2RP-66708-51797 · OpenVSafe

Timeline

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

2021-01-21
Registered in v-safe
2021-01-21
Dose 1 — Moderna
2021-01-21
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-23
Survey response — days 1–6 daily, dose 1
MedDRA: Injection site discomfort — Feeling: Good · Site: Pain

Free text: No just sore at injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-24
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-26
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-27
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-28
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-02-04
Survey response — day 14, dose 1
MedDRA: Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling, Rash erythematous, Self-medication — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Red rash, itching, swelling at injection site about 6-days later. Took Zyrtec and cold compress to get rid of it is starting to go away now I think.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-04
Report sent to call center — day 14, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-11
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-18
Health check-in — day 28, dose 1
Feeling: Good

Adult check-in
2021-02-23
Dose 2 — Moderna
2021-02-24
Survey response — days 1–6 daily, dose 2
MedDRA: Adverse reaction, Insomnia, Reaction to previous exposure to any vaccine — Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: With the first shot I got a rash swelling warm to touch six days after. The second shot Ive been up with all the symptoms indicated above all night and most of the day today. My husband received the second shot yesterday to with no symptoms but hes not getting the V safe surveys could you please send them to him at (b)(6)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-25
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Fair · Site: Pain, Redness, Itching · Headache, Muscle or body aches, Fatigue or tiredness

Free text: A lot better today then yesterday!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-26
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Redness, Swelling, Itching · Fatigue or tiredness

Adult check-in
2021-02-27
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Redness, Itching · None

Adult check-in
2021-02-28
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Redness, Itching · None

Adult check-in
2021-03-01
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-03-02
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-03-09
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-03-16
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-25
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-30
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-04-06
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-25
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-06-29
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-08-24
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-02-23
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-21	Moderna
2	2021-02-23	Moderna

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-23

Systemic reaction (other): No just sore at injection site

Release 3 — day 14, dose 1

2021-02-04

Symptoms: Red rash, itching, swelling at injection site about 6-days later. Took Zyrtec and cold compress to get rid of it is starting to go away now I think.

Release 4 — days 1–6 daily, dose 2

2021-02-24

Systemic reaction (other): With the first shot I got a rash swelling warm to touch six days after. The second shot Ive been up with all the symptoms indicated above all night and most of the day today. My husband received the second shot yesterday to with no symptoms but hes not getting the V safe surveys could you please send them to him at (b)(6)

redacted (b)(6)

2021-02-25

Systemic reaction (other): A lot better today then yesterday!

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	Injection site pruritus	✓	✓	✓
SD	Injection site rash	○	✓	○
SD	Injection site reaction	✓	·	✓
SD	Injection site swelling	✓	✓	✓
SD	Rash erythematous	✓	·	✓
SD	Self-medication	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Injection site discomfort	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Rash	○	○	○
SRO	Reaction to previous exposure to any vaccine	✓	✓	✓
SRO	Skin warm	○	○	○
SRO	Swelling	○	○	○
SRO	Unevaluable event	✓	✓	✓
SRO	Vaccine positive rechallenge	○	○	○

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