Adverse reactions to the first and second doses of Pfizer-BioNTech COVID-19 vaccine among healthcare workers

IntroductionIn the current coronavirus infection 2019 (COVID-19) pandemic, the messenger RNA vaccines have been shown to help protect high-risk groups from COVID-19. Among healthcare workers vaccinated with Pfizer-BioNTech COVID-19 vaccine, a survey was conducted to analyze the relationship between the incidence and severity of adverse reactions after vaccination.MethodsWe conducted a prospective self-reported survey of adverse reactions among healthcare workers vaccinated with the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Japan. After the first and second dose of vaccine, local and systemic reactions for 8 days after vaccination were reported by volunteer participants using a website. After receiving vaccination, 374 respondents participated in this matched-pair study.ResultsBoth the incidence and severity of adverse reactions tended to be higher after the second vaccine dose than after the first dose. However, the incidence and numeric rating scale (NRS) score of muscle and skin pain were nearly the same after the first and second doses. In a comparison by sex, women had significantly higher incidence and NRS scores for adverse reactions such as headache, skin pain, erythema, and itching. The results also showed that younger age groups had higher incidence rates and NRS scores for all adverse reactions investigated, except for muscle pain, compared with older age groups.ConclusionSome adverse reactions to the Pfizer-BioNTech Comirnaty® COVID-19 vaccine showed gender and age differences. However, generally speaking, all side reactions disappear within a week. Therefore, these side reactions are not a significant concern in recommending vaccination.     

Delayed headache after COVID-19 vaccination: a red flag for vaccine induced cerebral venous thrombosis

BackgroundHeadache is a frequent symptom following COVID-19 immunization with a typical onset within days post-vaccination. Cases of cerebral venous thrombosis (CVT) have been reported in adenovirus vector-based COVID-19 vaccine recipients.FindingsWe reviewed all vaccine related CVT published cases by April 30, 2021. We assessed demographic, clinical variables and the interval between the vaccination and onset of headache. We assessed whether the presence of headache was associated with higher probability of death or intracranial hemorrhage.We identified 77 cases of CVT after COVID-19 vaccination. Patients’ age was below 60 years in 74/77 (95.8%) cases and 61/68 (89.7%) were women. Headache was described in 38/77 (49.4%) cases, and in 35/38 (92.1%) was associated with other symptoms. Multiple organ thrombosis was reported in 19/77 (24.7%) cases, intracranial hemorrhage in 33/77 (42.9%) cases and 19/77 (24.7%) patients died. The median time between vaccination and CVT-related headache onset was 8 (interquartile range 7.0–9.7) days. The presence of headache was associated with a higher odd of intracranial hemorrhage (OR 7.4; 95% CI: 2.7–20.8, p < 0.001), but not with death (OR: 0.51, 95% CI: 0.18–1.47, p = 0.213).ConclusionDelayed onset of headache following an adenovirus vector-based COVID-19 vaccine is associated with development of CVT. Patients with new-onset headache, 1 week after vaccination with an adenovirus vector-based vaccine, should receive a thorough clinical evaluation and CVT must be ruled out.Supplementary InformationThe online version contains supplementary material available at 10.1186/s10194-021-01324-5.     

Prolonged migraine aura resembling ischemic stroke following CoronaVac vaccination: an extended case series

BackgroundAfter the initiation of the COVID-19 vaccination program in Thailand, thousands of patients have experienced unusual focal neurological symptoms. We report 8 patients with focal neurological symptoms after receiving inactivated virus vaccine, CoronaVac.Case seriesPatients were aged 24–48 years and 75% were female. Acute onset of focal neurological symptoms occurred within the first 24 h after vaccination in 75% and between 1-7d in 25%. All presented with lateralized sensory deficits, motor deficits, or both, of 2–14 day duration. Migraine headache occurred in half of the patients. Magnetic resonance imaging of the brain during and after the attacks did not demonstrate any abnormalities suggesting ischemic stroke. All patients showed moderately large regions of hypoperfusion and concurrent smaller regions of hyperperfusion on SPECT imaging while symptomatic. None developed permanent deficits or structural brain injury.DiscussionsHere, we present a case series of transient focal neurological syndrome following Coronavac vaccination. The characteristic sensory symptoms, history of migraine, female predominant, and abnormal functional brain imaging without structural changes suggest migraine aura as pathophysiology. We propose that pain related to vaccine injection, component of vaccine, such as aluminum, or inflammation related to vaccination might trigger migraine aura in susceptible patients.Supplementary InformationThe online version contains supplementary material available at 10.1186/s10194-022-01385-0.     

