NDA-98114-06045 · OpenVSafe

Timeline

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

2021-03-19
Registered in v-safe
2021-03-19
Dose 1 — Janssen/Johnson & Johnson
2021-03-19
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-03-20
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Chills, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2021-03-21
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-22
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-23
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-02
Survey response — day 14, dose 1
MedDRA: Ageusia, Anosmia, Cough, Rhinorrhoea, Sneezing — Feeling: Poor · Be unable to work, 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: Coughing, sneezing, runny nose, lots of taste and smell

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-02
Report sent to call center — day 14, 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)
2021-04-06
Call 1 — Left Voicemail
2021-04-11
Health check-in — day 21, single dose
Feeling: Good

Adult check-in
2021-04-16
Health check-in — day 28, single dose
Feeling: Good

Adult check-in
2021-09-19
Health check-in — 6 months, dose 1
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-19	Janssen/Johnson & Johnson

Call center

1 call center case

1 unsuccessful

See the call center timeline

Free text

Release 6 — day 14, dose 1

2021-04-02

Symptoms: Coughing, sneezing, runny nose, lots of taste and smell

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	Ageusia	✓	✓	✓
SD	Anosmia	✓	✓	✓
SD	Cough	✓	✓	✓
SD	Rhinorrhoea	✓	✓	✓
SD	Sneezing	✓	✓	✓

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