5EM-26961-54002 · OpenVSafe

Timeline

Registration Vaccinations Survey responses Call reports Cases without a report Call attempts Call successful Pregnancy survey

2020-12-28
Dose 1 — Moderna
2021-01-22
Registered in v-safe
2021-01-25
Survey response — day 28, dose 1
MedDRA: Erythema, Pain, Pruritus, Self-medication, Skin warm, Swelling, Urticaria — Feeling: Poor · Be unable to do your normal daily activities

Free text: one wk. post vaccine I got a red circle with defined borders- warm to the touch, swollen, sore, itchy. One week after that I had all over itchiness . Now in past week I have systemic daily hives that will not go away unless I take an allergy med.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-03
Dose 2 — Moderna
2021-02-08
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Good · Site: Pain

Free text: So you only want to list symptoms experienced 5 days later? Is there no way to report symptoms experienced on day one and day two?

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-10
Survey response — day 7, dose 2
MedDRA: Adverse reaction — Feeling: Good · Site: Pain · Fever · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: 24 hours after vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-17
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-24
Survey response — day 21, dose 2
MedDRA: Headache — Feeling: Fair

Free text: Headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-10
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-17
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-05
Survey response — 3 months, dose 2
MedDRA: Pruritus — Feeling: Fair

Free text: Itchy

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2022-02-05
Survey response — 12 months, dose 2
MedDRA: Heart rate increased — Feeling: Fair · Be unable to do your normal daily activities

Free text: Fast heart rate for long periods. Between 90 and 110.

MedDRA releases: 2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-28	Moderna
2	2021-02-03	Moderna

Free text

Release 2 — day 28, dose 1

2021-01-25

Symptoms: one wk. post vaccine I got a red circle with defined borders- warm to the touch, swollen, sore, itchy. One week after that I had all over itchiness . Now in past week I have systemic daily hives that will not go away unless I take an allergy med.

Release 3 — days 1–6 daily, dose 2

2021-02-08

Systemic reaction (other): So you only want to list symptoms experienced 5 days later? Is there no way to report symptoms experienced on day one and day two?

Release 4 — day 7, dose 2

2021-02-10

Systemic reaction (other): 24 hours after vaccine

Release 4 — day 21, dose 2

2021-02-24

Symptoms: Headache

Release 8 — 3 months, dose 2

2021-05-05

Symptoms: Itchy

Release 11 — 12 months, dose 2

2022-02-05

Symptoms: Fast heart rate for long periods. Between 90 and 110.

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

Field	Preferred term	2021-09	2023-04	2024-11
SD	Erythema	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Heart rate increased	·	·	✓
SD	Pain	✓	✓	✓
SD	Pruritus	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Skin warm	✓	✓	✓
SD	Swelling	✓	✓	✓
SD	Urticaria	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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