LAY-20797-28386

3 vaccinations 4 coded responses 29 check-ins 4 free-text entries 2 call cases

Sex: Female
Age at first dose: 0-4
ZIP prefix: 553 / MN
Registered: 2022-06-22

Relationship: Child or adolescent in my care
Guardian: YZS-21232-78905
Race: White
Ethnicity: Not Hispanic or Latino

Timeline

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

2022-06-22
Registered in v-safe
2022-06-22
Dose 1 — Pfizer-BioNTech
2022-06-22
Health check-in — day 0, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-06-23
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-06-24
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-06-26
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-06-27
Survey response — days 1–6 daily, dose 1, under 3
MedDRA: Rash, Rash papular — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Mild rash on cheeks, 4 days post injection. 5 raised bumps, look similar to molluscum.

MedDRA releases: 2024-11 · check-in free text available
2022-06-28
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-01
Health check-in — day 7, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-06
Health check-in — day 14, dose 1, under 3
Feeling: Good

Under 3 check-in
2022-07-14
Survey response — day 21, dose 1, under 3
MedDRA: Dysphonia, Pyrexia, SARS-CoV-2 test negative — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Fever ranging from 99.5 to 102 degrees since 7/12. Other symptom is raspy voice. Fever is present as of right now. She has been unable to get her second vaccine yet, as her fever needs to subside. Tested negative for COVID 7/13. No one else is sick.

MedDRA releases: 2024-11 · check-in free text available
2022-07-14
Report sent to call center — day 21, dose 1, under 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-07-15
Call 1 — Requested Callback
2022-07-18
Dose 2 — Pfizer-BioNTech
2022-07-18
Health check-in — day 0, dose 2, under 3
Feeling: Good · Sleepiness

Under 3 check-in
2022-07-18
Callback requested for
2022-07-18
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-07-19
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · Site: Pain · Sleepiness, Irritability/crying

Under 3 check-in
2022-07-20
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-07-24
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-07-25
Health check-in — day 7, dose 2, under 3
Feeling: Good · None

Under 3 check-in
2022-08-01
Health check-in — day 14, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-08-08
Health check-in — day 21, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-08-15
Health check-in — day 28, dose 2, under 3
Feeling: Good

Under 3 check-in
2022-08-26
Survey response — day 35, dose 2, under 3
MedDRA: Pyrexia, SARS-CoV-2 test negative — Feeling: Good

Free text: Following a family vacation, Emery had a 2 day fever from 8/17 to 8/18 in the 101-102 F range. She tested negative for COVID on 2 separate days. The rest of our household came down with mild cold-like symptoms. All of us tested negative, as well.

MedDRA releases: 2024-11 · check-in free text available
2022-09-12
Dose 3 — Pfizer-BioNTech
2022-09-16
Health check-in — days 1–6 daily, dose 3, under 3
Feeling: Good · None

Under 3 check-in
2022-09-17
Health check-in — days 1–6 daily, dose 3, under 3
Feeling: Good · None

Under 3 check-in
2022-09-18
Health check-in — days 1–6 daily, dose 3, under 3
Feeling: Good · None

Under 3 check-in
2022-09-19
Health check-in — day 7, dose 3, under 3
Feeling: Good · None

Under 3 check-in
2022-09-26
Health check-in — day 14, dose 3, under 3
Feeling: Good

Under 3 check-in
2022-10-03
Health check-in — day 21, dose 3, under 3
Feeling: Good

Under 3 check-in
2022-10-11
Health check-in — day 28, dose 3, under 3
Feeling: Good

Under 3 check-in
2022-10-17
Health check-in — day 35, dose 3, under 3
Feeling: Good

Under 3 check-in
2022-10-24
Health check-in — day 42, dose 3, under 3
Feeling: Good

Under 3 check-in
2022-12-12
Survey response — 3 months, dose 3, under 3
MedDRA: Body temperature increased, Cough, Influenza virus test negative, Malaise, Office visit, SARS-CoV-2 test negative, Viral infection — Feeling: Poor · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Symptoms: She is sick with a fever of 100 degrees and cough since Wednesday (12/7). Negative for flu, covid, rsv, strep, etc. Her pediatrician believes it is a virus. I do not believe this is from the vaccine. · Healthcare visit (other): Swabbed for various sicknesses, checked by pediatrician

MedDRA releases: 2024-11 · check-in free text available
2022-12-12
Report sent to call center — 3 months, dose 3, under 3
Be unable to work or attend school · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-12-14
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2023-03-13
Health check-in — 6 months, dose 3, under 3
Feeling: Good

Under 3 check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2022-06-22	Pfizer-BioNTech	No
2	2022-07-18	Pfizer-BioNTech	No
3	2022-09-12	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2022-07-14	Successful 2022-07-18	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-12-12	Successful 2022-12-14	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Free text

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

2022-06-27

Systemic reaction (other): Mild rash on cheeks, 4 days post injection. 5 raised bumps, look similar to molluscum.

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

2022-07-14

Symptoms: Fever ranging from 99.5 to 102 degrees since 7/12. Other symptom is raspy voice. Fever is present as of right now. She has been unable to get her second vaccine yet, as her fever needs to subside. Tested negative for COVID 7/13. No one else is sick. cut off by CDC

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

2022-08-26

Symptoms: Following a family vacation, Emery had a 2 day fever from 8/17 to 8/18 in the 101-102 F range. She tested negative for COVID on 2 separate days. The rest of our household came down with mild cold-like symptoms. All of us tested negative, as well.

Release 12 (Under 3) — 3 months, dose 3, under 3

2022-12-12

Symptoms: She is sick with a fever of 100 degrees and cough since Wednesday (12/7). Negative for flu, covid, rsv, strep, etc. Her pediatrician believes it is a virus. I do not believe this is from the vaccine.

Healthcare visit (other): Swabbed for various sicknesses, checked by pediatrician

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	Body temperature increased	·	·	✓
SD	Cough	·	·	✓
SD	Dysphonia	·	·	✓
SD	Influenza virus test negative	·	·	✓
SD	Malaise	·	·	✓
SD	Pyrexia	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Viral infection	·	·	✓
SRO	Rash	·	·	✓
SRO	Rash papular	·	·	✓

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