SXR-25776-02267 · OpenVSafe

Timeline

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

2020-12-19
Registered in v-safe
2020-12-19
Dose 1 — Pfizer-BioNTech
2020-12-19
Health check-in — day 0, dose 1
Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness

Adult check-in
2020-12-20
Survey response — days 1–6 daily, dose 1
MedDRA: Abdominal discomfort, Fatigue, Injection site pain — Feeling: Good · Site: Pain

Free text: Pain at site moderate to severe at about 10 hrs post injection. Also felt more fatigued and some GI upset around the same time

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-21
Survey response — days 1–6 daily, dose 1
MedDRA: Fatigue, Headache, Injection site pain, Sleep deficit — Feeling: Good · Headache, Fatigue or tiredness

Free text: Soreness at injection site. Headache/fatigue from sleep deprivation

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-22
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-26
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-01-02
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-09
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-01-12
Dose 2 — Pfizer-BioNTech
2021-01-12
Health check-in — day 0, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-13
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-01-13
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities

1 call case(s)
2021-01-14
Survey response — days 1–6 daily, dose 2
MedDRA: Adverse reaction — Feeling: Good · Site: Pain · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Felt in the last 24 hours since my last check in but greatly improved this morning

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-14
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities

1 call case(s)
2021-01-15
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-16
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Muscle or body aches

Adult check-in
2021-01-17
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-18
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-19
Survey response — day 7, dose 2
MedDRA: Adverse reaction — Feeling: Good · Headache · Be unable to do your normal daily activities

Free text: Possibly from sleep deprivation/sleep position

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-26
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-02
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-02
Call successful
Participant prefers to complete VAERS report online
2021-02-09
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-02-16
Survey response — day 35, dose 2
MedDRA: Postpartum disorder, Pre-eclampsia — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Hospitalization

Free text: Preeclampsia and currently postpartum

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-16
Report sent to call center — day 35, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-23
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-03-08
Call 1 — Left Voicemail
2021-04-13
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-13
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-01-14
Health check-in — 12 months, dose 2
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-19	Pfizer-BioNTech
2	2021-01-12	Pfizer-BioNTech

Call center

3 call center cases

2 successful · 1 unsuccessful

VAERS report filed, before or during a call: 2

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2020-12-20

Systemic reaction (other): Pain at site moderate to severe at about 10 hrs post injection. Also felt more fatigued and some GI upset around the same time

2020-12-21

Systemic reaction (other): Soreness at injection site. Headache/fatigue from sleep deprivation

Release 2 — days 1–6 daily, dose 2

2021-01-14

Systemic reaction (other): Felt in the last 24 hours since my last check in but greatly improved this morning

Release 2 — day 7, dose 2

2021-01-19

Systemic reaction (other): Possibly from sleep deprivation/sleep position

Release 4 — day 35, dose 2

2021-02-16

Symptoms: Preeclampsia and currently postpartum

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	Postpartum disorder	✓	✓	✓
SD	Pre-eclampsia	✓	✓	✓
SRO	Abdominal discomfort	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Sleep deficit	✓	✓	✓

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