Background: Vaccine hesitancy has become a prominent public health concern, particularly within the coronavirus disease 2019 (COVID-19) pandemic context. Worries about vaccine side effects are often cited as a reason for hesitancy, while media reporting about this topic plays an important role in influencing the public\'s perspectives about vaccines and vaccination. In Vietnam, during 2012-2013, there were several adverse events following immunization (AEFIs) of Quinvaxem- a pentavalent vaccine in the Expanded Immunization Program, which made big headlines in the media. Such incidences have contributed to changes in vaccination policies and influenced parents\' concerns to date. This study explores the portrayal of Quinvaxem in Vietnam digital news during four periods marked by important events. Methods: We performed quantitative and qualitative analysis with a coding framework to identify main content focus, sentiments towards Quinvaxem, and emotional tones in these articles. Results: In total, we included 360 articles into analysis. The amount of news coverage about Quinvaxem increased after AEFIs happened, from 7 articles before AEFIs to 98 and 159 articles in the following periods when AEFIs and investigation into vaccine safety occurred. Most articles are neutral in titles (n=255/360) and content (n=215/360) towards Quinvaxem and do not convey emotional expressions (n=271/360). However, articles focusing on side effects contain negative sentiments and emotional expressions more frequently than articles of other contents while AEFIs details were conflicting across articles. Vaccine sentiments are provoked in the information about vaccine quality and safety, health authority, local delivery, and quoted vaccine opinions. Emotion-conveying elements in 89/360 articles included emotional wording and imagery and expressive punctuation. Conclusions: The heterogeneity of information in online news may reinforce uncertainty about vaccine safety and decrease vaccine intention. Our results have important implications for vaccine communication, given the current plan of the Vietnamese government to roll out COVID-19 vaccination to younger children.

UNASSIGNED: The Haemophilus influenzae type b (Hib) conjugate vaccine is widely administered in China.
UNASSIGNED: We extracted data on Hib vaccine doses administered and adverse events following immunization (AEFI) reported between 2010 and 2021 from the Chinese National Immunization Information System (CNIIS). A descriptive analysis was conducted to examine the characteristics and incidence rates of AEFI with the Hib vaccine.
UNASSIGNED: In China, between 2010 and 2021, a total of 52,910 AEFIs with the Hib vaccine were reported, resulting in an overall AEFI reporting rate of 38.10 per 100,000 doses. Common (typically minor) and rare (potentially serious) vaccine reactions occurred at rates of 34.71 and 2.78 per 100,000 doses, respectively. Among the common vaccine reactions, the incidences of fever (axillary temperature ≥38.6 ℃), injection site redness and swelling (>2.5 cm in diameter), and injection site induration (>2.5 cm in diameter) were 11.93, 9.69, and 3.38 per 100,000 doses, respectively. Rare vaccine reactions included anaphylactic rash, angioedema, and febrile convulsion with reported incidences of 2.42, 0.10, and 0.05 per 100,000 doses, respectively. The incidence of serious rare vaccine reactions was 0.16 per 100,000 doses.
UNASSIGNED: The reported incidence of AEFI with the Hib vaccine was low, with the occurrence of serious rare adverse reactions also being markedly low throughout the period 2010-2021 in China.

OBJECTIVE: Most reported adverse events following COVID-19 vaccination have been transient. However, persistent adverse events may occur with some frequency. This study aimed to analyze patient background characteristics and trends, with a focus on whether adverse events following COVID-19 vaccination were transient or persistent.
METHODS: A retrospective study was performed at a single institution in Japan.
METHODS: The study cohort included 47 patients who presented with symptoms after COVID-19 vaccination between May 2021 and September 2023. The patients were classified into two groups based on the duration of symptoms: transient group, less than four weeks; persistent group, greater than or equal to four weeks. Data on age, sex, body mass index, smoking history, underlying conditions, type of COVID-19 vaccination, number of doses, onset, symptoms, and treatments were collected retrospectively.
RESULTS: The median age was 51.0 years and 74.5% were females, with a particularly high proportion of women in their 40s. The use of the bivalent omicron-containing booster vaccine (BA.1) was significantly more common in the persistent group than in the transient group (p = 0.0267). Onset in the transient group was more common after the first vaccination, whereas onset in the persistent group was more common after the second and subsequent vaccinations (p = 0.003). Regarding symptoms, pain was more frequent in the persistent group than in the transient group (60% vs. 13.6%; p = 0.001).
CONCLUSIONS: This study investigated the presence of persistent symptoms, especially pain, after COVID-19 vaccination. Persistent symptoms were frequently reported after the second vaccination. It should be noted that the study does not negate the usefulness of COVID-19 vaccines.

