3NA-23622-90066

Timeline

1. 2020-12-24
   Dose 1 — Pfizer-BioNTech
2. 2021-01-13
   Dose 2 — Pfizer-BioNTech
3. 2021-02-02
   Registered in v-safe
4. 2021-02-02
   Survey response — day 14, dose 2

   MedDRA: Condition aggravated, Emergency care, Feeling abnormal, Immediate post-injection reaction, Pain, Pre-existing disease, Syncope — Feeling: Poor · 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: I have Lupus and since receiving the 2nd vaccine dose I have been having a lupus flare. I was in bed for 7 days feeling like I wanted to die from all the pain. They watched me in the ER for 1.5 hours after my second shot · Healthcare visit (other): They also watched me in the ER for 1.5 hours after getting my second dose since the first dose made me feel like I was going to pass out and caused all over pain about 10 minutes after dose administration. After 1st dose the pain improved after about 3 days. With the second dose the pain started again about 10 minutes after shot and the pain continues. I am now in a lupus flare and am being treated with steroids.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-02-02
   Report sent to call center — day 14, 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)
6. 2021-02-03
   Survey response — day 21, dose 2

   MedDRA: Abdominal discomfort, Condition aggravated, Feeding disorder, Malaise, Pre-existing disease, Unevaluable event — Feeling: Poor · 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: I am just so sick I feel like Im dying. Lupus flare and now my stomach is so sick. I cant eat anything or I feel so sick. · Healthcare visit (other): I want to go to the hospital

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-02-03
   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)
8. 2021-02-12
   Survey response — day 28, dose 2

   MedDRA: Abdominal pain upper, Feeding disorder, Gastrooesophageal reflux disease, Mobility decreased, Nausea, Pain, Pre-existing disease, Systemic lupus erythematosus, Unevaluable event — 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, Outpatient clinic or urgent care clinic visit

   Free text: Symptoms: Lupus flare still there. Pain everywhere. This past week I have been unable to eat anything. Anything I eat causes nausea, stomach pain, and acid reflux. It is like the symptoms I have had before with SIBO. I am in bed. Cant move. · Healthcare visit (other): I should probably just be hospitalized at this point.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-02-12
   Report sent to call center — day 28, 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. 2021-02-17
    Survey response — day 35, dose 2

    MedDRA: Dyspnoea, Malaise, Oropharyngeal pain, Systemic lupus erythematosus, Unevaluable event — 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, Outpatient clinic or urgent care clinic visit

    Free text: Symptoms: SIBO persists and lupus pain. Throat pain since 1st vaccine shot worsened with 2nd shot. I feel terrible. Im in bed most of the day and very limited food I am able to eat. · Healthcare visit (other): I want to be admitted to the hospital

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2021-02-17
    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)
12. 2021-02-26
    Survey response — day 42, dose 2

    MedDRA: Condition aggravated, Gastrointestinal bacterial overgrowth, Medical counselling, Pre-existing disease, Red blood cell sedimentation rate increased, Steroid therapy, Systemic lupus erythematosus — Feeling: Poor · 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: Same flare and SIBO. Still battling. My rheumatologist and primary care doctor said the lupus flare was from the 2nd Pfizer vaccine. My Sed rate was elevated and lupus flared. Had to be put on steroids. Then I had a SIBO flare. Taking xifaxan

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-02-26
    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)
14. 2021-04-14
    Health check-in — 3 months, dose 2

    Feeling: Poor

    Adult check-in
15. 2021-06-17
    Call 1 — Left Voicemail