XVJ-31570-03190 · OpenVSafe

Timeline

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

2021-01-09
Registered in v-safe
2021-01-09
Dose 1 — Pfizer-BioNTech
2021-01-09
Survey response — 0 day, dose 1
MedDRA: Chest discomfort, Dizziness, Heart rate increased, Medical observation, Palpitations — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness, Nausea · Get care from a doctor or other healthcare professional

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-09
Report sent to call center — 0 day, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-10
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-01-10
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-11
Survey response — days 1–6 daily, dose 1
MedDRA: Palpitations — Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

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

1 call case(s)
2021-01-12
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Fatigue or tiredness, Nausea

Adult check-in
2021-01-13
Survey response — days 1–6 daily, dose 1
MedDRA: Hypersensitivity — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-14
Survey response — days 1–6 daily, dose 1
MedDRA: Dizziness — Feeling: Fair · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-15
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Fatigue or tiredness

Adult check-in
2021-01-16
Survey response — 7 day, dose 1
MedDRA: Feeling abnormal — Feeling: Fair · Headache, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-23
Survey response — 14 day, dose 1
MedDRA: Dizziness, Heart rate increased — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-30
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-02-06
Health check-in — 28 day, dose 1
Feeling: Fair

Adult check-in
2021-02-13
Health check-in — 35 day, dose 1
Feeling: Good

Adult check-in
2021-02-19
Call 1 — Left Voicemail
2021-02-20
Health check-in — 42 day, dose 1
Feeling: Good

Adult check-in
2021-02-24
Call successful
Participant prefers to complete VAERS report online
2021-07-10
Survey response — 6 month, dose 1
MedDRA: Dyspnoea, Fatigue, Palpitations — 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

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-07-10
Report sent to call center — 6 month, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-14
Call 1 — Could Not Reach Participant
2021-07-19
Call 2 — Left Voicemail
2021-08-05
Call successful
Does not wish to fill out VAERS report
2022-01-09
Health check-in — 12 month, dose 1
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-09	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-01-09	Successful	Participant prefers to complete VAERS report online
2021-01-10	Successful	Participant prefers to complete VAERS report online
2021-01-11	Successful 2021-02-24	Participant prefers to complete VAERS report online
2021-07-10	Successful 2021-08-05	Does not wish to fill out VAERS report

Free text

Release 1

Systemic reaction (other): Heart pounding and fast rate, dizziness, chest pressure,

Healthcare visit (other): Urgent help team at vaccine clinic

Systemic reaction (other): Intermittent palpitations

Systemic reaction (other): I had an allergic reaction to my COVID shot and presumably from polyethylene glycol. I had been using Tylenol and hand sanitizer daily with the same symptoms only milder than after the vaccine. I found out those have PEG in them. Stopped using and feel fine today.

Release 2

Systemic reaction (other): Dizzy

Systemic reaction (other): Foggy headed

Symptoms: Fast heart rate with nausea and dizziness while going for a walk which normally does not cause symptoms

Release 9

Symptoms: Heart palpitations with shortness of breath with activity, fatigue

Free-text releases are not linked to a specific 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	Medical observation	✓	✓	✓
SD	Dizziness	✓	✓	✓
SD	Dyspnoea	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Heart rate increased	✓	✓	✓
SD	Palpitations	✓	✓	✓
SRO	Chest discomfort	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Feeling abnormal	✓	✓	✓
SRO	Heart rate increased	✓	✓	✓
SRO	Hypersensitivity	✓	✓	✓
SRO	Palpitations	✓	✓	✓

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