XZQ-23295-86654

Timeline

1. 2021-03-17
   Dose 1 — Moderna
2. 2021-04-09
   Registered in v-safe
3. 2021-04-09
   Survey response — day 21, dose 1

   MedDRA: Discomfort, Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Insomnia, Pain in extremity — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

   Free text: I had first dose over 3 weeks ago and have continued to have various uncomfortable symptoms. These include hot itchy red swollen arm at injection site, headaches, and most bothersome achy legs that hurt and keep me up at night. These are all from vac

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-04-09
   Report sent to call center — day 21, 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)
5. 2021-04-17
   Dose 2 — Moderna
6. 2021-04-17
   Survey response — day 0, dose 2

   MedDRA: Lymphadenopathy, Pain, Pain in extremity — Feeling: Fair · Site: Pain · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: My glands in throat feel uncomfortable. Periodic shooting pain down injection arm into fingers.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-04-19
   Survey response — days 1–6 daily, dose 2

   MedDRA: Chills, Dyskinesia, Musculoskeletal stiffness, Screaming, Seizure, Tremor — Feeling: Poor · Site: Pain, Swelling · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: IMPORTANT- 13 hours after this second dose I had multiple convulsions. I suddenly began to shake, felt a strange chill run down each side of my body then my entire body would go stiff and I would uncontrollably arch my back until it would release. These lasted 6-8 seconds. I had this happen repeatedly for about an hour. I was screaming. If not for Covid risk my family was going to call 911. Had it continued longer they would have. I have reported this all to my doctor. (b)(6) in (b)(6) California. PLEASE LOOK INTO THIS. I am very concerned about ever getting a Covid vaccine again. Or any other vaccine. I am available if anyone wishes to talk with me. (b)(6). My name is (b)(6).

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-04-20
   Survey response — days 1–6 daily, dose 2

   MedDRA: Blood pressure increased, Blood pressure measurement, Heart rate increased, Tachycardia — Feeling: Poor · Site: Pain, Swelling · Fever · Headache, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

   Free text: My resting heart rate and my blood pressure are both elevated. I have some tachycardia.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-04-20
   Report sent to call center — days 1–6 daily, dose 2

   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)
10. 2021-04-21
    Survey response — days 1–6 daily, dose 2

    MedDRA: Oropharyngeal discomfort, Tension, Tongue discomfort — Feeling: Fair · Site: Pain · Joint pains, Muscle or body aches · Be unable to work, Be unable to do your normal daily activities

    Free text: Tense jaw and still have burning tongue. Discomfort in my glands on side of throat.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2021-07-19
    Health check-in — 3 months, dose 2

    Feeling: Good

    Adult check-in
12. 2022-04-11
    Call 1 — Left Voicemail