2J6-16063-76348 · OpenVSafe

Timeline

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

2020-12-29
Registered in v-safe
2020-12-29
Dose 1 — Moderna
2020-12-29
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2020-12-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2020-12-31
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-02
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-03
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-04
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-05
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-01-12
Survey response — day 14, dose 1
MedDRA: Erythema, Feeling hot, Pruritus, Swelling, Tenderness — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Had sudden onset of allergic reaction at vaccine site on Day 8 and remaining through Day 11. Extremely itchy, swollen, hot, red in a 4 by 3 inch patch surrounding injection site. Treated with Benedryl and ice packs. More tender after this reaction

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-12
Report sent to call center — day 14, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-21
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-01-26
Dose 2 — Moderna
2021-01-26
Health check-in — day 0, dose 2
Feeling: Fair · Site: Pain, Swelling · Nausea

Adult check-in
2021-01-27
Survey response — days 1–6 daily, dose 2
MedDRA: Heart rate increased — Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

Free text: Heart rate over 100 for several hours

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-28
Survey response — days 1–6 daily, dose 2
MedDRA: Lymph node pain — Feeling: Good · Site: Pain, Redness, Swelling, Itching · Joint pains

Free text: Axillary lymph node pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-29
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Joint pains

Adult check-in
2021-01-30
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Swelling, Itching · None

Adult check-in
2021-01-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-02-01
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-02-02
Health check-in — day 7, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-02-09
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-16
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-23
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-02-25
Call 1 — Could Not Reach Participant
2021-03-02
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-02
Call 2 — Could Not Reach Participant
2021-03-05
Call 3 — Could Not Reach Participant
2021-03-09
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-28
Survey response — 3 months, dose 2
MedDRA: Injection site rash, Rash, Rash pruritic — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Not sure if related or not but have had rashes/itchy bumps pop up on my body. Had very itchy large rash at injection site post vaccination so that is the only reason I am wondering if some connection

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-28
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-17
Call 1 — Left Voicemail
2021-07-27
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-01-26
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-29	Moderna
2	2021-01-26	Moderna

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 1 — day 14, dose 1

2021-01-12

Symptoms: Had sudden onset of allergic reaction at vaccine site on Day 8 and remaining through Day 11. Extremely itchy, swollen, hot, red in a 4 by 3 inch patch surrounding injection site. Treated with Benedryl and ice packs. More tender after this reaction cut off by CDC

Release 2 — days 1–6 daily, dose 2

2021-01-27

Systemic reaction (other): Heart rate over 100 for several hours

Release 3 — days 1–6 daily, dose 2

2021-01-28

Systemic reaction (other): Axillary lymph node pain

Release 8 — 3 months, dose 2

2021-04-28

Symptoms: Not sure if related or not but have had rashes/itchy bumps pop up on my body. Had very itchy large rash at injection site post vaccination so that is the only reason I am wondering if some connection

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	Feeling hot	✓	✓	✓
SD	Injection site rash	✓	✓	✓
SD	Pruritus	✓	✓	✓
SD	Rash	✓	✓	✓
SD	Rash pruritic	✓	✓	✓
SD	Swelling	✓	✓	✓
SD	Tenderness	✓	✓	✓
SRO	Heart rate increased	✓	✓	✓
SRO	Lymph node pain	✓	✓	✓

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