. Design, Setting, and Participants: This study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021. Exposures: Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2. Main Outcomes and Measures: Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted. Results: A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273. Conclusions and Relevance: In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.


Subject(s)
COVID-19 Vaccines/adverse effects , Adolescent , Adult , Aged , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Child , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocarditis/epidemiology , Myocarditis/etiology , Public Health Surveillance , Time Factors , Vaccines, Synthetic/adverse effects , Young Adult
12.
JAMA Netw Open ; 4(8): e2122255, 2021 08 02.
Article in English | MEDLINE | ID: covidwho-1378909

ABSTRACT

Importance: Allergic reactions among some individuals who received the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine discourage patients with allergic conditions from receiving this vaccine and physicians from recommending the vaccine. Objective: To describe the assessment and immunization of highly allergic individuals with the BNT162b2 vaccine. Design, Setting, and Participants: In a prospective cohort study from December 27, 2020, to February 22, 2021, 8102 patients with allergies who applied to the COVID 19 vaccine referral center at the Sheba Medical Center underwent risk assessment using an algorithm that included a detailed questionnaire. High-risk patients (n = 429) were considered "highly allergic" and were immunized under medical supervision. Exposures: Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Main Outcomes and Measures: Allergic and anaphylactic reactions after the first and second doses of BNT162b2 vaccine among highly allergic patients. Results: Of the 429 individuals who applied to the COVID-19 referral center and were defined as highly allergic, 304 (70.9%) were women and the mean (SD) age was 52 (16) years. This highly allergic group was referred to receive immunization under medical supervision. After the first dose of the BNT162b2 vaccine, 420 patients (97.9%) had no immediate allergic event, 6 (1.4%) developed minor allergic responses, and 3 (0.7%) had anaphylactic reactions. During the study period, 218 highly allergic patients (50.8%) received the second BNT162b2 vaccine dose, of which 214 (98.2%) had no allergic reactions and 4 patients (1.8%) had minor allergic reactions. Other immediate and late reactions were comparable with those seen in the general population, except for delayed itch and skin eruption, which were more common among allergic patients. Conclusions and Relevance: The rate of allergic reactions to BNT162b2 vaccine, is higher among patients with allergies, particularly among a subgroup with a history of high-risk allergies. This study suggests that most patients with a history of allergic diseases and, particularly, highly allergic patients can be safely immunized by using an algorithm that can be implemented in different medical facilities and includes a referral center, a risk assessment questionnaire, and a setting for immunization under medical supervision of highly allergic patients. Further studies are required to define more specific risk factors for allergic reactions to the BNT162b2 vaccine.


Subject(s)
Anaphylaxis/etiology , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Vaccination/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Anaphylaxis/epidemiology , Female , Humans , Hypersensitivity/epidemiology , Hypersensitivity/etiology , Male , Middle Aged , Prevalence , Prospective Studies , Risk Assessment , SARS-CoV-2 , Young Adult
13.
Vaccine ; 39(38): 5368-5375, 2021 09 07.
Article in English | MEDLINE | ID: covidwho-1377852

ABSTRACT

BACKGROUND: Anaphylaxis is a rare, serious allergic reaction. Its identification in large healthcare databases can help better characterize this risk. OBJECTIVE: To create an ICD-10 anaphylaxis algorithm, estimate its positive predictive values (PPVs) in a post-vaccination risk window, and estimate vaccination-attributable anaphylaxis rates in the Medicare Fee For Service (FFS) population. METHODS: An anaphylaxis algorithm with core and extended portions was constructed analyzing ICD-10 anaphylaxis claims data in Medicare FFS from 2015 to 2017. Cases of post-vaccination anaphylaxis among Medicare FFS beneficiaries were then identified from October 1, 2015 to February 28, 2019 utilizing vaccine relevant anaphylaxis ICD-10 codes. Information from medical records was used to determine true anaphylaxis cases based on the Brighton Collaboration's anaphylaxis case definition. PPVs were estimated for incident anaphylaxis and the subset of vaccine-attributable anaphylaxis within a 2-day post-vaccination risk window. Vaccine-attributable anaphylaxis rates in Medicare FFS were also estimated. RESULTS: The study recorded 66,572,128 vaccinations among 21,685,119 unique Medicare FFS beneficiaries. The algorithm identified a total of 190 suspected anaphylaxis cases within the 2-day post-vaccination window; of these 117 (62%) satisfied the core algorithm, and 73 (38%) additional cases satisfied the extended algorithm. The core algorithm's PPV was 66% (95% CI [56%, 76%]) for identifying incident anaphylaxis and 44% (95% CI [34%, 56%]) for vaccine-attributable anaphylaxis. The vaccine-attributable anaphylaxis incidence rate after any vaccination was 0.88 per million doses (95% CI [0.67, 1.16]). CONCLUSION: The ICD-10 claims algorithm for anaphylaxis allows the assessment of anaphylaxis risk in real-world data. The algorithm revealed vaccine-attributable anaphylaxis is rare among vaccinated Medicare FFS beneficiaries.