With the widespread use of the 13-valent pneumonia vaccine (PCV13) in China, monitoring adverse events following immunization (AEFIs) is critical. We conducted a descriptive analysis of the AEFI occurrences reported within Hangzhou between the years 2020 and 2023, including the temporal trend of case reports and variables such as sex, age, type of PCV13, dose number, type of reporter, cause-specific classification, severity, and onset from vaccination. Vaccine safety signals were analyzed using reporting odds ratios (RORs). Over the 4 years analyzed in the study, 2564 AEFI cases were reported, including seven severe cases. Most AEFIs occurred within 0-1 days after vaccination (2398, 93.53%), with over half affecting infants aged 1.5-6 months of age. No statistically significant difference was observed between PCV13-TT and PCV-CRM197. Seasonal differences in AEFI reports were noted. Positive signals were detected for fever (ROR-1.96SE: 1.64) and persistent crying (ROR-1.96SE: 1.61). Four serious AEFI cases were coincidental events, while three others were considered vaccine-related cases (including one case each of allergic reaction, febrile seizure, and thrombocytopenia). The safety and tolerability of PCV13 are good, and attention should be paid to severe AEFIs, as well as long-term safety disparities between different types of PCV13.

Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.

We present the case of a female who developed cerebral venous thrombosis with thrombocytopenia after inoculation with the anti-coronavirus disease 2019 (COVID-19) Vaxzevria vaccine, followed by splanchnic thrombosis and diffuse hemorrhages. Despite receiving treatment, the complications increased, and hence therapeutic plasma exchange (TPE) was attempted, leading to laboratory and clinical improvements and discharge after a period of intensive care. Almost two years after the first episode, in the interim of which the patient complained of only minor symptoms such as asthenia and difficulty concentrating, she developed an epileptic syndrome that required neurological treatment. In addition, her fatigue and difficulty concentrating worsened and other serious symptoms of dysautonomia appeared, such as trembling of her right arm, loss of stability, and postural orthostatic tachycardia. As serum analysis revealed a significant number of alterations in autoantibodies against various G-protein-coupled receptors (GPCRs) and RAS-related proteins, two further TPEs were performed, resulting in rapid and sustained clinical improvement. This report highlights the role of the different types of autoantibodies produced in response to anti-COVID-19 vaccination, which can have functional, regulatory, and possibly pathogenic effects on the vascular and nervous systems.

UNASSIGNED: The Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) is a comprehensive vaccine safety surveillance system that includes both passive and active surveillance of vaccines administered in Canada. This work presents a summary of adverse events following immunization (AEFI) nationally for 2018 and 2019.
UNASSIGNED: Data extracted from CAEFISS included all AEFI reports received by the Public Health Agency of Canada by April 30, 2022, for vaccines marketed in Canada and administered between January 1, 2018, and December 31, 2019. Descriptive statistics were conducted on AEFI reports by type of surveillance program (i.e., active vs. passive), AEFIs, demographics, healthcare utilization, outcome, seriousness of adverse events and type of vaccine.
UNASSIGNED: Between 2018 and 2019, 5,875 AEFI reports were received from across Canada. The average annual AEFI reporting rate was 10.9/100,000 doses distributed in Canada for vaccines administered during 2018-2019 and was found to be inversely proportional to age. The majority of reports (91%) were non-serious events, involving vaccination site reactions, rash and allergic events. Overall, there were 511 serious adverse event reports during 2018-2019. Of the serious adverse event reports, the most common primary AEFIs were anaphylaxis followed by seizure. There were no unexpected vaccine safety issues identified or increases in frequency or severity of adverse events.
UNASSIGNED: Canada\'s continuous monitoring of the safety of marketed vaccines during 2018-2019 did not identify any increase in the frequency or severity of AEFIs, previously unknown AEFIs, or areas that required further investigation or research.

