Self-reported reactogenicity after different COVID-19 vaccination regimens

Pfrommer, Laura R; Schoeps, Melissa; Blettner, Maria; Wollschläger, Daniel; Herm-Stapelberg, Nils; Mittnacht, Lukas; Kachel, Philipp; Jahn, Klaus; Loewenich, Friederike D. von; Gianicolo, Emilio Antonio Luca

doi:10.3238/arztebl.m2022.0298

Cited by 4 publications

(6 citation statements)

References 18 publications

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“…For example, Rolfes et al reported that ChAdOx1 had the highest odds, followed by Ad26.COV2-S, mRNA-1273, and BNT126b2, for the outcome of systemic reactions after the first vaccination [ 31 ]. Higher odds for systemic reactions with ChAdOx1 than BNT162b2 were also shown by other studies [ 12 , 30 , 35 ]. In our results, we saw that a second ChAdOx1 vaccination was associated with less local reactions and comparable systemic reactions as compared to a second BNT162b2 vaccination.…”

Section: Discussionsupporting

confidence: 80%

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Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study

Warkentin

Werner

Zeschick

et al. 2023

BMC Med

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Background Since the beginning of the COVID-19 vaccination campaigns, recommendations regarding the vaccination have been very dynamic. Although the safety and efficacy of different vaccines have been analysed, data were scarce for vaccine regimens combining different vaccines. We therefore aimed to evaluate and compare the perceived reactogenicity and need for medical consultation after the most frequently applied homologous and heterologous COVID-19 vaccination regimens. Methods In an observational cohort study, reactogenicity and safety were assessed within a maximum follow-up time of 124 days using web-based surveys. Reactogenicity was assessed for different vaccination regimens 2 weeks after a vaccination (short-term survey). The following surveys, long-term and follow-up surveys, focused on the utilisation of medical services, including those that were not suspected to be vaccine-related. Results Data of 17,269 participants were analysed. The least local reactions were seen after a ChAdOx1 − ChAdOx1 regimen (32.6%, 95% CI [28.2, 37.2]) and the most after the first dose with mRNA-1273 (73.9%, 95% CI [70.5, 77.2]). Systemic reactions were least frequent in participants with a BNT162b2 booster after a homologous primary immunisation with ChAdOx1 (42.9%, 95% CI [32.1, 54.1]) and most frequent after a ChAdOx1 − mRNA-1273 (85.5%, 95% CI [82.9, 87.8]) and mRNA-1273/mRNA-1273 regimen (85.1%, 95% CI [83.2, 87.0]). In the short-term survey, the most common consequences were medication intake and sick leave (after local reactions 0% to 9.9%; after systemic reactions 4.5% to 37.9%). In the long-term and follow-up surveys, between 8.2 and 30.9% of participants reported consulting a doctor and between 0% and 5.4% seeking hospital care. The regression analyses 124 days after the first and after the third dose showed that the odds for reporting medical consultation were comparable between the vaccination regimens. Conclusions Our analysis revealed differences in reactogenicity between the COVID-19 vaccines and vaccination regimens in Germany. The lowest reactogenicity as reported by participants was seen with BNT162b2, especially in homologous vaccination regimens. However, in all vaccination regimens reactogenicity rarely led to medical consultations. Small differences in seeking any medical consultation after 6 weeks diminished during the follow-up period. In the end, none of the vaccination regimens was associated with a higher risk for medical consultation. Trial registration DRKS DRKS00025881 (https://drks.de/search/de/trial/DRKS00025373). Registered on 14 October 2021. DRKS DRKS00025373 (https://drks.de/search/de/trial/DRKS00025881). Registered on 21 May 2021. Registered retrospectively.

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Section: Discussionsupporting

confidence: 80%

“…Regarding differences between vaccination regimens after the second vaccination, Pfrommer et al reported comparable results [ 12 ]. Heterologous vaccination regimens and the homologous mRNA-1273 regimen were associated with a higher reactogenicity than a homologous BNT162b2 regimen.…”

Section: Discussionmentioning

confidence: 99%

Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study

Warkentin

Werner

Zeschick

et al. 2023

BMC Med

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“…This explanation assumes that women were more likely to present to outpatient care due to symptoms—which is supported by our short-term data—but were not more likely to have severe symptoms requiring inpatient care than men. A higher prevalence of adverse events in women has been reported before in vaccinations against SARS-CoV-2 [ 45 , 46 ] as well as in the vaccines used as comparators [ 47 – 50 ]. Despite the fact that antibody responses to specific vaccine doses often tend to be higher in females than in males, low dose vaccination of comparator vaccines for women to reduce the prevalence of side effects has not been systematically investigated or deliberated to our knowledge so far [ 51 ].…”

