5QJ-27330-14559

1 vaccination 8 coded responses 14 check-ins 8 free-text entries 4 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 080 / NJ
Registered: 2021-01-23

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-01-22
Dose 1 — Moderna
2021-01-23
Registered in v-safe
2021-01-23
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fever · Headache

Adult check-in
2021-01-24
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Site: Pain · Fever · Headache, Diarrhea, Rash, not including the immediate area around the injection site

Free text: I habe SLE, many alto immune diseases. I have MCTD

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-25
Survey response — days 1–6 daily, dose 1
MedDRA: Fear, Mixed connective tissue disease, Pre-existing disease, Systemic lupus erythematosus — Feeling: Fair · Fever · Headache, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

Free text: Since I have MCTD , Lupus being bad, ImScared.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-26
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fever · Headache, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-01-27
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache

Adult check-in
2021-01-28
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Fatigue or tiredness

Adult check-in
2021-01-31
Health check-in — day 7, dose 1
Feeling: Fair · Fever · Headache

Adult check-in
2021-02-06
Survey response — day 14, dose 1
MedDRA: Mouth ulceration, Swollen tongue — Feeling: Poor

Free text: Ulcers in mouth swollen tounge

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-12
Survey response — day 21, dose 1
MedDRA: Lip swelling, Nasal congestion, Office visit, Oral mucosal blistering, Pre-existing disease — Feeling: Poor · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Symptoms: My whole mouth filled with blisters. Lips swelled. White sweet nasal congestion . I have lupus and many other autoimmune diseases · Healthcare visit (other): Doctor

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-12
Report sent to call center — day 21, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-19
Survey response — day 28, dose 1
MedDRA: Condition aggravated, Eye swelling, Mouth ulceration, Swelling face — Feeling: Poor · 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: Severe lupus flare. Mouth ulcers, eyes face nose swelling

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-19
Report sent to call center — day 28, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-28
Survey response — day 35, dose 1
MedDRA: Condition aggravated, Peripheral swelling, Pre-existing disease — Feeling: Fair

Free text: Fingers swelled, mouth ulcers reappeared

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Survey response — day 42, dose 1
MedDRA: Malaise, Pre-existing disease, Systemic lupus erythematosus — Feeling: Poor · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: A week after the first shot I went into the worst LUPUS flare of my life!! Im still i. It. Not getting second shot yet , The first made me so sick.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Report sent to call center — day 42, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-24
Survey response — 3 months, dose 1
MedDRA: Condition aggravated, Eye swelling, Mouth ulceration, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit, Hospitalization

Free text: Mouth ulcers worse lupus flare ever!! Face Eyes swelled, still in a severe lupus flare up

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-24
Report sent to call center — 3 months, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-16
Call successful
Participant prefers to complete VAERS report online
2021-07-23
Health check-in — 6 months, dose 1
Feeling: Poor

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-22	Moderna

Call center

4 call center cases

4 successful

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-24

Systemic reaction (other): I habe SLE, many alto immune diseases. I have MCTD

2021-01-25

Systemic reaction (other): Since I have MCTD , Lupus being bad, ImScared.

Release 3 — day 14, dose 1

2021-02-06

Symptoms: Ulcers in mouth swollen tounge

Release 4 — day 21, dose 1

2021-02-12

Symptoms: My whole mouth filled with blisters. Lips swelled. White sweet nasal congestion . I have lupus and many other autoimmune diseases

Healthcare visit (other): Doctor

Release 4 — day 28, dose 1

2021-02-19

Symptoms: Severe lupus flare. Mouth ulcers, eyes face nose swelling

Release 4 — day 35, dose 1

2021-02-28

Symptoms: Fingers swelled, mouth ulcers reappeared

Release 5 — day 42, dose 1

2021-03-05

Symptoms: A week after the first shot I went into the worst LUPUS flare of my life!! Im still i. It. Not getting second shot yet , The first made me so sick.

Release 7 — 3 months, dose 1

2021-04-24

Symptoms: Mouth ulcers worse lupus flare ever!! Face Eyes swelled, still in a severe lupus flare up

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	Eye swelling	✓	✓	✓
SD	Lip swelling	✓	✓	✓
SD	Malaise	✓	✓	✓
SD	Mouth ulceration	✓	✓	✓
SD	Nasal congestion	✓	✓	✓
SD	Oral mucosal blistering	✓	✓	✓
SD	Peripheral swelling	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Swelling face	✓	✓	✓
SD	Swollen tongue	✓	✓	✓
SD	Systemic lupus erythematosus	✓	✓	✓
SRO	Fear	✓	✓	✓
SRO	Mixed connective tissue disease	○	✓	○
SRO	Pre-existing disease	✓	✓	✓
SRO	Systemic lupus erythematosus	○	✓	○

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