5VS-90097-00645

Timeline

1. 2020-12-23
   Registered in v-safe
2. 2020-12-23
   Dose 1 — Pfizer-BioNTech
3. 2020-12-23
   Survey response — day 0, dose 1

   MedDRA: Burning sensation, Chest discomfort, Dizziness, Medical counselling, Paraesthesia, Tongue discomfort — Feeling: Fair · Site: Pain · Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): Face and arms burned and tingled. Felt dizzy and almost passed out. Chest felt Alittle tight. Base of tongue felt uncomfortable · Healthcare visit (other): Paramedics called

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2020-12-23
   Report sent to call center — day 0, dose 1

   Get care from a doctor or other healthcare professional

   1 call case(s)
5. 2020-12-24
   Survey response — days 1–6 daily, dose 1

   MedDRA: Immediate post-injection reaction, Self-medication — Feeling: Good · Site: Pain

   Free text: The severe reaction I had 30 minutes after I received the vaccine yesterday resolved by 10 pm yesterday. I have felt fine since and have not taken any more Benadryl or prednisone.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2020-12-25
   Survey response — days 1–6 daily, dose 1

   MedDRA: Burning sensation, Chest discomfort, Dizziness, Immediate post-injection reaction, Palpitations, Rash, Swelling face — Feeling: Fair · Site: Pain · Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

   Free text: I received the Pfizer vaccine 2 days ago. 30 minutes later I developed facial burning then dizziness, heart racing, chest pressure and almost passed out. Called 911. Have been on Benadryl, prednisone since. Felt fine all day yesterday until 10:30 pm when my face and arms started to burn, face swelled and rash developed on my face. I have had on off burning and fine rash on my face since. Felt dizzy again this morning.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2020-12-25
   Report sent to call center — days 1–6 daily, dose 1

   Be unable to do your normal daily activities

   1 call case(s)
8. 2020-12-26
   Survey response — days 1–6 daily, dose 1

   MedDRA: Anaphylactoid reaction, Burning sensation, Chest discomfort, Hypersensitivity, Immediate post-injection reaction, Medical counselling, Presyncope, Rash — Feeling: Fair · Headache, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): I continue with an allergic reaction that started 30 minutes after I received the vaccine. I had a near syncopal event and so he have had burning in my face and arms and a mild bumpy rash on my face. I felt fine when I woke up this am but around 1 pm my face and arms starting burning again and mild chest tightness. I am on Benadryl, Zyrtec, Pepcid and prednisone. Hope this ends soon. Someone needs to record my reaction. I believe it was anaphylactoid. · Healthcare visit (other): I am a physician and have consulted with multiple physicians. I will see an allergist on Monday.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2020-12-26
   Report sent to call center — days 1–6 daily, dose 1

   Get care from a doctor or other healthcare professional

   1 call case(s)
10. 2020-12-27
    Survey response — days 1–6 daily, dose 1

    MedDRA: Burning sensation, Chills, Feeling abnormal, Headache, Malaise — Feeling: Poor · Fever · Chills, Headache, Fatigue or tiredness, Rash, not including the immediate area around the injection site · 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: Systemic reaction (other): Burning of my face arms and legs. Chills. Headache. Malaise. · Healthcare visit (other): I have been speaking with an allergist (b)(6) as well as my partners (b)(6) and (b)(6). My sister (b)(6) is with me now. I have felt terrible all day.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2020-12-27
    Report sent to call center — days 1–6 daily, 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)
12. 2020-12-28
    Survey response — days 1–6 daily, dose 1

    MedDRA: Chest discomfort, Skin burning sensation — Feeling: Fair · Site: Pain · Fatigue or tiredness · Be unable to do your normal daily activities

    Free text: Skin burning, chest tightness

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2020-12-28
    Report sent to call center — days 1–6 daily, dose 1

    Be unable to do your normal daily activities

    1 call case(s)
14. 2020-12-29
    Survey response — days 1–6 daily, dose 1

    MedDRA: Burning sensation, Chest discomfort, Dizziness, Emergency care, Immediate post-injection reaction, Malaise, Palpitations, Paraesthesia, Self-medication — Feeling: Poor · Site: Pain · Chills, Headache, Fatigue or tiredness, Rash, not including the immediate area around the injection site · 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: Systemic reaction (other): I had severe reaction the vaccine at 30 minutes and called 911. Felt burning and tingling in face, heart racing, chest tightness and felt I was passing out. I have been very ill since with chest tightness, burning of face and extremities, malaise. I have been on Zyrtec, Pepcid, Benadryl, prednisone and am not improving. I am a physician. · Healthcare visit (other): Paramedics called

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
15. 2020-12-29
    Report sent to call center — days 1–6 daily, 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)
16. 2020-12-30
    Survey response — day 7, dose 1