Association between COVID-19 vaccines and the menstrual cycle in young Japanese women

IntroductionAlthough several studies have investigated the association between coronavirus disease 2019 (COVID-19) vaccines and the menstrual cycle, available data are limited. Therefore, this study investigated the effect of COVID-19 vaccines on the menstrual cycle and the effect of the menstrual cycle phase on the vaccine side effects during vaccine administration in Japan.MethodsA self-administered questionnaire was used to collect data on the date of vaccination; type of vaccine; type, grade, and duration of the side effects; regularity of menstruation; normal length of the menstrual cycle; and the day one date of menstruation around vaccination. The survey was conducted from October 2021 to March 2022.ResultsThe difference between the predicted and actual menstrual cycle length was 1.9 ± 3.0, 1.6 ± 2.8 (p = 0.557), and 2.5 ± 3.8 (p = 0.219) days before vaccination and after the first and second dose of the vaccine, respectively. In participants who received vaccinations twice within a single menstrual cycle, this difference was 1.3 ± 3.5 and 3.9 ± 3.3 (p = 0.045) days before and after vaccination, respectively. The grade and proportion of the side effects after the second dose of the vaccine was highest during the menstrual period and lowest during the ovulation period, with a significant effect on headache and chills.ConclusionCOVID-19 vaccines tended to prolong the menstrual cycle. The side effects of the COVID-19 vaccine tended to be at a maximum when vaccination occurred during the menstrual period and minimal during the ovulation period.     

Trends in adolescent COVID-19 vaccination receipt and parental intent to vaccinate their adolescent children,United States,July to October, 2021

IntroductionThere was a five-fold increase in COVID-19 hospitalization case counts among children and adolescents between June and October 2021. However, polls suggest that adolescent COVID-19 vaccination coverage has plateaued in the United States.MethodsUsing the Census Bureau’s Household Pulse Survey, we assessed trends in COVID-19 vaccination among adolescents ages 12–17 years, parents’ intention to vaccinate their adolescent children, and their reasons for not intending to vaccinate their children from July to October 2021 using a large, nationally representative survey of U.S. households (n = 59,424). Trends in COVID-19 adolescent vaccination coverage, nationally and by sociodemographic characteristics, factors associated with adolescent vaccination status and parental intent to vaccinate their adolescent children, as well as changes in reasons for non-vaccination were examined using regression models.ResultsReceipt of ≥1 dose of a COVID-19 vaccine among adolescents ages 12–17 years increased five percentage points, from 56% (July) to 61% (October), with significant increases across most sociodemographic variables. However, there were no significant changes in parental intention to vaccinate their adolescent children during the same time period. Approximately one-quarter of parents were unsure about or reluctant to vaccinate their children, which remained consistent from July to October. Among those who had not vaccinated their children, lack of trust in the government and vaccines, and the belief that the COVID-19 vaccine is not needed or effective, was higher in October compared to July.ConclusionsParental intention to vaccinate their children has remained relatively stable throughout the late summer and early fall of 2021. Encouraging paediatricians to discuss the importance and safety of COVID-19 vaccines, addressing concerns and misinformation, as well as recommending and offering vaccines are important for increasing parental confidence in vaccines as well as vaccination uptake among adolescents.

KEY MESSAGE

• Receipt of ≥1 dose of a COVID-19 vaccine among adolescents ages 12–17 years increased five percentage points, from 56% (July) to 61% (October), with significant increases across most sociodemographic variables.
• Approximately one quarter of parents were unsure about or reluctant to vaccinate their children, which remained consistent from July to October.
• Encouraging paediatricians to discuss the importance and safety of COVID-19 vaccines, addressing concerns and misinformation, as well as recommending and offering vaccines is important for increasing parental confidence in vaccines as well as vaccination uptake among adolescents.

