Incidence of Guillain-Barré syndrome following SARS-CoV-2 immunization: Analysis of a nationwide registry of recipients of 81 million doses of seven vaccines.

BACKGROUND AND PURPOSE: Information on Guillain-Barré syndrome (GBS) as an adverse event following immunization (AEFI) against SARS-CoV-2 remains scarce. We aimed to report GBS incidence as an AEFI among adult (≥18 years) recipients of 81,842,426 doses of seven anti-SARS-CoV-2 vaccines between December 24, 2020, and October 29, 2021, in Mexico. METHODS: Cases were retrospectively collected through passive epidemiological surveillance. The overall observed incidence was calculated according to the total number of administered doses. Vaccines were analyzed individually and by vector as mRNA-based (mRNA-1273 and BNT162b2), adenovirus-vectored (ChAdOx1 nCov-19, rAd26-rAd5, Ad5-nCoV, and Ad26.COV2-S), and inactivated whole-virion-vectored (CoronaVac) vaccines. RESULTS: We identified 97 patients (52 males [53.6%]; median [interquartile range] age 44 [33-60] years), for an overall observed incidence of 1.19/1,000,000 doses (95% confidence interval [CI] 0.97-1.45), with incidence higher among Ad26.COV2-S (3.86/1,000,000 doses, 95% CI 1.50-9.93) and BNT162b2 recipients (1.92/1,00,000 doses, 95% CI 1.36-2.71). The interval (interquartile range) from vaccination to GBS symptom onset was 10 (3-17) days. Preceding diarrhea was reported in 21 patients (21.6%) and mild COVID-19 in four more (4.1%). Only 18 patients were tested for Campylobacter jejuni (positive in 16 [88.9%]). Electrophysiological examinations were performed in 76 patients (78.4%; axonal in 46 [60.5%] and demyelinating in 25 [32.8%]); variants were similar across the platforms. On admission, 91.8% had a GBS disability score ≥3. Seventy-five patients (77.3%) received intravenous immunoglobulin, received seven plasma exchange (7.2%), and 15 (15.5%) were treated conservatively. Ten patients (10.3%) died, and 79.1% of survivors were unable to walk independently. CONCLUSIONS: Guillain-Barré syndrome was an extremely infrequent AEFI against SARS-CoV-2. The protection provided by these vaccines outweighs the risk of developing GBS.

Psychological and Psychiatric Events Following Immunization with Five Different Vaccines against SARS-CoV-2.

BACKGROUND: Despite the high number of vaccines administered against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) worldwide, the information on the psychological/psychiatric adverse events following immunization (AEFI) with these newly developed vaccines remains scarce. OBJECTIVE: To describe the frequency of psychological/psychiatric symptoms among recipients of five different anti-SARS-CoV-2 vaccines and to explore the factors associated with their development reported in the nationwide Mexican registry of AEFI against SARS-CoV-2. METHODS: Descriptive study of all the psychological/psychiatric symptoms, including anxiety, panic attacks, insomnia, and agitation reported to the Mexican Epidemiological Surveillance System from 21 December 2020 to 27 April 2021, among adult (≥18 years old) recipients of 7,812,845 doses of BNT162b2, ChAdOx1 nCov-19, rAd26-rAd5, Ad5-nCoV, or CoronaVac. The factors associated with their development are determined by multivariate regression analysis. RESULTS: There were 19,163 AEFI reports during the study period; amongst them, 191 (1%) patients had psychological/psychiatric symptoms (median age of 41 years, interquartile range of 32-54; 149 [78%] women) for an observed incidence of 2.44 cases per 100,000 administered doses (95% confidence interval [CI] 2.12-2.82), 72.8% of psychiatric AEFIs were reported among recipients of BNT162b2. The median time from vaccination to symptom onset was 35 min (interquartile range: 10-720). Overall, the most common psychological/psychiatric symptoms were anxiety in 129 (67.5%) patients, panic attacks in 30 (15.7%), insomnia in 25 (13%), and agitation in 11 (5.7%). After adjusting for the confounding factors, the odds for developing psychological/psychiatric symptoms were higher for those concurrently reporting syncope (odds ratio [OR]: 4.73, 95% CI: 1.68-13.33); palpitations (OR: 2.47, 95% CI: 1.65-3.70), and dizziness (OR: 1.59, 95% CI: 1.10-2.28). CONCLUSION: In our population, psychological/psychiatric symptoms were extremely infrequent AEFIs. No severe psychiatric AEFIs were reported. Immunization stress-related responses might explain most of the detected cases.

Seizures following COVID-19 vaccination in Mexico: A nationwide observational study.

