XY8-16392-97774 · OpenVSafe

Timeline

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

2021-01-16
Dose 1 — Moderna
2021-02-11
Dose 2 — Moderna
2021-02-12
Registered in v-safe
2021-02-12
Survey response — days 1–6 daily, dose 2
MedDRA: Chills, Fatigue, Insomnia, Nasal congestion, Pain — Feeling: Poor · Site: Pain · Fever · Headache, Joint pains, 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
2021-02-13
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-14
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-15
Survey response — days 1–6 daily, dose 2
MedDRA: Feeling cold — Feeling: Good · Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-16
Survey response — days 1–6 daily, dose 2
MedDRA: Arthritis, Back pain, Nasopharyngitis, Pain in extremity, Pre-existing disease — Feeling: Fair · Muscle or body aches, Nausea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-17
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-18
Survey response — 7 day, dose 2
MedDRA: Unevaluable event — Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-25
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-03-04
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-03-11
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-03-18
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-03-25
Survey response — 42 day, dose 2
MedDRA: Dizziness, Headache — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-13
Survey response — 3 month, dose 2
MedDRA: Arthralgia, Pyrexia — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-13
Report sent to call center — 3 month, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-12
Health check-in — 6 month, dose 2
Feeling: Good

Adult check-in
2021-11-03
Dose 3 — Moderna
2022-02-11
Survey response — 12 month, dose 2
MedDRA: Abdominal discomfort, Flatulence — Feeling: Good

MedDRA releases: 2024-11 · check-in answers available
2022-03-31
Dose 4 — Pfizer-BioNTech
2022-04-07
Call 1 — Left Voicemail
2022-04-26
Health check-in — 21 day, dose 4
Feeling: Good

Adult check-in
2022-04-28
Health check-in — 28 day, dose 4
Feeling: Good

Adult check-in
2022-05-05
Health check-in — 35 day, dose 4
Feeling: Fair

Adult check-in
2022-05-12
Health check-in — 42 day, dose 4
Feeling: Good

Adult check-in
2022-06-30
Health check-in — 3 month, dose 4
Feeling: Good

Adult check-in
2022-10-01
Health check-in — 6 month, dose 4
Feeling: Good

Adult check-in
2023-04-01
Survey response — 12 month, dose 4
MedDRA: COVID-19, Tinnitus — 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

MedDRA releases: 2024-11 · check-in answers available
2023-04-01
Report sent to call center — 12 month, dose 4
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Telehealth, virtual health, or email health consultation · 1 call case(s)
2023-04-04
Call successful
Participant prefers to complete VAERS report online
2023-04-04
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-16	Moderna
2	2021-02-11	Moderna
3	2021-11-03	Moderna	No
4	2022-03-31	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-05-13	Successful 2023-04-04	Participant prefers to complete VAERS report online
2023-04-01	Successful 2023-04-04	Participant prefers to complete VAERS report online

Free text

Release 4

Systemic reaction (other): The worst was last night with such body pain all over that I could hardly sleep so I was very tired today and still body pains. Also stuffy nose this evening and feeling chilled but not shaking with chills.

Systemic reaction (other): Freezing weather, electricity out, no heat, so very cold!@

Systemic reaction (other): Power is out and very cold so that might account for any symptoms and arthritis, but since the vaccine e I have had leg pains at night. It could be because of my lower back.

Systemic reaction (other): Could be arthritis and cold weather

Release 6

Symptoms: Some dizziness and slight headache

Release 8

Symptoms: Joint aches and fever for one day

Release 11

Symptoms: Digestive upsets, gas

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	Abdominal discomfort	·	·	✓
SD	Arthralgia	✓	✓	✓
SD	COVID-19	·	·	✓
SD	Dizziness	✓	✓	✓
SD	Flatulence	·	·	✓
SD	Headache	✓	✓	✓
SD	Pyrexia	✓	✓	✓
SD	Tinnitus	·	·	✓
SRO	Arthritis	✓	✓	✓
SRO	Back pain	✓	✓	○
SRO	Chills	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Feeling cold	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Nasal congestion	✓	✓	✓
SRO	Nasopharyngitis	✓	✓	○
SRO	Pain	✓	✓	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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