scholarly journals Anaphylactic events in mRNA vaccines: a reporting case-control study

2021 ◽  
Author(s):  
Chris von Csefalvay
Keyword(s):  
Adverse Events ◽  
Anaphylactoid Reaction ◽  
Case Control Study ◽  
Quantitative Estimation ◽  
Rare Complication ◽  
Case Control ◽  
Vaccine Hesitancy ◽  
Reporting Odds Ratio ◽  
Anaphylactoid Reactions ◽  
Control Study

Background: mRNA vaccines are a novel method of eliciting immunity, and play a significant role in the global fight against COVID-19. Anaphylactic reactions are a widespread concern driving vaccine hesitancy due to the serious and potentially fatal nature of anaphylaxis. A quantitative estimation of the risk of anaphylactic and anaphylactoid reactions deriving from mRNA vaccines is of a significant public health importance. Objective: To estimate the relative Reporting Odds Ratio of anaphylactic and anaphylactoid reactions following mRNA vaccination vis-a-vis other vaccinations. Design: Reporting case-control study. Setting: Persons reporting adverse events following vaccination to VAERS whose reports were received between 01 January 2000 and 02 July 2021, inclusive. Patients: Each case of anaphylaxis or anaphylactoid reaction was matched with 2.7 unique controls on average, by gender and age rounded to the nearest integer. Measurements: Overall and stratified Reporting Odds Ratios (ROR) were calculated. Stratified contingency tables were tested for homogeneity using the Breslow-Day procedure, and Cochran-Mantel-Haenszel statistics were calculated to test the hypothesis of a ROR of unity. Results: 2,665 cases of anaphylaxis or anaphylactoid reactions and 7,125 controls of non-anaphylactic/anaphylactoid reports were compared. The ROR of an anaphylactic or anaphylactoid reaction was 1.325 (95% CI: 1.212 - 1.448, p < 0.001). The matched set of cases and controls did not reveal inhomogeneity by gender or age band strata, suggesting that these factors have no impact on the likelihood to report an anaphylactic event as opposed to a non-anaphylactic event following mRNA vaccination. A slightly elevated ROR was observed with patients who reported a history of allergic reactions to NSAIDs and/or fluoroquinolone antibiotics. The precise meaning and relevance of this finding remains to be elucidated. Previous reactions to vaccines do not appear to correlate statistically significantly with a higher risk of reporting an anaphylactic adverse effect after mRNA vaccination. Limitations: As a reporting study using data from VAERS, our analysis is subject to under- and overreporting, the extent of each of which is not known with any degree of precision. Since the Emergency Use Authorizations for both mRNA vaccines mandate reporting of all serious adverse events, reporting bias is likely in favour of non- mRNA vaccines, where such reporting is not mandatory in adults. Consequently, this analysis may exaggerate the ROR of anaphylactic and anaphylactoid events associated with mRNA vaccines, which may in reality be significantly lower. Conclusions: mRNA vaccination is not associated with a statistically significant higher risk of reporting an anaphylactic adverse event to VAERS. Anaphylaxis is a serious but very rare complication of all immunisations. No significant increase in reporting odds was found in any age group or gender, nor in most cases of previously known allergic adverse events in relation to vaccines. This study contributes to the growing body of evidence proving the safety and tolerability of mRNA vaccines.

scholarly journals Pre-vaccination vulnerability and suspected adverse events following HPV vaccination. A case-control study nested in the Danish national birth cohort

Vaccine ◽  
2021 ◽  
Vol 39 (43) ◽  
pp. 6364-6369
Author(s):  
Anna Melgaard ◽  
Lene Wulff Krogsgaard ◽  
Tina Hovgaard Lützen ◽  
Oleguer Plana-Ripoll ◽  
Bodil Hammer Bech ◽  
...  
Keyword(s):  
Adverse Events ◽  
Birth Cohort ◽  
Case Control Study ◽  
Hpv Vaccination ◽  
Case Control ◽  
Danish National Birth Cohort ◽  
Control Study

Midazolam for urethral catheterisation in female infants with suspected urinary tract infection: a case-control study

