Update March 26' Spikevax (Moderna) PSURs, including raw data sets

released on an ongoing basis by the European Medicines Agency as requested since 2023 by the PSUR4doctors initiative comprising 130 European doctors

Welcome to the Spikevax/Moderna PSUR Disclosure Archive

This archive reveals official safety data the public was never meant to see.
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2.PSUR Update

Two new documents of 2. PSUR Appendices have been released by EMA:

• Spikevax second-pbrer-1jul21-31dec21-pages 4182-4446 (end of Appendices 11.12 & 11.13)

• Spikevax second-pbrer-1jul21-31dec21-pages 4447-4645 (Appendix 11.14-16)

You also find these updates and all documents ever released by EMA since 2023 in the chronological list below:

Photo by Piron Guillaume on Unsplash

COLLECTION OF SPIKEVAX PSUR DATA

7. PSUR Spikevax : 18 December 2023 - 17 December 2024

EMA-PRAC Assessment Report of 7. PSUR Spikevax & PSUR body

6. PSUR Spikevax: 18 June 2023 to 17 December 2023

EMA-PRAC Assessment Report of 6. PSUR Spikevax & PSUR body

5. PSUR Spikevax: 18 December 2022 to 17 June 2023

EMA-PRAC Assessment Report of 5. PSUR Spikevax & PSUR body

4.PSUR Spikevax – 19 June 2022 to 17 December 2022

EMA-PRAC Assessment Report of 4. PSUR Spikevax & PSUR body

All Appendices requested at EMA, still pending

3. PSUR Spikevax (01/01/2022 – 18/06/2022)

3.PSUR Spikevax – EMA-PRAC Spikevax

Appendix 1 Reference Safety Information 567
Appendix 2 Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials 568
Appendix 3 Cumulative and Interval Summary Tabulations of Serious and Non-Serious Adverse Reactions from Post-marketing Data Sources 569
Appendix 4.1 Tabular Summary of Safety Signals 570
Appendix 4.2a Signal Evaluation report: Autoimmune hepatitis
Appendix 4.2b Signal Evaluation report: Giant Cell Arteritis
Appendix 4.2c Signal Evaluation report: Amenorrhea (additional signal evaluation report) 586
Appendix 4.2d Signal Evaluation report: Heavy menstrual bleeding (additional signal evaluation report) 587
Appendix 4.2e Signal Evaluation report: Urticaria (additional signal evaluation report) 588

(Info: Appendices 1-4.2 (pp. 566-914) are comprised in one document)

Appendix 4.2f A Signal Evaluation report: Corneal graft rejection (additional signal evaluation report) 589
Appendix 4.2g Signal Evaluation report: IgA Nephropathy (additional signal evaluation report) 590
Appendix 5 Listing of all MAH-Sponsored Interventional Trials with the Primary Aim of Identifying, Characterising, or Quantifying a Safety Hazard or Confirming the Safety Profile of the Medicinal Product 591

(Info: Appendices 4.2f-5 (pp.915-1268) are comprised in one document)

Appendix 6 Listing of all the MAH-sponsored Non-interventional Studies with the Primary Aim of Identifying, Characterising, or Quantifying a Safety Hazard; Confirming the Safety Profile of the Medicinal Product; or Measuring the Effectiveness of Risk Management Measures 611
Appendix 7 List of the Sources of Information Used to Prepare the PBRER (if desired by the MAH) 616
Appendix 8 EU Regional Appendices 639
Appendix 9 US Regional Appendices 641
Appendix 10 Canada Regional appendix 642
Appendix 11 Other Appendices Supporting PBRER 647
Appendix 11.1 Worldwide Marketing Authorization status 648
Appendix 11.2 Summary of Exposure from Marketing Experience and
Distribution and Administration Data
Appendix 11.3 Observed Expected Appendix
Appendix 11.4a Anaphylaxis Adolescents ages 12 to 17 years_Medical Review
Appendix 11.4b Anaphylaxis: Adolescents ages 12 to 17 years_Medical Review with Brighton Collaboration -Narratives
Appendix 11.4c Anaphylaxis: Literature Search Methodology with Brighton Collaboration

(Info: Appendices 6-11.4c (pp. 915-1268) are comprised in one document)

