Document Appendices 11.19a-11.20c available here (pp. 4088-4371)

Appendix 11.21a Autoimmune Hepatitis: Cumulative Cases with WHO Causality and Confounders-Case listings 751
Appendix 11.21b Autoimmune Hepatitis: Cumulative Cases with WHO Causality and Confounders-Case narratives 752
Appendix 11.21c Autoimmune Hepatitis: AIH confirmed case-Case listings 753
Appendix 11.21d Autoimmune Hepatitis: AIH confirmed case-Case narratives 754
Appendix 11.21e Autoimmune Hepatitis: Summary of Fatal Cases 755
Appendix 11.21f Autoimmune Hepatitis: tabular Overview of Fatal cases with
WHO Causality-Case listings 756
Appendix 11.21g Autoimmune Hepatitis: tabular Overview of Fatal cases with WHO Causality-Case narratives 757
Appendix 11.21h Autoimmune Hepatitis: Literature Search Methodology 758
Appendix 11.22a SOCV: Detailed summary of Cumulative cases that met Brighon's Collaboration Level of diagnostic certainty 1 to 3, and their WHO-UMC causality assessment 759
Appendix 11.22b SOCV: Literature Search Methodology 760
Appendix 11.23a Polymyalgia Rheumatica and exacerbation or flar:-up- Overview of Flare/Aggravated and New-Onset PMR cases with case summaries andcompany comments- Reporting Period 01 Jan 2022 to 18 Jun 2022 761
Appendix 11.23b Polymyalgia Rheumatica and exacerbation or flare-up: Re-evaluation of the causality assessment of the 22 possible cases presented in PBRER#2 762
Appendix 11.23c Polymyalgia Rheumatica and exacerbation or flare-up: Literature Search Methodology 763

Document Appendices 11.21a-11.23c available here (pp. 4372-4685)

Appendix 11.25a Overdose: Reporting Period Case Listings
Appendix 11.25b Overdose: Reporting Period Case Narratives
Appendix 11.25c Overdose: Literature Search Methodology
Appendix 11.26a Off-label use: Reporting Period Case Listing
Appendix 11.26b Off-label use: Reporting Period Case Narratives
Appendix 11.26c Off-label use: Literature Search Methodology
Appendix 11.27a Interactions with Other Vaccines: Literature cases
Appendix 11.27b Interactions with Other Vaccines: Literature Search Methodology
Appendix 11.28a Lack of Efficacy/Vaccine failure: Variant cases
Appendix 11.28b Lack of Efficacy/Vaccine failure: Fatal case listings-RP
Appendix 11.28c Lack of Efficacy/Vaccine failure: Fatal case narratives-RP
Appendix 11.28d Lack of Efficacy/Vaccine failure: Fatal case listings after Booster
Appendix 11.28e Lack of Efficacy/Vaccine failure: Fatal case narratives after Booster
Appendix 11.28e Lack of Efficacy/Vaccine failure: literature Search Vaccine Inefficacy cases
Appendix 11.28f Lack of Efficacy/Vaccine failure: Scientific abstracts
Appendix 11.28g Lack of Efficacy/Vaccine failure: Additional literature search strategy
Appendix 11.29a Elderly: Fatal case listings
Appendix 11.29b Elderly: Fatal case narratives

Document Appendices 11.25a-11.28g available here (pp. 5472-5848)

Appendix 11.29c. Elderly: Fatal case listings after Booster
Appendix 11.29d. Elderly: Fatal case narratives after Booster
Appendix 11.29e Elderly: Literature Search Methodology
Appendix 11.30a Children: Cumulative event counts in the < 18 years age group
Appendix 11.30b Children: Summary of Serious cases in children 2-11 years of age
Appendix 11.30c Children: Details on event counts during the reporting period in
the 0-5 years age group
Appendix 11.30d Children: Details on event counts during the reporting period in the 5-11 years age group
Appendix 11.30e Children: Details on event counts during the reporting period in the 12-17 years age group
Appendix 12 Literature search strategies

Document Appendices 11.29c-12 available here (pp. 5849-6053)

2. PSUR Spikevax
2.PSUR Body – EMA PRAC AR 2.PSUR
1. PSUR Spikevax
1.PSUR Body – EMA PRAC AR 2.PSUR

Appendix 1 Reference Information (02 December 2021) 353

1. PSUR Spikevax
1.PSUR Spikevax – EMA-PRAC Spikevax