# A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe

^{*}

## Abstract

**:**

## 1. Introduction

#### Literature Review

## 2. Materials and Methods

- -
- for myocarditis: $\frac{\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{n}\mathrm{u}\mathrm{m}\mathrm{b}\mathrm{e}\mathrm{r}\text{}\mathrm{o}\mathrm{f}\text{}\mathrm{m}\mathrm{y}\mathrm{o}\mathrm{c}\mathrm{a}\mathrm{r}\mathrm{d}\mathrm{i}\mathrm{t}\mathrm{i}\mathrm{s}\text{}\mathrm{A}\mathrm{D}\mathrm{R}\mathrm{s}\text{}\mathrm{r}\mathrm{e}\mathrm{p}\mathrm{o}\mathrm{r}\mathrm{t}\mathrm{e}\mathrm{d}\text{}\mathrm{i}\mathrm{n}\text{}\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{s}\mathrm{t}\mathrm{u}\mathrm{d}\mathrm{y}\text{}\mathrm{p}\mathrm{e}\mathrm{r}\mathrm{i}\mathrm{o}\mathrm{d}}{\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{n}\mathrm{u}\mathrm{m}\mathrm{b}\mathrm{e}\mathrm{r}\text{}\mathrm{o}\mathrm{f}\text{}\mathrm{i}\mathrm{n}\mathrm{d}\mathrm{i}\mathrm{v}\mathrm{i}\mathrm{d}\mathrm{u}\mathrm{a}\mathrm{l}\mathrm{s}\text{}\mathrm{w}\mathrm{h}\mathrm{o}\text{}\mathrm{r}\mathrm{e}\mathrm{c}\mathrm{e}\mathrm{i}\mathrm{v}\mathrm{e}\mathrm{d}\text{}\mathrm{t}\mathrm{h}\mathrm{e}\mathrm{i}\mathrm{r}\text{}\mathrm{f}\mathrm{i}\mathrm{r}\mathrm{s}\mathrm{t}\text{}\mathrm{d}\mathrm{o}\mathrm{s}\mathrm{e}\text{}\mathrm{o}\mathrm{f}\text{}\mathrm{v}\mathrm{a}\mathrm{c}\mathrm{c}\mathrm{i}\mathrm{n}\mathrm{e}\text{}\mathrm{i}\mathrm{n}\text{}\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{s}\mathrm{t}\mathrm{u}\mathrm{d}\mathrm{y}\text{}\mathrm{p}\mathrm{e}\mathrm{r}\mathrm{i}\mathrm{o}\mathrm{d}}$
- -
- for pericarditis: $\frac{\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{n}\mathrm{u}\mathrm{m}\mathrm{b}\mathrm{e}\mathrm{r}\text{}\mathrm{o}\mathrm{f}\text{}\mathrm{p}\mathrm{e}\mathrm{r}\mathrm{i}\mathrm{c}\mathrm{a}\mathrm{r}\mathrm{d}\mathrm{i}\mathrm{t}\mathrm{i}\mathrm{s}\text{}\mathrm{A}\mathrm{D}\mathrm{R}\mathrm{s}\text{}\mathrm{r}\mathrm{e}\mathrm{p}\mathrm{o}\mathrm{r}\mathrm{t}\mathrm{e}\mathrm{d}\text{}\mathrm{i}\mathrm{n}\text{}\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{s}\mathrm{t}\mathrm{u}\mathrm{d}\mathrm{y}\text{}\mathrm{p}\mathrm{e}\mathrm{r}\mathrm{i}\mathrm{o}\mathrm{d}}{\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{n}\mathrm{u}\mathrm{m}\mathrm{b}\mathrm{e}\mathrm{r}\text{}\mathrm{o}\mathrm{f}\text{}\mathrm{i}\mathrm{n}\mathrm{d}\mathrm{i}\mathrm{v}\mathrm{i}\mathrm{d}\mathrm{u}\mathrm{a}\mathrm{l}\mathrm{s}\text{}\mathrm{w}\mathrm{h}\mathrm{o}\text{}\mathrm{r}\mathrm{e}\mathrm{c}\mathrm{e}\mathrm{i}\mathrm{v}\mathrm{e}\mathrm{d}\text{}\mathrm{t}\mathrm{h}\mathrm{e}\mathrm{i}\mathrm{r}\text{}\mathrm{f}\mathrm{i}\mathrm{r}\mathrm{s}\mathrm{t}\text{}\mathrm{d}\mathrm{o}\mathrm{s}\mathrm{e}\text{}\mathrm{o}\mathrm{f}\text{}\mathrm{v}\mathrm{a}\mathrm{c}\mathrm{c}\mathrm{i}\mathrm{n}\mathrm{e}\text{}\mathrm{i}\mathrm{n}\text{}\mathrm{t}\mathrm{h}\mathrm{e}\text{}\mathrm{s}\mathrm{t}\mathrm{u}\mathrm{d}\mathrm{y}\text{}\mathrm{p}\mathrm{e}\mathrm{r}\mathrm{i}\mathrm{o}\mathrm{d}}$

