N3L-22364-04068

Timeline

1. 2021-01-16
   Dose 1 — Moderna
2. 2021-01-17
   Registered in v-safe
3. 2021-01-17
   Survey response — days 1–6 daily, dose 1

   MedDRA: Dysgeusia, Swollen tongue — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fatigue or tiredness, Nausea, Abdominal pain

   Free text: Metallic taste and swollen tongue

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-01-18
   Health check-in — days 1–6 daily, dose 1

   Feeling: Fair · Site: Pain, Redness, Swelling · Fatigue or tiredness

   Adult check-in
5. 2021-01-19
   Health check-in — days 1–6 daily, dose 1

   Feeling: Fair · Site: Redness, Swelling, Itching · Fatigue or tiredness, Nausea

   Adult check-in
6. 2021-01-22
   Health check-in — days 1–6 daily, dose 1

   Feeling: Fair · Fatigue or tiredness, Diarrhea

   Adult check-in
7. 2021-01-23
   Health check-in — day 7, dose 1

   Feeling: Poor · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

   Adult check-in
8. 2021-01-30
   Survey response — day 14, dose 1

   MedDRA: Fatigue, Injection site erythema, Injection site swelling — Feeling: Fair

   Free text: Site injection and entire arm swelled and turned red, extreme fatigue (may or may not be related to the vaccine)

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-02-06
   Health check-in — day 21, dose 1

   Feeling: Fair

   Adult check-in
10. 2021-02-13
    Dose 2 — Moderna
11. 2021-02-13
    Survey response — day 0, dose 2

    MedDRA: Eye irritation, Head discomfort, Lacrimation increased, Oropharyngeal pain, Pollakiuria — Feeling: Fair · Site: Pain, Itching · Chills, Fatigue or tiredness, Nausea

    Free text: Watery/burning eyes, pressure in head w/out actual headache, sore throat, increased urination

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-02-14
    Survey response — days 1–6 daily, dose 2

    MedDRA: Injection site reaction, Injection site swelling — Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Abdominal pain

    Free text: Injection site reaction appears as if it is two different sites connected by the swelling

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-02-15
    Health check-in — days 1–6 daily, dose 2

    Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Be unable to do your normal daily activities

    Adult check-in
14. 2021-02-16
    Health check-in — days 1–6 daily, dose 2

    Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fatigue or tiredness

    Adult check-in
15. 2021-02-17
    Health check-in — days 1–6 daily, dose 2

    Feeling: Fair · Site: Pain, Itching · Fatigue or tiredness

    Adult check-in
16. 2021-02-19
    Survey response — days 1–6 daily, dose 2

    MedDRA: Oropharyngeal pain — Feeling: Fair · Site: Itching · Fatigue or tiredness

    Free text: Sore throat

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
17. 2021-02-20
    Survey response — day 7, dose 2

    MedDRA: Dysphonia — Feeling: Fair · Site: Itching · Fatigue or tiredness

    Free text: Hoarseness in throat

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
18. 2021-02-27
    Health check-in — day 14, dose 2

    Feeling: Fair

    Adult check-in
19. 2021-03-06
    Health check-in — day 21, dose 2

    Feeling: Fair

    Adult check-in
20. 2021-03-13
    Survey response — day 28, dose 2

    MedDRA: Fatigue, Insomnia, Oropharyngeal pain, Paranasal sinus discomfort, Paranasal sinus hypersecretion, Sinus congestion — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities

    Free text: Sore throat, sinus drainage/pressure/congestion, fatigue, insomnia

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
21. 2021-03-20
    Health check-in — day 35, dose 2

    Feeling: Fair

    Adult check-in
22. 2021-03-27
    Health check-in — day 42, dose 2

    Feeling: Fair

    Adult check-in
23. 2021-05-15
    Health check-in — 3 months, dose 2

    Feeling: Poor

    Adult check-in
24. 2021-08-15
    Survey response — 6 months, dose 2

    MedDRA: Hypertension, Migraine, Sinusitis — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities

    Free text: Sinus infection, migraines, high BP

    MedDRA releases: 2021-09,2024-11 · check-in free text available
25. 2022-02-13
    Survey response — 12 months, dose 2

    MedDRA: COVID-19, Fatigue, Pre-existing disease, Pregnancy, Pyrexia, Respiratory tract congestion — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

    Free text: COVID+ 01/05/22, pregnant + autoimmune disorders: mAb infusion 01/09/22, fever since 01/10/22 currently still spiking daily (most other symptoms have subsided, still extremely exhausted and have congestion), I've experienced numerous symptoms

    MedDRA releases: 2024-11 · check-in free text available
26. 2022-02-13
    Report sent to call center — 12 months, dose 2

    Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

    Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · 1 call case(s)
27. 2022-02-16
    Call 1 — Could Not Reach Participant
28. 2022-02-18
    Call 2 — Left Voicemail
29. 2022-02-28
    Call successful

    Not applicable (accidental reporting or does not believe symptoms are related to vaccine)