4AF-22692-43738 · OpenVSafe

Timeline

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

2021-01-20
Dose 1 — Moderna
2021-01-24
Registered in v-safe
2021-01-24
Survey response — days 1–6 daily, dose 1
MedDRA: Office visit, SARS-CoV-2 test negative — Feeling: Fair · Site: Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Allergist examination and tested negative for COVID-19 at urgent care

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-24
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-25
Survey response — days 1–6 daily, dose 1
MedDRA: Urticaria — Feeling: Fair · Site: Redness, Swelling, Itching · Rash, not including the immediate area around the injection site · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Hives all over body (none local) spread entire body today. Went to (b)(6) and got Dexamethasone steroid intramuscular shot in the left gluteus maximus

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-25
Report sent to call center — days 1–6 daily, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-26
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Redness, Swelling, Itching · None · Be unable to do your normal daily activities

Adult check-in
2021-01-27
Survey response — day 7, dose 1
MedDRA: Emergency care, Medical observation, Rash — Feeling: Poor · Site: Redness, Swelling, Itching · Rash, not including the immediate area around the injection site · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit, Hospitalization

Free text: Systemic reaction (other): Severe rash all over body since Saturday. Extreme this morning had to go to ER · Healthcare visit (other): (b)(6)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-27
Report sent to call center — day 7, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-05
Survey response — day 14, dose 1
MedDRA: Emergency care, Inflammation, Office visit, Pyrexia, Urticaria — Feeling: Good · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit, Hospitalization

Free text: Delayed reaction within 48 hours of first dose. Breakout in hives all over body. Entire body was inflammed. Low grade fever. Hives lasted for days. Went to Urgent care, then R, then (b)(6) Hospital for treatment.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-05
Report sent to call center — day 14, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-12
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-17
Health check-in — day 28, dose 1
Feeling: Good

Adult check-in
2021-06-03
Call 1 — Could Not Reach Participant
2021-06-08
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-20	Moderna

Call center

4 call center cases

4 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-24

Healthcare visit (other): Allergist examination and tested negative for COVID-19 at urgent care

2021-01-25

Systemic reaction (other): Hives all over body (none local) spread entire body today. Went to (b)(6) and got Dexamethasone steroid intramuscular shot in the left gluteus maximus

redacted (b)(6)

Release 2 — day 7, dose 1

2021-01-27

Systemic reaction (other): Severe rash all over body since Saturday. Extreme this morning had to go to ER

Healthcare visit (other): (b)(6)

redacted (b)(6)

Release 3 — day 14, dose 1

2021-02-05

Symptoms: Delayed reaction within 48 hours of first dose. Breakout in hives all over body. Entire body was inflammed. Low grade fever. Hives lasted for days. Went to Urgent care, then R, then (b)(6) Hospital for treatment.

redacted (b)(6)

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
HCVO	Medical observation	✓	✓	✓
HCVO	Office visit	✓	✓	✓
HCVO	SARS-CoV-2 test negative	✓	✓	✓
SD	Emergency care	✓	✓	✓
SD	Inflammation	✓	✓	✓
SD	Office visit	✓	✓	✓
SD	Pyrexia	✓	✓	✓
SD	Urticaria	✓	✓	✓
SRO	Emergency care	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Urticaria	✓	✓	✓

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