63H-16204-71848

4 vaccinations 12 coded responses 26 check-ins 11 free-text entries 5 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 407 / KY
Registered: 2021-01-17

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-01-08
Dose 1 — Moderna
2021-01-17
Registered in v-safe
2021-01-17
Survey response — day 7, dose 1
MedDRA: Headache — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Headache was bad. Went on for two days. Better today.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-17
Report sent to call center — day 7, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-22
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-29
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-05
Dose 2 — Moderna
2021-02-05
Health check-in — day 0, dose 2
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Redness, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-02-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness · Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-02-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness, Itching · Headache, Muscle or body aches · Be unable to do your normal daily activities

Adult check-in
2021-02-09
Survey response — days 1–6 daily, dose 2
MedDRA: Dizziness — Feeling: Poor · Site: Pain, Redness · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

Free text: Dizziness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-10
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site erythema, Injection site pruritus, Injection site warmth, Pollakiuria — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Twice since I had the second vaccine, Ive had very frequent urination lasting several hours. Also yesterday the red around the vaccine entry point on my arm has migrated down about four inches. Yesterday it was really red, hot, and itchy. This happened at the same time as the frequent urinating. Thought Id better let you know in case someone else had it happen to them.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-11
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Redness, Itching · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-02-12
Health check-in — day 7, dose 2
Feeling: Fair · Site: Itching · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-02-19
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-26
Survey response — day 21, dose 2
MedDRA: Fatigue, Feeling cold, Headache, Oral mucosal blistering — Feeling: Fair · Be unable to do your normal daily activities

Free text: Headache, feel cold sometimes, burn up others, no temp though. Blisters inside mouth. Fatigued

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-03-12
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-03-21
Survey response — day 42, dose 2
MedDRA: Nodule, Skin discolouration, Skin mass, Tenderness — Feeling: Fair

Free text: This past Tuesday I woke up with a knot on my shin a little bigger than half a golf ball. It wasnt due to any trauma...it just appeared. Its still there, and is now a little painful to the touch. Only very pale discoloration. Not as large.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-07
Health check-in — 3 months, dose 2
Feeling: Fair

Adult check-in
2021-08-06
Survey response — 6 months, dose 2
MedDRA: Muscular weakness, Nasal congestion, Sinus congestion — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Congestion in sinus passages and noseWeakness in legs and arms

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-06
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-30
Call 2 — Left Voicemail
2021-11-04
Dose 3 — Moderna
2022-02-05
Survey response — 12 months, dose 2
MedDRA: Atrial fibrillation — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: A-Fib

MedDRA releases: 2024-11 · check-in free text available
2022-02-05
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-02-07
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-05-09
Survey response — 6 months, dose 3
MedDRA: Atrial fibrillation, Cardiac pacemaker insertion — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Hospitalization

Free text: Had pacemaker implanted Feb 15 2022 Had AFib recorded once

MedDRA releases: 2024-11 · check-in free text available
2022-05-09
Report sent to call center — 6 months, dose 3
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · Hospitalization · 1 call case(s)
2022-05-10
Call 1 — Left Voicemail
2022-05-10
Call 1 — Left Voicemail
2022-05-16
Call successful
Not applicable - Accidental Reporting
2022-05-16
Call successful
Not applicable - Accidental Reporting
2022-09-19
Dose 4 — Moderna
2022-10-14
Survey response — day 21, dose 4
MedDRA: Atrial fibrillation, Cardiac pacemaker insertion — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Hospitalization

Free text: Had pacemaker implanted Feb 2022 after detecting AFib in December 2021

MedDRA releases: 2024-11 · check-in free text available
2022-10-14
Report sent to call center — day 21, dose 4
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · Hospitalization · 1 call case(s)
2022-10-17
Health check-in — day 28, dose 4
Feeling: Fair

Adult check-in
2022-10-17
Call 1 — Requested Callback
2022-10-19
Callback requested for
03:01PM ET
2022-10-21
Call 2 — Could Not Reach Participant
2022-10-25
Survey response — day 35, dose 4
MedDRA: Fatigue, Poor quality sleep — Feeling: Fair · Be unable to do your normal daily activities

Free text: I was tired before, but this week I'm extremely tired. ..I'm not sleeping well either.

