6E4-12314-45623 · OpenVSafe

Timeline

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

2021-02-22
Dose 1 — Pfizer-BioNTech
2021-02-28
Registered in v-safe
2021-02-28
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Fatigue or tiredness, Diarrhea · 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: I have crohns and am having a flare. Don't believe it is related to the vaccine.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-28
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-01
Survey response — day 7, dose 1
MedDRA: Crohn's disease, Pre-existing disease — Feeling: Fair · Diarrhea · Be unable to do your normal daily activities

Free text: I have been thinking about it, and my crohns flare did start after 1st vaccine dose-not sure if it is related or a coincidence, if the flare started earlier

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-10
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-15
Dose 2 — Pfizer-BioNTech
2021-03-16
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-03-17
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Headache, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-03-18
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Fatigue or tiredness, Diarrhea · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-03-19
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness, Diarrhea

Adult check-in
2021-03-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness, Diarrhea

Adult check-in
2021-03-22
Health check-in — day 7, dose 2
Feeling: Fair · Fatigue or tiredness, Nausea, Diarrhea

Adult check-in
2021-03-29
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-04-05
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-12
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-04-21
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-06-14
Survey response — 3 months, dose 2
MedDRA: Chest pain, Crohn's disease, Electrocardiogram normal, Flank pain, Headache, Nausea, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities

Free text: Nausea, chest pains, pain in my lower right side. EKG was normal. Having a stress test this week as well as other tests. Do have some chronic health conditions. I do think the vaccine caused my crohns to flare

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-09-15
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-12-09
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-22	Pfizer-BioNTech
2	2021-03-15	Pfizer-BioNTech

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 4 — days 1–6 daily, dose 1

2021-02-28

Systemic reaction (other): I have crohns and am having a flare. Don't believe it is related to the vaccine.

Release 4 — day 7, dose 1

2021-03-01

Systemic reaction (other): I have been thinking about it, and my crohns flare did start after 1st vaccine dose-not sure if it is related or a coincidence, if the flare started earlier

Release 9 — 3 months, dose 2

2021-06-14

Symptoms: Nausea, chest pains, pain in my lower right side. EKG was normal. Having a stress test this week as well as other tests. Do have some chronic health conditions. I do think the vaccine caused my crohns to flare

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
SD	Chest pain	✓	✓	✓
SD	Crohn's disease	✓	✓	✓
SD	Electrocardiogram normal	○	✓	○
SD	Flank pain	✓	✓	✓
SD	Headache	○	✓	○
SD	Nausea	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SRO	Crohn's disease	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓

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