    MedDRA: Chest discomfort, Hypersensitivity, Immediate post-injection reaction, Medical observation, Presyncope, Skin burning sensation, Swollen tongue — Feeling: Fair · Site: Itching · Rash, not including the immediate area around the injection site · 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: Systemic reaction (other): Still having allergic reaction one week after the vaccine. Skin burning and tongue swollen. Chest less tight. Started prednisone 40 mg daily yesterday, helping. This has been a severe allergic reaction to the vaccine starting about 30 minutes after I received it. · Healthcare visit (other): Paramedics were called 30 minutes after the vaccination. Had near syncopal event.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
17. 2020-12-30
    Report sent to call center — day 7, 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)
18. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
19. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
20. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
21. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
22. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
23. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
24. 2021-01-05
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
25. 2021-01-06
    Survey response — day 14, dose 1

    MedDRA: Office visit, Type IV hypersensitivity reaction — 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 had a severe reaction to the vaccine. Dr Kari nadeau at Stanford is helping me and thinks I have had a complement mediated allergic reaction and have anti PEG antibodies. She is getting blood from me. Today is day 14 and the worst day yet. · Healthcare visit (other): Under the care of many doctors

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
26. 2021-01-06
    Report sent to call center — day 14, 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)
27. 2021-01-15
    Survey response — day 21, dose 1

    MedDRA: Malaise — Feeling: Poor · Be unable to work

    Free text: I have been deathly ill since I received the covid vaccine on 12/23. No one knows what happened to me and no one is helping me. I feel like I am going to die.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
28. 2021-01-15
    Report sent to call center — day 21, dose 1

    Be unable to work

    1 call case(s)
29. 2021-01-22
    Survey response — day 28, dose 1

    MedDRA: Asthenia, Chest discomfort, Dizziness, Immediate post-injection reaction, Paraesthesia, Paraesthesia oral — Feeling: Poor · Be unable to work

    Free text: I have been severely ill starting 30 minutes after I got the Covid vaccine on 12/23/20. I have severe paresthesias in my face tongue and limbs, dizziness and weakness and a band like constriction around my chest. I am under the care of(b)(6)md

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
30. 2021-01-27
    Survey response — day 35, dose 1

    MedDRA: Asthenia, Dizziness, Hypersensitivity, Medical counselling, Paraesthesia, Tremor — 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: I have had a type 3 hypersensitivity reaction to the vaccine and have been seriously ill for 35 days with paresthesias, tremor, dizziness, headache and weakness. Does anyone ever look at this? I have reported so many times with no response. · Healthcare visit (other): Paramedics twice

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
31. 2021-01-27
    Report sent to call center — day 35, 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)
32. 2021-02-03
    Survey response — day 42, dose 1

    MedDRA: Dizziness, Emergency care, Headache, Immediate post-injection reaction, Paraesthesia, Tremor — 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: I have been very ill since 30 minutes after receiving the Pfizer covid vaccine with paresthesias, headache, dizziness, tremor. I have been under the care of many doctors who are trying to figure out what happened to me. · Healthcare visit (other): Paramedics

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
33. 2021-02-03
    Report sent to call center — day 42, 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)
34. 2021-03-24
    Survey response — 3 months, dose 1

    MedDRA: Asthenia, Paraesthesia, Tremor — 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, Emergency room or emergency department visit

    Free text: I have had severe paresthesias, tremor, weakness, chest banding for 13 weeks since I received the Pfizer covid vaccine. I have reported this to you and VAERS too many times to count with no response from you.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
35. 2021-03-24
    Report sent to call center — 3 months, 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)
36. 2021-06-07
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
37. 2021-06-23
    Survey response — 6 months, dose 1

    MedDRA: Malaise, Muscle twitching, Paraesthesia, Tinnitus, Tremor — Feeling: Poor · 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, Emergency room or emergency department visit

    Free text: Ongoing severe paresthesias, tremors and twitches. Now I have tinnitus as well. Labs show evidence of mast cell activation and now I have an IGA paraprotein. I am very ill.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
38. 2021-06-23
    Report sent to call center — 6 months, dose 1

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

    1 call case(s)
39. 2021-06-26
    Call successful

    Completed over the phone
40. 2021-12-23
    Survey response — 12 months, dose 1

    MedDRA: Chest pain, Dizziness, Fatigue, Malaise, Muscular weakness, Pain, Paraesthesia, Tinnitus, Tremor, Unevaluable event, Vertigo, Vision blurred — Feeling: Poor · 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: I have been severely I'll since receiving the first dose of Pfizer 12/23/20 with painful paresthesias from head to toe, tremors and vibrations, loud tinnitus, blurred vision, chest pains, dizziness and vertigo, weakness in legs, fatigue. · Healthcare visit (other): I went to er but was never seen

    MedDRA releases: 2024-11 · check-in free text available
41. 2021-12-23
    Report sent to call center — 12 months, dose 1

    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)
42. 2021-12-27
    Call successful

    Reported to VAERS during previous contact from GDIT