MedDRA releases: 2024-11 · check-in free text available
2022-10-31
Survey response — day 42, dose 4
MedDRA: Fatigue, Somnolence — Feeling: Poor · Be unable to do your normal daily activities

Free text: Sleepy and fatigued all the time

MedDRA releases: 2024-11 · check-in free text available
2022-12-19
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2023-03-20
Survey response — 6 months, dose 4
MedDRA: Pain in extremity — Feeling: Poor · Be unable to do your normal daily activities

MedDRA releases: 2024-11

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-08	Moderna
2	2021-02-05	Moderna
3	2021-11-04	Moderna	No
4	2022-09-19	Moderna	No

Call center

5 call center cases

3 successful · 1 unsuccessful · 1 priority 2/3 (triaged and no follow up)

See the call center timeline

Free text

Release 2 — day 7, dose 1

2021-01-17

Systemic reaction (other): Headache was bad. Went on for two days. Better today.

Release 3 — days 1–6 daily, dose 2

2021-02-09

Systemic reaction (other): Dizziness

2021-02-10

Systemic reaction (other): Twice since I had the second vaccine, Ive had very frequent urination lasting several hours. Also yesterday the red around the vaccine entry point on my arm has migrated down about four inches. Yesterday it was really red, hot, and itchy. This happened at the same time as the frequent urinating. Thought Id better let you know in case someone else had it happen to them.

Release 4 — day 21, dose 2

2021-02-26

Symptoms: Headache, feel cold sometimes, burn up others, no temp though. Blisters inside mouth. Fatigued

Release 6 — day 42, dose 2

2021-03-21

Symptoms: This past Tuesday I woke up with a knot on my shin a little bigger than half a golf ball. It wasnt due to any trauma...it just appeared. Its still there, and is now a little painful to the touch. Only very pale discoloration. Not as large.

Release 9 — 6 months, dose 2

2021-08-06

Symptoms: Congestion in sinus passages and noseWeakness in legs and arms

Release 11 — 12 months, dose 2

2022-02-05

Symptoms: A-Fib

Release 11 — 6 months, dose 3

2022-05-09

Symptoms: Had pacemaker implanted Feb 15 2022 Had AFib recorded once

Release 12 — day 21, dose 4

2022-10-14

Symptoms: Had pacemaker implanted Feb 2022 after detecting AFib in December 2021

Release 12 — day 35, dose 4

2022-10-25

Symptoms: I was tired before, but this week I'm extremely tired. ..I'm not sleeping well either.

Release 12 — day 42, dose 4

2022-10-31

Symptoms: Sleepy and fatigued all the time

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	Atrial fibrillation	·	·	✓
SD	Cardiac pacemaker insertion	·	·	✓
SD	Fatigue	✓	✓	✓
SD	Feeling cold	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Muscular weakness	✓	·	✓
SD	Nasal congestion	✓	·	✓
SD	Nodule	·	·	✓
SD	Oral mucosal blistering	✓	✓	✓
SD	Pain in extremity	·	·	✓
SD	Poor quality sleep	·	·	✓
SD	Sinus congestion	✓	·	✓
SD	Skin discolouration	·	·	✓
SD	Skin mass	✓	✓	○
SD	Somnolence	·	·	✓
SD	Tenderness	·	·	✓
SRO	Dizziness	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Injection site erythema	✓	✓	✓
SRO	Injection site pruritus	✓	✓	✓
SRO	Injection site warmth	✓	✓	✓
SRO	Pollakiuria	✓	✓	✓

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