     

Dynamic observation of SARS‐CoV‐2 IgM,IgG, and neutralizing antibodies in the development of population immunity through COVID‐19 vaccination

BackgroundCurrently, mass vaccine inoculation against coronavirus disease‐2019 (COVID‐19) has been being implemented globally. Rapid and the large‐scale detection of serum neutralizing antibodies (NAbs) laid a foundation for assessing the immune response against SARS‐CoV‐2 infection and vaccine. Additional assessments include the duration of antibodies and the optimal time for a heightened immune response.MethodsThe performance of five surrogate NAbs—three chemiluminescent immunoassay (CLIA) and two enzyme‐linked immunosorbent assays (ELISAs)—and specific IgM and IgG assays were compared using COVID‐19‐vaccinated serum (n = 164). Conventional virus neutralization test (cVNT) was used as a criterion and the diagnostic agreement and correlation of the five assays were evaluated. We studied the antibody responses after the two‐dose vaccine in volunteers up to 6 months.ResultsThe sensitivity and specificity of five surrogate NAb assays ranged from 84% to 100%. Our cVNT results indicated great consistency with the surrogate assays. At 28 days after primary vaccination, the seropositivities of the NAbs, IgG, and IgM were 6%, 4%, and 13%, respectively. After the booster dose, seropositivities reached 14%, 65%, and 97%, respectively. Six months after receipt of the second dose, the NAb positive rate was eventually maintained at 66%. In all COVID‐19 convalescents, patients were detected with 100% NAb sat three months after discharge.ConclusionCOVID‐19 vaccine induced a humoral immune response lasting at least six months. Rapid serological detection was used as a proxy for identifying changes in immunity levels and as a guide to whether an individual may require a booster vaccination.     

First-dose mRNA vaccination is sufficient to reactivate immunological memory to SARS-CoV-2 in subjects who have recovered from COVID-19

The characterization of the adaptive immune response to COVID-19 vaccination in individuals who recovered from SARS-CoV-2 infection may define current and future clinical practice. To determine the effect of the 2-dose BNT162b2 mRNA COVID-19 vaccination schedule in individuals who recovered from COVID-19 (COVID-19–recovered subjects) compared with naive subjects, we evaluated SARS-CoV-2 Spike–specific T and B cell responses, as well as specific IgA, IgG, IgM, and neutralizing antibodies titers in 22 individuals who received the BNT162b2 mRNA COVID-19 vaccine, 11 of whom had a previous history of SARS-CoV-2 infection. Evaluations were performed before vaccination and then weekly until 7 days after second injection. Data obtained clearly showed that one vaccine dose is sufficient to increase both cellular and humoral immune response in COVID-19–recovered subjects without any additional improvement after the second dose. On the contrary, the second dose proved mandatory in naive subjects to further enhance the immune response. These findings were further confirmed at the serological level in a larger cohort of naive (n = 68) and COVID-19–recovered (n = 29) subjects, tested up to 50 days after vaccination. These results question whether a second vaccine injection in COVID-19–recovered subjects is required, and indicate that millions of vaccine doses may be redirected to naive individuals, thus shortening the time to reach herd immunity.     

Acceptance of a COVID-19 Vaccine and Its Related Determinants among the General Adult Population in Kuwait