UNASSIGNED: This study sought to assess the prevalence of adverse events following immunization (AEFI) and factors associated with AEFI of the ChAdOx1 nCoV-19 vaccine (Covishield) among healthcare workers (HCW) of a medicine-teaching institution of North India.
UNASSIGNED: A cross-sectional study was conducted in the months of June and July 2021 among HCW (N = 203) of 18 years and above, vaccinated with at least the first dose of Covishield. A semi-structured, prevalidated, and pretested questionnaire was used to collect information through an interview schedule. The questionnaire was divided into five sections: the sociodemographic profile, behavioral characteristics, past medical history, COVID-19 awareness, and past infection and COVID-19 vaccine related information. Chi-squared test was applied to check the association of different factors with AEFI.
UNASSIGNED: In our study, 73.89% of participants suffered from at least one AEFI after the first dose of the vaccine, while 48.66% had at least one AEFI after the second dose. Females reported significantly high AEFI for both doses (P = 0.001, 0.000). We found a significant association between the occurrence of AEFI and occupation (first dose P = 0.015), substance abuse (first dose P = 0.002), diet (first dose P = 0.016), and allergy (first dose P = 0.027). Other significant findings were headaches among HCW ≥40 years of age (dose P = 0.034) and systemic AEFI in participants with comorbidity (first dose P = 0.020).
UNASSIGNED: More AEFI were reported after the first dose as compared to the second dose. AEFI were more among females after both the doses. Occupation, substance use, diet, and history of allergy were significantly associated with AEFI.

A comprehensive, up-to-date systematic review (SR) of the new-onset rheumatic immune-mediated inflammatory diseases (R-IMIDs) following COVID-19 vaccinations is lacking. Therefore, we investigated the demographics, management, and prognosis of new R-IMIDs in adults following SARS-CoV-2 vaccinations. A systematic literature search of Medline, Embase, Google Scholar, LitCovid, and Cochrane was conducted. We included any English-language study that reported new-onset R-IMID in adults following the post-COVID-19 vaccination. A total of 271 cases were reported from 39 countries between January 2021 and May 2023. The mean age of patients was 56 (range 18-90), and most were females (170, 62.5%). Most (153, 56.5%) received the Pfizer BioNTech COVID-19 vaccine. Nearly 50% of patients developed R-IMID after the second dose of the vaccine. Vasculitis was the most prevalent clinical presentation (86, 31.7%), followed by connective tissue disease (66, 24.3%). The mean duration between the vaccine\'s \'trigger\' dose and R-IMID was 11 days. Most (220, 81.2%) received corticosteroids; however, 42% (115) received DMARDs such as methotrexate, cyclophosphamide, tocilizumab, anakinra, IV immunoglobulins, plasma exchange, or rituximab. Complete remission was achieved in 75 patients (27.7%), and 137 (50.6%) improved following the treatment. Two patients died due to myositis. This SR highlights that SARS-CoV-2 vaccines may trigger R-IMID; however, further epidemiology studies are required.

BACKGROUND: This study investigated the impact of vaccinated population profiles, vaccine type/interval, and the number of vaccine doses on adverse reactions to receiving a coronavirus disease 2019 (COVID-19) booster vaccination.
METHODS: A survey of adverse reactions was conducted from January 2022 to December 2022 among Osaka University Dental Hospital employees who received their third or fourth doses. The study included 194 third-dose recipients and 131 fourth-dose recipients. Comparisons of the occurrence of adverse reactions between the third- and fourth-dose groups were analyzed via a chi-squared test. The relationships between each adverse reaction occurrence and recipient profiles, vaccine type/interval, and the number of vaccine doses were analyzed via a logistic regression analysis.
RESULTS: No significant differences were found in the occurrence of adverse reactions between the third and fourth doses. Younger recipients often developed injection site reaction, fatigue, chills, fever, arthralgia, headache, diarrhea, and any adverse reactions more often. Females had higher frequencies of fatigue, chills, headache, and nausea compared to males. Recipients without underlying diseases had higher frequencies of fever and nausea than those with underlying diseases.
CONCLUSIONS: Younger recipients and females were at higher risk for adverse reactions to a COVID-19 booster vaccination, while the number of vaccinations, vaccination interval, vaccine type, and cross-vaccination showed no significant associations.