4KD-11473-09961

Timeline

1. 2021-04-16
   Dose 1 — Pfizer-BioNTech
2. 2021-04-17
   Registered in v-safe
3. 2021-04-17
   Survey response — days 1–6 daily, dose 1

   MedDRA: Disorientation, Dizziness — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

   Free text: Lightheaded and Disorientated for a few hours after vaccination, legs felt like jello. Have experienced some dizziness over past 24 hours.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-04-18
   Survey response — days 1–6 daily, dose 1

   MedDRA: Tinnitus — Feeling: Fair · Site: Pain · Fatigue or tiredness · Be unable to do your normal daily activities

   Free text: Mild ringing/tinnitus type ear symptoms today.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-04-19
   Survey response — days 1–6 daily, dose 1

   MedDRA: Tinnitus — Feeling: Fair · Site: Pain · Fatigue or tiredness

   Free text: Still mild ringing/tinnitus in ears.

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

   MedDRA: Dyspnoea, Muscular weakness, Pre-existing disease — Feeling: Fair · Site: Pain · Fatigue or tiredness · Be unable to do your normal daily activities

   Free text: I have the Autoimmune Disease Sjogren's Syndrome. Since my vaccination last Friday I have experienced a few instances of my muscles feeling heavy. Proximal bilateral muscle weakness and a few instances of shortness of breath.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-04-21
   Survey response — days 1–6 daily, dose 1

   MedDRA: Discomfort, Injection site bruising, Muscular weakness, Tinnitus — Feeling: Fair · Fatigue or tiredness

   Free text: Bilateral proximal muscles still feeling heavy/weak at times. Mild ear ringing/tinnitus at times. Injection site developed a bruise.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-04-22
   Survey response — days 1–6 daily, dose 1

   MedDRA: Pre-existing disease — Feeling: Fair · Fatigue or tiredness

   Free text: I have the Autoimmune Disease Sjogren's Syndrome.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-04-24
   Health check-in — day 7, dose 1

   Feeling: Fair · Fatigue or tiredness

   Adult check-in
10. 2021-05-01
    Health check-in — day 14, dose 1

    Feeling: Good

    Adult check-in
11. 2021-05-14
    Dose 2 — Pfizer-BioNTech
12. 2021-05-14
    Survey response — day 0, dose 2

    MedDRA: Unevaluable event — Feeling: Good

    Free text: Just got vaccine at 4:30pm.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-05-15
    Survey response — days 1–6 daily, dose 2

    MedDRA: Condition aggravated, Dizziness, Dysgeusia, Faeces soft, Hyperhidrosis, Malaise, Pre-existing disease, Pyrexia, Tachycardia, Vision blurred — Feeling: Poor · Site: Pain · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

    Free text: Approximately 15 hours after the second vaccine: I was awoken suddenly at 7am feeling feverish and sweating with a general feeling of being unwell. I experienced tachycardia of 115-120 beats per minute for 10-15 minutes taken via pulse oximeter. Oxygen saturation was normal at 98 percent. I sat on our deck in the fresh air and drank some water and symptoms eventually subsided. A rather unsettling experience. I have Sjogren's Syndrome and Dysautonomia (POTS Syndrome). However the level of sweating, tachycardia, and dizziness present today has been outside of clinical norms, especially considering the level of hydration present. A rather unsettling experience. Also experienced a change in taste- metallic taste. Some slight blurred vision in my right eye over the past 24 hours. Also a change in bowel consistency-very soft stool.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
14. 2021-05-16
    Survey response — days 1–6 daily, dose 2

    MedDRA: Dizziness, Muscular weakness — Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

    Free text: Experiencing some bilateral proximal muscle weakness and some dizziness.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
15. 2021-05-17
    Survey response — days 1–6 daily, dose 2

    MedDRA: Dizziness — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

    Free text: Still experiencing some dizziness or lightheadedness.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
16. 2021-05-18
    Survey response — days 1–6 daily, dose 2

    MedDRA: Arthralgia, Asthenia, Condition aggravated, Dizziness, Fatigue, Headache, Pain, Pre-existing disease, Tachycardia, Tinnitus — Feeling: Poor · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

    Free text: It's possible that the vaccine immune inflammation process may have flared up some of my Autoimmune/Dysautonomia disease. Still experiencing some low level tachycardia over 100 beats per minute at times, dizziness, fatigue, body aches, joint pain, and some headache. Also have experienced ringing/tinnitus in both ears, which also occured after first shot of Pfizer vaccine. Low energy even after sleeping 12 hours last night.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
17. 2021-05-19
    Survey response — days 1–6 daily, dose 2

