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XZA-30489-13229

5 vaccinations 17 coded responses 54 check-ins 17 free-text entries 4 call cases
Sex
Female
Age at first dose
66+
ZIP prefix
240 / VA
Registered
2021-02-02
Relationship
Self
Race
White
Ethnicity
Not Hispanic or Latino

Timeline

  1. 2021-01-30
    Dose 1 — Pfizer-BioNTech
  2. 2021-02-02
    Registered in v-safe
  3. 2021-02-02
    Survey response — days 1–6 daily, dose 1
    MedDRA: Condition aggravated, Pre-existing disease — Feeling: Fair · Site: Pain, Swelling · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  4. 2021-02-03
    Survey response — days 1–6 daily, dose 1
    MedDRA: Cholecystectomy, Diarrhoea, Fatigue, Fibromyalgia, Pain — Feeling: Fair · Muscle or body aches, Fatigue or tiredness, Diarrhea
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  5. 2021-02-04
    Survey response — days 1–6 daily, dose 1
    MedDRA: Fibromyalgia, Pre-existing disease — Feeling: Good · Muscle or body aches
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  6. 2021-02-05
    Survey response — days 1–6 daily, dose 1
    MedDRA: Unevaluable event — Feeling: Good · Muscle or body aches · Be unable to do your normal daily activities
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  7. 2021-02-07
    Survey response — 7 day, dose 1
    MedDRA: Fibromyalgia, Pain, Pre-existing disease — Feeling: Fair · Muscle or body aches · Be unable to do your normal daily activities
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  8. 2021-02-13
    Health check-in — 14 day, dose 1
    Feeling: Fair
    Adult check-in
  9. 2021-02-20
    Dose 2 — Pfizer-BioNTech
  10. 2021-02-20
    Survey response — 0 day, dose 2
    MedDRA: No adverse event — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  11. 2021-02-21
    Survey response — days 1–6 daily, dose 2
    MedDRA: Fibromyalgia, Injection site pain, Medical counselling, Pre-existing disease, Self-medication — Feeling: Poor · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness · Get care from a doctor or other healthcare professional
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  12. 2021-02-21
    Report sent to call center — days 1–6 daily, dose 2
    Get care from a doctor or other healthcare professional
    1 call case(s)
  13. 2021-02-22
    Survey response — days 1–6 daily, dose 2
    MedDRA: Adverse reaction — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  14. 2021-02-23
    Survey response — days 1–6 daily, dose 2
    MedDRA: Pre-existing disease — Feeling: Good · Muscle or body aches
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  15. 2021-02-24
    Health check-in — days 1–6 daily, dose 2
    Feeling: Good · None
    Adult check-in
  16. 2021-02-25
    Health check-in — days 1–6 daily, dose 2
    Feeling: Good · None
    Adult check-in
  17. 2021-02-26
    Health check-in — days 1–6 daily, dose 2
    Feeling: Good · None
    Adult check-in
  18. 2021-02-27
    Health check-in — 7 day, dose 2
    Feeling: Good · None
    Adult check-in
  19. 2021-03-06
    Health check-in — 14 day, dose 2
    Feeling: Fair
    Adult check-in
  20. 2021-03-13
    Health check-in — 21 day, dose 2
    Feeling: Good
    Adult check-in
  21. 2021-03-20
    Health check-in — 28 day, dose 2
    Feeling: Good
    Adult check-in
  22. 2021-03-27
    Health check-in — 35 day, dose 2
    Feeling: Fair
    Adult check-in
  23. 2021-04-03
    Survey response — 42 day, dose 2
    MedDRA: Arthralgia, Arthritis, Condition aggravated, Emergency care, Fibromyalgia, Gait inability, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
  24. 2021-04-03
    Report sent to call center — 42 day, dose 2
    Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional
    1 call case(s)
  25. 2021-05-22
    Health check-in — 3 month, dose 2
    Feeling: Poor
    Adult check-in
  26. 2021-06-09
  27. 2021-06-15
  28. 2021-06-23
  29. 2021-06-23
    Call successful
    Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
  30. 2021-08-21
    Survey response — 6 month, dose 2
    MedDRA: Eyelid pain, Eyelid ptosis, Office visit, Seborrhoeic dermatitis — Feeling: Fair · Get care from a doctor or other healthcare professional
    MedDRA releases: 2021-09,2024-11 · check-in answers available
  31. 2021-08-21
    Report sent to call center — 6 month, dose 2