Section: Discussionmentioning

confidence: 93%

Patient-reported reactogenicity and safety of COVID-19 vaccinations vs. comparator vaccinations: a comparative observational cohort study

Werner,

Zeschick,

Kühlein

et al. 2023

BMC Med

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Background In the course of the SARS-CoV-2 pandemic, multiple vaccines were developed. Little was known about reactogenicity and safety in comparison to established vaccines, e.g. influenza, pneumococcus, or herpes zoster. Therefore, the present study aimed to compare self-reported side effects in persons vaccinated against SARS-CoV-2 with the incidence of side effects in persons receiving one of the established vaccines. Methods A longitudinal observational study was conducted over a total of 124 days using web-based surveys. Persons receiving either a vaccination against SARS-CoV-2 or one of the established vaccines (comparator group) were included. In the first questionnaire (short-term survey), 2 weeks after vaccination, mainly local and systemic complaints were evaluated. The long-term survey (42 days after vaccination) and follow-up survey (124 weeks after vaccination) focused on medical consultations for any reason. Multivariate analyses were conducted to determine the influence of the vaccine type (SARS-CoV-2 vs. comparator) and demographic factors. Results In total, data from 16,636 participants were included. Self-reported reactogenicity was lowest in the comparator group (53.2%) and highest in the ChAdOx1 group (85.3%). Local reactions were reported most frequently after mRNA-1273 (73.9%) and systemic reactions mainly after vector-based vaccines (79.8%). Almost all SARS-CoV-2 vaccines showed increased odds of reporting local or systemic reactions. Approximately equal proportions of participants reported medical consultations. None in the comparator group suspected a link to vaccination, while this was true for just over one in 10 in the mRNA-1273 group. The multivariate analysis showed that people with SARS-CoV-2 vaccination were not more likely to report medical consultations; patients who had received a regimen with at least one ChAdOx1 were even less likely to report medical consultations. Younger age, female gender and higher comorbidity were mostly associated with higher odds of medical consultations. Conclusion The rate of adverse reactions after established vaccinations was roughly comparable to previous studies. Two weeks after vaccination, participants in the SARS-CoV-2 vaccination group reported more local and systemic local reactions than participants in the comparator group. In the further course, however, there were no higher odds of medical consultations in either of the two groups. Thus, altogether, we assume comparable safety. Trial registration DRKS-ID DRKS00025881 and DRKS-ID DRKS00025373.

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“…Vaccination against SARS-CoV-2 is one of the best examples for generating real-world data due to the accelerated medical context that requires adaptation to more personalized medicine. Thus, one of the first questions asked was the tolerance to vaccination, which has been widely assessed for the normal population in prospective registration studies as well as by self-reporting of vaccination in a dedicated centralized registry and different government reports [ 13 , 14 ]. In patients with cancer, tolerance has only been reported in association with immunogenicity studies also based on self-reported analyses [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical and Serological Follow-Up of 216 Patients with Hematological Malignancies after Vaccination with Pfizer-BioNT162b2 mRNA COVID-19 in a Real-World Study

et al. 2023

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Hematological malignancies (HMs) have heterogeneous serological responses after vaccination due to disease or treatment. The aim of this real-world study was to analyze it after Pfizer-BioNT162b2 mRNA vaccination in 216 patients followed up for 1 year. The first 43 patients had an initial follow-up by a telemedicine (TM) system with no major events reported. The anti-spike IgG antibodies were checked 3–4 weeks post-first vaccination and every 3–4 months, by two standard bioassays and a rapid serological test (RST). Vaccine boosts were given when the level was <7 BAU/mL. Patients who did not seroconvert after 3–4 doses received tixagevimab/cilgavimab (TC). Fifteen results were discordant between two standard bioassays. Good agreement was observed between the standard and RST in 97 samples. After two doses, 68% were seroconverted (median = 59 BAU/mL) with a median of 162 BAU/mL and 9 BAU/mL, respectively, in untreated and treated patients (p < 0.001), particularly for patients receiving rituximab. Patients with gammaglobulin levels < 5 g/L had reduced seroconversion compared to higher levels (p = 0.019). The median levels were 228 BAU/mL post-second dose if seroconverted post-first and second, or if seroconverted only post-second dose. A total of 68% of post-second dose negative patients were post-third dose positive. A total of 16% received TC, six with non-severe symptomatic COVID-19 within 15–40 days. Personalized serological follow-up should apply particularly to patients with HMs.

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Self-reported reactogenicity after different COVID-19 vaccination regimens

Cited by 4 publications

References 18 publications

Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study

Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study

Patient-reported reactogenicity and safety of COVID-19 vaccinations vs. comparator vaccinations: a comparative observational cohort study

Clinical and Serological Follow-Up of 216 Patients with Hematological Malignancies after Vaccination with Pfizer-BioNT162b2 mRNA COVID-19 in a Real-World Study

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