Appendix 11.5a Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 (additional signal evaluation report) 667
Appendix 11.5b Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 and Dose 3: Case Narratives and Dose 3: Case Listings) 668

(Info: Appendices 11.5a-11.5b (pp. 1269-1568) are comprised in one document)

Appendix 11.5b from pp. 1569-1697 is available here

Appendix 11.5c Myocarditis/Pericarditis Patients less than 18 of age after Dose 2 and Dose 3-Case listings 669
Appendix 11.5d Myocarditis/Pericarditis Patients less than 18 of age after Dose 2 and Dose 3-Case narratives 670
Appendix 11.5e Myocarditis-Pericarditis Fatal reports Case Listings 671
Appendix 11.5f Myocarditis-Pericarditis Fatal reports Case Narratives 672
Appendix 11.5g Myocarditis: Literature search Methodology 673
Appendix 11.6a Pregnancy: Distribution of Case and Event Counts by
SOC/HLT/PT Stratified by Event seriousness for Interval and Cumulative 675
Appendix 11.6b Pregnancy: Summary of pregnancy outcomes by trimester of exposure, and retrospective/prospective case classification, Reporting Period 676
Appendix 11.6c Pregnancy: Summary of pregnancy outcomes by trimester of exposure, and retrospective/prospective case classification, Cumulative 677
Appendix 11.6d Pregnancy: Sun nary of reported congenital anomalies by HLT and PT that occurred in fetuses and neonates, Cumulative 678
Appendix 11.6e Pregnancy: Distribution of Case and Event Counts by SOC/HLT/PT Stratified by Event Seriousness for Adolescents, Interval and Cumulative 679
Appendix 11.6f Pregnancy: Targeted Literature Search Strategy for Pregnancy and Lactation for The Reporting Period (01 Jan 2022-18 Jun 2022 680
Appendix 11.7 Lactation-related Cases Under 5 years of Age with Serious Lactation-related events, Cumulative 681
Appendix 11.8 Use in immunocompromised subjects: Literature search methodology 682
Appendix 11.9a Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Literature search 683
Appendix 11.9b Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Various Synonyms terms of SPIKEVAX 684
Appendix 11.9c Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Articles/Abstracts Appendix 11.9c Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Articles/Abstracts 685
Appendix 11.9d Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Fatal cases: Case Listings and Case Narratives) 686

(Info: Appendices 5.c-11.9d (pp.1569-1868) are comprised in one document)

Appendix 11.9d from pp. (pp. 1869-2268) is available here

Appendix 11.9e Interaction: with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Immunocompromised co-morbidities Dose 3 & 4 688

(Info: Appendix 11.9e (pp. 2269-2734) is comprised in one document) and Appendix 11.9e (pp. 2735-3034) is available here

Appendix 11.9f Interaction: with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Immunocompromised co-morbidities Dose 3 & 4
Appendix 11.10 Narratives-RP Use in frail subjects: Fatal cases: Case Listings and Case 689

(Info: Appendices 11.9f -11.10 (pp. 2735-3034) are comprised in one document)

Appendix 11.11a Use in Patients with Autoimmune or Inflammatory Disorders:
Literature Search Methodology
Appendix 11.11b Use in patients with Autoimmune or Inflammatory Disorders:
Fatal cases: Case Listings and Case Narratives
Appendix 11.11c Use in Patients with Autoimmune or Inflammatory Disorders: PTs of Autoimmune/Inflammatory Disorder (AI/M) SMQ in Reports with Past MIHX of AI/ID, representing a subset of potential flares (Cumulative)
Appendix 11.12a Myasthenia gravis: New Onset MG-Case Listings
Appendix 11.12b Myasthenia gravis: New Onset MG-Case Narratives
Appendix 11.12c Myasthenia gravis: MG flare-Case Listings
Appendix 11.12d Myasthenia gravis: MG flare-Case Narratives
Appendix 11.12e Myasthenia gravis: Literature Search Methodology
Appendix 11.13a Use in Patients with Autoimmune c• Irlammatory Disorders
(Autoimmune Hemolytic Anemia): Cumulative Evaluation-Case listings
Appendix 11.13b Use in Patients with Autoimmune or Inflammatory Disorders
(Autoimmune Hemolytic Anemia): Cumulative Evaluation-Case Narratives

