NRP-18552-08561 · OpenVSafe

Timeline

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

2022-07-14
Registered in v-safe
2022-07-14
Dose 1 — Moderna
2022-07-14
Survey response — day 0, dose 1, under 3
MedDRA: Injection site rash — Feeling: Good · Site: Redness, Swelling/hardness · Rash, not including the immediate area around the injection site

Free text: The rash is about 1" diameter around the injection site

MedDRA releases: 2024-11 · check-in free text available
2022-07-15
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-16
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Fair · Sleepiness, Irritability/crying, Loss of appetite

Under 3 check-in
2022-07-17
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-18
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Fair · Irritability/crying

Under 3 check-in
2022-07-19
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-20
Health check-in — days 1–6 daily, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-21
Health check-in — day 7, dose 1, under 3
Feeling: Good · None

Under 3 check-in
2022-07-28
Survey response — day 14, dose 1, under 3
MedDRA: Decreased appetite, Fatigue, Irritability, Nasopharyngitis, Rhinorrhoea, Sneezing — Feeling: Fair · Be unable to work or attend school

Free text: (b)(6) currently has a bad head cold. Runny nose, sneezing, lack of appetite, and fussiness/fatigue.

MedDRA releases: 2024-11 · check-in free text available
2022-08-04
Survey response — day 21, dose 1, under 3
MedDRA: Nasopharyngitis, Respiratory tract congestion — Feeling: Fair

Free text: (b)(6) coming down with another cold. He's stuffy and congested.

MedDRA releases: 2024-11 · check-in free text available
2022-08-11
Dose 2 — Moderna
2022-08-13
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Fair · Sleepiness, Irritability/crying, Loss of appetite

Under 3 check-in
2022-08-14
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Fair · Sleepiness, Irritability/crying, Loss of appetite

Under 3 check-in
2022-08-15
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Fair · Sleepiness, Irritability/crying, Loss of appetite

Under 3 check-in
2022-08-16
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Fair · Sleepiness, Irritability/crying

Under 3 check-in
2022-08-17
Health check-in — days 1–6 daily, dose 2, under 3
Feeling: Fair · Sleepiness, Irritability/crying, Loss of appetite

Under 3 check-in
2022-08-18
Health check-in — day 7, dose 2, under 3
Feeling: Fair · Sleepiness, Irritability/crying, Loss of appetite

Under 3 check-in
2022-08-27
Health check-in — day 14, dose 2, under 3
Feeling: Fair

Under 3 check-in
2022-09-01
Health check-in — day 21, dose 2, under 3
Feeling: Fair

Under 3 check-in
2022-09-08
Survey response — day 28, dose 2, under 3
MedDRA: Nasopharyngitis — Feeling: Fair

Free text: He has a head cold

MedDRA releases: 2024-11 · check-in free text available
2022-09-22
Health check-in — day 42, dose 2, under 3
Feeling: Fair

Under 3 check-in
2022-11-11
Survey response — 3 months, dose 2, under 3
MedDRA: Asthma, Cough, Ear infection, Nasopharyngitis, Rhinorrhoea — Feeling: Poor · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: (b)(6) has been struggling with a bad cold and an ear infection. Coughing, running nose, increase asthma attacks.

MedDRA releases: 2024-11 · check-in free text available
2022-11-11
Report sent to call center — 3 months, dose 2, under 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-11-14
Call 1 — Left Voicemail
2022-11-14
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2023-02-09
Health check-in — 6 months, dose 2, under 3
Feeling: Good

Under 3 check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2022-07-14	Moderna	No
2	2022-08-11	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2022-11-11	Successful 2022-11-14	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Free text

Release 12 (Under 3) — day 0, dose 1, under 3

2022-07-14

Systemic reaction (other): The rash is about 1" diameter around the injection site

Release 12 (Under 3) — day 14, dose 1, under 3

2022-07-28

Symptoms: (b)(6) currently has a bad head cold. Runny nose, sneezing, lack of appetite, and fussiness/fatigue.

redacted (b)(6)

Release 12 (Under 3) — day 21, dose 1, under 3

2022-08-04

Symptoms: (b)(6) coming down with another cold. He's stuffy and congested.

redacted (b)(6)

Release 12 (Under 3) — day 28, dose 2, under 3

2022-09-08

Symptoms: He has a head cold

Release 12 (Under 3) — 3 months, dose 2, under 3

2022-11-11

Symptoms: (b)(6) has been struggling with a bad cold and an ear infection. Coughing, running nose, increase asthma attacks.

redacted (b)(6)

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	Asthma	·	·	✓
SD	Cough	·	·	✓
SD	Decreased appetite	·	·	✓
SD	Ear infection	·	·	✓
SD	Fatigue	·	·	✓
SD	Irritability	·	·	✓
SD	Nasopharyngitis	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Sneezing	·	·	✓
SRO	Injection site rash	·	·	✓

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