PUA-71663-56690

3 vaccinations 5 coded responses 38 check-ins 5 free-text entries 3 call cases

Sex: Female
Age at first dose: 31-35
ZIP prefix: 200 / DC
Registered: 2021-01-29

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Registered dependents

EUX-28043-62480 Child or adolescent in my care · Male · 2023-01-14

Timeline

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

2021-01-29
Registered in v-safe
2021-01-29
Dose 1 — Pfizer-BioNTech
2021-01-29
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-01-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Swelling · Fever · Fatigue or tiredness

Adult check-in
2021-01-31
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-02-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Itching · None

Adult check-in
2021-02-02
Survey response — days 1–6 daily, dose 1
MedDRA: Tinnitus — Feeling: Good

Free text: Ringing in my ears that comes and goes

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-03
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-02-04
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache

Adult check-in
2021-02-05
Health check-in — day 7, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-02-12
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-17
Dose 2 — Pfizer-BioNTech
2021-02-18
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Chills, Fatigue or tiredness

Adult check-in
2021-02-19
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-22
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-23
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Headache

Adult check-in
2021-02-24
Health check-in — day 7, dose 2
Feeling: Good · Fever · Headache, Fatigue or tiredness

Adult check-in
2021-03-03
Survey response — day 14, dose 2
MedDRA: Tinnitus — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Ringing in my left ear since 48 hours after first dose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-03
Report sent to call center — day 14, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-10
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-17
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-24
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-31
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-19
Health check-in — 3 months, dose 2
Feeling: Fair

Adult check-in
2021-08-18
Survey response — 6 months, dose 2
MedDRA: Abortion spontaneous, Tinnitus — Feeling: Good · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: I got pregnant and had a miscarriage at 11 weeks. I still have tinnitus which began 2 days after my first dose.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-18
Report sent to call center — 6 months, dose 2
Be unable to work or attend school · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-19
Call 2 — Left Voicemail
2021-12-22
Dose 3 — Pfizer-BioNTech
2021-12-23
Survey response — days 1–6 daily, dose 3
MedDRA: Tinnitus — Feeling: Good · Site: Pain, Swelling, Itching · Headache, Fatigue or tiredness

Free text: Ringing in my left ear

MedDRA releases: 2024-11 · check-in free text available
2021-12-24
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain, Redness, Swelling, Itching · Headache

Adult check-in
2021-12-25
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Redness, Swelling · None

Adult check-in
2021-12-26
Health check-in — days 1–6 daily, dose 3
Feeling: Good · None

Adult check-in
2021-12-27
Health check-in — days 1–6 daily, dose 3
Feeling: Good · None

Adult check-in
2021-12-28
Health check-in — days 1–6 daily, dose 3
Feeling: Good · None

Adult check-in
2021-12-29
Health check-in — day 7, dose 3
Feeling: Good · Headache

Adult check-in
2022-01-06
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2022-01-12
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2022-01-19
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2022-01-26
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2022-02-02
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-03-23
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-06-22
Survey response — 6 months, dose 3
MedDRA: Gestational diabetes — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Gestational diabetes

MedDRA releases: 2024-11 · check-in free text available
2022-06-22
Report sent to call center — 6 months, dose 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-06-23
Call 1 — Left Voicemail
2022-06-23
Call 1 — Left Voicemail
2022-06-23
Call 1 — Left Voicemail
2022-12-22
Health check-in — 12 months, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-29	Pfizer-BioNTech
2	2021-02-17	Pfizer-BioNTech
3	2021-12-22	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-03-03	Unsuccessful
2021-08-18	Unsuccessful
2022-06-22	Unsuccessful

Free text

Release 3 — days 1–6 daily, dose 1

2021-02-02

Systemic reaction (other): Ringing in my ears that comes and goes

Release 5 — day 14, dose 2

2021-03-03

Symptoms: Ringing in my left ear since 48 hours after first dose

Release 9 — 6 months, dose 2

2021-08-18

Symptoms: I got pregnant and had a miscarriage at 11 weeks. I still have tinnitus which began 2 days after my first dose.

Release 10 — days 1–6 daily, dose 3

2021-12-23

Systemic reaction (other): Ringing in my left ear

Release 12 — 6 months, dose 3

2022-06-22

Symptoms: Gestational diabetes

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	Abortion spontaneous	✓	·	✓
SD	Gestational diabetes	·	·	✓
SD	Tinnitus	✓	✓	✓
SRO	Tinnitus	✓	✓	✓

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