ObjectiveThe objective of this study was to determine the acceptance of a coronavirus disease 2019 (COVID-19) vaccine among the general adult population in Kuwait and assess its determinants.Subjects and MethodsA web-based cross-sectional study was conducted by enrolling adults living in Kuwait (n = 2,368; aged ≥21 years). Acceptance of a COVID-19 vaccine was inferred if participants indicated that they “definitely or probably will accept vaccination against COVID-19 once a vaccine is available.” Associations were explored by applying a modified Poisson regression to estimate and infer adjusted prevalence ratios (aPR) and their 95% confidence intervals (CI).ResultsIn total, 53.1% (1,257/2,368) of the participants were willing to accept a COVID-19 vaccine once available. Male subjects were more willing to accept a COVID-19 vaccine than females (58.3 vs. 50.9%, p < 0.001). Subjects who viewed vaccines in general to have health-related risks were less willing to accept vaccination (aPR = 0.39, 95% CI: 0.35–0.44). Moreover, participants who previously received an influenza vaccine were more likely to accept a COVID-19 vaccine (aPR = 1.44, 95% CI: 1.31–1.58). Willingness to get vaccinated against COVID-19 increased as the self-perceived chances of contracting the infection increased (p < 0.001).ConclusionOverall, 53.1% of the study participants demonstrated willingness to get vaccinated against COVID-19. We found several factors influencing the level of acceptance. Since vaccination appears to be an essential preventive measure that can halt the COVID-19 pandemic, factors relating to low vaccine acceptance need to be urgently addressed by public health strategies.     

BCG vaccination history associates with decreased SARS-CoV-2 seroprevalence across a diverse cohort of health care workers

BACKGROUNDSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused more than 1 million deaths worldwide; thus, there is an urgent need to develop preventive and therapeutic strategies. The antituberculosis vaccine bacillus Calmette-Guérin (BCG) demonstrates nonspecific, protective innate immune–boosting effects. Here, we determined whether a history of BCG vaccination was associated with decreased SARS-CoV-2 infection and seroconversion in a longitudinal, retrospective observational study of a diverse cohort of health care workers (HCWs).METHODSWe assessed SARS-CoV-2 seroprevalence and collected medical questionnaires, which included information on BCG vaccination status and preexisting demographic and clinical characteristics, from an observational cohort of HCWs in a multisite Los Angeles health care organization. We used multivariate analysis to determine whether a history of BCG vaccination was associated with decreased rates of SARS-CoV-2 infection and seroconversion.RESULTSOf the 6201 HCWs, 29.6% reported a history of BCG vaccination, whereas 68.9% had not received BCG vaccination. Seroprevalence of anti–SARS-CoV-2 IgG as well as the incidence of self-reported clinical symptoms associated with coronavirus disease 2019 (COVID-19) were markedly decreased among HCWs with a history of BCG vaccination compared with those without BCG vaccination. After adjusting for age and sex, we found that a history of BCG vaccination, but not meningococcal, pneumococcal, or influenza vaccination, was associated with decreased SARS-CoV-2 IgG seroconversion.CONCLUSIONSA history of BCG vaccination was associated with a decrease in the seroprevalence of anti–SARS-CoV-2 IgG and a lower number of participants who self-reported experiencing COVID-19–related clinical symptoms in this cohort of HCWs. Therefore, large randomized, prospective clinical trials of BCG vaccination are urgently needed to confirm whether BCG vaccination can confer a protective effect against SARS-CoV-2 infection.     

COVID‐19 vaccine‐related new‐onset lichen planus

Coronavirus disease 2019 (COVID‐19) vaccines significantly impacted world health and well‐being. However, various adverse events have been observed following severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccination. Cutaneous reactions have been prevalent following many vaccines, including COVID‐19 vaccines. Here, we present a case of new‐onset lichen planus in a patient who received the COVID‐19 vaccine at the same time as being infected with SARS‐CoV‐2. A 52‐year‐old woman presented to the clinic with extensive pruritic skin lesions. The eruptions had appeared a week after her second dose of the Sinopharm COVID‐19 vaccine. She mentioned a history of SARS‐CoV‐2 infection approximately 10 days following the first dose of her vaccine, causing a 1‐month delay in getting the second dose. Her past medical history was not significant. On examination, erythematous and squamous papules were demonstrated predominantly on the extremities, including inguinal and axillary folds. Moreover, desquamation of the lips was visible, and buccal lesions were also found. After consultation with a dermatologist, a skin biopsy was indicated for the patient, but she refused to undergo the procedure. Therefore, considering the typical appearance of the eruptions, lichen planus was suspected, for which she was treated with oral antihistamines and topical corticosteroids.     