## 3. Results

## 4. Discussion

## 5. Conclusions

## Author Contributions

## Funding

## Institutional Review Board Statement

## Informed Consent Statement

## Data Availability Statement

## Conflicts of Interest

## References

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**Table 1.**All myocarditis ADRs reported from 1 January 2021 to 11 February 2022 stratified by age group and sex.

Vaccine Name, n of Total Cardiac ADRs (1 January 2021–11 February 2022) | Patient Age Group | Patient Sex | Myocarditis ADRs | ||
---|---|---|---|---|---|

Female | Male | NS | n (%) | ||

Moderna (CX-024414) N = 9078 | 12–17 Years | 5 | 67 | 0 | 72 (5.67) |

18–64 Years | 231 | 883 | 6 | 1120 (88.26) | |

65–85 Years | 29 | 27 | 0 | 56 (4.41) | |

More than 85 | 2 | 1 | 0 | 3 (0.24) | |

Not Specified | 6 | 10 | 2 | 18 (1.42) | |

Total (%) | 273 (21.51) | 988 (77.86) | 8 (0.63) | 1269 (100) | |

Pfizer-BioNTech (TOZINAMERAN) N = 38,297 | 5–11 Years | 3 | 4 | 0 | 7 (0.17) |

12–17 Years | 65 | 492 | 5 | 562 (13.75) | |

18–64 Years | 897 | 2187 | 22 | 3106 (76.00) | |

65–85 Years | 122 | 122 | 2 | 246 (6.02) | |

More than 85 | 11 | 12 | 0 | 23 (0.56) | |

Not Specified | 40 | 85 | 18 | 143 (3.50) | |

Total (%) | 1138 (27.84) | 2902 (71.01) | 47 (1.15) | 4087 (100) |

**Table 2.**All pericarditis ADRs reported from 1 January 2021 to 11 February 2022 stratified by age group and sex.

Vaccine Name, n of Total Cardiac ADRs (1 January 2021–11 February 2022) | Patient Age Group | Patient Sex | Pericarditis ADRs | ||
---|---|---|---|---|---|

Female | Male | NS | n (%) | ||

Moderna (CX-024414) N = 9078 | 12–17 Years | 5 | 7 | 0 | 12 (1.67) |

18–64 Years | 266 | 336 | 4 | 606 (84.52) | |

65–85 Years | 46 | 43 | 0 | 89 (12.41) | |

More than 85 | 2 | 0 | 0 | 2 (0.28) | |

Not Specified | 4 | 4 | 0 | 8 (1.12) | |

Total | 323 (45.05) | 390 (54.39) | 4 (0.56) | 717 (100) | |

Pfizer-BioNTech (TOZINAMERAN) N = 38,297 | 12–17 Years | 49 | 89 | 0 | 138 (4.92) |

18–64 Years | 1157 | 1068 | 10 | 2235 (79.74) | |

65–85 Years | 160 | 184 | 0 | 344 (12.27) | |

More than 85 | 15 | 25 | 0 | 40 (1.43) | |

Not Specified | 24 | 20 | 2 | 46 (1.64) | |

Total | 1405 (50.12) | 1386 (49.45) | 12 (0.43) | 2803 (100) |

**Table 3.**The severity of the ADRs reported from 1 January 2021 to 11 February 2022 stratified by the mRNA COVID-19 vaccines. The ADR categories are not mutually exclusive. Some cases might belong to 2 or more categories. Thus, the row sum is greater than the total number of observations.