    Get care from a doctor or other healthcare professional
    1 call case(s)
  32. 2021-08-24
  33. 2021-09-28
    Dose 3 — Pfizer-BioNTech
  34. 2021-10-01
    Health check-in — days 1–6 daily, dose 3
    Feeling: Fair · Site: Pain · Fatigue or tiredness
    Adult check-in
  35. 2021-10-02
    Survey response — days 1–6 daily, dose 3
    MedDRA: Pre-existing disease — Feeling: Fair · Muscle or body aches
    MedDRA releases: 2024-11 · check-in answers available
  36. 2021-10-03
    Survey response — days 1–6 daily, dose 3
    MedDRA: No adverse event — Feeling: Fair · Muscle or body aches
    MedDRA releases: 2024-11 · check-in answers available
  37. 2021-10-04
    Survey response — days 1–6 daily, dose 3
    MedDRA: Discomfort, Insomnia, Unevaluable event — Feeling: Fair · Fever · Muscle or body aches, Fatigue or tiredness, Diarrhea, Abdominal pain · Be unable to do your normal daily activities
    MedDRA releases: 2024-11 · check-in answers available
  38. 2021-10-05
    Survey response — 7 day, dose 3
    MedDRA: Unevaluable event — Feeling: Good · Muscle or body aches, Fatigue or tiredness
    MedDRA releases: 2024-11 · check-in answers available
  39. 2021-10-12
    Health check-in — 14 day, dose 3
    Feeling: Fair
    Adult check-in
  40. 2021-10-19
    Health check-in — 21 day, dose 3
    Feeling: Fair
    Adult check-in
  41. 2021-10-26
    Health check-in — 28 day, dose 3
    Feeling: Good
    Adult check-in
  42. 2021-11-02
    Survey response — 35 day, dose 3
    MedDRA: Pruritus, Seborrhoeic dermatitis — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit
    MedDRA releases: 2024-11 · check-in answers available
  43. 2021-11-02
    Report sent to call center — 35 day, dose 3
    Get care from a doctor or other healthcare professional
    Outpatient clinic or urgent care clinic visit · 1 call case(s)
  44. 2021-11-05
  45. 2021-11-09
    Health check-in — 42 day, dose 3
    Feeling: Fair
    Adult check-in
  46. 2021-12-28
    Health check-in — 3 month, dose 3
    Feeling: Good
    Adult check-in
  47. 2022-03-29
    Health check-in — 6 month, dose 3
    Feeling: Good
    Adult check-in
  48. 2022-04-05
    Dose 4 — Pfizer-BioNTech
  49. 2022-04-16
    Health check-in — 7 day, dose 4
    Feeling: Good · None
    Adult check-in
  50. 2022-04-19
    Health check-in — 14 day, dose 4
    Feeling: Good
    Adult check-in
  51. 2022-04-26
    Health check-in — 21 day, dose 4
    Feeling: Fair
    Adult check-in
  52. 2022-05-03
    Health check-in — 28 day, dose 4
    Feeling: Good
    Adult check-in
  53. 2022-05-10
    Health check-in — 35 day, dose 4
    Feeling: Good
    Adult check-in
  54. 2022-05-17
    Health check-in — 42 day, dose 4
    Feeling: Good
    Adult check-in
  55. 2022-07-05
    Health check-in — 3 month, dose 4
    Feeling: Fair
    Adult check-in
  56. 2022-09-28
    Dose 5 — Pfizer-BioNTech
  57. 2022-09-29
    Survey response — days 1–6 daily, dose 5
    MedDRA: Fatigue, Pain — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness
    MedDRA releases: 2024-11 · check-in answers available
  58. 2022-09-30
    Health check-in — days 1–6 daily, dose 5
    Feeling: Good · None
    Adult check-in
  59. 2022-10-01
    Health check-in — days 1–6 daily, dose 5
    Feeling: Good · None
    Adult check-in
  60. 2022-10-02
    Health check-in — days 1–6 daily, dose 5
    Feeling: Good · None
    Adult check-in
  61. 2022-10-03
    Health check-in — days 1–6 daily, dose 5
    Feeling: Good · None
    Adult check-in
  62. 2022-10-04
    Health check-in — days 1–6 daily, dose 5
    Feeling: Good · None
    Adult check-in
  63. 2022-10-05
    Health check-in — 7 day, dose 5
    Feeling: Good · None
    Adult check-in
  64. 2022-10-12
    Health check-in — 14 day, dose 5
    Feeling: Good
    Adult check-in
  65. 2022-10-19
    Health check-in — 21 day, dose 5
    Feeling: Good
    Adult check-in
  66. 2022-10-26
    Health check-in — 28 day, dose 5
    Feeling: Good
    Adult check-in
  67. 2022-11-02
    Health check-in — 35 day, dose 5
    Feeling: Fair
    Adult check-in
  68. 2022-11-09
    Health check-in — 42 day, dose 5
    Feeling: Good
    Adult check-in
  69. 2022-12-28
    Health check-in — 3 month, dose 5
    Feeling: Fair
    Adult check-in
  70. 2023-03-29
    Health check-in — 6 month, dose 5
    Feeling: Fair
    Adult check-in

