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26U-27979-11581

4 vaccinations 14 coded responses 44 check-ins 13 free-text entries 1 call case
Sex
Female
Age at first dose
61-65
ZIP prefix
480 / MI
Registered
2021-03-16
Relationship
Self
Race
Black or African American
Ethnicity
Not Hispanic or Latino

Timeline

  1. 2021-03-15
    Dose 1 — Janssen/Johnson & Johnson
  2. 2021-03-16
    Registered in v-safe
  3. 2021-03-16
    Survey response — days 1–6 daily, dose 1
    MedDRA: Poor quality sleep, Pruritus — Feeling: Fair · Site: Pain, Swelling
    Free text: Wakefulness @0202 and 0432 with increased intense itchiness from waist down.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  4. 2021-03-17
    Health check-in — days 1–6 daily, dose 1
    Feeling: Fair · Site: Swelling, Itching · None
    Adult check-in
  5. 2021-03-18
    Survey response — days 1–6 daily, dose 1
    MedDRA: Urine odour abnormal — Feeling: Fair · Site: Pain, Swelling, Itching
    Free text: On Wednesday(yesterday) I failed to report colorless -like water-urine along with an odor that had a 'medicinal' smell. TODAY: urine appears light yellow and odor as in yesterday was decreased.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  6. 2021-03-19
    Survey response — days 1–6 daily, dose 1
    MedDRA: Limb discomfort, Musculoskeletal discomfort, Nerve compression, Pain, Pain in extremity, Self-medication — Feeling: Fair · Site: Pain, Swelling · Muscle or body aches
    Free text: Intense left arm pain radiating to hand. Pain reminiscent of pinched nerve pain. Required need to take one 325 mg aspirin. Some current discomfort in left side of neck and arm remains.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  7. 2021-03-20
    Survey response — days 1–6 daily, dose 1
    MedDRA: Cough, Throat irritation — Feeling: Fair
    Free text: Itchy throat with cough.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  8. 2021-03-21
    Survey response — days 1–6 daily, dose 1
    MedDRA: Hypersomnia, Pain, Pre-existing disease, Sciatica, Sleep apnoea syndrome, Systemic lupus erythematosus — Feeling: Fair · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities
    Free text: Pain reminiscent of sciatica on left side from trunk downward. Excessive sleeping.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  9. 2021-03-22
    Health check-in — day 7, dose 1
    Feeling: Good · None
    Adult check-in
  10. 2021-03-29
    Survey response — day 14, dose 1
    MedDRA: Dyspnoea — Feeling: Fair
    Free text: Late P.M. on March 22 @ approximately 11, breathing was somewhat laborious. I monitored it for any worsening symtoms and it remained constant. No gasping for air just a slowed down process of lung inhale/exhale cycle. No repeat symptoms to date.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  11. 2021-04-05
    Health check-in — day 21, single dose
    Feeling: Good
    Adult check-in
  12. 2021-04-12
    Health check-in — day 28, single dose
    Feeling: Fair
    Adult check-in
  13. 2021-04-19
    Survey response — day 35, single dose
    MedDRA: Dyspnoea, Headache, Vision blurred — Feeling: Good
    Free text: Intermittent headaches lasting less than an hour, blurred vision and labored breathing. (Age suggests new cataract as I use progressive lens and have worn prescription lenses since age 9.) Respiratory depression may be tied to Norco 750mg daily(QHS)
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  14. 2021-04-26
    Survey response — day 42, single dose
    MedDRA: Chills, Dysphagia, Headache, Nasal congestion, Oropharyngeal pain, Throat irritation — Feeling: Fair
    Free text: Exra throat irritation with slight difficulty swallowing. Intermittent chills over 48 hrs. NO fever, emesis or diarrhea. Nasal stuffiness (may be attributable to pollen from outdoor air). Throat irritation after clinic appt 4/22.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  15. 2021-06-14
    Health check-in — 3 months, dose 1
    Feeling: Good
    Adult check-in
  16. 2021-09-15
    Health check-in — 6 months, dose 1
    Feeling: Good
    Adult check-in
  17. 2021-10-28
    Dose 2 — Janssen/Johnson & Johnson
  18. 2021-11-01
    Survey response — days 1–6 daily, dose 2
    MedDRA: Breakthrough COVID-19 — Feeling: Fair · Site: Pain, Redness, Swelling · Fatigue or tiredness · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit
    Free text: COVID Breakthrough:9/15-10/1
    MedDRA releases: 2024-11 · check-in free text available
  19. 2021-11-01
    Report sent to call center — days 1–6 daily, dose 2
    Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional
    Emergency room or emergency department visit · 1 call case(s)
  20. 2021-11-02
    Health check-in — days 1–6 daily, dose 2
    Feeling: Good · Diarrhea, Abdominal pain
    Adult check-in
  21. 2021-11-02
  22. 2021-11-03
    Health check-in — days 1–6 daily, dose 2
    Feeling: Poor · Headache, Nausea, Diarrhea, Abdominal pain · Be unable to do your normal daily activities
    Adult check-in
  23. 2021-11-04
    Health check-in — day 7, dose 2
    Feeling: Fair · Fatigue or tiredness · Be unable to do your normal daily activities
    Adult check-in
  24. 2021-11-11
    Health check-in — day 14, dose 2
    Feeling: Good
    Adult check-in
  25. 2021-11-18
    Health check-in — day 21, dose 2
    Feeling: Fair
    Adult check-in
  26. 2021-11-26
    Health check-in — day 28, dose 2
    Feeling: Good
    Adult check-in
  27. 2021-12-02
    Health check-in — day 35, dose 2
    Feeling: Fair
    Adult check-in
  28. 2021-12-09
    Survey response — day 42, dose 2
    MedDRA: Oropharyngeal pain, Pyrexia, Throat irritation — Feeling: Fair · Be unable to do your normal daily activities
    Free text: Intermittent low-grade fevers; itchy and mildly sore throat.
    MedDRA releases: 2024-11 · check-in free text available
  29. 2022-01-28
    Survey response — 3 months, dose 2
    MedDRA: COVID-19, Fatigue, Lethargy, Somnolence — Feeling: Poor · Be unable to do your normal daily activities
    Free text: Extreme fatigue/lethargy. Excessive daytime sleepiness/drowsiness. Sleeping 12 plus hours yet still feel tired. Please note: these symptoms began after COVID infection on September 30 thru October 10(post vaccine).
    MedDRA releases: 2024-11 · check-in free text available
  30. 2022-04-28
    Dose 3 — Janssen/Johnson & Johnson
  31. 2022-05-21
    Health check-in — day 21, dose 3
    Feeling: Fair
    Adult check-in
  32. 2022-05-26
    Health check-in — day 28, dose 3
    Feeling: Good
    Adult check-in
  33. 2022-06-02
    Health check-in — day 35, dose 3
    Feeling: Good
    Adult check-in
  34. 2022-06-09
    Health check-in — day 42, dose 3
    Feeling: Good
    Adult check-in
  35. 2022-07-28
    Health check-in — 3 months, dose 3
    Feeling: Good
    Adult check-in
  36. 2022-10-14
    Dose 4 — Moderna
  37. 2022-10-14
    Health check-in — day 0, dose 4
    Feeling: Good · None
    Adult check-in
  38. 2022-10-15
    Survey response — days 1–6 daily, dose 4
    MedDRA: Blood pressure increased, Body temperature increased — Feeling: Good · Site: Pain · Headache
    Free text: Low-grade fever(10/14):99.1 and increased BP of:132/71.
    MedDRA releases: 2024-11 · check-in free text available
  39. 2022-10-16
    Health check-in — days 1–6 daily, dose 4
    Feeling: Good · Site: Pain · Chills
    Adult check-in
  40. 2022-10-17
    Health check-in — days 1–6 daily, dose 4
    Feeling: Good · None
    Adult check-in
  41. 2022-10-18
    Survey response — days 1–6 daily, dose 4
    MedDRA: Body temperature increased — Feeling: Good · Site: Pain · Headache
    Free text: Low-grade fever 99.1 :10/17@1855.
    MedDRA releases: 2024-11 · check-in free text available
  42. 2022-10-19
    Health check-in — days 1–6 daily, dose 4
    Feeling: Good · Site: Pain · None
    Adult check-in
  43. 2022-10-20
    Health check-in — days 1–6 daily, dose 4
    Feeling: Good · None
    Adult check-in
  44. 2022-10-21
    Health check-in — day 7, dose 4
    Feeling: Good · None
    Adult check-in
  45. 2022-10-28
    Health check-in — day 14, dose 4
    Feeling: Good
    Adult check-in
  46. 2022-11-04
    Health check-in — day 21, dose 4
    Feeling: Good
    Adult check-in
  47. 2022-11-11
    Health check-in — day 28, dose 4
    Feeling: Good
    Adult check-in
  48. 2022-11-18
    Health check-in — day 35, dose 4
    Feeling: Good
    Adult check-in
  49. 2022-11-25
    Health check-in — day 42, dose 4
    Feeling: Good
    Adult check-in
  50. 2023-01-13
    Survey response — 3 months, dose 4
    MedDRA: Chills, Headache, Pyrexia — Feeling: Good
    MedDRA releases: 2024-11
  51. 2023-04-14
    Health check-in — 6 months, dose 4
    Feeling: Fair
    Adult check-in

Vaccinations

DoseDateManufacturerCo-administered
12021-03-15Janssen/Johnson & Johnson
22021-10-28Janssen/Johnson & Johnson No
32022-04-28Janssen/Johnson & Johnson No
42022-10-14Moderna No

Call center

1 call center case

1 unsuccessful

See the call center timeline

Free text

Release 5 — days 1–6 daily, dose 1

2021-03-16

Systemic reaction (other): Wakefulness @0202 and 0432 with increased intense itchiness from waist down.

