Table 4.

Literature review.

Cohort	N of pts	Control group	Vaccine	Methods for evaluation of AE	AE reported	Severe AE
Allo-HSCT ( 20, 24 )	192	26 healthy subjects	BNT162b2	Questionnaire within 7 days following the first vaccination (24). Interview and clinical evaluation, grading CTC AE v5 (20)	Only grade 1 or 2 AEs were observed. Cytopenia 12% after the 1st dose and 10% after the 2nd dose (20). 3 cases of GvHD exacerbation after each dose (20).	There were no grade 3 or 4 non-hematological adverse events. A single case of impending graft rejection was summarized as possibly related.
Oncohematology ( 23, 25 )	977	67 healthy subjects + 36 elderly w/o cancers	BNT162b2	Questionnaires adapted from the original phase 3 BNT162b2 trial (25) Registration of local and systemic side effects (23)	AEs were more common after the 2nd dose (25). Mild pain at the injection site most common side effect in all the cohorts (23).	No grade 4 adverse events were reported
Cancer ( 19, 21, 38–42, 44, 45 )	2,387	739 healthy subjects	BNT162b2 mRNA-1273 ChAdOx1	Solicited and unsolicited AE collection through face-to-face or telephone consultations (19). Weekly telephone consultation (21). Patient-reported outcomes between 1–2–4 weeks after each dose (38). Web-based electronic platform for home toxicity monitoring (39) AE graded according to patients interview within 2–4-week windows (40). Patient-reported scale (very mild/mild/moderate/severe) (41). Questionnaire (42, 44). Review of medical records (45).	The most frequently reported local AE was mild-to-moderate pain at the injection site (39). AEs occurred between 39% and 56% patients after the 1st dose and between 29% and 58% after the 2nd (21, 41, 44) 1st dose AEs: local side effects 29.8%–31.5%, fatigue 8.3%–7%, headaches 3.9%–8.17% and arthralgia/myalgia 3.7%–2.71% (38–41). 2nd dose AEs: fever 5.8%–14.1%, local reactions 12.6%–33.46%, fatigue 10.4%–8.9%, arthralgia/myalgia 5.2% (41). Overall: 45%–69% injection site pain, myalgia 9.5%–15%, bone pain 5%, headache 10%–24.3%, fatigue 10%–28.6%, chills 10%, appetite loss 5% (19, 40, 42, 45). AEs were more common after the 2nd vaccine dose than that with the 1st (33.3% vs. 7%) (44).	No grade 3/4 side effects were recorded (21, 38, 40, 42, 44, 45). Low rate of grade 3/4 AE: 2.1% vaccine related AE grade 3 (19), 3.3% of patients after the 1st inoculum and 1.4% after the booster (41). One sudden death occurred after 5 days of the vaccine in a hospitalized patient who received active chemotherapy for advanced bladder cancer. The post-mortem examination revealed pulmonary embolism (41). Three cancer-related deaths were considered unrelated to the BNT162b2 vaccine (39). One patient died due to myocardial infarction—the authors cannot complete rule out that this event was vaccine related (39). Severe reactogenicity occurred in 1% of the patients following the priming dose and in 3% of the patients following the booster dose (39).
Cancers (checkpoint inhibitors) ( 18, 43 )	222	2,241 healthy subjects	BNT162b2	Solicited and unsolicited AE collection Telephone questionnaires 17–21 days after the first vaccine dose and median 19 days after the second	1st dose AEs pain at the injection site 21%–28.57% (18)– (43). 2nd dose AEs fever 6.94% (43,) pain at the injection site 63%, local rash 2%, local swelling 9%; muscle pain 34%, fatigue 34%, headache 16%, fever 10%, chills 10%, gastrointestinal complications 10%, flu-like symptoms 2% (18). Systemic events more frequent after the 2nd dose, while local effects were less common (43).	No thrombosis, hypersensitivity adverse events or vaccine-related anaphylaxis were signaled. One patient has reported two immune-related side effects (hepatitis G3 and colitis G3) 10 days after the first dose of vaccine.
Multiple sclerosis ( 26–28, 37 )	896	7 healthy subjects	BNT162b2 ChAdOx1 mRNA-1273	Questionnaires (26, 28) Telemedicine and face-to-face evaluation (7–21 days after each dose) (27)	Between 56.9% and 94% reported AEs (26, 28). AEs: sore arm 70%, flu-like symptoms 64%, fever 21%, fatigue 27%, headache 21% (27, 28, 37).	No severe adverse effects occurred (28) 15.1% of participants reported new or worsening neurological symptoms (26). Acute relapse 2.1% and 1.6% following the first and second doses, respectively (27). 2 people reported new or worsening MS symptoms (37)
Systemic autoimmune Disease ( 14, 22, 29–36, 46 )	6492	394 healthy subjects + 26 patients COVID recovered (28)	BNT162b2 ChAdOx1 mRNA-1273 BBV152 CoronaVac Ad26COV2.S	Registration of local and systemic side effects (22) Questionnaire distributed via e-mail (35), phone (29), web-based (32) 7th days after vaccination collection of data (33) Questionnaire within the 1st week after vaccination (34) Questionnaires, (30, 31, 36, 46)	Absence of AEs 20% of patients (22). Overall occurrence of AEs 35%–60.5% (14, 33, 35, 36, 46) AEs: local reactions 17%–89%; systemic symptoms 69%, headache 12%–20%; muscle sore 10%–22.8% fatigue 7.4%–33.4% (22, 30, 31, 33, 36). 1st dose AEs 45%–53%, 2nd dose AEs 26%–53% (30, 32). Patients who received both vaccine doses and reported side effects after the 1st dose were more likely to report side effects after the 2nd dose than those who did not (relative risk 2·30, 95% CI 1·88–2·82; p < 0.0001) (32).	No participants reported severe adverse events (22, 32–34, 46). Severe adverse events 1% (35). Major adverse events: death (2) several weeks after the 2nd dose, non-disseminated herpes zoster (6), uveitis (2), and pericarditis (1) (29). Postvaccination disease activity remained stable in the majority of patients (29). Relapses of the underlying disease 2.2% of patients after the first dose of vaccine (30). 11% of patients reported that their psoriasis worsened after vaccination (22). Immunosuppressive treatment was postponed because of COVID-19 vaccination in 6% patients (35) Four patients reported flare of arthritis that resolved within 5 days (33). One patient with Familial Mediterranean fever reported new-onset arthritis 2 weeks after the 1st dose. No flare-up of the underlying IRD occurred in any other patient (31). Flares of existing systemic rheumatic disease 13.4%, 4.6% requiring treatment (36).