A54-19273-72122 · OpenVSafe

Timeline

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

2022-07-22
Dose 1 — Pfizer-BioNTech
2022-07-25
Registered in v-safe
2022-07-25
Survey response — days 1–6 daily, dose 1, under 3
MedDRA: Rhinorrhoea — Feeling: Poor · Fever · Sleepiness, Irritability/crying, Loss of appetite

Free text: Runny nose

MedDRA releases: 2024-11 · check-in free text available
2022-07-26
Survey response — days 1–6 daily, dose 1, under 3
MedDRA: Respiratory tract congestion, Rhinorrhoea — Feeling: Fair

Free text: Congestion / runny nose

MedDRA releases: 2024-11 · check-in free text available
2022-07-27
Survey response — days 1–6 daily, dose 1, under 3
MedDRA: Respiratory tract congestion, Rhinorrhoea — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Congestion/runny nose

MedDRA releases: 2024-11 · check-in free text available
2022-07-27
Report sent to call center — days 1–6 daily, dose 1, under 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-07-28
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-28
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-07-29
Health check-in — day 7, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-08-05
Health check-in — day 14, dose 1, under 3
Feeling: Good

Under 3 check-in
2022-08-14
Survey response — day 21, dose 1, under 3
MedDRA: COVID-19, Cough, Pyrexia, Respiratory tract congestion — Feeling: Poor · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Covid-19 - cough, congestion, fever

MedDRA releases: 2024-11 · check-in free text available
2022-08-21
Health check-in — day 28, dose 1, under 3
Feeling: Good

Under 3 check-in
2022-08-24
Dose 2 — Pfizer-BioNTech
2022-08-25
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Fair · Fever · Sleepiness, Irritability/crying

Under 3 check-in
2022-08-26
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-27
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-28
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-29
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-31
Health check-in — day 7, dose 2, under 3
Feeling: Fair · Fever · Sleepiness, Irritability/crying, Loss of appetite · Be unable to work or attend school

Under 3 check-in
2022-09-07
Health check-in — day 14, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-09-16
Health check-in — day 21, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-09-21
Health check-in — day 28, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-09-28
Survey response — day 35, dose 2, under 3
MedDRA: Respiratory syncytial virus infection — Feeling: Poor · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: (b)(6) has RSV. Non-Covid related.

MedDRA releases: 2024-11 · check-in free text available
2022-09-28
Report sent to call center — day 35, dose 2, under 3
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Emergency room or emergency department visit · 1 call case(s)
2022-09-29
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-10-05
Health check-in — day 42, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-11-23
Health check-in — 3 months, dose 2, under 3
Feeling: Good

Under 3 check-in
2023-02-22
Health check-in — 6 months, dose 2, under 3
Feeling: Good

Under 3 check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2022-07-22	Pfizer-BioNTech	No
2	2022-08-24	Pfizer-BioNTech	No

Call center

2 call center cases

2 successful

See the call center timeline

Free text

Release 12 (Under 3) — days 1–6 daily, dose 1, under 3

2022-07-25

Systemic reaction (other): Runny nose

2022-07-26

Systemic reaction (other): Congestion / runny nose

2022-07-27

Systemic reaction (other): Congestion/runny nose

Release 12 (Under 3) — day 21, dose 1, under 3

2022-08-14

Symptoms: Covid-19 - cough, congestion, fever

Release 12 (Under 3) — day 35, dose 2, under 3

2022-09-28

Symptoms: (b)(6) has RSV. Non-Covid related.

redacted (b)(6)

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	Cough	·	·	✓
SD	COVID-19	·	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory syncytial virus infection	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SRO	Respiratory tract congestion	·	·	✓
SRO	Rhinorrhoea	·	·	✓

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