XUX-22596-19786 · OpenVSafe

Timeline

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

2021-01-06
Registered in v-safe
2021-01-06
Dose 1 — Moderna
2021-01-06
Health check-in — 0 day, dose 1
Feeling: Good · None

Adult check-in
2021-01-07
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-08
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-10
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache

Adult check-in
2021-01-12
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-13
Health check-in — 7 day, dose 1
Feeling: Good · Muscle or body aches

Adult check-in
2021-01-21
Survey response — 14 day, dose 1
MedDRA: Myalgia — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-27
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-02-03
Health check-in — 28 day, dose 1
Feeling: Good

Adult check-in
2021-02-06
Dose 2 — Moderna
2021-02-17
Health check-in — 7 day, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-20
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-02-27
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-03-06
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-03-13
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-03-20
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-05-08
Survey response — 3 month, dose 2
MedDRA: Decreased activity, Dyspnoea, Palpitations, Pre-existing disease — Feeling: Good · 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
2021-05-08
Report sent to call center — 3 month, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-07
Survey response — 6 month, dose 2
MedDRA: Dizziness, Dyspnoea, Exercise tolerance decreased, Palpitations, Pre-existing disease — 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: 2021-09,2024-11 · check-in answers available
2021-08-07
Report sent to call center — 6 month, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-15
Call 1 — Left Voicemail
2021-08-19
Call successful
Participant prefers to complete VAERS report online
2021-08-19
Call successful
Participant prefers to complete VAERS report online
2021-11-03
Dose 3 — Moderna
2022-02-06
Health check-in — 12 month, dose 2
Feeling: Good

Adult check-in
2022-05-18
Dose 4 — Pfizer-BioNTech
2022-10-06
Dose 5 — Moderna
2022-10-24
Health check-in — 14 day, dose 5
Feeling: Good

Adult check-in
2022-10-27
Health check-in — 21 day, dose 5
Feeling: Good

Adult check-in
2022-11-05
Health check-in — 28 day, dose 5
Feeling: Good

Adult check-in
2022-11-10
Health check-in — 35 day, dose 5
Feeling: Good

Adult check-in
2022-11-17
Survey response — 42 day, dose 5
MedDRA: Hypertension, Palpitations — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2022-11-17
Report sent to call center — 42 day, dose 5
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-11-18
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-06	Moderna
2	2021-02-06	Moderna
3	2021-11-03	Moderna	No
4	2022-05-18	Pfizer-BioNTech	No
5	2022-10-06	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-05-08	Successful 2021-08-19	Participant prefers to complete VAERS report online
2021-08-07	Successful 2021-08-19	Participant prefers to complete VAERS report online
2022-11-17	Successful 2022-11-18	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Free text

Release 2

Symptoms: Left hip pain. I feel it is muscular in nature. May be exercise related, but I cannot identify a causal event.

Release 8

Symptoms: Increased heart palpitations. I do have this issue, but in Mid March for3 weeks, I experienced increased palpitations, decreased ability to run without getting short of breath and general decrease in wellbeing. I am now recovered.

Release 9

Symptoms: From 3/5/21 - mid April, my ability to run decreased significantly. SOB, heart palpitations (history of PVCs & PACs) and dizziness of increased severity. Many tests resulted normal. By June, I was able to begin to run well. VO2 returned to normal.

Release 12

Symptoms: Heart palpitations- worsening; increased high blood pressure

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	Decreased activity	✓	✓	✓
SD	Dizziness	✓	·	✓
SD	Dyspnoea	✓	✓	✓
SD	Exercise tolerance decreased	✓	·	✓
SD	Hypertension	·	·	✓
SD	Myalgia	✓	✓	✓
SD	Palpitations	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓

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