2021-03-18

Systemic reaction (other): On Wednesday(yesterday) I failed to report colorless -like water-urine along with an odor that had a 'medicinal' smell. TODAY: urine appears light yellow and odor as in yesterday was decreased.

2021-03-19

Systemic reaction (other): Intense left arm pain radiating to hand. Pain reminiscent of pinched nerve pain. Required need to take one 325 mg aspirin. Some current discomfort in left side of neck and arm remains.

Release 6 — days 1–6 daily, dose 1

2021-03-20

Systemic reaction (other): Itchy throat with cough.

2021-03-21

Systemic reaction (other): Pain reminiscent of sciatica on left side from trunk downward. Excessive sleeping.

Release 6 — day 14, dose 1

2021-03-29

Symptoms: Late P.M. on March 22 @ approximately 11, breathing was somewhat laborious. I monitored it for any worsening symtoms and it remained constant. No gasping for air just a slowed down process of lung inhale/exhale cycle. No repeat symptoms to date.

Release 7 — day 35, single dose

2021-04-19

Symptoms: Intermittent headaches lasting less than an hour, blurred vision and labored breathing. (Age suggests new cataract as I use progressive lens and have worn prescription lenses since age 9.) Respiratory depression may be tied to Norco 750mg daily(QHS) cut off by CDC

Release 8 — day 42, single dose

2021-04-26

Symptoms: Exra throat irritation with slight difficulty swallowing. Intermittent chills over 48 hrs. NO fever, emesis or diarrhea. Nasal stuffiness (may be attributable to pollen from outdoor air). Throat irritation after clinic appt 4/22.

Release 10 — days 1–6 daily, dose 2

2021-11-01

Systemic reaction (other): COVID Breakthrough:9/15-10/1

Release 10 — day 42, dose 2

2021-12-09

Symptoms: Intermittent low-grade fevers; itchy and mildly sore throat.

Release 11 — 3 months, dose 2

2022-01-28

Symptoms: Extreme fatigue/lethargy. Excessive daytime sleepiness/drowsiness. Sleeping 12 plus hours yet still feel tired. Please note: these symptoms began after COVID infection on September 30 thru October 10(post vaccine).

Release 12 — days 1–6 daily, dose 4

2022-10-15

Systemic reaction (other): Low-grade fever(10/14):99.1 and increased BP of:132/71.

2022-10-18

Systemic reaction (other): Low-grade fever 99.1 :10/17@1855.

Each entry is dated by the survey it was written in (the CDC re-sent the releases with survey dates in 2025); click a date to see that 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
SDChills ✓ ✓ ✓
SDCOVID-19 · · ✓
SDDysphagia ✓ ✓ ✓
SDDyspnoea ✓ ✓ ✓
SDFatigue · · ✓
SDHeadache ✓ ✓ ✓
SDLethargy · · ✓
SDNasal congestion ✓ ✓ ✓
SDOropharyngeal pain ✓ ✓ ✓
SDPyrexia · · ✓
SDSomnolence · · ✓
SDThroat irritation ✓ ✓ ✓
SDVision blurred ✓ ✓ ✓
SROBlood pressure increased · · ✓
SROBody temperature increased · · ✓
SROBreakthrough COVID-19 · · ✓
SROCough ✓ ✓ ✓
SROHypersomnia ✓ ✓ ✓
SROLimb discomfort ✓ ✓ ✓
SROMusculoskeletal discomfort ✓ ✓ ✓
SRONerve compression ✓ ✓ ✓
SROPain ✓ ✓ ✓
SROPain in extremity ✓ ✓ ✓
SROPoor quality sleep ✓ ✓ ✓
SROPre-existing disease · · ✓
SROPruritus ✓ ✓ ✓
SROSciatica ✓ ✓ ○
SROSelf-medication ✓ ✓ ✓
SROSleep apnoea syndrome ✓ ✓ ○
SROSystemic lupus erythematosus ✓ ✓ ○
SROThroat irritation ✓ ✓ ✓
SROUrine odour abnormal ✓ ✓ ✓

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