53E-11360-23364

Timeline

1. 2021-03-15
   Dose 1 — Moderna
2. 2021-03-23
   Registered in v-safe
3. 2021-03-23
   Health check-in — day 7, dose 1

   Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain, Rash, not including the immediate area around the injection site · Be unable to work, Be unable to do your normal daily activities

   Adult check-in
4. 2021-03-29
   Survey response — day 14, dose 1

   MedDRA: Arthritis, Condition aggravated, Fatigue, Insomnia, Irritable bowel syndrome, Pre-existing disease, Pruritus, Sjogren's syndrome, Unevaluable event — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

   Free text: Symptoms: Persistent itching in my neck, scalp abs now arms. IBS increased as well as sleeplessness and fatigue. I cannot discern whether it is youd, sjogrens or arthritis since the symptoms started prior to the first vacccine. · Healthcare visit (other): Booked Dr. who manages my anemia for blood tests. Also called to see my rheumatologist.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-03-29
   Report sent to call center — day 14, dose 1

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

   1 call case(s)
6. 2021-04-12
   Dose 2 — Moderna
7. 2021-04-12
   Survey response — day 0, dose 2

   MedDRA: Back pain — Feeling: Fair · Site: Pain, Itching · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

   Free text: Back pain

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-07-13
   Survey response — 3 months, dose 2

   MedDRA: Gastrointestinal disorder, Office visit, Pre-existing disease, Surgery — Feeling: Poor · Be unable to work or attend school, 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: Symptoms: Stomach related - having surgery in August. Unlikely related. I have mixed connective tissue along with multiple surgeries. · Healthcare visit (other): Doctors officer, multiple procedures with abesthesia

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-07-13
   Report sent to call center — 3 months, dose 2

   Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

   1 call case(s)
10. 2021-07-15
    Call 1 — Left Voicemail
11. 2021-10-11
    Survey response — 6 months, dose 2

    MedDRA: Ageusia, Anosmia, Breast pain, Confusional state, Fatigue, Food intolerance, Hypersensitivity, Migraine, Office visit, Pre-existing disease, Rash, Sciatica, Visual impairment — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

    Free text: Symptoms: Chronic fatigue, migraines, sciatica, skin rashes, confusion & lack of taste, smell with decrease in vision on left side, intermittent breast pain on left and increase in sensitivity to foods, meds & pollen. I have 5 mixed connective disorders. · Healthcare visit (other): PCP & specialists in office

    MedDRA releases: 2024-11 · check-in free text available
12. 2021-10-11
    Report sent to call center — 6 months, dose 2

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

    Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · 1 call case(s)
13. 2021-10-12
    Call 1 — Left Voicemail