ADR Reported by the Type of mRNA COVID-19 Vaccines | Requires Hospitalizations or Prolongation of Hospitalization n (%) | Other Medically Important Information n (%) | Life Threatening n (%) | Non-Serious n (%) | Results in Disability or Incapacity n (%) | Results in Death n (%) | |
---|---|---|---|---|---|---|---|

Myocarditis | Moderna (CX-024414) N = 1269 | 977 (76.99) | 277 (21.83) | 138 (10.88) | 40 (3.15) | 34 (2.68) | 7 (0.55) |

Pfizer-BioNTech (TOZINAMERAN) N = 4087 | 2573 (62.96) | 1224 (29.95) | 454 (11.11) | 111 (2.72) | 114 (2.79) | 37 (0.91) | |

Pericarditis | Moderna (CX-024414) N = 717 | 326 (45.47) | 325 (45.33) | 35 (4.88) | 75 (10.46) | 11 (1.53) | 4 (0.56) |

Pfizer-BioNTech (TOZINAMERAN) N = 2803 | 1190 (42.46) | 1344 (47.95) | 165 (5.89) | 296 (10.56) | 85 (3.03) | 9 (0.32) |

Vaccine Name | Person-Time at Risk (100,000 Person-Years) | Background Incidence (Lowest, Highest) | Expected Myocarditis | Observed Myocarditis | SMR (95% CI) | IC (95% CI) |
---|---|---|---|---|---|---|

Moderna (CX-024414) | 56.32 | 1 | 56.32 | 1269 | 22.53 (21.31–23.81) | 4.48 (4.39–4.55) |

10 | 563.2 | 2.253 (2.13–2.38) | 1.17 (1.08–1.24) | |||

Pfizer-BioNTech (TOZINAME RAN) | 371.35 | 1 | 371.35 | 4087 | 11.01 (10.67–11.35) | 3.46 (3.41–3.50) |

10 | 3713.5 | 1.10 (1.07–1.14) | 0.14 (0.09–0.18) |

Vaccine Name | Person-Time at Risk (100,000 Person-Years) | Background Incidence (Lowest, Highest) | Expected Pericarditis | Observed Pericarditis | SMR (95% CI) | IC (95% CI) |
---|---|---|---|---|---|---|

Moderna (CX-024414) | 56.32 | 1 | 56.32 | 717 | 12.73 (11.82–13.70) | 3.66 (3.54–3.75) |

10 | 563.2 | 1.27 (1.18–1.37) | 0.35 (0.23–0.44) | |||

Pfizer-BioNTech (TOZINAME RAN) | 371.35 | 1 | 371.35 | 2803 | 7.55 (7.27–7.83) | 2.91 (2.85–2.96) |

10 | 3713.5 | 0.75 (0.73–0.78) | −0.41 (–0.47––0.36) |

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**MDPI and ACS Style**

Tome, J.; Cowan, L.T.; Fung, I.C.-H.
A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe. *Microorganisms* **2023**, *11*, 1099.
https://doi.org/10.3390/microorganisms11051099

**AMA Style**

Tome J, Cowan LT, Fung IC-H.
A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe. *Microorganisms*. 2023; 11(5):1099.
https://doi.org/10.3390/microorganisms11051099

**Chicago/Turabian Style**

Tome, Joana, Logan T. Cowan, and Isaac Chun-Hai Fung.
2023. "A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe" *Microorganisms* 11, no. 5: 1099.
https://doi.org/10.3390/microorganisms11051099