2RD-48273-74580

Timeline

1. 2021-01-21
   Dose 1 — Moderna
2. 2021-01-29
   Registered in v-safe
3. 2021-01-29
   Survey response — day 7, dose 1

   MedDRA: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling — Feeling: Poor · Site: Pain, Redness, Swelling, Itching

   Free text: On day 8 a large knot formed underneath the injection site that is painful and is quite hard. Others is swelling and redness and itchiness around it also.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-02-04
   Health check-in — day 14, dose 1

   Feeling: Good

   Adult check-in
5. 2021-02-11
   Health check-in — day 21, dose 1

   Feeling: Good

   Adult check-in
6. 2021-02-19
   Dose 2 — Moderna
7. 2021-02-20
   Survey response — days 1–6 daily, dose 2

   MedDRA: Blood pressure decreased, Dizziness, Emergency care, Headache, Self-medication — Feeling: Fair · Site: Pain, Redness, Swelling · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): Major headache, blood pressure dropped, making me extremely dizzy and felt like I was going to pass out · Healthcare visit (other): Called the emergency department because it was so late once the symptoms hit. Was instructed to take 600 mg of ibuprofen, 2 tablets of Tylenol and a dose of promethazine that I had at home. Was told to alternate Tylenol and ibuprofen doses every 6 hours.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-02-20
   Report sent to call center — days 1–6 daily, dose 2

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

   1 call case(s)
9. 2021-02-21
   Health check-in — days 1–6 daily, dose 2

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

   Adult check-in
10. 2021-02-22
    Health check-in — days 1–6 daily, dose 2

    Feeling: Good · Site: Pain · Headache, Diarrhea

    Adult check-in
11. 2021-02-24
    Survey response — days 1–6 daily, dose 2

    MedDRA: Unevaluable event — Feeling: Poor · Chills, Headache, Nausea, Diarrhea · Be unable to do your normal daily activities

    Free text: I dont think this is vaccine related

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-02-25
    Survey response — days 1–6 daily, dose 2

    MedDRA: Unevaluable event — Feeling: Fair · Headache

    Free text: I dont think its vaccine related

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-08-12
    Call 1 — Left Voicemail
14. 2022-02-19
    Health check-in — 12 months, dose 2

    Feeling: Good

    Adult check-in