TJQ-30318-98030 · OpenVSafe

Timeline

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

2020-12-23
Registered in v-safe
2020-12-23
Dose 1 — Pfizer-BioNTech
2020-12-24
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2020-12-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Swelling · Fatigue or tiredness, Diarrhea

Adult check-in
2020-12-26
Survey response — days 1–6 daily, dose 1
MedDRA: Muscle twitching — Feeling: Good · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2020-12-27
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-28
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-29
Survey response — days 1–6 daily, dose 1
MedDRA: Rash — Feeling: Good · Headache, Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2020-12-30
Health check-in — 7 day, dose 1
Feeling: Good · None

Adult check-in
2021-01-06
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-01-13
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-01-15
Dose 2 — Pfizer-BioNTech
2021-01-15
Health check-in — 0 day, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-01-16
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · Headache, Fatigue or tiredness

Adult check-in
2021-01-17
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Rash, not including the immediate area around the injection site

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

Adult check-in
2021-01-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-22
Health check-in — 7 day, dose 2
Feeling: Good · None

Adult check-in
2021-01-29
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-02-05
Survey response — 21 day, dose 2
MedDRA: Chills, Cough, Fatigue, Headache, Myalgia, Night sweats, Respiratory tract congestion — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-12
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-02-19
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-02-26
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-04-16
Health check-in — 3 month, dose 2
Feeling: Good

Adult check-in
2021-07-16
Survey response — 6 month, dose 2
MedDRA: Dyspnoea exertional, Electrocardiogram ambulatory abnormal, Extrasystoles, Tachycardia — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

MedDRA releases: 2021-09,2024-11 · check-in answers available
2021-07-16
Report sent to call center — 6 month, dose 2
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

1 call case(s)
2021-07-23
Call 2 — Left Voicemail
2022-01-15
Survey response — 12 month, dose 2
MedDRA: Burning sensation, Night sweats, Temperature intolerance — Feeling: Fair · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2022-01-15
Report sent to call center — 12 month, dose 2
Be unable to work or attend school · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-01-15
Call 1 — Left Voicemail
2022-01-18
Call 1 — Could Not Reach Participant
2022-01-21
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-23	Pfizer-BioNTech
2	2021-01-15	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-07-16	Unsuccessful
2022-01-15	Unsuccessful

Free text

Release 1

Systemic reaction (other): Muscle/Nerve twitches in and around nose

Systemic reaction (other): Rash may be unrelated it's on my neck

Release 3

Symptoms: I did get congested and had fatigue, a cough, muscle aches, chills, night sweats and headache around the 2 week and 3 day mark.

Release 9

Symptoms: Ectopic heart beats diagnosed on holter monitor and periods of tachycardia. Shortness of breath (on exertion).

Release 10

Symptoms: Night sweats. When I go outside from warm to cold my hands burn when I come in and at night if I get up to go to the restroom.

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
SD	Burning sensation	·	·	✓
SD	Chills	✓	✓	✓
SD	Cough	✓	✓	✓
SD	Dyspnoea exertional	✓	·	✓
SD	Electrocardiogram ambulatory abnormal	✓	·	✓
SD	Extrasystoles	✓	·	✓
SD	Fatigue	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Myalgia	✓	✓	✓
SD	Night sweats	✓	✓	✓
SD	Respiratory tract congestion	✓	✓	✓
SD	Tachycardia	✓	·	✓
SD	Temperature intolerance	·	·	✓
SRO	Muscle twitching	✓	✓	✓
SRO	Rash	✓	✓	✓

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