2013 ◽  
Vol 31 (4) ◽  
pp. 278-280 ◽  
Author(s):  
Itai Shavit ◽  
Liat Feraru ◽  
Dan Miron ◽  
Giora Weiser
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Length Of Stay ◽  
Adverse Events ◽  
Case Control Study ◽  
Case Control ◽  
Serious Adverse Events ◽  
Urethral Catheterisation ◽  
Intranasal Midazolam ◽  
Control Study

ObjectivesBased on the 2010 Israeli Medical Association recommendations, young children with suspected urinary tract infection (UTI) are mildly sedated with oral or intranasal midazolam to reduce the distress associated with urethral catheterisation (UC). The primary objective of this study was to examine the rate of urine culture contamination (UCC) in infants who underwent UC with and without sedation. Other objectives were to evaluate serious adverse events and emergency department (ED) length of stay.MethodsA retrospective case-control study was conducted in a paediatric ED.ResultsTwo cohorts of patients who underwent UC were compared, 164 female infants who were sedated with midazolam (case subjects) and 173 who were not (controls). Cases and controls had a mean temperature of 38.3°C and 38.2°C, respectively. One hundred and forty-one patients were treated with oral midazolam and 23 received the drug intranasally. Cases and controls had a UCC rate of 20/164 (12%) and 45/173 (26%), respectively. Compared with controls, cases had lower odds of UCC (OR=0.39, 95% CI 0.21 to 0.73).Serious adverse events related to midazolam were not recorded. Case subjects and controls had a mean ED length of stay of 2.96 h and 2.50 h, respectively. The difference between the groups was statistically significant (p<0.014, 95% CI 0.10 to 0.90 for difference between means).ConclusionsIn this cohort of febrile infants, sedation with oral or intranasal midazolam reduced the risk of culture contamination during UC without causing serious adverse events. However, patients who were treated with sedation had longer length of stay in the ED.

scholarly journals Case-control study to investigate variables associated with incidents and adverse events in the emergency department

2017 ◽  
Vol 29 (2) ◽  
pp. 149-157 ◽  
Author(s):  
Jamie Hendrie ◽  
Michael Yeoh ◽  
Jo Richardson ◽  
Andrew Blunt ◽  
Peter Davey ◽  
...  
Keyword(s):  
Emergency Department ◽  
Adverse Events ◽  
Case Control Study ◽  
Case Control ◽  
Control Study

Pediatric perioperative adverse events requiring rapid response: a retrospective case-control study

2016 ◽  
Vol 26 (7) ◽  
pp. 734-741 ◽  
Author(s):  
Laura E. Schleelein ◽  
Ariel M. Vincent ◽  
Abbas F. Jawad ◽  
Eric Y. Pruitt ◽  
Genna D. Kreher ◽  
...  
Keyword(s):  
Adverse Events ◽  
Case Control Study ◽  
Case Control ◽  
Rapid Response ◽  
Retrospective Case ◽  
Control Study

scholarly journals A case-control study of autoimmune AEFIs following COVID-19 vaccination reported to VAERS

2021 ◽  
Author(s):  
Chris von Csefalvay
Keyword(s):  
Myasthenia Gravis ◽  
Case Control Study ◽  
Case Reports ◽  
Transverse Myelitis ◽  
Case Control ◽  
Vaccine Hesitancy ◽  
Control Analysis ◽  
Safety Signal ◽  
Case Control Analysis ◽  
Control Study

