ZFZ-33056-03731

Timeline

1. 2021-06-02
   Registered in v-safe
2. 2021-06-02
   Dose 1 — Moderna
3. 2021-06-02
   Survey response — day 0, dose 1

   MedDRA: Immediate post-injection reaction, Pruritus, Self-medication, Urticaria — Feeling: Fair · Site: Redness, Swelling, Itching · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

   Free text: Almost immediately after the injection my left arm began to develop hives.I took Benadryl and Zyrtec and 1,000mg if Tylenol as soon as I got home. It by then had spread to my chest and my right upper and lower back. My face got itchy as well. I am out of my Epipens of I would have used it.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-06-03
   Survey response — days 1–6 daily, dose 1

   MedDRA: Anaphylactic reaction, Urticaria — Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit, Hospitalization

   Free text: Hives, anaphylaxis

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-06-03
   Report sent to call center — days 1–6 daily, dose 1

   Get care from a doctor or other healthcare professional

   1 call case(s)
6. 2021-06-04
   Survey response — days 1–6 daily, dose 1

   MedDRA: Hospitalisation, Pharyngeal swelling, Self-medication, Swollen tongue, Throat irritation — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): Itchy throat, throat and tongue mildly swollen · Healthcare visit (other): I have already been hospitalized. Dr.s called and I have more medicine to take on top of the steroids and high dose Benadryl I was Rx by the hospital. I am taking 1,000mg Tylenol and I am not supposed to eat or drink or do anything that will bring my body temperature up.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-06-04
   Report sent to call center — days 1–6 daily, dose 1

   Get care from a doctor or other healthcare professional

   1 call case(s)
8. 2021-06-06
   Health check-in — days 1–6 daily, dose 1

   Feeling: Fair · Site: Swelling, Itching · Chills, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site

   Adult check-in
9. 2021-06-07
   Health check-in — days 1–6 daily, dose 1

   Feeling: Fair · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

   Adult check-in
10. 2021-06-08
    Health check-in — days 1–6 daily, dose 1

    Feeling: Good · Site: Itching · Muscle or body aches, Fatigue or tiredness

    Adult check-in
11. 2021-06-09
    Health check-in — day 7, dose 1

    Feeling: Good · Site: Itching · Fatigue or tiredness

    Adult check-in
12. 2021-06-16
    Health check-in — day 14, dose 1

    Feeling: Good

    Adult check-in
13. 2021-12-01
    Call 1 — Left Voicemail
14. 2021-12-01
    Call successful

    Completed over the phone