XXB-13079-27928 · OpenVSafe

Timeline

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

2021-01-04
Registered in v-safe
2021-01-04
Dose 1 — Moderna
2021-01-04
Survey response — 0 day, dose 1
MedDRA: Pre-existing disease, Systemic lupus erythematosus — Feeling: Good · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-05
Survey response — days 1–6 daily, dose 1
MedDRA: Fatigue, Myalgia, Pain, Pre-existing disease — Feeling: Fair · Site: Pain, Swelling · Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-06
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-01-07
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-01-07
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-08
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Joint pains, Fatigue or tiredness

Adult check-in
2021-01-09
Survey response — days 1–6 daily, dose 1
MedDRA: Diarrhoea — Feeling: Fair · Site: Pain · Fatigue or tiredness, Diarrhea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-18
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-01-25
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-02-01
Dose 2 — Moderna
2021-02-01
Survey response — 0 day, dose 2
MedDRA: Dizziness — Feeling: Fair · Headache · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-02
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-02-04
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Swelling · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work

Adult check-in
2021-02-05
Survey response — days 1–6 daily, dose 2
MedDRA: Nasopharyngitis, Pre-existing disease, Systemic lupus erythematosus — Feeling: Good · Site: Pain · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Joint pains, Fatigue or tiredness, Diarrhea

Adult check-in
2021-02-07
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Fatigue or tiredness, Nausea, Vomiting, Diarrhea · Be unable to work

Adult check-in
2021-02-09
Health check-in — 7 day, dose 2
Feeling: Good · Fatigue or tiredness, Diarrhea

Adult check-in
2021-02-15
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-02-22
Survey response — 21 day, dose 2
MedDRA: Injection site movement impairment, Injection site pain — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-01
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-03-08
Survey response — 35 day, dose 2
MedDRA: Myalgia — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-15
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-05-03
Survey response — 3 month, dose 2
MedDRA: Injection site pain — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-08-02
Health check-in — 6 month, dose 2
Feeling: Good

Adult check-in
2022-02-01
Survey response — 12 month, dose 2
MedDRA: Arthralgia, Gastroenteritis viral, Influenza, Muscular weakness, Tendon disorder — Feeling: Poor · Be unable to work or attend school

MedDRA releases: 2024-11 · check-in answers available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-04	Moderna
2	2021-02-01	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-01-07	priority 2/3

Free text

Release 1

Systemic reaction (other): These are because I have SLE, not because of the vaccine.

Systemic reaction (other): Muscle and body aches could be SLE, but the fatigue was def from the injection

Systemic reaction (other): I've had diarrhea for 3-4 days but by the time I check in it's gone and I have forgotten about it

Release 3

Systemic reaction (other): A little dizzy

Systemic reaction (other): I think yesterday was due to a head cold and maybe a flare up of my Lupes SLE

Release 4

Symptoms: Sore in muscles of arm of injection site. Its actually just never gone away since my first shot. There are times I cannot raise my arm above shoulder height. Lifting is an issue also, but managed.

Release 5

Symptoms: The muscles in my arm where I got the shot are still hurting. I havent put this on some of the other check ins because I thought it was ridiculous. Now Im beginning to wonder.

Release 8

Symptoms: The spot where I received my first shot is still hurting me. I dont know if it hit a nerve or what, but the pain is real.

Release 11

Symptoms: Since my third full shot, I have been sick twice with symptoms of the flu and/or stomach virus. I have pain and weakness in my shoulder of the arm I received the shot. Feels like rotator cuff issues.

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	Arthralgia	·	·	✓
SD	Gastroenteritis viral	·	·	✓
SD	Influenza	·	·	✓
SD	Injection site movement impairment	✓	✓	✓
SD	Injection site pain	✓	✓	✓
SD	Muscular weakness	·	·	✓
SD	Myalgia	✓	✓	✓
SD	Tendon disorder	·	·	✓
SRO	Diarrhoea	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Myalgia	✓	✓	✓
SRO	Nasopharyngitis	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Systemic lupus erythematosus	✓	✓	✓
SRO	Unevaluable event	○	○	○

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