XX3-17415-59114 · OpenVSafe

Timeline

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

2021-01-05
Dose 1 — Moderna
2021-01-07
Registered in v-safe
2021-01-07
Survey response — days 1–6 daily, dose 1
MedDRA: Injection site pain, Nausea — Feeling: Good · Site: Pain · Nausea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-08
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-09
Survey response — days 1–6 daily, dose 1
MedDRA: Exposure to SARS-CoV-2 — Feeling: Good · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-10
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-01-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-12
Health check-in — 7 day, dose 1
Feeling: Good · None

Adult check-in
2021-01-19
Survey response — 14 day, dose 1
MedDRA: Fatigue, Myalgia, SARS-CoV-2 test negative — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-26
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-02-02
Dose 2 — Moderna
2021-02-09
Survey response — 7 day, dose 2
MedDRA: Arthralgia, Chills, Fatigue, Myalgia, Pain — Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-16
Survey response — 14 day, dose 2
MedDRA: Fatigue, Feeling abnormal — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-23
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-03-02
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-03-09
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-03-16
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-05-04
Health check-in — 3 month, dose 2
Feeling: Good

Adult check-in
2021-08-05
Health check-in — 6 month, dose 2
Feeling: Fair

Adult check-in
2022-02-02
Survey response — 12 month, dose 2
MedDRA: Influenza, Office visit, SARS-CoV-2 test negative — 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 · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2022-02-02
Report sent to call center — 12 month, 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

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-02-07
Call 1 — Could Not Reach Participant
2022-02-10
Call 2 — Could Not Reach Participant
2022-02-10
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-05	Moderna
2	2021-02-02	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2022-02-02	Successful 2022-02-10	Participant prefers to complete VAERS report online

Free text

Release 1

Systemic reaction (other): The evening & next day after receiving shot, the injection site pain was 7of 10, first night experienced nausea

Systemic reaction (other): My office mates husband tested positive today

Release 2

Symptoms: Moderate to Severe fatigue/ muscle aches. Was cv19 tested 1/15/2021-negative. Today fss as youve is mild .

Release 3

Systemic reaction (other): Severe pain, chills, muscle & joint ache fatigue all of Feb 3 and 4

Release 4

Symptoms: Ongoing /relentless fatigue / just dont feel like myself since the second injection 2/3/2021

Release 11

Symptoms: I was dx with the flu at Christmas although vaccinated in Aug 2021. Two negative Covid tests at urgent care in Dec 2022. I have not had COVID that I am aware of. I have been boosted with moderna at Sam's club in wake forest in November 2021

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
SD	Fatigue	✓	✓	✓
SD	Feeling abnormal	✓	✓	✓
SD	Influenza	·	·	✓
SD	Myalgia	✓	✓	✓
SD	Office visit	·	·	✓
SD	SARS-CoV-2 test negative	✓	✓	✓
SRO	Arthralgia	✓	✓	✓
SRO	Chills	✓	✓	✓
SRO	Exposure to SARS-CoV-2	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Myalgia	✓	✓	✓
SRO	Nausea	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Unevaluable event	○	○	○

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