OpenVSafe by OpenVAERS
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54Y-11054-89192

2 vaccinations 10 coded responses 23 check-ins 10 free-text entries 7 call cases
Sex
Female
Age at first dose
31-35
ZIP prefix
430 / OH
Registered
2021-01-14
Relationship
Self
Race
White
Ethnicity
Not Hispanic or Latino

Timeline

  1. 2021-01-14
    Registered in v-safe
  2. 2021-01-14
    Dose 1 — Moderna
  3. 2021-01-14
    Survey response — day 0, dose 1
    MedDRA: Burning sensation, Lip swelling, Oral discomfort — Feeling: Fair · Headache
    Free text: Burning to hands, upper lip. Slight upper lip edema.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  4. 2021-01-15
    Health check-in — days 1–6 daily, dose 1
    Feeling: Good · Site: Pain, Swelling · Headache
    Adult check-in
  5. 2021-01-16
    Health check-in — days 1–6 daily, dose 1
    Feeling: Fair · Site: Pain, Swelling · Fever · Headache, Joint pains, Fatigue or tiredness · Be unable to do your normal daily activities
    Adult check-in
  6. 2021-01-16
    Report sent to call center — days 1–6 daily, dose 1
    Be unable to do your normal daily activities
    1 call case(s)
  7. 2021-01-17
    Survey response — days 1–6 daily, dose 1
    MedDRA: Decreased appetite, Respiratory tract congestion — Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities
    Free text: Congestion, lack of appetite
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  8. 2021-01-17
    Report sent to call center — days 1–6 daily, dose 1
    Be unable to do your normal daily activities
    1 call case(s)
  9. 2021-01-18
    Survey response — days 1–6 daily, dose 1
    MedDRA: Oropharyngeal pain, Respiratory tract congestion — Feeling: Fair · Fever · Headache, Fatigue or tiredness · Be unable to work
    Free text: Congestion, mild sore throat.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  10. 2021-01-18
  11. 2021-01-21
    Health check-in — day 7, dose 1
    Feeling: Good · Headache
    Adult check-in
  12. 2021-01-28
    Health check-in — day 14, dose 1
    Feeling: Good
    Adult check-in
  13. 2021-02-04
    Health check-in — day 21, dose 1
    Feeling: Good
    Adult check-in
  14. 2021-02-11
    Dose 2 — Moderna
  15. 2021-02-11
    Health check-in — day 0, dose 2
    Feeling: Good · Site: Pain, Redness, Swelling · Headache
    Adult check-in
  16. 2021-02-12
    Health check-in — days 1–6 daily, dose 2
    Feeling: Poor · Site: Pain, Redness, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Rash, not including the immediate area around the injection site · Be unable to work
    Adult check-in
  17. 2021-02-13
    Health check-in — days 1–6 daily, dose 2
    Feeling: Good · Fever · Headache, Fatigue or tiredness
    Adult check-in
  18. 2021-02-14
    Survey response — days 1–6 daily, dose 2
    MedDRA: Chest pain, Cough, Dyspnoea — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness · Be unable to do your normal daily activities
    Free text: Chest pain 7/10 (worse w deep breath), SOB, and cough.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  19. 2021-02-14
  20. 2021-02-16
    Survey response — days 1–6 daily, dose 2
    MedDRA: Erythema, Pruritus, Self-medication, Urticaria — Feeling: Good
    Free text: Itch, redness, and hives to both forearms, hands, feet, and ankles yesterday. Improved with Benadryl. Only occasional itch and one hive today.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  21. 2021-02-17
    Health check-in — days 1–6 daily, dose 2
    Feeling: Good · Fever · Headache, Fatigue or tiredness
    Adult check-in
  22. 2021-02-18
    Health check-in — day 7, dose 2
    Feeling: Good · None
    Adult check-in
  23. 2021-02-25
    Health check-in — day 14, dose 2
    Feeling: Good
    Adult check-in
  24. 2021-03-05
    Health check-in — day 21, dose 2
    Feeling: Good
    Adult check-in
  25. 2021-03-12
    Survey response — day 28, dose 2
    MedDRA: Erythema, Joint swelling, Pruritus, Rash pruritic, Vaccine positive rechallenge — Feeling: Good
    Free text: Itching to arms, hands, feet, ankles. Raised red area, approximately quarter sized to right anterior ankle. This is similar to the itching/rash experienced after the COVID-19 vaccine.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  26. 2021-03-19
    Survey response — day 35, dose 2
    MedDRA: Medical observation, Pruritus — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit
    Free text: Itching all over. OBGYN is checking labs to rule out cholystasis of pregnancy.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  27. 2021-03-19
    Report sent to call center — day 35, dose 2
    Get care from a doctor or other healthcare professional
    1 call case(s)
  28. 2021-03-25
    Health check-in — day 42, dose 2
    Feeling: Good
    Adult check-in
  29. 2021-04-06
  30. 2021-05-13
    Survey response — 3 months, dose 2
    MedDRA: Delivery, Polyhydramnios — Feeling: Good · Get care from a doctor or other healthcare professional · Hospitalization
    Free text: Polyhydramnios (AFI of 31 at 37 weeks); labor induced at 38 weeks. Healthy baby.
    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
  31. 2021-05-13
    Report sent to call center — 3 months, dose 2
    Get care from a doctor or other healthcare professional
    1 call case(s)
  32. 2021-05-17
  33. 2021-08-12
    Survey response — 6 months, dose 2
    MedDRA: Abdominal pain upper, Cholelithiasis, Diarrhoea, Hepatic enzyme increased, Lipase increased, Nausea, Office visit, Pruritus, Rash, Ultrasound scan abnormal, Vomiting — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit
    Free text: Gallstones identified on ultrasound. Elevated liver enzymes and lipase. upper abdominal pain, n/v/d. GI consult. Recommended gallbladder removal. Continue to have intermittent rash/itching.
    MedDRA releases: 2021-09,2024-11 · check-in free text available
  34. 2021-08-12
    Report sent to call center — 6 months, dose 2
    Get care from a doctor or other healthcare professional
    1 call case(s)
  35. 2021-08-16
    Call successful
    Participant prefers to complete VAERS report online
  36. 2022-02-11
    Survey response — 12 months, dose 2
    MedDRA: COVID-19, Cholecystectomy, Surgery — Feeling: Good · 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, Hospitalization
    Free text: Symptoms: Gallbladder removal 10-4-21 d/t sludge/microstones. COVID-19. · Healthcare visit (other): Surgery
    MedDRA releases: 2024-11 · check-in free text available
  37. 2022-02-11
    Report sent to call center — 12 months, dose 2
    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 · Hospitalization · 1 call case(s)
  38. 2022-02-14

