Table 4 List of 35 adverse events (AE) with relative reporting frequency (RRF) percentage changes ≥ 200% between 2020 and 2021; with the number of signals of disproportionate reporting (SDR) identified by using the total number of unique reports (NRTotal) up to 31/Dec/2021 and by excluding reports solely registering COVID-19 vaccines (NRwoVAC) for VigiBase, FAERS and JADER and the percentage of signals masked by COVID-19 vaccines when considering all reports.
AE | % change of the RRF between, 2020–2021 | Number of drugs with disproportionally reported event (PRR ≥ 2, Chi square ≥ 4, and number of individual cases ≥ 3) | Percentage of SDRs masked when considering all reports | Average masking ratio (MR) | |
|---|---|---|---|---|---|
NRtotal | NRwoVAC | ||||
Axillary pain | 2143.8 | 121 | 218 | 44.5 | 2.3 |
Vaccination site pain | 1980.1 | 137 | 242 | 43.4 | 3.7 |
Polymenorrhoea | 1474.3 | 40 | 101 | 60.4 | 2.6 |
Menstrual disorder | 1101.0 | 108 | 172 | 37.2 | 3.5 |
Extensive swelling of vaccinated limb | 958.9 | 148 | 163 | 9.2 | 1.5 |
Lymphadenopathy | 937.8 | 258 | 433 | 40.4 | 1.6 |
Injection site inflammation | 910.1 | 188 | 215 | 12.6 | 1.2 |
Menstruation delayed | 785.5 | 42 | 69 | 39.1 | 2.0 |
Vaccination site reaction | 747.1 | 132 | 169 | 21.9 | 2.7 |
Myalgia | 698.5 | 193 | 342 | 43.6 | 1.6 |
Menstruation irregular | 506.5 | 70 | 89 | 21.3 | 1.6 |
Dysmenorrhoea | 501.1 | 62 | 98 | 36.7 | 1.5 |
Menorrhagia | 445.6 | 74 | 100 | 26.0 | 1.3 |
Limb discomfort | 393.8 | 155 | 330 | 53.0 | 1.7 |
Pericarditis | 392.7 | 246 | 327 | 24.8 | 1.3 |
Facial paralysis | 357.1 | 257 | 343 | 25.1 | 1.2 |
Influenza like illness | 334.5 | 184 | 249 | 26.1 | 1.4 |
Amenorrhoea | 324.2 | 121 | 138 | 12.3 | 1.2 |
Lethargy | 321.0 | 294 | 440 | 33.2 | 1.4 |
Myocarditis | 318.0 | 190 | 280 | 32.1 | 1.3 |
Pyrexia | 303.7 | 447 | 643 | 30.5 | 1.3 |
Formication | 303.2 | 132 | 197 | 33.0 | 1.3 |
Headache | 295.1 | 221 | 387 | 42.9 | 1.3 |
Vaccination site swelling | 292.2 | 166 | 187 | 11.2 | 1.4 |
Metrorrhagia | 278.8 | 89 | 99 | 10.1 | 1.1 |
Chills | 270.9 | 283 | 443 | 36.1 | 1.4 |
Application site pain | 263.3 | 220 | 294 | 25.2 | 2.0 |
Feeling cold | 252.9 | 229 | 321 | 28.7 | 2.0 |
Vaccination site erythema | 251.0 | 179 | 200 | 10.5 | 1.5 |
Fatigue | 250.1 | 315 | 508 | 38.0 | 1.3 |
Injection site haematoma | 240.5 | 121 | 145 | 16.6 | 1.3 |
Arthralgia | 218.2 | 284 | 423 | 32.9 | 1.2 |
Malaise | 215.7 | 249 | 388 | 35.8 | 1.3 |
Tenderness | 200.9 | 382 | 416 | 8.2 | 1.1 |
Guillain-Barre syndrome | 200.0 | 264 | 288 | 8.3 | 3.8 |