(Info: Appendices 11.11a-11.13b (pp. 3035-3417) are comprised in one document)

Appendix 11.13c Use in Patients with Autoimmune or Inflammatory Disorders (Autoimmune Hemolytic Anemia): Tables with culmulative literature for AIHA and mRNA vaccines and Covid-19 infection
Appendix 11.13d Use in Patients with Autoimmune or Inflammatory Disorders (Autoimmune Hemolytic Anemia): Detailed review of fatal cases
Appendix 11.13e Use in Patients with Autoimmune or Inflammatory Disorders (Autoimmune Hemolytic Anemia): Summary of 15 cases which met International Consensus case definition
Appendix 11.14a Acquired haemophilia: Case listings
Appendix 11.14b Acquired haemophilia: Case narratives
Appendix 11.14c Acquired haemophilia: Literature Search Methodology
Appendix 11.14d Acquired haemophilia: Literature articles/Abstracts
Appendix 11.14e Acquired haemophilia: Various Synonyms of SPIKEVAX
Appendix 11.15a Thrombosis with Thrombocytopenia Syndrome (TTS): Reporting Period Case Listings According to The Brighton Collaboration Case Definitions
Appendix 11.15b Thrombosis with Thrombocytopenia Syndrome (TTS): Reporting Period Case Narratives According to The Brighton Collaboration Case Definitions
Appendix 11.16a Guillain-Barre Syndrome (GBS) Listings
Appendix 11.16b Guillain-Barre Syndrome (GBS) Narratives
Appendix 11.17a Acute Disseminated Encephalomyelitis (ADEM): Detailed Summary of Cumulative Data Concerning ADEM and Brighton’s Collaboration Level of diagnostic certainty 1 to 5: Case Listings
Appendix 11.17b Acute Disseminated Encephalomyelitis (ADEM): Detailed Summary of Cumulative Data Concerning ADEM and Brighton’s Collaboration Level of diagnostic certainty 1 to 5: Case Narratives
(Info: Appendices 11.13c-11.17b (pp. 3418-3764) are comprised in one document)

Appendix 11.17c Acute Disseminated Encephalomyelitis (ADEM): Detailed Summary of Cumulative Data Concerning ADEM and Brighton's CollaborationLevel of diagnostic certainty 1 to 3 and their WHO-UMC Causality Assessment: Case Listings 731
Appendix 11.17d Acute Disseminated Encephilc -myelitis (ADEM): Detailed Summary of Cumulative Data Concerning ADEM and Brighton's Collaboration Level of diagnostic certainty 1 to 3 and their WHO-UMC Causality Assessment: Case Narratives 732
Appendix 11.17e Acute Disseminated Encephalomyelitis (ADEM): Various synonymous terms of SPIKEVAX
Appendix 11.17f Acute Dissemitfted Encephalomyelitis (ADEM): Literature Search Methodology 734
Appendix 11.18a Neuralgic Amyotrophy: Cumulative reports of Neuralgic amyotrophy with Case Assessment and WHO Causality information 735
Appendix 11.18b Neuralgic Amyotrophy: Cumulative reports of Neuralgic Amyotrophy with Case Assessment and WHO Causality information: Casenarratives 736
Appendix 11.18c Neuralgic Amyotrophy: Cumulative reports of Neuralgic Amyotrophy with Case Assessment and WHO Causality infermation: Case listings 737
Appendix 11.18d Neuralgic Amyotrophy: Literature Search Methodology 738

(Info: Appendices 11.17.c-11.18d (pp. 3765-4087) are comprised in one document)

