YVC-16290-67244

Timeline

1. 2021-03-10
   Dose 1 — Pfizer-BioNTech
2. 2021-03-31
   Dose 2 — Pfizer-BioNTech
3. 2021-04-01
   Registered in v-safe
4. 2021-04-02
   Survey response — days 1–6 daily, dose 2

   MedDRA: Insomnia — Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

   Free text: Trouble sleeping. Only Had 10 hours of sleep since my shot.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-04-04
   Survey response — days 1–6 daily, dose 2

   MedDRA: Pre-existing disease — Feeling: Fair · Site: Swelling · Fever · Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

   Free text: I do have mast cell activation syndrome, hereditary Alphatryptasemia syndrome, and POTS.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2021-04-05
   Health check-in — days 1–6 daily, dose 2

   Feeling: Poor · Site: Pain · Fever · Headache, Joint pains, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Be unable to do your normal daily activities

   Adult check-in
7. 2021-04-06
   Health check-in — days 1–6 daily, dose 2

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

   Adult check-in
8. 2021-04-07
   Survey response — day 7, dose 2

   MedDRA: Condition aggravated, Lymphatic disorder, Physiotherapy, Pre-existing disease, Swelling — Feeling: Poor · Fever · Fatigue or tiredness · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): I have POTS and my temp regulation, sleep, and sitting (not standing) are usually well balanced but have been completely flared since the shot. · Healthcare visit (other): Had a lymphatic physical therapy visit as I was so swollen everywhere. I do have Hereditary Alphatryptasemia Syndrome and Mast Cell Activation Syndrome

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-04-07
   Report sent to call center — day 7, dose 2

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

   1 call case(s)
10. 2021-04-14
    Survey response — day 14, dose 2

    MedDRA: Condition aggravated, Pre-existing disease — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities

    Free text: My POTS has been much worse since the vaccine

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2021-04-23
    Survey response — day 21, dose 2

    MedDRA: Condition aggravated, Lymphadenopathy, Pre-existing disease — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

    Free text: Symptoms: My POTS symptoms continue to flare post 2nd dose. · Healthcare visit (other): Lymphatic drainage and autonomic retraining

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-04-23
    Report sent to call center — day 21, 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)
13. 2021-05-05
    Survey response — day 35, dose 2

    MedDRA: Physiotherapy, Pre-existing disease — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

    Free text: Symptoms: POTS, MCAS, migraine, and Hereditary Alphatryptasemia Syndrome are all worse than before my vaccine. · Healthcare visit (other): Physical therapy rehabilitation

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
14. 2021-05-05
    Report sent to call center — day 35, 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)
15. 2021-05-12
    Survey response — day 42, dose 2

    MedDRA: Condition aggravated, Migraine, Physiotherapy, Pre-existing disease — 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: Symptoms: POTS, Migraine, and Mast Cell Activation Syndrome are all worse than they were prior to my vaccines · Healthcare visit (other): Physical therapy retraining of the autonomic nervous system

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
16. 2021-05-12
    Report sent to call center — day 42, 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)
17. 2021-06-30
    Survey response — 3 months, dose 2

    MedDRA: Condition aggravated, Menstruation irregular, Pre-existing disease — 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, Emergency room or emergency department visit

    Free text: Irregular period, worsened POTS (already had severe POTS), and worsened MCAS & Hereditary Alphatryptasemia Syndrome

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
18. 2021-06-30
    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)
19. 2021-07-02
    Call successful

    Other