Vaccinations

DoseDateManufacturerCo-administered
12021-01-14Moderna
22021-02-11Moderna

Call center

ReportedOutcomeVAERS-related outcome
2021-01-16 Unsuccessful
2021-01-17 Unsuccessful
2021-01-18 Unsuccessful
2021-03-19 Successful Participant prefers to complete VAERS report online
2021-05-13 Successful Participant prefers to complete VAERS report online
2021-08-12 Successful
2021-08-16
Participant prefers to complete VAERS report online
2022-02-11 Unsuccessful

Free text

Release 2 — day 0, dose 1

2021-01-14

Systemic reaction (other): Burning to hands, upper lip. Slight upper lip edema.

Release 2 — days 1–6 daily, dose 1

2021-01-17

Systemic reaction (other): Congestion, lack of appetite

2021-01-18

Systemic reaction (other): Congestion, mild sore throat.

Release 4 — days 1–6 daily, dose 2

2021-02-14

Systemic reaction (other): Chest pain 7/10 (worse w deep breath), SOB, and cough.

2021-02-16

Systemic reaction (other): Itch, redness, and hives to both forearms, hands, feet, and ankles yesterday. Improved with Benadryl. Only occasional itch and one hive today.

Release 5 — day 28, dose 2

2021-03-12

Symptoms: Itching to arms, hands, feet, ankles. Raised red area, approximately quarter sized to right anterior ankle. This is similar to the itching/rash experienced after the COVID-19 vaccine.

Release 5 — day 35, dose 2

2021-03-19

Symptoms: Itching all over. OBGYN is checking labs to rule out cholystasis of pregnancy.

Release 8 — 3 months, dose 2

2021-05-13

Symptoms: Polyhydramnios (AFI of 31 at 37 weeks); labor induced at 38 weeks. Healthy baby.

Release 9 — 6 months, dose 2

2021-08-12

Symptoms: Gallstones identified on ultrasound. Elevated liver enzymes and lipase. upper abdominal pain, n/v/d. GI consult. Recommended gallbladder removal. Continue to have intermittent rash/itching.

Release 11 — 12 months, dose 2

2022-02-11

Symptoms: Gallbladder removal 10-4-21 d/t sludge/microstones. COVID-19.
Healthcare visit (other): Surgery

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
HCVOSurgery · · ✓
SDAbdominal pain upper ✓ · ✓
SDCholecystectomy · · ✓
SDCholelithiasis ✓ · ✓
SDCOVID-19 · · ✓
SDDelivery ✓ ✓ ✓
SDDiarrhoea ✓ · ✓
SDErythema ✓ ✓ ✓
SDHepatic enzyme increased ✓ · ✓
SDJoint swelling ✓ ✓ ✓
SDLipase increased ✓ · ✓
SDMedical observation ✓ ✓ ✓
SDNausea ✓ · ✓
SDOffice visit ✓ · ✓
SDPolyhydramnios ✓ ✓ ✓
SDPruritus ✓ ✓ ✓
SDRash ✓ · ✓
SDRash pruritic ✓ ✓ ✓
SDUltrasound scan abnormal ✓ · ✓
SDVaccine positive rechallenge ✓ ✓ ✓
SDVomiting ✓ · ✓
SROBurning sensation ✓ ✓ ✓
SROChest pain ✓ ✓ ✓
SROCough ✓ ✓ ✓
SRODecreased appetite ✓ ✓ ✓
SRODyspnoea ✓ ✓ ✓
SROErythema ✓ ✓ ✓
SROLip swelling ✓ ✓ ✓
SROOral discomfort ✓ ✓ ✓
SROOropharyngeal pain ✓ ✓ ✓
SROPruritus ✓ ✓ ✓
SRORespiratory tract congestion ✓ ✓ ✓
SROSelf-medication ✓ ✓ ✓
SROUrticaria ✓ ✓ ✓

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