3KE-21206-89851 · OpenVSafe

Timeline

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

2021-01-14
Registered in v-safe
2021-01-14
Dose 1 — Pfizer-BioNTech
2021-01-14
Health check-in — day 0, dose 1
Feeling: Good · None

Adult check-in
2021-01-15
Survey response — days 1–6 daily, dose 1
MedDRA: Limb discomfort — Feeling: Good · Muscle or body aches

Free text: My arm was a little sore where I had the injection, but it was not painful. ful

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-16
Survey response — days 1–6 daily, dose 1
MedDRA: Injection site pain — Feeling: Good · Muscle or body aches

Free text: Small bit of soreness on my upper arm where I got the injection - similar to getting a flu shot.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-21
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-01-28
Survey response — day 14, dose 1
MedDRA: Anaemia — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Anemia

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-28
Report sent to call center — day 14, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-04
Dose 2 — Pfizer-BioNTech
2021-02-04
Survey response — day 0, dose 2
MedDRA: Injection site discomfort — Feeling: Good

Free text: Arm a little sore where injected, not painful

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-05
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness

Adult check-in
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-02-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-09
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · None

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

Adult check-in
2021-02-18
Survey response — day 14, dose 2
MedDRA: Fatigue, Nausea, Somnolence, Urinary tract infection — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: UTI - antibiotic, bactrim, had side effects of sleepiness, nausea, fatigue. No fever.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-18
Report sent to call center — day 14, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-25
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-04
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-11
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-18
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-27
Call 1 — Could Not Reach Participant
2021-05-06
Survey response — 3 months, dose 2
MedDRA: Ear discomfort, Tenderness — Feeling: Fair · Be unable to do your normal daily activities

Free text: I have done something to my back. When I move it makes a popping sound and is tender.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-08-05
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-08-18
Dose 3 — Pfizer-BioNTech
2021-10-01
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-11-17
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-02-16
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in
2022-08-18
Health check-in — 12 months, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-14	Pfizer-BioNTech
2	2021-02-04	Pfizer-BioNTech
3	2021-08-18	Pfizer-BioNTech	No

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-15

Systemic reaction (other): My arm was a little sore where I had the injection, but it was not painful. ful

2021-01-16

Systemic reaction (other): Small bit of soreness on my upper arm where I got the injection - similar to getting a flu shot.

Release 2 — day 14, dose 1

2021-01-28

Symptoms: Anemia

Release 3 — day 0, dose 2

2021-02-04

Systemic reaction (other): Arm a little sore where injected, not painful

Release 4 — day 14, dose 2

2021-02-18

Symptoms: UTI - antibiotic, bactrim, had side effects of sleepiness, nausea, fatigue. No fever.

Release 8 — 3 months, dose 2

2021-05-06

Symptoms: I have done something to my back. When I move it makes a popping sound and is tender.

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	Anaemia	✓	✓	✓
SD	Ear discomfort	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Nausea	✓	✓	✓
SD	Somnolence	✓	✓	✓
SD	Tenderness	✓	✓	✓
SD	Urinary tract infection	✓	✓	✓
SRO	Injection site discomfort	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Limb discomfort	✓	✓	✓

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