YNV-76679-49596 · OpenVSafe

Timeline

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

2021-04-07
Dose 1 — Pfizer-BioNTech
2021-05-02
Registered in v-safe
2021-05-02
Survey response — day 21, dose 1
MedDRA: Headache, Lip swelling, Mydriasis, Oral discomfort — Feeling: Fair · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: I had burning swelling of my bottom lip. I have slight headache, my right eyes is slightly dilated.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-02
Report sent to call center — day 21, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-05
Dose 2 — Pfizer-BioNTech
2021-05-06
Survey response — days 1–6 daily, dose 2
MedDRA: Lip swelling, Oral discomfort — Feeling: Good · Headache

Free text: I had burning lips inside with a little swelling. Was better Before I received 2 before shot.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-05-10
Survey response — days 1–6 daily, dose 2
MedDRA: Lip swelling, Oral discomfort — Feeling: Good

Free text: I have had lip swelling and burning lips with both shots. Not comfortable

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-11
Survey response — days 1–6 daily, dose 2
MedDRA: Burning sensation, Emergency care, Oral herpes — Feeling: Good

Free text: I have slightly burning and cold sores flaring up again after my second shot. I also have a weird thing going on with my pupil. I had to go to emergency room to make sure I wasnt having a stroke. They found nothing but my pupil keeps dilating then not. No pain not vision issues. I wish I had not had any shots!!!!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-12
Survey response — day 7, dose 2
MedDRA: Aphthous ulcer, Lip swelling, Oral discomfort — Feeling: Fair

Free text: The inside of my bottom lips are swollen and slight burning plus canker sores

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2022-01-04
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-07	Pfizer-BioNTech
2	2021-05-05	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-05-02	Unsuccessful

Free text

Release 8 — day 21, dose 1

2021-05-02

Symptoms: I had burning swelling of my bottom lip. I have slight headache, my right eyes is slightly dilated.

Release 8 — days 1–6 daily, dose 2

2021-05-06

Systemic reaction (other): I had burning lips inside with a little swelling. Was better Before I received 2 before shot.

2021-05-10

Systemic reaction (other): I have had lip swelling and burning lips with both shots. Not comfortable

2021-05-11

Systemic reaction (other): I have slightly burning and cold sores flaring up again after my second shot. I also have a weird thing going on with my pupil. I had to go to emergency room to make sure I wasnt having a stroke. They found nothing but my pupil keeps dilating then not. No pain not vision issues. I wish I had not had any shots!!!!

Release 8 — day 7, dose 2

2021-05-12

Systemic reaction (other): The inside of my bottom lips are swollen and slight burning plus canker sores

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	Headache	✓	✓	✓
SD	Lip swelling	✓	✓	✓
SD	Mydriasis	✓	✓	✓
SD	Oral discomfort	✓	✓	✓
SRO	Aphthous ulcer	✓	✓	✓
SRO	Burning sensation	✓	✓	✓
SRO	Emergency care	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Oral discomfort	✓	✓	✓
SRO	Oral herpes	✓	✓	✓

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