XZG-14046-36927 · OpenVSafe

Timeline

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

2021-01-20
Dose 1 — Moderna
2021-01-25
Registered in v-safe
2021-01-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Itching · Fatigue or tiredness

Adult check-in
2021-01-27
Survey response — 7 day, dose 1
MedDRA: Erythema, Urticaria — Feeling: Good · Site: Itching

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-05
Survey response — 14 day, dose 1
MedDRA: Erythema, Injection site erythema, Injection site infection, Office visit, Rash, Specialist consultation — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

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

1 call case(s)
2021-02-10
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-02-17
Dose 2 — Moderna
2021-02-17
Health check-in — 0 day, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-19
Survey response — days 1–6 daily, dose 2
MedDRA: Immunisation, Malaise, Rash, Swelling — Feeling: Fair · Site: Pain, 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

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-19
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

1 call case(s)
2021-02-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness, Swelling, Itching · None

Adult check-in
2021-02-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness, Swelling, Itching · None

Adult check-in
2021-02-22
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Itching · None

Adult check-in
2021-02-24
Health check-in — 7 day, dose 2
Feeling: Fair · Headache

Adult check-in
2021-03-03
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-03-10
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-03-24
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-03-31
Survey response — 42 day, dose 2
MedDRA: Headache — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-07-06
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-20	Moderna
2	2021-02-17	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-02-05	Successful	Participant prefers to complete VAERS report online
2021-02-19	Successful 2021-07-06	Participant prefers to complete VAERS report online

Free text

Release 2

Systemic reaction (other): I have a red welt on my right collar bone about 1.5 inches. Same arm as shot. Looks like a bug bite, but its not. Hopefully not related to vaccine!

Release 3

Symptoms: My arm and neck had red circles. Arpund where i got thr vaccine. I went to the dr and they said it was an infection from the vaccine needle. I went on Keflex 500mg. The infection went away

Healthcare visit (other): I went to my primary doctor at summit medical wjere i got thr vaccine

Release 4

Systemic reaction (other): Welt/rash by my collar bone same as 1st dose

Healthcare visit (other): I did not ferl well enough to go into the office

Release 6

Symptoms: Headaches but could be related to allergies

Free-text releases are not linked to a specific 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	Malaise	✓	✓	✓
HCVO	Office visit	·	·	✓
HCVO	Specialist consultation	✓	✓	○
SD	Erythema	·	·	✓
SD	Headache	✓	✓	✓
SD	Injection site erythema	·	·	✓
SD	Injection site infection	✓	✓	✓
SD	Office visit	·	·	✓
SD	Rash	✓	✓	○
SRO	Erythema	✓	✓	✓
SRO	Immunisation	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Swelling	✓	✓	✓
SRO	Urticaria	✓	✓	✓

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