The COVID-19 pandemic led to the development and emergency approval of an array of effective vaccines against SARS-CoV-2. Given the relatively small number of patients included in vaccine trials, postapproval epidemiological surveillance is crucial to detect infrequent vaccine-related adverse events. We conducted a nationwide retrospective descriptive study evaluating the incidence of seizures among recipients of SARS-CoV-2 vaccines in Mexico from December 24, 2020 (date of administration of first doses nationwide) to October 29, 2021. Among 81 916 351 doses of any vaccine that were administered, we documented seizures in 53 patients, of which 31 (60%) were new onset seizures. The incidence rate of seizures per million doses was highest for mRNA-1273 (Moderna) with 2.73 per million, followed by BNT162b2 (Pfizer-BioNTech) with 1.02 per million, and Ad5-nCoV (CanSino) with 1.01 per million. Thus, we found that seizures following SARS-CoV-2 vaccination are exceedingly rare events.

Stroke Among SARS-CoV-2 Vaccine Recipients in Mexico: A Nationwide Descriptive Study.

BACKGROUND AND OBJECTIVES: Information on stroke among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines remains scarce. We report stroke incidence as an adverse event following immunization (AEFI) among recipients of 79,399,446 doses of 6 different SARS-CoV-2 vaccines (BNT162b2, ChAdOx1 nCov-19, Gam-COVID-Vac, CoronaVac, Ad5-nCoV, and Ad26.COV2-S) between December 24, 2020, and August 31, 2021, in Mexico. METHODS: This retrospective descriptive study analyzed stroke incidence per million doses among hospitalized adult patients (≥18 years) during an 8-month interval. According to the World Health Organization, AEFIs were defined as clinical events occurring within 30 days after immunization and categorized as either nonserious or serious, depending on severity, treatment, and hospital admission requirements. Acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), and cerebral venous thrombosis (CVT) cases were collected through a passive epidemiologic surveillance system in which local health providers report potential AEFI to the Mexican General Board of Epidemiology. Data were captured with standardized case report formats by an ad hoc committee appointed by the Mexican Ministry of Health to evaluate potential neurologic AEFI against SARS-COV-2. RESULTS: We included 56 patients (31 female patients [55.5%]) for an overall incidence of 0.71 cases per 1,000,000 administered doses (95% CI 0.54-0.92). Median age was 65 years (interquartile range [IQR] 55-76 years); median time from vaccination to stroke (of any subtype) was 2 days (IQR 1-5 days). In 27 (48.2%) patients, the event was diagnosed within the first 24 hours after immunization. The most frequent subtype was AIS in 43 patients (75%; 0.54 per 1,000,000 doses, 95% CI 0.40-0.73), followed by ICH in 9 (16.1%; 0.11 per 1,000,000 doses, 95% CI 0.06-0.22) and SAH and CVT, each with 2 cases (3.6%; 0.03 per 1,000,000 doses, 95% CI 0.01-0.09). Overall, the most common risk factors were hypertension in 33 (58.9%) patients and diabetes in 22 (39.3%). Median hospital length of stay was 6 days (IQR 4-13 days). At discharge, functional outcome was good (modified Rankin Scale score 0-2) in 41.1% of patients; in-hospital mortality rate was 21.4%. DISCUSSION: Stroke is an exceedingly rare AEFI against SARS-CoV-2. Preexisting stroke risk factors were identified in most patients. Further research is needed to evaluate causal associations between SARS-COV-2 vaccines and stroke.

Transient sensory symptoms among first-dose recipients of the BNT162b2 mRNA COVID-19 vaccine: A case-control study.

mRNA-based COVID-19 vaccines are effective; however, persistent vaccine hesitancy is partly due to a misperception of their potential adverse events. Non-specific sensory symptoms (NSSS) following immunization are thought to be mediated by stress-related responses. In this case-control study, we evaluated NSSS from a cohort of 7,812,845 BNT162b2 first-dose recipients, of whom 10,929 reported an adverse event following immunization (AEFI). We found an overall frequency of 3.4% (377 cases) or 4.8 cases per 100,000 doses administered. Anatomically, the arms (61%) and face/neck region (36.2%) were the most commonly affected sites. The control group had significantly higher rates of reactogenicity-associated symptoms, suggesting that NSSS are reactogenicity-independent; in multivariable analysis, healthcare workers reported sensory symptoms less frequently (aOR 0.54; 95% CI 0.40-0.72;p < 0.001). This is the first study describing the topography and associated factors for developing NSSS among BNT162b2 recipients. The benign nature of these symptoms may help dissipate hesitation towards this vaccine.