5DN-10015-83360

3 vaccinations 11 coded responses 26 check-ins 11 free-text entries 3 call cases

Sex: Female
Age at first dose: 51-55
ZIP prefix: 760 / TX
Registered: 2021-01-04

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

2021-01-04
Registered in v-safe
2021-01-04
Dose 1 — Moderna
2021-01-04
Health check-in — day 0, dose 1
Feeling: Good · None

Adult check-in
2021-01-06
Survey response — days 1–6 daily, dose 1
MedDRA: Ear congestion, Sinus congestion — Feeling: Fair · Site: Pain, Swelling · Fever · Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Had significant sinus and ear congestion several hours after receiving the vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-06
Report sent to call center — days 1–6 daily, dose 1
Be unable to work · Be unable to do your normal daily activities

1 call case(s)
2021-01-07
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-08
Survey response — days 1–6 daily, dose 1
MedDRA: Sinus congestion — Feeling: Good

Free text: Sinus congestion but most likely related to sinus/allergies

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-09
Survey response — days 1–6 daily, dose 1
MedDRA: Oropharyngeal pain, Sinus congestion — Feeling: Fair · Fatigue or tiredness

Free text: Sore throat, sinus congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-11
Survey response — day 7, dose 1
MedDRA: Sinus congestion — Feeling: Fair · Fever · Headache, Fatigue or tiredness · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Sinus congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-11
Report sent to call center — day 7, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-18
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-25
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-01-29
Dose 2 — Moderna
2021-01-29
Survey response — day 0, dose 2
MedDRA: Hypersensitivity — Feeling: Good

Free text: Allergies

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-30
Survey response — days 1–6 daily, dose 2
MedDRA: Hypersensitivity, Nasal congestion — Feeling: Fair · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Stuffy nose but have allergies

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-02-01
Survey response — days 1–6 daily, dose 2
MedDRA: Hypersensitivity, Nasal congestion, Pre-existing disease — Feeling: Good · Fatigue or tiredness

Free text: Allergies w nasal congestion

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

Adult check-in
2021-02-03
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-04
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-05
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-02-14
Survey response — day 14, dose 2
MedDRA: Respiratory tract congestion — Feeling: Fair

Free text: Congestion but possibly allergies

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-18
Call 1 — Left Voicemail
2021-02-19
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-26
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-05
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-12
Survey response — day 42, dose 2
MedDRA: Cough, Dizziness, Malaise — Feeling: Fair

Free text: Coughing, malaise , dizziness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-02
Survey response — 3 months, dose 2
MedDRA: Ear pain, Fatigue, Respiratory tract congestion — Feeling: Fair · Be unable to do your normal daily activities

Free text: Congestion, ear aches, fatigue but possibly allergies

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-30
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-11-21
Dose 3 — Moderna
2022-01-31
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-02-23
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-11-21
Survey response — 12 months, dose 3
MedDRA: Asthma, Infection, Pre-existing disease, SARS-CoV-2 test negative — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Allergy/asthma/infection treated with steroids and antibiotics. Tested negative for Covid and pneumonia.

MedDRA releases: 2024-11 · check-in free text available
2022-11-21
Report sent to call center — 12 months, dose 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-11-22
Call 1 — Left Voicemail
2022-11-22
Call 2 — Left Voicemail
2022-11-22
Call 1 — Could Not Reach Participant
2022-11-28
Call 2 — Left Voicemail
2022-11-28
Call 3 — Left Voicemail
2022-11-28
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-04	Moderna
2	2021-01-29	Moderna
3	2021-11-21	Moderna	No

Call center

3 call center cases

3 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-06

Systemic reaction (other): Had significant sinus and ear congestion several hours after receiving the vaccine

2021-01-08

Systemic reaction (other): Sinus congestion but most likely related to sinus/allergies

2021-01-09

Systemic reaction (other): Sore throat, sinus congestion

Release 1 — day 7, dose 1

2021-01-11

Systemic reaction (other): Sinus congestion

Release 3 — day 0, dose 2

2021-01-29

Systemic reaction (other): Allergies

Release 3 — days 1–6 daily, dose 2

2021-01-30

Systemic reaction (other): Stuffy nose but have allergies

2021-02-01

Systemic reaction (other): Allergies w nasal congestion

Release 4 — day 14, dose 2

2021-02-14

Symptoms: Congestion but possibly allergies

Release 5 — day 42, dose 2

2021-03-12

Symptoms: Coughing, malaise , dizziness

Release 8 — 3 months, dose 2

2021-05-02

Symptoms: Congestion, ear aches, fatigue but possibly allergies

Release 12 — 12 months, dose 3

2022-11-21

Symptoms: Allergy/asthma/infection treated with steroids and antibiotics. Tested negative for Covid and pneumonia.

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	Dizziness	✓	✓	✓
SD	Ear pain	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Infection	·	·	✓
SD	Malaise	✓	✓	✓
SD	Pre-existing disease	·	·	✓
SD	Respiratory tract congestion	✓	✓	✓
SD	SARS-CoV-2 test negative	·	·	✓
SRO	Ear congestion	✓	✓	✓
SRO	Hypersensitivity	✓	✓	✓
SRO	Nasal congestion	✓	✓	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Pre-existing disease	✓	·	✓
SRO	Sinus congestion	✓	✓	✓

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