Antibody responses induced by the BNT162b2 mRNA COVID-19 vaccine in healthcare workers in a single community hospital in Japan

IntroductionThe effectiveness of several vaccines against coronavirus disease (COVID-19) has been reported in the real-world setting. However, it is still unknown how long antibodies persist following vaccination and whether or not the persistence of antibodies has a protective effect against COVID-19.MethodsHealthcare workers who had received two doses of the BNT162b2 mRNA COVID-19 vaccine were enrolled, and a single-center study was conducted at the National Hospital Organization Hakodate National Hospital. Serum samples from all participants were collected 13–21 weeks (median: 20 weeks) after the second dose of vaccination. The antibody titers were measured using an electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2 S). Data on characteristics of the participants were gathered from patient records and interview sheets.ResultsA total of 401 participants, among whom 70.1% were women and the median age was 42 years, were evaluated in this study. None of the participants had a definite COVID-19 history, and all participants who received complete vaccination showed positive antibody titers. The antibody titer was observed to be higher in participants with younger age (p < 0.001) and those who were females (p = 0.028). Despite the higher risk of infection than that of the general public, no vaccinated staff developed breakthrough infections.ConclusionsThis study demonstrates the significant contribution of the BNT162b2 vaccine in the acquisition of anti-SARS-CoV-2S antibodies; therefore, the general population should benefit from these two vaccine doses, which are expected to be protective for at least five months.     

Modeling the recovery time of patients with coronavirus disease 2019 using an accelerated failure time model

ObjectiveTo identify factors associated with recovery time from coronavirus disease 2019 (COVID-19).MethodsIn this retrospective study, data for patients with COVID-19 were obtained between 21 June and 30 August 2020. An accelerated failure time (AFT) model was used to identify covariates associated with recovery time (days from hospital admission to discharge). AFT models with different distributions (exponential, log-normal, Weibull, generalized gamma, and log-logistic) were generated. Akaike’s information criterion (AIC) was used to identify the most suitable model.ResultsA total of 730 patients with COVID-19 were included (92.5% recovered and 7.5% censored). Based on its low AIC value, the log-logistic AFT model was the best fit for the data. The covariates affecting length of hospital stay were oxygen saturation, lactate dehydrogenase, neutrophil-lymphocyte ratio, D-dimer, ferritin, creatinine, total leucocyte count, age > 80 years, and coronary artery disease.ConclusionsThe log-logistic AFT model accurately described the recovery time of patients with COVID-19.     

Effect of gentle exercises on injection site reaction after Covid-19 vaccination. A case report

IntroductionA series of atypical acute respiratory diseases were caused in Wuhan, China, in December 2019 by a novel coronavirus (COVID-19). Over six million confirmed COVID-19 cases had been reported worldwide, and total deaths in the USA from March 1 to May 30, 2020, were approximately 7,81,000. Worldwide, scientists are developing many potential COVID-19 vaccines. Few of the companies got success in the development of a vaccine for COVID-19, but most of the recipients reported injection site reactions like pain, redness, or erythema after vaccination. The present study aimed to evaluate the effect of gentle upper limb exercises to reduce injection site reactions, and here we present a case with post vaccination site reaction that reported pre-assessment score 7 for visual analog scale for pain and score 2 for redness and erythema with Investigator-reported and rated injection site reactions. Then he performed gentle upper limb exercises after 8 and 24 hours of vaccination.ResultThe study reported a beneficial effect of these exercises to reduce pain and redness or erythema after Covid-19 vaccination.DiscussionThe potential benefit of gentle exercises may be due to their blood flow boost-up and anti-inflammatory effects. However, high-quality controlled trials are warranted further to evaluate the potential benefit of upper limb gentle exercises for the reduction of injection site reactions after the Covid-19 vaccination injection.ConclusionThe clinical experience with the subect shows that gentle exercises for upper limb may reduce the inection site reaction after COVID-19 vaccination.     

