XZM-24436-65539 · OpenVSafe

Timeline

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

2021-03-19
Dose 1 — Pfizer-BioNTech
2021-04-09
Dose 2 — Pfizer-BioNTech
2021-04-12
Registered in v-safe
2021-04-12
Survey response — days 1–6 daily, dose 2
MedDRA: Aphthous ulcer — Feeling: Fair · Joint pains

Free text: Sudden influx of canker sores on soft body tissues

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-13
Survey response — days 1–6 daily, dose 2
MedDRA: Aphthous ulcer — Feeling: Fair · Joint pains · Be unable to do your normal daily activities

Free text: Canker sores (mouth), vulvar sores

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-14
Survey response — days 1–6 daily, dose 2
MedDRA: Aphthous ulcer, Vulval ulceration — Feeling: Fair · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Canker sores (mouth), vulvar sores (worse than previous day)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-15
Survey response — days 1–6 daily, dose 2
MedDRA: Aphthous ulcer, Vulval ulceration — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Canker sores, Vulvar sores

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-15
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-16
Survey response — day 7, dose 2
MedDRA: Stomatitis, Vulval disorder — Feeling: Fair · Be unable to do your normal daily activities

Free text: Mouth sores, vulvar sores

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-25
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-05-07
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-23
Survey response — day 42, dose 2
MedDRA: Genital ulceration, Mouth ulceration, Pre-existing disease — Feeling: Fair

Free text: I had an outbreak of several ulcers in my mouth (occasional but typical for me) but it was accompanied by a genital ulcer as well (these did not appear for me at random prior to the vaccine). One ulcer appeared this time instead of 8-12.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-10-10
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-04-01
Call 1 — Left Voicemail
2022-04-13
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-19	Pfizer-BioNTech
2	2021-04-09	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-04-15	Unsuccessful

Free text

Release 7 — days 1–6 daily, dose 2

2021-04-12

Systemic reaction (other): Sudden influx of canker sores on soft body tissues

2021-04-13

Systemic reaction (other): Canker sores (mouth), vulvar sores

2021-04-14

Systemic reaction (other): Canker sores (mouth), vulvar sores (worse than previous day)

2021-04-15

Systemic reaction (other): Canker sores, Vulvar sores

Release 7 — day 7, dose 2

2021-04-16

Systemic reaction (other): Mouth sores, vulvar sores

Release 8 — day 42, dose 2

2021-05-23

Symptoms: I had an outbreak of several ulcers in my mouth (occasional but typical for me) but it was accompanied by a genital ulcer as well (these did not appear for me at random prior to the vaccine). One ulcer appeared this time instead of 8-12.

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	Genital ulceration	✓	✓	✓
SD	Mouth ulceration	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SRO	Aphthous ulcer	✓	✓	✓
SRO	Stomatitis	✓	✓	✓
SRO	Vulval disorder	✓	✓	✓
SRO	Vulval ulceration	✓	✓	✓

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