    MedDRA: Tinnitus — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

    Free text: Still experiencing high pitched ringing/tinnitus in both ears after vaccination. Planning to contact my doctor tomorrow about the ongoing ringing in ears.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
18. 2021-05-20
    Survey response — days 1–6 daily, dose 2

    MedDRA: Tinnitus — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

    Free text: Still noticing ringing/tinnitus in both ears since second Pfizer Vaccine. Contacted my doctor.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
19. 2021-05-20
    Report sent to call center — days 1–6 daily, dose 2

    Get care from a doctor or other healthcare professional

    1 call case(s)
20. 2021-05-21
    Survey response — day 7, dose 2

    MedDRA: Tinnitus — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

    Free text: Both ears still ringing/tinnitus.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
21. 2021-05-29
    Survey response — day 14, dose 2

    MedDRA: Tinnitus — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

    Free text: My ears are still ringing/tinnitus.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
22. 2021-05-29
    Report sent to call center — day 14, dose 2

    Get care from a doctor or other healthcare professional

    1 call case(s)
23. 2021-06-06
    Survey response — day 21, dose 2

    MedDRA: Tinnitus — Feeling: Good

    Free text: Still experiencing ringing/tinnitus in both ears.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
24. 2021-06-14
    Survey response — day 28, dose 2

    MedDRA: Headache, Tinnitus — Feeling: Good

    Free text: Ears are still ringing/tinnitus and have been experiencing some additional headaches in the back of my head. I don't normally get headaches. Plan to discuss with my doctor on June 29th.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
25. 2021-06-25
    Survey response — day 42, dose 2

    MedDRA: Tinnitus — Feeling: Good

    Free text: Still experiencing tinnitus/ringing in the ears. Appointment scheduled with my primary care doctor for June 29th.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
26. 2021-08-16
    Survey response — 3 months, dose 2

    MedDRA: Tinnitus — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

    Free text: Ears still ringing/tinnitus.

    MedDRA releases: 2021-09,2024-11 · check-in free text available
27. 2021-08-16
    Report sent to call center — 3 months, dose 2

    Get care from a doctor or other healthcare professional

    1 call case(s)
28. 2021-08-19
    Call 1 — Left Voicemail
29. 2021-08-19
    Call 1 — Left Voicemail
30. 2021-08-19
    Call 1 — Left Voicemail
31. 2021-08-20
    Call successful

    Participant prefers to complete VAERS report online
32. 2021-12-13
    Dose 3 — Pfizer-BioNTech
33. 2021-12-14
    Survey response — days 1–6 daily, dose 3

    MedDRA: Heart rate increased, Sleep disorder, Tachycardia — Feeling: Poor · Site: Pain · Muscle or body aches, Fatigue or tiredness, Nausea, Rash, not including the immediate area around the injection site · 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: I experienced tachycardia this morning roughly 16 hours after my booster shot. The tachycardia woke me up out of my sleep and I was still laying flat in bed, heart rate was in excess of 130 beats per minute on my pulse oximeter.

    MedDRA releases: 2024-11 · check-in free text available
34. 2021-12-14
    Report sent to call center — days 1–6 daily, dose 3

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

    Telehealth, virtual health, or email health consultation · 1 call case(s)
35. 2021-12-15
    Survey response — days 1–6 daily, dose 3

    MedDRA: Lymph node pain, Lymphadenopathy — Feeling: Poor · Site: Pain · Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work or attend school, Be unable to do your normal daily activities

    Free text: Swollen/Painful Lymph node under right armpit. Same arm as vaccine.

    MedDRA releases: 2024-11 · check-in free text available
36. 2021-12-16
    Survey response — days 1–6 daily, dose 3

    MedDRA: Axillary pain — Feeling: Poor · Site: Pain · Chills, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work or attend school, Be unable to do your normal daily activities

    Free text: Vaccine side armpit still sore.

    MedDRA releases: 2024-11 · check-in free text available
37. 2021-12-16
    Call successful

    Participant prefers to complete VAERS report online
38. 2021-12-17
    Health check-in — days 1–6 daily, dose 3

    Feeling: Fair · Site: Pain · Fatigue or tiredness, Nausea · Be unable to work or attend school, Be unable to do your normal daily activities

    Adult check-in
39. 2021-12-19
    Health check-in — days 1–6 daily, dose 3

    Feeling: Good · Site: Pain · Fatigue or tiredness

    Adult check-in
40. 2021-12-20
    Health check-in — day 7, dose 3

    Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness

    Adult check-in
41. 2021-12-27
    Survey response — day 14, dose 3

    MedDRA: Arthralgia, Axillary pain, Joint range of motion decreased, Paraesthesia, Pre-existing disease — 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

    Free text: I received my booster in the right arm. Shots 1&2 as well. I have had some worsening shoulder pain, limited range of motion, little finger tingling. I do have a history of frozen shoulder in the opposite arm. Right armpit also still sore.

