ZAK-18057-21077 · OpenVSafe

Timeline

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

2021-02-08
Dose 1 — Moderna
2021-02-09
Registered in v-safe
2021-02-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Redness, Swelling · None

Adult check-in
2021-02-10
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Redness, Swelling · None

Adult check-in
2021-02-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Redness, Swelling · None

Adult check-in
2021-02-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Swelling · None

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

Adult check-in
2021-02-15
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-02-22
Survey response — day 14, dose 1
MedDRA: Self-medication, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus — Feeling: Fair

Free text: Area of vaccination started itching two days ago. The area of redness enlarged around vaccination site to about 3 inches in diameter. Firmness in muscle where needle went in & seemed to become noticeably painful. Ibupro helped. Today Worse redness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-01
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-03-08
Dose 2 — Moderna
2021-03-08
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-03-09
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-03-10
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Fever · None

Adult check-in
2021-03-12
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-13
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-14
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-15
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-03-22
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-03-29
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-05
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-04-12
Survey response — day 35, dose 2
MedDRA: Pyrexia, Sinusitis — Feeling: Good · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Sinusitis with fever - my PCP said this was unusual. She wants to follow me closely when my body responds to disease. She thought my fever was from an overcharged immune response precipitated by this vaccination.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-12
Report sent to call center — day 35, dose 2
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-19
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-07
Survey response — 3 months, dose 2
MedDRA: Pyrexia, Sinusitis — Feeling: Good · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Sinus infection with fever; requiring antibiotics

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-07
Report sent to call center — 3 months, dose 2
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-04
Call 1 — Left Voicemail
2021-09-06
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-03-08
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-08	Moderna
2	2021-03-08	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-04-12	Unsuccessful
2021-06-07	Unsuccessful

Free text

Release 4 — day 14, dose 1

2021-02-22

Symptoms: Area of vaccination started itching two days ago. The area of redness enlarged around vaccination site to about 3 inches in diameter. Firmness in muscle where needle went in & seemed to become noticeably painful. Ibupro helped. Today Worse redness

Release 7 — day 35, dose 2

2021-04-12

Symptoms: Sinusitis with fever - my PCP said this was unusual. She wants to follow me closely when my body responds to disease. She thought my fever was from an overcharged immune response precipitated by this vaccination.

Release 8 — 3 months, dose 2

2021-06-07

Symptoms: Sinus infection with fever; requiring antibiotics

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	Pyrexia	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Sinusitis	✓	✓	✓
SD	Vaccination site erythema	✓	✓	✓
SD	Vaccination site induration	✓	✓	✓
SD	Vaccination site pain	✓	✓	✓
SD	Vaccination site pruritus	✓	✓	✓

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