RGX-12067-98628 · OpenVSafe

Timeline

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

2021-02-25
Dose 1 — Pfizer-BioNTech
2021-03-18
Dose 2 — Pfizer-BioNTech
2021-03-20
Registered in v-safe
2021-03-20
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting · Be unable to do your normal daily activities

Adult check-in
2021-03-21
Survey response — days 1–6 daily, dose 2
MedDRA: Insomnia — Feeling: Fair · Fever · Headache, Fatigue or tiredness

Free text: Sleeplessness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-22
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-23
Survey response — days 1–6 daily, dose 2
MedDRA: Tongue geographic — Feeling: Good

Free text: Geographic tongue

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-24
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-25
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-03
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-08
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-15
Survey response — day 28, dose 2
MedDRA: Injection site pain — Feeling: Fair

Free text: Sore arm at injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-22
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-04-29
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-19
Survey response — 3 months, dose 2
MedDRA: Anaemia, Glossitis — Feeling: Good

Free text: Anemia, glossitis

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-09-16
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-10-17
Dose 3 — Pfizer-BioNTech
2022-03-20
Survey response — 12 months, dose 2
MedDRA: Glossitis — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Reoccurring idiopathic glossitis on right side of tongue

MedDRA releases: 2024-11 · check-in free text available
2022-03-20
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-03-22
Call successful
Participant prefers to complete VAERS report online
2022-04-23
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-25	Pfizer-BioNTech
2	2021-03-18	Pfizer-BioNTech
3	2021-10-17	Pfizer-BioNTech	No

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 6 — days 1–6 daily, dose 2

2021-03-21

Systemic reaction (other): Sleeplessness

2021-03-23

Systemic reaction (other): Geographic tongue

Release 7 — day 28, dose 2

2021-04-15

Symptoms: Sore arm at injection site

Release 9 — 3 months, dose 2

2021-06-19

Symptoms: Anemia, glossitis

Release 11 — 12 months, dose 2

2022-03-20

Symptoms: Reoccurring idiopathic glossitis on right side of tongue

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	Anaemia	✓	✓	✓
SD	Glossitis	✓	✓	✓
SD	Injection site pain	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Tongue geographic	✓	✓	✓

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