Table 2 Reactogenicity of COVID-19 vaccines approved by WHO for emergency use.

From: Use of analgesics/antipyretics in the management of symptoms associated with COVID-19 vaccination

Vaccine

Trial/population

Reactogenicity

Injection-site pain

Selected systemic symptoms

mRNA-based

BNT162b2 (Pfizer/BioNTech)37

Phase 2/3, OB, PC, R

N = 18,556 (n = 8,183 reactogenicity subset)

Age: ≥16 years (median 52 years, range 16–91 years)

Males: 51%

Dose 1: 83% (≤55 years); 71% (>55 years)

Dose 2: 71% (≤55 years); 66% (>55 years)

Fatigue

Dose 1: 47% (≤55 years); 34% (>55 years)

Dose 2: 59% (≤55 years); 51% (>55 years)

Headache

Dose 1: 42% (≤55 years); 25% (>55 years)

Dose 2: 52% (≤55 years); 39% (>55 years)

mRNA-1273 (Moderna)43

Phase 3, OB, PC, R

N = 30,420

Age: ≥18 years (mean 51.4 years, range 18–95 years)

Males: 52.7%

Dose 1: 83.7% (all); 86.9% (<65 years); 74.0% (≥65 years)

Dose 2: 88.2% (all); 89.9% (<65 years); 83.2% (≥65 years)

Fatigue

Dose 1: 37.2% (all); 38.4% (<65 years);

33.3% (≥65 years)

Dose 2: 65.3% (all); 67.6% (<65 years);

58.3% (≥65 years)

Headache

Dose 1: 32.7% (all); 35.3% (<65 years);

24.5% (≥65 years)

Dose 2: 58.6% (all); 62.8% (<65 years);

46.2% (≥65 years)

Adenovirus-based

AZD1222 (Oxford/AZ)47

Phase 2, R, C

N = 420

Age: ≥18 years (n = 100 aged 18–55, n = 120 aged 56–69, and n = 200 aged ≥70)

Males: 50%*

Dose 1: 61% (18–55 years); 43% (56–69 years); 20% (≥70 years)

Dose 2: 49% (18–55 years); 34% (56–69 years); 10% (≥70 years)

Fatigue

Dose 1: 76% (18–55 years); 50% (56–69 years);

41% (≥70 years)

Dose 2: 55% (18–55 years); 41% (56–69 years);

33% (≥70 years)

Headache

Dose 1: 65% (18–55 years); 50% (56–69 years);

41% (≥70 years)

Dose 2: 31% (18–55 years); 34% (56–69 years);

20% (≥70 years)

Ad26.COV2.S (Janssen/J&J)50

Phase 3, DB, PC, R

N = 44,325

Age: ≥18 years (median 52 years, range 18–100 years)

Males: 54.9%

48.6% (all); 58.6% (18–59 years);

33.3% (≥60 years)

Fatigue

38.2% (all); 43.8% (18–59 years); 29.7% (≥60 years)

Headache

38.9% (all); 44.4% (18–59 years); 30.4% (≥60 years)

Inactivated virus

BBIBP-CorV (Sinopharm)52

Phase 2, R, DB, PC

N = 448

Age: 18–59 years (mean 41.7 years, SD 9.9 years)

Males: 45%

16%‡

Fatigue: 3%‡

Headache: 1%‡

CoronaVac (Sinovac Biotech)53

Phase 2, R, DB, PC

N = 600

Age: 18–59 years (mean 42 years)

Males: N/A#

Doses on Day 0 and 14:

Dose 1: 9.2% (3 µg), 16.7% (6 µg)

Dose 2: 13.3% (3 µg), 11.8% (6 µg)

Doses on Day 0 and 28:

Dose 1: 7.5% (3 µg), 10.0% (6 µg)

Dose 2: 2.6% (3 µg), 5.9% (6 µg)

Fatigue

Doses on Day 0 and 14:

Dose 1: 1.7% (3 µg), 5.0% (6 µg)

Dose 2: 1.7% (3 µg), 1.7% (6 µg)

Doses on Day 0 and 28:

Dose 1: 8.3% (3 µg), 1.7% (6 µg)

Dose 2: 2.6% (3 µg), 0.9% (6 µg)

Headache

Doses on Day 0 and 14:

Dose 1: 0.8% (3 µg), 0.8% (6 µg)

Dose 2: 0.8% (3 µg), 2.5% (6 µg)

Doses on Day 0 and 28:

Dose 1: 2.5% (3 µg), 0.8% (6 µg)

Dose 2: 1.7% (3 µg), 0.0% (6 µg)

CoronaVac (Sinovac Biotech)54

Phase 1/2, R, DB, PC

N = 349 (Phase 2)

Age: ≥60 years (mean 66.6 years, SD 4.7 years)

Males: 48%

Dose 1: 2% (1.5 µg), 8% (3 µg),

5.1% (6 µg)

Dose 2: 9.1% (1.5 µg), 7% (3 µg),

5.1% (6 µg)

Doses were administered on Day 0 and 28

Fatigue

Dose 1: 3% (1.5 µg), 3% (3 µg), 2% (6 µg)

Dose 2: 1% (1.5 µg), 0 (3 µg), 1% (6 µg)

Headache

Dose 1: 0 (1.5 µg), 0 (3 µg), 2% (6 µg)

Dose 2: 0 (1.5 µg), 0 (3 µg), 0 (6 µg)

  1. *Based on N = 552 in the Phase 2/3 trial. ‡AEs after first and second doses combined. #Proportion of male participants was 44% in the Day 0 and 14 vaccination cohort (n = 372) and 49% in the Day 0 and 28 vaccination cohort (n = 371) for Phase 1 and 2 combined data. AE adverse event, AZ AstraZeneca, C controlled, COVID-19 coronavirus disease 2019, DB double-blind, J&J Johnson & Johnson, mRNA messenger ribonucleic acid, OB observer-blinded, PC placebo-controlled, R randomized, SD standard deviation, WHO World Health Organization.