Autoimmune adverse effects following immunisation (AEFIs) are widely regarded as a chief concern driving vaccine hesitancy. This case-control study seeks to shed light on the true risk of autoimmune AEFIs associated with the COVID-19 vaccine through a case-control analysis of VAERS reports. Reports of autoimmune aetiology were matched with reports of non-autoimmune controls. Statistical analysis reveals that the safety profile of COVID-19 vaccines with regard to autoimmune AEFIs is highly favourable. In particular, neuroautoimmune AEFIs have statistically significant reporting odds ratios below unity (Guillain-Barre syndrome: 0.35, multiple sclerosis: 0.70, transverse myelitis: 0.79), indicating a reduced association of reports of these conditions with the COVID-19 vaccine versus other vaccines. Only three autoimmune aetiologies exceed a ROR of 2.0 and thus present a potential signal. Of these, myasthenia gravis (ROR = 3.90, p < 0.001, 95% CI: 2.63-5.80) may be the result of epidemiological confounding factors not sufficiently controlled by matching, as the population most likely to develop myasthenia gravis was strongly prioritised in the COVID-19 vaccine's initial rollout. Immune thrombocytopaenia (ROR = 26.83, p < 0.001, 95% CI: 16.93-42.54) is a clear safety signal, confirming a large number of case reports and studies that indicate a risk of immune thrombocytopaenic events following the COVID- 19 vaccine. The lone strong safety signal of immune thrombocytopaenia notwithstanding, this study attests to the safety of the COVID-19 vaccine where autoimmune conditions are concerned. Through quantifying the risk of autoimmune disorders associated with COVID-19 vaccination, this study contributes to a growing body of evidence supporting the safety of such vaccines.

Cytogenetic Response in Relation to the Adherence to Treatment with Imatinib Mesylate: A Case Control Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4553-4553 ◽  
Author(s):  
Carlos Doti ◽  
German Stemmelin ◽  
Claudia Shanley ◽  
Jose Ceresetto ◽  
Oscar Rabinovich ◽  
...  
Keyword(s):  
Adverse Events ◽  
Imatinib Mesylate ◽  
Case Control Study ◽  
Chronic Phase ◽  
Cytogenetic Response ◽  
Case Control ◽  
Control Group ◽  
Hematological Response ◽  
Control Study

Abstract Introduction: The treatment of chronic myeloid leukemia (CML) suffered a dramatic change with the introduction of Imatinib mesylate. This drug has become the choice for first line treatment of CML. However, it has been shown that the effectiveness of the treatment requires a high compliance with the prescribed dose for a long period of time, and sub-dosing has been associated with a delay in achieving cytogenetic response and development of resistance. We conducted a prospective case-control study, in order to analyze how a better compliance affects the cytogenetic response to Imatinib. Materials and Methods: Between January and June 2006, 24 patients with newly diagnosed Phi (+) chronic phase CML were recruited and followed for the next 12 months. Patients were put on 400mg of Imatinib and were asked to note down all taken doses, and reasons for non-compliance. During each of the monthly visits, the dosing schedules were revised, non-adherence reasons were discussed and the medication was counted. All adverse events were noted and graded according to the NCI CTCAE (VERSION 3.0) code. Reductions or interruptions in the schedule were only allowed for related adverse events with a CTC score ≥3. All other events were treated accordingly, without modifications in the Imatinib dosing. As a control group, we matched each case with a chronic phase Phi (+) CML patient from our data base (controls were matched for sex, age, and hematological response). Only patients who received treatment with Imatinib and with complete information about dosing and adverse events were acceptable as controls. Compliance was measured as: mg taken /mg prescribed x 100 during the study period. Cytogenetic response was reported as the percentage of t(9;22) negative metaphases. Results: Twenty-four patients, 14 males with median age 55 yo (range: 23–82) were included in the study; three were lost to follow up, leaving only twenty-one for analysis of compliance. At the end of the year of follow up, all patients have achieved a complete hematological response. Compliance during the 12 months was 96.1 ± 9% 1SD for the cases group, which is clearly superior to the 80% reported in the setting of clinical trials. As for one year cytogenetic response, 60 ± 25% of the control group achieved a mayor response (Phi < 35%), while 89.9 ± 20% of the cases achieved that same response. This difference is statistically significant with a p=0.027. The incidence of adverse events was similar for both groups, being nausea, vomiting, peripheral edema and skin rash the most common ones. As for hematological toxicity, CTC grade 1–2 leucopenia (11%) and thrombocytopenia (17%) were the more frequent. However, although moderate, these were the main reasons for interruption or reduction of Imatinib dosage in the control group. Conclusions: This study shows that improving compliance is associated with a better cytogenetic response. As this response is the ultimate goal in the treatment of CML patients, physicians should make an effort to assure the best adherence to the treatment and avoid sub-dosing. Doing this will help patients obtain a better cytogenetic response which has already proved to be essential for long term survival in CML.

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