68B-89086-04482 · OpenVSafe

Timeline

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

2021-03-03
Dose 1 — Moderna
2021-03-26
Registered in v-safe
2021-03-26
Survey response — day 21, dose 1
MedDRA: Pre-existing disease, Systemic lupus erythematosus — Feeling: Good

Free text: I had a flare up of lupus with normal adverse symptoms as well as new adverse reactions.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-31
Dose 2 — Moderna
2021-04-02
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2021-04-03
Survey response — days 1–6 daily, dose 2
MedDRA: Chapped lips, Lip pain, Lip swelling — Feeling: Good · Site: Itching

Free text: My lips swelled up after 1st shot and are still very sore and chapped.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-04
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Itching · None

Adult check-in
2021-04-05
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-06
Survey response — days 1–6 daily, dose 2
MedDRA: Stomatitis — Feeling: Good

Free text: Mouth sores

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-02
Survey response — 3 months, dose 2
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Good · Be unable to do your normal daily activities

Free text: Lupus flare up with new outbreak symptoms

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-09-29
Survey response — 6 months, dose 2
MedDRA: Office visit, Pre-existing disease, Systemic lupus erythematosus — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: Repeated lupus flares with symptoms me since receiving the COVID vaccines. · Healthcare visit (other): PCP, dermatology, immunologist, and rheumatologist appointments.

MedDRA releases: 2024-11 · check-in free text available
2021-09-29
Report sent to call center — 6 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-12-03
Call 1 — Left Voicemail
2022-03-31
Survey response — 12 months, dose 2
MedDRA: Office visit, Pre-existing disease, Systemic lupus erythematosus — Feeling: Good · 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: Symptoms: Heightened lupus flare symptoms of long duration. · Healthcare visit (other): Office visits with PCP, dermatologist, immunologist, rheumatologist, and functional medicine doctors.

MedDRA releases: 2024-11 · check-in free text available
2022-03-31
Report sent to call center — 12 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-04-04
Call 1 — Could Not Reach Participant
2022-04-07
Call 2 — Could Not Reach Participant

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-03	Moderna
2	2021-03-31	Moderna

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 6 — day 21, dose 1

2021-03-26

Symptoms: I had a flare up of lupus with normal adverse symptoms as well as new adverse reactions.

Release 6 — days 1–6 daily, dose 2

2021-04-03

Systemic reaction (other): My lips swelled up after 1st shot and are still very sore and chapped.

Release 7 — days 1–6 daily, dose 2

2021-04-06

Systemic reaction (other): Mouth sores

Release 9 — 3 months, dose 2

2021-07-02

Symptoms: Lupus flare up with new outbreak symptoms

Release 9 — 6 months, dose 2

2021-09-29

Symptoms: Repeated lupus flares with symptoms me since receiving the COVID vaccines.

Healthcare visit (other): PCP, dermatology, immunologist, and rheumatologist appointments.

Release 11 — 12 months, dose 2

2022-03-31

Symptoms: Heightened lupus flare symptoms of long duration.

Healthcare visit (other): Office visits with PCP, dermatologist, immunologist, rheumatologist, and functional medicine doctors.

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	Office visit	·	·	✓
SD	Condition aggravated	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Systemic lupus erythematosus	✓	✓	✓
SRO	Chapped lips	✓	✓	✓
SRO	Lip pain	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Stomatitis	✓	✓	✓

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