Vaccinations

DoseDateManufacturerCo-administered
12021-01-30Pfizer-BioNTech
22021-02-20Pfizer-BioNTech
32021-09-28Pfizer-BioNTech No
42022-04-05Pfizer-BioNTech No
52022-09-28Pfizer-BioNTech No

Call center

ReportedOutcomeVAERS-related outcome
2021-02-21 Successful Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-04-03 Successful
2021-06-23
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-08-21 Unsuccessful
2021-11-02 Unsuccessful

Free text

Release 3

Systemic reaction (other): I have fibromyalgia so I am attributing all body aches and weakness (with the exception of injection site which is now virtually pain-free) to fibro and a way too-small wheelchair for the hours at the vaccination clinic, not the shot.

Systemic reaction (other): I attribute my aches to fibromyalgia, my fatigue to a restless night and being cooped up at home, and the diarrhea to surgery a few years ago for gallblader removal. Many foods don't agree with my lowertract since then.e

Systemic reaction (other): Fibromyalgia pain, not Covid-19 pain. Good days and bad days are the norm for me.

Systemic reaction (other): Chronic pain from fibromyalgia.

Systemic reaction (other): Pains due to fibromyalgia.

Release 4

Systemic reaction (other): No, thank you.

Systemic reaction (other): Wheelchair use while at clinic could be exacerbating my fibromyalgia chronic pain.
Healthcare visit (other): Called the on-call doc and was told to take Tylenol or Aleve. I'd already been taking Tylenol every six hours all night with little to no relief. He said it just means it's working. (?) Pain at injection site is the worst of my pains -- nounusual for me even with some flu shots. relief.

Systemic reaction (other): Much better than yesterday, thank you!

Systemic reaction (other): Same ol' fibromyalgia aches. That's all.

Release 6

Symptoms: Searing pain upon awakening today in right knee. Unable to walk without walker. Went to ER. Sudden flare of arthritis or fibromyalgia in a new place. No clot.

Release 9

Symptoms: 1. Diagnosed w/ seborrheic dermatitis; 2. Droopy left eyelid w/ slight pain. Am being treated by dermatologist and will see an opthalmologist.
Healthcare visit (other): In-person appointment.

Systemic reaction (other): I do not attribute my pains to the Pfizer booster. I have fibromyalgia. Mild to moderate pain is normal for me.

Systemic reaction (other): No.

Release 10

Systemic reaction (other): Up all night with symptoms of a 24-hour bug. Most uncomfortable but, seemingly, not related to the Pfizer booster. Feeling much better.

Systemic reaction (other): Normal for me.

Symptoms: Severe itching on back and shoulders. Was diagnosed as seborrheic dermatitis but perhaps I was misdiagnosed. Will get a second opinion.

Release 12

Systemic reaction (other): Aches and fatique could be attributed to a very tiring day yesterday, not due, necessarily to the third booster.

Free-text releases are not linked to a specific survey response. The CDC cut some text off at about 250 characters: symptoms in every release, and the other two fields in releases 9-12. Those entries are marked "cut off by CDC".

MedDRA terms by release

FieldPreferred term2021-092023-042024-11
HCVOInjection site pain ✓ ✓ ✓
HCVOMedical counselling ✓ ✓ ✓
HCVOOffice visit ✓ · ✓
HCVOSelf-medication ✓ ✓ ✓
SDArthralgia ✓ ✓ ✓
SDArthritis ✓ ✓ ✓
SDCondition aggravated ✓ ✓ ✓
SDEmergency care ✓ ✓ ✓
SDEyelid pain ✓ · ✓
SDEyelid ptosis ✓ · ✓
SDFibromyalgia ✓ ✓ ✓
SDGait inability ✓ ✓ ✓
SDOffice visit ✓ · ✓
SDPre-existing disease ✓ ✓ ✓
SDPruritus · · ✓
SDSeborrhoeic dermatitis ✓ · ✓
SROAdverse reaction ✓ ✓ ✓
SROCholecystectomy ✓ ✓ ✓
SROCondition aggravated ✓ ✓ ✓
SRODiarrhoea ✓ ✓ ✓
SRODiscomfort · · ✓
SROFatigue ✓ ✓ ✓
SROFibromyalgia ✓ ✓ ✓
SROInsomnia · · ✓
SRONo adverse event ✓ ✓ ✓
SROPain ✓ ✓ ✓
SROPre-existing disease ✓ ✓ ✓
SROUnevaluable event ✓ ✓ ✓

✓ active code · ○ coded but marked inactive · blank = not in that release