Appendix 11.19a Multisystem Inflaming'ory Syndrome (MIS): Summary Informs_ on on the Reported Evens Eiring the Reporting Period with a Fatal Outcome: Case Listings
Appendix 11.19b Multisystem Inflan )ry Syndrome (MIS): Summary Inform c on the Reported Evens Eiring the Reporting Period will) a Fatal Outcome: Narratives Appendix 11.19c Multisystem Inflammatory Syndrome (MIS): Information on MIS-C Related Events for the reporting period: Case Listings
Appendix 11.19d Multisystem Inflammatory Syndrome (MIS): Information on MIS-C Related Events for the reporting period: Narratives
Appendix 11.19e Multisystem Inflammatory Syndrome (MIS): Brighton Collaboration Summary Information Level 1 to 3 for the Reporting Period: Case Listings
Appendix 11.19f Multisystem Inflammatory Syndrome (MIS): Brighton Collaboration Summary Information Level 1 to 3 for the Reporting Period: Narratives
Appendix 11.19g Multisystem Inflammatory Syndrome (MIS): Summary Information for all MIS-C/A related cases for the reporting period: Case Listings Appendix 11.19h Multisystem Inflammatory Syndrome (MIS): Summary Information on all MIS-C/A related cases for the reporting period: Narratives Appendix 11.19i Multisystem Inflammatory Syndrome (MIS): Various synonymous terms of SPIKEVAX
Appendix 11.20a Chronic Urticaria: Cases classified by the MAH as Chronic Urtica is Flare/Worsening (n=9) Appendix 11.20b Chronic Urticaria: Case Narratives for "Definite" cases of Chronic Urticaria (N=35)
Appendix 11.20c Chronic Urticaria: Literature Search Methodology

(Info: Appendices 11.19a-11.20c (pp. 4088-4371) are comprised in one document)

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

(Info: Appendices 11.21a-11.23c (pp. 4372-4685) are comprised in one document)

Document-pages 4687-4884 missing!

Document 4885-5085 (bad quality)

Document-pages 5086-5471 missing!

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
(Info: Appendices 11.25a-11.28g (pp. 5472-5848) are comprised in one document)

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

(Info: Appendices 11.29c-12 (pp. 5849-6053) are comprised in one document)

2. PSUR Spikevax - 1 Jul 2021 to 31 Dec 2021

2.PSUR Body – EMA PRAC AR 2.PSUR

• Appendices 1-4b3 (pp. 1-278) here

Appendix Reference Safety Information……………………………516
Appendix Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials………………………………………………………………………………517
Appendix Cumulative and Interval Summary Tabulations of Serious and Non-Serious Adverse Reactions from Post-marketing Data Sources .........519
Appendix Tabular Summary of Safety Signals ..........................................520
4.1. Appendix 4a Tabular summary of safety signals new, ongoing or closed during the reporting interval ..........................................................................521
4.2. Appendix 4b Signal Evaluation Reports ........................................................536
4.2.1. Appendix 4b1: Signal Evaluation report: Dizziness
4.2.2. Appendix 4b2: Signal Evaluation report: Neuralgic Amyotrophy
4.2.3. Appendix 4b3: Signal Evaluation report: Erythema Multiforme

(Info: Appendices 1-4b3 (pp. 516-536) are comprised in one document)

• Appendices 4b4-6 pp.540-682 (=794-1277pp) here

4. Appendix 4b4: Signal Evaluation report: Glomerulonephritis and Nephrotic Syndrome
5. Appendix 4b5: Signal Evaluation report: Serious Hypertension
6. Appendix 4b6: Signal Evaluation report: Multisystem Inflammatory Syndrome