Subject(s)
Anaphylaxis , Vaccines , Aged , Algorithms , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Humans , Incidence , International Classification of Diseases , Medicare , United States/epidemiology , Vaccines/adverse effects
14.
Euro Surveill ; 26(33)2021 Aug.
Article in English | MEDLINE | ID: covidwho-1367740

ABSTRACT

The South Korea mass vaccination programme administered 3.8 million doses of COVID-19 vaccinations between 26 February and 30 April 2021. After 173 suspected anaphylaxis reports to the nationwide monitoring system for adverse events following immunisation, 44 anaphylaxis cases were confirmed using Brighton Collaboration case definitions. The rates per million doses were 18.2 cases and 6.2 cases for Vaxzevria and Comirnaty, respectively. Median time of onset was 14 min after vaccination and most cases had recovered at the time of review.


Subject(s)
Anaphylaxis , COVID-19 , Anaphylaxis/chemically induced , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , Humans , Mass Vaccination , Republic of Korea/epidemiology , SARS-CoV-2 , Vaccination/adverse effects
15.
Drug Saf ; 44(11): 1209-1214, 2021 11.
Article in English | MEDLINE | ID: covidwho-1340491

ABSTRACT

INTRODUCTION: In mid-February, the nationwide immunization plan for the prevention of coronavirus disease 2019 (COVID-19) started in Japan (at first primarily focused on health professionals) using an mRNA-based vaccine (Pfizer/BioNTech). During the phase-in period from February to March, attention was focused on post-vaccination anaphylaxis and anaphylactoid symptoms from the viewpoint of ensuring the safety of the vaccination program. OBJECTIVE: The aim of this report was to provide an update on the status of anaphylaxis and anaphylactoid symptoms occurring after vaccination for COVID-19, as reported under the Adverse Event Following Immunization (AEFI) reporting system in Japan. METHODS: The Pharmaceutical and Medical Devices Agency (PMDA) received AEFI reports from health professionals and manufacturers under the reporting system for AEFI after vaccination for COVID-19, which has been in operation since mid-February 2021. Reported AEFIs of anaphylaxis and anaphylactoid symptoms were assessed using the Brighton Collaboration Criteria to assess diagnostic certainty. RESULTS: 1-month since Japan started the vaccination program for COVID-19 in February 2021, 578,835 doses have been administered to health professionals, with the PMDA receiving 181 suspected event reports of anaphylaxis and anaphylactoid symptoms. In 171 of these 181 cases, women developed these symptoms. Among 181 cases evaluated according to the Brighton Collaboration Criteria, 47 cases (26%) were classified as level 1-3 (reporting rate: 8.1/100,000 doses). CONCLUSION: The results appear similar to reported AEFIs in foreign studies of coronavirus vaccine administration to health professionals, although the reporting rate was higher. Further work is needed to examine the causal relationship of anaphylaxis reactions to coronavirus vaccine administration. Issues of multiple reporting and possible sex/age bias also remain to be analyzed.


