ZDE-16849-32907 · OpenVSafe

Timeline

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

2021-03-16
Registered in v-safe
2021-03-16
Dose 1 — Janssen/Johnson & Johnson
2021-03-16
Survey response — day 0, dose 1
MedDRA: Pre-existing disease — Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

Free text: These symptoms are always present r/t lupus and multiple other medical Dx, I've been on immunosuppressants for over 10 yrs

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-17
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea

Free text: These symptoms are r/t medical issues have no changes from vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-18
Survey response — days 1–6 daily, dose 1
MedDRA: Condition aggravated, Pre-existing disease, Pyrexia — Feeling: Poor · Fever · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Free text: The fever and all other symptoms are r/t multiple medical Dx not vaccine. I HAVE NOT HAD ANY SYMPTOMS THAT ARE NEW OR R/T VACCINE

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-20
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Free text: Symptoms for medical dx not injection no symptoms that are new

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-21
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Poor · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Free text: Ã‘o

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-25
Survey response — day 7, dose 1
MedDRA: Autoimmune disorder, Pyrexia — Feeling: Poor · Fever · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting · 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: Fever and other symptoms r/t autoimmune diseases not shot

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-25
Report sent to call center — day 7, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-30
Health check-in — day 14, dose 1
Feeling: Fair

Adult check-in
2021-04-07
Health check-in — day 21, single dose
Feeling: Fair

Adult check-in
2021-04-14
Health check-in — day 28, single dose
Feeling: Fair

Adult check-in
2021-04-20
Health check-in — day 35, single dose
Feeling: Poor

Adult check-in
2021-04-27
Health check-in — day 42, single dose
Feeling: Fair

Adult check-in
2021-05-21
Call 1 — Left Voicemail
2021-06-15
Health check-in — 3 months, dose 1
Feeling: Fair

Adult check-in
2021-09-14
Health check-in — 6 months, dose 1
Feeling: Fair

Adult check-in
2021-10-29
Dose 2 — Moderna
2021-10-31
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting · Be unable to do your normal daily activities

Adult check-in
2021-11-02
Survey response — days 1–6 daily, dose 2
MedDRA: Pre-existing disease — Feeling: Fair · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting

Free text: I have autoimmune diseases so these symptoms are constant

MedDRA releases: 2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-16	Janssen/Johnson & Johnson
2	2021-10-29	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-03-25	Unsuccessful

Free text

Release 5 — day 0, dose 1

2021-03-16

Systemic reaction (other): These symptoms are always present r/t lupus and multiple other medical Dx, I've been on immunosuppressants for over 10 yrs

Release 5 — days 1–6 daily, dose 1

2021-03-17

Systemic reaction (other): These symptoms are r/t medical issues have no changes from vaccine

2021-03-18

Systemic reaction (other): The fever and all other symptoms are r/t multiple medical Dx not vaccine. I HAVE NOT HAD ANY SYMPTOMS THAT ARE NEW OR R/T VACCINE

Release 6 — days 1–6 daily, dose 1

2021-03-20

Systemic reaction (other): Symptoms for medical dx not injection no symptoms that are new

2021-03-21

Systemic reaction (other): Ã‘o

Release 6 — day 7, dose 1

2021-03-25

Systemic reaction (other): Fever and other symptoms r/t autoimmune diseases not shot

Release 10 — days 1–6 daily, dose 2

2021-11-02

Systemic reaction (other): I have autoimmune diseases so these symptoms are constant

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
SRO	Autoimmune disorder	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Pyrexia	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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