Changes in COVID-19 vaccination receipt and intention to vaccinate by socioeconomic characteristics and geographic area,United States,January 6 – March 29, 2021

IntroductionPrevious studies suggested that almost one-third of U.S. adults did not plan to get a COVID-19 vaccine once it is available to them. The purpose of this study was to examine changes in vaccine intentions and attitudes by sociodemographic characteristics and geographic areas, factors associated with vaccination intent, and reasons for non-vaccination among a nationally representative sample of U.S. adults.MethodsData from six waves of the Household Pulse Survey (6 January – 29 March 2021) were analyzed. Differences between January and March were assessed using t-tests. Factors associated with vaccination intent were examined in multivariable logistic regression models.ResultsFrom early January to late March, vaccination receipt of ≥1 dose of the COVID-19 vaccine or intention to definitely get vaccinated increased from 54.7 to 72.3%; however, disparities in vaccination intent continued to exist by age group, race/ethnic groups, and socioeconomic characteristics. Vaccine receipt and the intent were the lowest for region 4 (southeastern U.S.) throughout this period. Adults who had a previous COVID-19 diagnosis or were unsure if they have had COVID-19 were less likely to intend to get vaccinated [prevalence ratio = 0.92 (95%CI: 0.90–0.93) and 0.80 (95%CI: 0.74–0.85), respectively]. The belief that a vaccine is not needed increased by more than five percentage points from early January to late March.ConclusionIntent to definitely get a COVID-19 vaccine increased by almost 18 percentage points from early January to late March; however, younger adults, adults who are non-Hispanic Black or other races, adults of lower socioeconomic status, and adults living in the southeastern U.S. region (Region 4) continue to have higher coverage gaps and levels of vaccine hesitancy. Emphasizing the importance of vaccination among all populations, and removing barriers to vaccines, may lead to a reduction of COVID-19 incidence and bring an end to the pandemic.

KEY MESSAGES

• Receipt of ≥1 dose of the COVID-19 vaccine and intent to probably or definitely get vaccinated increased from early January to late March; however, disparities in vaccine intent continued to exist by age group, race/ethnic groups, and socioeconomic characteristics.
• Vaccine receipt and the intent were the lowest for region 4 (southeastern U.S.) compared to other regions during this period.
• Adults who had a previous COVID-19 diagnosis or were unsure if they have had COVID-19 were less likely to intend to get vaccinated; overall, the belief that a vaccine is not needed to be increased by more than 5% points from early January to late March.

     

An overview on inactivated and live‐attenuated SARS‐CoV‐2 vaccines

After about 2 years since severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), first infections were detected in Wuhan city of China in December 2019, which was followed by a worldwide pandemic with a record of 5.41 million deaths. Due to urgent need for the development of a safe and effective vaccine for coronavirus disease 2019 (COVID‐19), attempts for producing efficient vaccines are inexhaustibly continuing. According to a report by the World Health Organization (WHO) on COVID‐19 vaccine tracker and landscape, there are 149 vaccine candidates all over the world. Inactivated SARS‐CoV‐2 vaccines as a conventional vaccine platform consist of whole virus particles grown in cell culture and inactivated by chemicals. Because of benefits such as antigenic similarity to real virion inducing humoral and cellular immune responses and ease for transport and storage, these vaccines, including the vaccines produced by Bharat Biotech, Sinopharm, and Sinovac, are in use at large scales. In this study, we have a review on inactivated SARS‐CoV‐2 vaccines that are passing their phase 3 and 4 clinical trials, population which was included in the trials, vaccine producers, the efficiency, adverse effects, and components of vaccines, and other vaccine features.     

Fulminant myocarditis after the second dose of COVID‐19 mRNA vaccination

Myocarditis is an adverse event associated with coronavirus disease 2019 (COVID‐19) mRNA vaccination. A 50‐year‐old man presented with dyspnea and resting chest pain after receiving the second dose of the COVID‐19 mRNA vaccine and developed cardiogenic shock. Fulminant myocarditis was diagnosed by endomyocardial biopsy and treated with intravenous corticosteroids.     

