YVE-30403-16440 · OpenVSafe

Timeline

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

2021-02-20
Dose 1 — Moderna
2021-03-19
Dose 2 — Moderna
2021-03-22
Registered in v-safe
2021-03-22
Survey response — days 1–6 daily, dose 2
MedDRA: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Unevaluable event — Feeling: Fair · Site: Pain, Redness, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Covid Vaccine Arm after 1st shot on day 8. 2nd Moderna shot in alternate arm 3/19/2. Covid Vaccine Arm appeared one day after shot. Still red, heated, swollen on day 4 about 4"x6" just below shot site. · Healthcare visit (other): Clinic Dr. visit after 1st shot. not visited Primary care Dr. yet after 2nd shot

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-22
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-23
Survey response — days 1–6 daily, dose 2
MedDRA: Immunisation reaction, Office visit, Pruritus — Feeling: Fair · Site: Redness, Swelling, Itching · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Covid arm still present and ichiness of skin tissue. Saw doctor who prescribed antihistsmines and Medrol dose pack, also ibuprofen for pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-23
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-24
Survey response — days 1–6 daily, dose 2
MedDRA: Adverse reaction — Feeling: Fair · Site: Redness, Itching

Free text: Covid arm rapidly improving!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-26
Survey response — day 7, dose 2
MedDRA: Unevaluable event — Feeling: Good · Site: Itching

Free text: Good shape after 8 days

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-05
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-09
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-18
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-04-24
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-05-01
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-18
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-08-16
Dose 3 — Moderna
2021-09-17
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-12-29
Call 1 — Left Voicemail
2022-04-11
Dose 4 — Moderna
2022-04-29
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-05-04
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-05-09
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-05-16
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-05-23
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-07-11
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-20	Moderna
2	2021-03-19	Moderna
3	2021-08-16	Moderna	No
4	2022-04-11	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-03-22	Unsuccessful
2021-03-23	Unsuccessful

Free text

Release 6 — days 1–6 daily, dose 2

2021-03-22

Systemic reaction (other): Covid Vaccine Arm after 1st shot on day 8. 2nd Moderna shot in alternate arm 3/19/2. Covid Vaccine Arm appeared one day after shot. Still red, heated, swollen on day 4 about 4"x6" just below shot site.

Healthcare visit (other): Clinic Dr. visit after 1st shot. not visited Primary care Dr. yet after 2nd shot

2021-03-23

Systemic reaction (other): Covid arm still present and ichiness of skin tissue. Saw doctor who prescribed antihistsmines and Medrol dose pack, also ibuprofen for pain

2021-03-24

Systemic reaction (other): Covid arm rapidly improving!

Release 6 — day 7, dose 2

2021-03-26

Systemic reaction (other): Good shape after 8 days

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
HCVO	Unevaluable event	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Hypersensitivity	✓	✓	✓
SRO	Immunisation reaction	✓	✓	✓
SRO	Injection site erythema	✓	✓	✓
SRO	Injection site swelling	✓	✓	✓
SRO	Injection site warmth	✓	✓	✓
SRO	Office visit	✓	✓	✓
SRO	Pruritus	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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