EZD-11032-75767 · OpenVSafe

Timeline

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

2021-01-20
Dose 1 — Pfizer-BioNTech
2021-01-22
Registered in v-safe
2021-01-22
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-01-23
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Abdominal pain

Adult check-in
2021-01-24
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache

Adult check-in
2021-01-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-26
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-27
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-02-03
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-08
Dose 2 — Pfizer-BioNTech
2021-02-09
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Chills, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-02-10
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-11
Survey response — days 1–6 daily, dose 2
MedDRA: Chest discomfort — Feeling: Fair · Headache, Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: Chest tightness (may be environmental)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-12
Survey response — days 1–6 daily, dose 2
MedDRA: Chest discomfort — Feeling: Fair · Headache

Free text: Chest tightness (may be environmental)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-13
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Headache, Rash, not including the immediate area around the injection site

Adult check-in
2021-02-15
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-02-22
Survey response — day 14, dose 2
MedDRA: Head discomfort, Headache, Sinusitis — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Pain and pressure on right side of head may be sinus infection.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-22
Report sent to call center — day 14, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-01
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-08
Survey response — day 28, dose 2
MedDRA: Ear discomfort, Fatigue, Heart rate decreased, Ocular discomfort, Oral discomfort — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: I have had increasing fatigue in addition to persistent eye/ear pressure and sensation of burning in my mouth. I was prescribed prednisone which resulted in weakness and slow heart rate.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-08
Report sent to call center — day 28, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-15
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-22
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-10
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-08-02
Call 1 — Left Voicemail
2021-08-11
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-10-27
Dose 3 — Pfizer-BioNTech
2022-09-22
Dose 4 — Pfizer-BioNTech
Co-administered: Flu
2022-10-21
Survey response — day 28, dose 4
MedDRA: Pregnancy — Feeling: Good

Free text: Pregnancy

MedDRA releases: 2024-11 · check-in free text available
2022-10-27
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-11-05
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-12-22
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2023-03-23
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-20	Pfizer-BioNTech
2	2021-02-08	Pfizer-BioNTech
3	2021-10-27	Pfizer-BioNTech	No
4	2022-09-22	Pfizer-BioNTech	Flu

Call center

2 call center cases

2 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 4 — days 1–6 daily, dose 2

2021-02-11

Systemic reaction (other): Chest tightness (may be environmental)

2021-02-12

Systemic reaction (other): Chest tightness (may be environmental)

Release 4 — day 14, dose 2

2021-02-22

Symptoms: Pain and pressure on right side of head may be sinus infection.

Release 5 — day 28, dose 2

2021-03-08

Symptoms: I have had increasing fatigue in addition to persistent eye/ear pressure and sensation of burning in my mouth. I was prescribed prednisone which resulted in weakness and slow heart rate.

Release 12 — day 28, dose 4

2022-10-21

Symptoms: Pregnancy

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	Ear discomfort	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Head discomfort	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Heart rate decreased	✓	✓	✓
SD	Ocular discomfort	✓	✓	✓
SD	Oral discomfort	✓	✓	✓
SD	Pregnancy	·	·	✓
SD	Sinusitis	✓	✓	✓
SRO	Chest discomfort	✓	✓	✓

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