Immunogenicity and Safety of SpikoGen,an Adjuvanted Recombinant SARS-CoV-2 Spike Protein,as a Heterologous Third Booster Dose in Kidney Transplant Patients: A Single-arm Clinical Trial

PurposeStudies have found that immunocompromised patients have suboptimal responses to COVID-19 vaccines, leading to approval of a need for booster doses in this population. SpikoGen® is a subunit recombinant spike protein vaccine combined with Advax-CpG55.2? adjuvant to protect against COVID-19. Previous clinical trials found this vaccine to be tolerable, immunogenic, and efficacious in reducing the risk of COVID-19, including severe disease. However, the effects of this vaccine have not been assessed in immunocompromised patients. This study sought to assess the immunogenicity and safety of the SpikoGen vaccine as a third booster dose in patients undergoing kidney transplant who were receiving immunosuppressive therapy and had received their primary vaccination based on an inactivated whole virus platform (Sinopharm).MethodsThis single-arm trial was performed with 43 patients undergoing kidney transplant. The participants received a single booster dose of the SpikoGen vaccine 1 to 3 months after primary vaccination with 2 doses of the Sinopharm vaccine. Immunogenicity assessments were performed at baseline and 30 days after the booster dose. The primary outcomes were seroconversion rates of anti-S₁ and surrogate virus neutralizing antibodies. Safety outcomes included the incidence of solicited and unsolicited adverse events in the 7 days and 1 month after the booster dose, respectively.FindingsThe SpikoGen vaccine induced positive humoral and cellular responses 30 days after the booster dose in those patients who were seropositive or seronegative after 2 primary doses of the Sinopharm vaccine. Thirty days after the SpikoGen vaccine booster, seroconversion rates were 35.29% (95% CI, 19.75%–53.51%) to anti-S₁ and 29.41% (95% CI, 13.27%–46.57%) to surrogate neutralizing antibodies. The most common local and systemic reported solicited adverse events were injection site pain and fatigue, which were largely mild and transient. No serious adverse events were reported.ImplicationsA single booster dose of SpikoGen vaccine given 1 to 3 months after primary vaccination with 2 doses of Sinopharm vaccine induced positive humoral and cellular immune responses in immunosuppressed patients undergoing renal transplant, thereby achieving spike antibody levels predictive of protection. This study was performed as a single-center study, and it will be important for future large multicenter studies to extend these results to other immunocompromised patient groups.     

Bell's palsy after Sputnik V COVID‐19 (Gam‐COVID‐Vac) vaccination

A possible association between Bell''s palsy and COVID‐19 vaccination has been suggested previously. Here, we report two cases of facial nerve hemiparalysis following the Sputnik V COVID‐19 vaccination in a 27‐year‐old female patient and a 58‐year‐old male patient who were both clinically diagnosed with Bell''s palsy.     

COVID‐19 vaccine‐induced Radiation Recall Dermatitis: Report of a case

Radiation Recall Dermatitis (RRD) is an inflammatory process in the site of irradiation, induced by physical and medical agents. Few cases of RRD in the skin and lung have been reported after COVID‐19 vaccination. Here, we report radiation recall dermatitis after both doses of inactivated SARS‐CoV‐2 vaccine (Sinopharm, China).     

High prevalence of obstructive sleep apnea syndrome in Spain’s Stroke Belt

ObjectiveSpain’s so-called Stroke Belt is an area with high prevalence of vascular disease. We aimed to determine the prevalence of undetected obstructive sleep apnea–hypopnea syndrome (OSAHS) among patients with acute ischemic stroke (AIS) in southern Spain.MethodsWe conducted a cross-sectional study at the Virgen Macarena University Hospital Stroke Unit during 2018 to 2019. We included patients <72 hours after AIS with a neuroimaging lesion and performed sleep tests.ResultsSeventy-two patients were included. The median participant age was 72 years. Mean body mass index was 27.07 kg/m², and 40.28% were daily alcohol drinkers. Hypertension, atrial fibrillation, ischemic cardiomyopathy, and previous stroke were detected in 63.9%, 11.1%, 15.3%, and 17.6% of patients, respectively. Polygraphy was feasible in 91.38% of patients. The prevalence of OSAHS was 84.72% (apnea–hypopnea index ≥5). Patients with moderate and severe OSAHS were more likely to be obese and to have a larger neck circumference and facial palsy. The diagnostic criteria of central sleep apnea syndrome were met in only 1.38% of patients.ConclusionsThe high prevalence of OSAHS found in the Spanish Stroke Belt justifies further investigation and development of a screening program as a strategy to identify patients with undetected OSAHS.