67N-21370-27133

Timeline

1. 2021-01-20
   Registered in v-safe
2. 2021-01-20
   Dose 1 — Moderna
3. 2021-01-21
   Survey response — days 1–6 daily, dose 1

   MedDRA: Chest discomfort, Heart rate increased — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

   Free text: Racing heartbeat & tightness. I listed severe because for the hour (x 3 episodes) last night it was severe. Daytime and evening is moderate and lingering.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-01-22
   Survey response — days 1–6 daily, dose 1

   MedDRA: Migraine, Palpitations, Unevaluable event — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting, Abdominal pain · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): Racing heart rate, I can see my heart beating fast in my chest. Migraines. · Healthcare visit (other): (b)(6), my Montana doctor ar(b)(6) Medical is trying to schedule me for a televisit today.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-01-22
   Report sent to call center — days 1–6 daily, dose 1

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

   1 call case(s)
6. 2021-01-23
   Survey response — days 1–6 daily, dose 1

   MedDRA: Chest discomfort, Migraine, Palpitations, Telemedicine — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting, Abdominal pain · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

   Free text: Systemic reaction (other): Tightness in chest, heart palpatations, my doctor called on a med to help with the intense migraines · Healthcare visit (other): Televisit with Dr. (b)(6) at(b)(6) Medical in Montana at 6:45pm

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-01-23
   Report sent to call center — days 1–6 daily, dose 1

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

   1 call case(s)
8. 2021-01-24
   Survey response — days 1–6 daily, dose 1

   MedDRA: Angina pectoris, Chest pain, Emergency care, Office visit — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting · Be unable to work, Be unable to do your normal daily activities

   Free text: In emer room hooked up to iv chest pain and horrible heatc heart pain. Beofre here, went to urgent car in kauai

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-01-25
   Survey response — days 1–6 daily, dose 1

   MedDRA: Chest pain, Emergency care, Hypertension — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting, Abdominal pain · Be unable to work, 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, Emergency room or emergency department visit, Hospitalization

   Free text: Extremely high blood pressure, chest pain spent many hours in emegency room

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
10. 2021-01-25
    Report sent to call center — days 1–6 daily, dose 1

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

    1 call case(s)
11. 2021-01-26
    Survey response — days 1–6 daily, dose 1

    MedDRA: Heart rate increased, Migraine — Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

    Free text: Fast heart rate, mild migraine

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-01-27
    Health check-in — day 7, dose 1

    Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

    Adult check-in
13. 2021-02-04
    Health check-in — day 14, dose 1

    Feeling: Fair

    Adult check-in
14. 2021-05-11
    Call 1 — Could Not Reach Participant
15. 2021-05-14
    Call 2 — Could Not Reach Participant