5GM-19550-24016 · OpenVSafe

Timeline

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

2021-03-06
Dose 1 — Moderna
2021-03-12
Registered in v-safe
2021-03-12
Survey response — days 1–6 daily, dose 1
MedDRA: Eye pain, Office visit, Oral pain, Oropharyngeal pain, Pharyngeal ulceration, Stomatitis — Feeling: Poor · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Very painful White mouth sores in mouth and in throat, feels like in eyes too. Had to go to the doctor because it has been getting worse for 5 days now and very painful. · Healthcare visit (other): Immediate care

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-12
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-01
Survey response — day 21, dose 1
MedDRA: Mouth ulceration, Oral discomfort, Oral mucosal blistering, Stomatitis, Tongue discomfort — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: Worsening symptoms past 4 weeks. Mouth ulcers, blisters, inflammation. Feel it in my throat and sometimes my ears. On my tongue as well looks as if part of it is burnt off- can feel that in my mouth. Steroids and other topicals did not work

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-01
Report sent to call center — day 21, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-03
Survey response — day 28, dose 1
MedDRA: Dysphonia, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis, Ulcer — Feeling: Fair · Be unable to do your normal daily activities

Free text: Continuation of painful mouth sores and ulcers and feels like on and off raspy voice and my throat hurts on and off.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-07
Call 1 — Could Not Reach Participant
2021-06-07
Callback requested for
04:00PM ET
2021-06-08
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-06	Moderna

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 5 — days 1–6 daily, dose 1

2021-03-12

Systemic reaction (other): Very painful White mouth sores in mouth and in throat, feels like in eyes too. Had to go to the doctor because it has been getting worse for 5 days now and very painful.

Healthcare visit (other): Immediate care

Release 6 — day 21, dose 1

2021-04-01

Symptoms: Worsening symptoms past 4 weeks. Mouth ulcers, blisters, inflammation. Feel it in my throat and sometimes my ears. On my tongue as well looks as if part of it is burnt off- can feel that in my mouth. Steroids and other topicals did not work

Release 6 — day 28, dose 1

2021-04-03

Symptoms: Continuation of painful mouth sores and ulcers and feels like on and off raspy voice and my throat hurts on and off.

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	Dysphonia	✓	✓	✓
SD	Mouth ulceration	✓	✓	✓
SD	Oral discomfort	✓	✓	✓
SD	Oral mucosal blistering	✓	✓	✓
SD	Oral pain	✓	✓	✓
SD	Oropharyngeal pain	✓	✓	✓
SD	Stomatitis	✓	✓	✓
SD	Tongue discomfort	✓	✓	✓
SD	Ulcer	✓	✓	○
SRO	Eye pain	✓	✓	✓
SRO	Office visit	✓	✓	✓
SRO	Oral pain	✓	✓	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Pharyngeal ulceration	✓	✓	✓
SRO	Stomatitis	✓	✓	✓

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