    MedDRA releases: 2024-11 · check-in free text available
42. 2021-12-27
    Report sent to call center — day 14, dose 3

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

    Telehealth, virtual health, or email health consultation · 1 call case(s)
43. 2021-12-28
    Call 1 — Left Voicemail
44. 2022-01-03
    Survey response — day 21, dose 3

    MedDRA: Arthralgia, Injected limb mobility decreased, Pain in extremity — 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

    Free text: I am still experiencing pain and limited range of motion my right arm/shoulder I had the booster. I had all 3 vaccines in my right arm. I have an appointment scheduled tomorrow with my primary care doctor.

    MedDRA releases: 2024-11 · check-in free text available
45. 2022-01-03
    Report sent to call center — day 21, dose 3

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

    Telehealth, virtual health, or email health consultation · 1 call case(s)
46. 2022-01-07
    Call 1 — Left Voicemail
47. 2022-01-10
    Call 2 — Left Voicemail
48. 2022-01-11
    Survey response — day 28, dose 3

    MedDRA: Arthralgia, Joint range of motion decreased, Office visit, Periarthritis, Sleep disorder — 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: Saw primary care doctor 1/4/2022 due to ongoing shoulder pain in right shoulder since booster vaccination on 12/13/2022. Diagnosis of adhesive capsulitis (frozen shoulder). Range of motion affected. Sleep disturbances also present from pain. Awful.

    MedDRA releases: 2024-11 · check-in free text available
49. 2022-01-11
    Report sent to call center — day 28, dose 3

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

    Telehealth, virtual health, or email health consultation · 1 call case(s)
50. 2022-01-11
    Call successful

    Participant prefers to complete VAERS report online
51. 2022-01-17
    Call successful

    Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
52. 2022-01-20
    Health check-in — day 35, dose 3

    Feeling: Fair

    Adult check-in
53. 2022-01-27
    Survey response — day 42, dose 3

    MedDRA: Arthralgia, Insomnia, Joint range of motion decreased, Periarthritis — 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

    Free text: Frozen shoulder in right shoulder began a couple weeks after booster shot in right arm. It's been extremely painful and have lost range of motion in arm. Have experienced sleeping difficulties.

    MedDRA releases: 2024-11 · check-in free text available
54. 2022-01-27
    Report sent to call center — day 42, dose 3

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

    Telehealth, virtual health, or email health consultation · 1 call case(s)
55. 2022-01-31
    Call 1 — Left Voicemail
56. 2022-03-16
    Survey response — 3 months, dose 3

    MedDRA: Arthralgia, Mobility decreased, Pain in extremity, Paraesthesia, Periarthritis, Physiotherapy, Sleep disorder — 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

    Free text: Symptoms: Still experiencing intense shoulder/arm pain, finger tingling, and sleep disturbances. Also experiencing lost range of motion in right arm. Symptoms began 2 weeks after vaccination. Diagnosed with frozen shoulder/adhesive capsulitis. Total Misery. · Healthcare visit (other): X-ray on arm scheduled and Physical therapy exercises.

    MedDRA releases: 2024-11 · check-in free text available
57. 2022-03-16
    Report sent to call center — 3 months, dose 3

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

    Telehealth, virtual health, or email health consultation · 1 call case(s)
58. 2022-03-22
    Call 1 — Could Not Reach Participant
59. 2022-03-25
    Call successful

    Reported to VAERS voluntarily prior to GDIT contact
60. 2022-06-15
    Survey response — 6 months, dose 3

    MedDRA: Arthralgia, Joint range of motion decreased, Periarthritis — Feeling: Fair · 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: Still experiencing symptoms of frozen shoulder in my right shoulder which began days after my Pfizer booster shot on December 13th 2021. Still experiencing pain and lost range of motion.

    MedDRA releases: 2024-11 · check-in free text available
61. 2022-06-15
    Report sent to call center — 6 months, dose 3

    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)
62. 2022-06-16
    Call successful

    Reported to VAERS during previous contact from GDIT