ZRA-44654-14092 · OpenVSafe

Timeline

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

2022-07-05
Dose 1 — Pfizer-BioNTech
2022-07-08
Registered in v-safe
2022-07-08
Survey response — days 1–6 daily, dose 1, under 3
MedDRA: Fatigue, Irritability — Feeling: Fair · Sleepiness, Irritability/crying

Free text: Tired, clingy and a bit cranky but not much more than usual.

MedDRA releases: 2024-11 · check-in free text available
2022-07-09
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-10
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Poor · Fever · Sleepiness, Irritability/crying

Under 3 check-in
2022-07-11
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Poor · Fever · Sleepiness, Irritability/crying

Under 3 check-in
2022-07-12
Survey response — day 7, dose 1, under 3
MedDRA: Office visit, SARS-CoV-2 test, Unevaluable event, Urine analysis — Feeling: Poor · Fever · Sleepiness, Irritability/crying · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Systemic reaction (other): Waiting on test results from urine. No ear infection. No throat issue. No congestion or coughing. · Healthcare visit (other): Saw her pediatrician. Running urine test and Covid test. Waiting 24-36 hours per Dr instruction before doing bloodwork

MedDRA releases: 2024-11 · check-in free text available
2022-07-12
Report sent to call center — day 7, dose 1, under 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-07-13
Call 1 — Left Voicemail
2022-07-13
Call successful
Does not wish to fill out VAERS report
2022-07-19
Health check-in — day 14, dose 1, under 3
Feeling: Good

Under 3 check-in
2022-07-26
Health check-in — day 21, dose 1, under 3
Feeling: Fair

Under 3 check-in
2022-08-02
Health check-in — day 28, dose 1, under 3
Feeling: Good

Under 3 check-in
2022-08-09
Health check-in — day 35, dose 1, under 3
Feeling: Good

Under 3 check-in
2022-08-12
Dose 2 — Pfizer-BioNTech
2022-08-16
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-17
Survey response — days 1–6 daily, dose 2, under 3
MedDRA: Irritability, Sleep disorder — Feeling: Good

Free text: Since Friday after the shot she stopped taking naps and has been very irritable if we try to put her to bed. Otherwise she is very happy. Could just be 14 month sleep regression and separation anxiety.

MedDRA releases: 2024-11 · check-in free text available
2022-08-18
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-19
Health check-in — day 7, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-26
Health check-in — day 14, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-09-02
Health check-in — day 21, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-09-09
Survey response — day 28, dose 2, under 3
MedDRA: Respiratory tract congestion, Rhinorrhoea — Feeling: Fair · Be unable to do your normal daily activities

Free text: Stuffed up and runny nose since Tuesday morning. Likely bug picked up at indoor play space Saturday. Dad has scratchy throat. Mom has both throat and sinus issues.

MedDRA releases: 2024-11 · check-in free text available
2022-09-16
Health check-in — day 35, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-09-24
Health check-in — day 42, dose 2, under 3
Feeling: Good

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

Under 3 check-in
2023-02-10
Survey response — 6 months, dose 2, under 3
MedDRA: Pyrexia, Self-medication — Feeling: Good

MedDRA releases: 2024-11

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2022-07-05	Pfizer-BioNTech	No
2	2022-08-12	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2022-07-12	Successful 2022-07-13	Does not wish to fill out VAERS report

Free text

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

2022-07-08

Systemic reaction (other): Tired, clingy and a bit cranky but not much more than usual.

Release 12 (Under 3) — day 7, dose 1, under 3

2022-07-12

Systemic reaction (other): Waiting on test results from urine. No ear infection. No throat issue. No congestion or coughing.

Healthcare visit (other): Saw her pediatrician. Running urine test and Covid test. Waiting 24-36 hours per Dr instruction before doing bloodwork

Release 12 (Under 3) — days 1–6 daily, dose 2, under 3

2022-08-17

Systemic reaction (other): Since Friday after the shot she stopped taking naps and has been very irritable if we try to put her to bed. Otherwise she is very happy. Could just be 14 month sleep regression and separation anxiety.

Release 12 (Under 3) — day 28, dose 2, under 3

2022-09-09

Symptoms: Stuffed up and runny nose since Tuesday morning. Likely bug picked up at indoor play space Saturday. Dad has scratchy throat. Mom has both throat and sinus issues.

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	·	·	✓
HCVO	SARS-CoV-2 test	·	·	✓
HCVO	Urine analysis	·	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Self-medication	·	·	✓
SRO	Fatigue	·	·	✓
SRO	Irritability	·	·	✓
SRO	Sleep disorder	·	·	✓
SRO	Unevaluable event	·	·	✓

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