Document of these appendices are missing, forthcoming soon:
5. Appendix 5 Listing of all MAH-Sponsored Interventional Trials with the Primary Aim of Identifying, Characterizing, or Quantifying a Safety Hazard or Confirming the Safety Profile of the Medicinal Product ...........546
6. Appendix 6 Listing of all the MAH-sponsored Non-interventional Studies with the Primary Aim of Identifying, Characterizing, or Quantifying a Safety Hazard; Confirming the Safety Profile of the Medicinal Product; or Measuring the Effectiveness of Risk Management Measures ......................560
7. Appendix 7 List of the Sources of Information Used to Prepare the PBRER ……….563
8. Appendix 8 EU Regional Appendices ............................………………...............................584
8.1. Appendix 8a Proposed Product Information ................................................584
8.2. Appendix 8b Reference Information Comparison ........................................584
8.3. Appendix 8c Proposed Additional Pharmacovigilance and Risk
Minimization Activities ...................................................................................584
8.4. Appendix 8d Summary of Ongoing Safety Concerns ...................................584
8.5. Appendix 8e Reporting of Results from Post-authorisation Safety Studies..........................................................................................................................584
8.6. Appendix 8f Effectiveness of Risk Minimization ..........................................584
8.7. Appendix 8g Medication Errors .....................................................................584
9. Appendix 9 US Regional Appendices .............................................................585
10. Appendix 10 Canada Regional appendix .......................................................586
10.1. Introduction ......................................................................................................586
10.2. Adverse Drug Reactions Occurring in Canada.............................................586
10.3. Epidemiology of the Medical Condition(s) or Risk Factors that Reflect the
Authorized Indications(s) in Canada .............................................................587
10.4. Canadian Product Monograph for COVID-19 mRNA Vaccine ..................588
10.5. Information Related to Canadian Patient Exposure ....................................589
10.6. Post-marketing Experience in the Canadian Context ..................................589
10.7. Pharmacovigilance Activities within Canada ................................................589
10.8. Verification of AR records against Health Canada’s Canada Vigilance Database..590
10.9. Risk Minimization Strategies and Evaluation Of Effectiveness Of Risk Minimization Activities To The Canadian Context ......................................590)
11.5 Appendix 11 Other Appendices Supporting PBRER ...................................591
11. Appendix 11 Other Appendices Supporting PBRER ...................................591
11.1. Worldwide Marketing Authorization status .................................................592
11.2. Summary of Exposure from Marketing Experience and Distribution and
Administration Data ........................................................................................602
11.3. Observed Expected Appendix .........................................................................603
11.4. Myocarditis/Pericarditis: Fatal reports: Case Listings ................................604

Appendices 11.5.-6 here 1749-2248

11.5. Myocarditis/Pericarditis: Fatal reports: Case Narratives ...........................605
11.6. Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 and Dose 3: Case Listings ................................................................................................606

Appendix 11.7: first (starts at p. 78;1749-2248), second (pp. 2249-2724), third ( until p. 42; pp. 2725-3226),

11.7. Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 and Dose 3: Case Narratives

Appendices 11.8-9 here (pp. 2725-3226)

11.8. Myocarditis/Pericarditis: Patients < 40 years of age Brighton CDC and WHO Assessments after Dose 2 and Dose 3: Case Listings .........................608
11.9. Myocarditis/Pericarditis: Patients < 40 years of age Brighton CDC and WHO Assessments after Dose 2 and Dose 3: Case Narratives ....................609

Appendix 11.10 ( here pp. 3227-3682) & here ( until p. 18; pp. 3683-3931)
11.10. Myocarditis/Pericarditis: WHO UMC Case Causality assessment: Case Listings……………………………………………………………………………………………………………….610

Appendix 11.11 (here until p.197; pp. 3683-3931)

11.11. Myocarditis/Pericarditis: WHO UMC Case Causality assessment: Case Narratives .........................................................................................................611

Appendix 11.12 (here from p.198; pp. 3683-3931)

Appendix 11.12 (here from p. 211; pp. 3932-4181 & pp. 4182-4446)

11.12. Myocarditis/Pericarditis: CDC working case Definition: Case Listings ....612

Appendix 11.13-16 (here, pp. 4447-4645)

11.13. Myocarditis/Pericarditis: CDC working case Definition: Case Narratives 613
11.14. Pregnancy: Distribution of Case and Event Counts by SOC/HLT/PT Stratified by Event seriousness for Interval and Cumulative ......................614
11.15. Pregnancy: Summary of pregnancy outcomes by trimester of exposure, and retrospective/prospective case classification, Reporting Period ..................615
11.16. Pregnancy: Summary of pregnancy outcomes by trimester of exposure, and retrospective/prospective case classification, Cumulative ............................616

11.17. Pregnancy: Summary of reported congenital anomalies by HLT and PT that occurred in foetuses and neonates ..........................................................617
11.18. Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Abstract/Articles ...........................................................................618
11.19. Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Fatal cases: Case Listings and Case Narratives .........................619
11.20. Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Pfizer: Cumulative Case Narratives Listings .............................620
11.21. Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): AstraZeneca: Cumulative Case Narratives Listings..................621
11.22. Interaction: with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Cumulative Other MAH Case Narrative Listings .....................622
11.23. Interaction: with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Cumulative Jannssen Case Narrative Listings ...........................623

1. PSUR Spikevax

1.PSUR Body – EMA PRAC AR 2.PSUR (missing)

Appendices missing