Table 3 Use of analgesic/antipyretic medication on symptoms following COVID-19 vaccination in clinical trials.

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

Vaccine

Trial

Analgesics/antipyretics

Treatment/prophylaxis

Use (% patients)

Effect on vaccine reactogenicity

BNT162b2 (Pfizer/BioNTech)

Phase 1

N = 9057

Treatment: antipyretic/pain medication following vaccination (not specified)

Use of antipyretic/pain medication increased with increasing dose level and number of doses administered in both age groups (data not shown)

—

Phase 2/3

N = 8,183 (reactogenicity subset)37

Aged 16–55 years

Dose 1: 28% versus 14% for placebo

Dose 2: 45% versus 13% for placebo

Aged >55 years

Dose 1: 20% versus 12% for placebo

Dose 2: 38% versus 10% for placebo

—

AZD1222 (Oxford/AZ)

Phase 1/2

N = 54356

Prophylaxis: acetaminophen

(1 g) before vaccination and continued every 6 h for 24 h

10.3%*

Acetaminophen versus no acetaminophen prophylaxis

Local AEs

• Injection-site pain (50% vs 67%)

• Tenderness (77% vs 83%)

Systemic AEs

• Fatigue (71% vs 70%)

• Headache (61% vs 68%)

• Muscle ache (48% vs 60%)

• Malaise (48% vs 62%)

• Chills (27% vs 56%)

• Feeling feverish (36% vs 51%)

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

Phase 350,58

Treatment: antipyretic/pain medication following vaccination (not specified)

All: 19.9% versus 5.7% for placebo

Aged 18–59 years: 26.4% versus 6.0% for placebo

Aged ≥60 years: 9.8% versus 5.1% for placebo

—

  1. *A protocol amendment permitted prophylactic acetaminophen prior to vaccination at two of five trial sites with participants advised to continue with a 1-g dose of acetaminophen every 6 h for 24 h to reduce vaccine-associated reactions. AE adverse event, AZ AstraZeneca, COVID-19 coronavirus disease 2019, J&J Johnson & Johnson.