57H-15777-14884

Timeline

1. 2021-04-01
   Dose 1 — Moderna
2. 2021-04-04
   Registered in v-safe
3. 2021-04-04
   Survey response — days 1–6 daily, dose 1

   MedDRA: Erythema, Pruritus, Swelling face — Feeling: Poor · Site: Redness, Swelling, Itching · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

   Free text: Major itching and swelling on the Face. The face is all Red and checks puffed up that makes it hard to open the eyes

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-04-05
   Survey response — days 1–6 daily, dose 1

   MedDRA: Erythema, Feeling abnormal, Office visit, Pain, Pruritus, Swelling face — Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Diarrhea, Rash, not including the immediate area around the injection site · 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): Went to see my PCP Dr. (b)(6) tel (b)(6) for the swelling Red Itching on the face extreme itching got steroids proscription and will not be able to take the second dose if the vaccine due to the adverse reaction from the Moderna vaccine taken on April 1st 2021 · Healthcare visit (other): Went to see my PCP at 9:00am this morning due to the extreme itching pain sore and uneasy feeling. Dr. (b)(6) tel number (b)(6). He has the detail of this vaccine reaction.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-04-05
   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. 2021-04-06
   Survey response — days 1–6 daily, dose 1

   MedDRA: Erythema, Pruritus, Swelling face — Feeling: Poor · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

   Free text: My face is still very Red and itching. Swelling has gone down a bit. Taking Steroids and using steroid ointment for the face. Have had a very bad reaction from this Moderna Vaccine.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-04-07
   Survey response — days 1–6 daily, dose 1

   MedDRA: Pruritus, Swelling — Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

   Free text: The swelling is going down each day slowly. Itching is under control. Wish we could attach photos for CDC to see the results after the vaccine. These steroids have side effects too. Even the cream for the face. Hope to get well soon as this has scared me a lot.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-04-08
   Survey response — day 7, dose 1

   MedDRA: Pruritus, Rash, Self-medication — Feeling: Fair · Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

   Free text: The Rash is getting better with the Steroids cream and the itching has subsided. Getting back to normal

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-04-17
   Health check-in — day 14, dose 1

   Feeling: Fair

   Adult check-in
10. 2021-04-22
    Health check-in — day 21, dose 1

    Feeling: Fair

    Adult check-in
11. 2021-06-23
    Call 1 — Left Voicemail