4DU-14044-53944

Timeline

1. 2021-01-22
   Dose 1 — Moderna
2. 2021-01-24
   Registered in v-safe
3. 2021-01-24
   Health check-in — days 1–6 daily, dose 1

   Feeling: Fair · Site: Pain, Redness, Itching · Headache

   Adult check-in
4. 2021-01-25
   Survey response — days 1–6 daily, dose 1

   MedDRA: Pruritus — Feeling: Fair · Chills, Headache

   Free text: Itchy" sensation in my lower culf and the bottom of the heels

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-01-26
   Survey response — days 1–6 daily, dose 1

   MedDRA: Emergency care, Hypersensitivity, Hypertension, Immediate post-injection reaction, Pain in extremity, Palpitations, Pruritus, Rash — Feeling: Fair · Site: Pain · Fatigue or tiredness

   Free text: Some pain & "Itchy" sensation "inside" my whole left arm.I did not mention thatI had allergic reaction 15 minutes after receiving vaccine: heart racing, high blood pressure 170/120 and rush on my face and upper body. I had to go in the ambulance to emergency room.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2021-01-27
   Survey response — days 1–6 daily, dose 1

   MedDRA: Arthralgia, Hypertension, Injection site pain, Pain in extremity — Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness

   Free text: Muscle & body ache on left arm- injection site, high blood pressure 161/104, pain under left shoulder blade

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-01-28
   Survey response — days 1–6 daily, dose 1

   MedDRA: Hypotension, Lymph node pain, Pain in extremity, Paraesthesia, Rash — Feeling: Fair · Site: Pain, Itching · Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site

   Free text: My blood pressure was low this morning, 101/88, rash on the left side of my neck in the midle of the day, annoying pain/tingling of my left arm and lymph nodes on that side

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-01-29
   Health check-in — day 7, dose 1

   Feeling: Fair · Site: Pain · Fatigue or tiredness

   Adult check-in
9. 2021-02-05
   Health check-in — day 14, dose 1

   Feeling: Fair

   Adult check-in
10. 2021-02-12
    Health check-in — day 21, dose 1

    Feeling: Fair

    Adult check-in
11. 2021-02-19
    Survey response — day 28, dose 1

    MedDRA: Chest pain, Headache, Night sweats, Office visit — Feeling: Fair · Get care from a doctor or other healthcare professional

    Free text: Symptoms: Bad headaches, night sweating, chest pain · Healthcare visit (other): In-person visit

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-02-19
    Report sent to call center — day 28, dose 1

    Get care from a doctor or other healthcare professional

    1 call case(s)
13. 2021-02-28
    Survey response — day 35, dose 1

    MedDRA: Fatigue, Feeling hot, Headache — Feeling: Fair · Be unable to do your normal daily activities

    Free text: Severe headache that lasts for few days in a row, tired, feverish,

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
14. 2021-03-11
    Survey response — day 42, dose 1

    MedDRA: Erythema, Headache, Pruritus, Vision blurred — Feeling: Fair · Be unable to do your normal daily activities

    Free text: Getting red, itchy patches on my neck , chest , arms, getting headaches that travel from one side to the other, blury vision YOU NEVER RESPOND TO ANY OF REPORTS, WHY DO THAT?

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
15. 2021-08-10
    Call 1 — Left Voicemail