Subject(s)
Adverse Drug Reaction Reporting Systems , Anaphylaxis/chemically induced , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Adolescent , Adult , Aged , Anaphylaxis/epidemiology , COVID-19/epidemiology , Female , Humans , Japan/epidemiology , Male , Middle Aged , SARS-CoV-2
16.
Curr Opin Allergy Clin Immunol ; 21(5): 411-417, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1337288

ABSTRACT

PURPOSE OF REVIEW: Anaphylactic reactions reported after Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) RNA vaccines were expected to be more frequent in atopic subjects and attributed to its polyethylene glycol component. RECENT FINDINGS: Anaphylaxis to SARS-CoV2 RNA vaccines is no more frequent than in any vaccine and direct proofs for the role of its polyethylene glycol component are lacking. SUMMARY: Vaccines against coronavirus disease 2019 (COVID-19) are an essential global intervention to control the current pandemic situation. Anaphylactic reactions have rapidly been reported after SARS-CoV2 RNA vaccines. This risk is now measured at 2.5-11/1 000 000 in the context of vaccine safety surveillance programs and only one case was documented to be due to polyethylene glycol. Suggestions for its role are indirect. The COVID-19 vaccination is rolling out vastly and surveillance programs are key to monitor severe adverse reactions, such as anaphylaxis. Anaphylaxis due to vaccine is extremely rare and specific cases should receive individualized investigation and care, highlighting the key role of allergists in the vaccination programmes.


Subject(s)
Anaphylaxis/immunology , COVID-19 Vaccines/adverse effects , Adverse Drug Reaction Reporting Systems , Anaphylaxis/epidemiology , Animals , COVID-19 Vaccines/chemistry , COVID-19 Vaccines/immunology , Female , Humans , Hypersensitivity/immunology , Male , Polyethylene Glycols/adverse effects , Sex Characteristics
18.
Curr Opin Allergy Clin Immunol ; 21(5): 418-425, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1315706

ABSTRACT

PURPOSE OF REVIEW: This review aims to provide an updated report in regards to the correlation between vaccines and anaphylaxis and the related risk in the population. RECENT FINDINGS: Initial reports showed higher incidence of anaphylaxis following messenger RNA COVID-19 vaccines compared with 'routine' vaccinations, likely influenced by the great attention paid to these 'new' vaccines. However, anaphylaxis has still to be considered quite rare and its incidence will be systematically reconsidered in the light of additional data collected. SUMMARY: Adverse reactions to vaccines are commonly reported but most of them are nonspecific mild events, whereas vaccine-related anaphylaxis is considered a rare event, with an incidence rate equal to 1.3 cases per million vaccine doses administered. As anaphylaxis reports usually start to be reported to passive pharmacovigilance during postmarketing surveillance, the first data are used to be influenced by under- and over-reporting and lack of denominators and following studies are needed to confirm the causal relationship. This might create an initial overcautiously approach to new immunization practices but, being anaphylaxis a potential life-threatening event, every suspected contraindication has to be deepened to maximize effectiveness and safety profile and constantly redefined not to exclude an overestimated population group who could receive the vaccine uneventfully.


Subject(s)
Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , COVID-19 Vaccines/adverse effects , Anaphylaxis/immunology , COVID-19 Vaccines/chemistry , COVID-19 Vaccines/immunology , Female , Humans , Male , Vaccines/adverse effects , Vaccines/chemistry
19.
Vaccine ; 39(32): 4407-4409, 2021 07 22.
Article in English | MEDLINE | ID: covidwho-1284600

ABSTRACT

Two mRNA vaccines for COVID-19, Pfizer-BioNTech and Moderna, are approved for emergency use in the United States. After their approval and dosing in millions of recipients, reports of anaphylaxis began to appear in the Vaccine Adverse Reporting System (VAERS). Here we provide an analysis of the relationship between prior history of allergy and/or anaphylaxis and anaphylaxis rates following the administration of mRNA COVID-19 vaccines. Overall reported incidence of anaphylaxis was estimated to be rare at 4.2 cases per million doses. It appeared that the relative incidence of anaphylaxis following administration of these COVID-19 vaccines was two and seven times higher for recipients with a prior history of allergies and/or anaphylaxis, respectively. This report provides valuable metrics to make evidence-based decisions for subjects with pre-existing allergic conditions receiving a COVID-19 mRNA vaccine.


Subject(s)
Anaphylaxis , COVID-19 , Vaccines , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , COVID-19 Vaccines , Humans , RNA, Messenger/genetics , SARS-CoV-2 , United States/epidemiology , Vaccines/adverse effects
20.
J Allergy Clin Immunol Pract ; 9(10): 3546-3567, 2021 10.
Article in English | MEDLINE | ID: covidwho-1275424

ABSTRACT

Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.


Subject(s)
Anaphylaxis , COVID-19 , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , COVID-19 Vaccines , Consensus , GRADE Approach , Humans , RNA, Viral , SARS-CoV-2
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