2HL-21558-49124

Timeline

1. 2021-03-18
   Dose 1 — Moderna
2. 2021-04-15
   Dose 2 — Moderna
3. 2021-04-20
   Registered in v-safe
4. 2021-04-20
   Survey response — days 1–6 daily, dose 2

   MedDRA: Herpes zoster — Feeling: Poor · Fever · Headache, Fatigue or tiredness · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

   Free text: Beginning shingles involving right side of head and radiating through nerve paths onvolving right ear, right cheek, and right upper lip

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-04-20
   Report sent to call center — days 1–6 daily, dose 2

   Get care from a doctor or other healthcare professional

   1 call case(s)
6. 2021-04-21
   Survey response — days 1–6 daily, dose 2

   MedDRA: Unevaluable event — Feeling: Fair · Fever · Headache, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: On anti-viral *valtrex 3g daily + gabapentin* for suspected non-rash shingles affecting nerve pathways right side head, right ear and right facial area

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-04-22
   Survey response — day 7, dose 2

   MedDRA: Herpes zoster, Neuralgia — Feeling: Fair · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

   Free text: I continue medication to manage 4th day non-rash shingles for right-side head, ear, cheek and right upper lip nerve path pain/discomfort

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-05-01
   Survey response — day 14, dose 2

   MedDRA: Dizziness, Headache — Feeling: Good · Be unable to do your normal daily activities

   Free text: Two brief dizzy spells with residual headache lasting approx. 24 hours each time

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-05-29
   Health check-in — day 42, dose 2

   Feeling: Good

   Adult check-in
10. 2021-10-14
    Survey response — 6 months, dose 2

    MedDRA: Atrial fibrillation, Bradycardia, Cardiac disorder, Pre-existing disease, Tachycardia — Feeling: Fair · 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

    Free text: Heart-related issues. Exasperation of previous afib symptoms. Vascillation between tachycardia with standing and bradycardia when sitting. This flare lasted 6 weeks before cardiologist could manage symptoms with metropolol and flecainide.

    MedDRA releases: 2024-11 · check-in free text available
11. 2021-10-14
    Report sent to call center — 6 months, dose 2

    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 · 1 call case(s)
12. 2021-10-15
    Call 1 — Left Voicemail
13. 2021-10-18
    Call 2 — Left Voicemail
14. 2022-04-15
    Survey response — 12 months, dose 2

    MedDRA: Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

    Free text: Orthostatic hypotension and other issues related to Autonomic Dysfunction. Many of these symptoms were evident a few years prior to COVID vaccines. Only now beginning the process of diagnosis. Awaiting appointment at Mayo in MN after neuro referral

    MedDRA releases: 2024-11 · check-in free text available
15. 2022-04-15
    Report sent to call center — 12 months, dose 2

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

    Outpatient clinic or urgent care clinic visit · 1 call case(s)
16. 2022-04-19
    Call 1 — Left Voicemail