YL4-27642-09681

2 vaccinations 11 coded responses 20 check-ins 11 free-text entries 4 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 775 / TX
Registered: 2021-03-02

Relationship: Self
Race: Black or African American
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-02-27
Dose 1 — Moderna
2021-03-02
Registered in v-safe
2021-03-02
Survey response — days 1–6 daily, dose 1
MedDRA: Erythema, Papule, Peripheral swelling, Pruritus — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Itchy, raised red areas on inner arms, that fade away

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-03
Survey response — days 1–6 daily, dose 1
MedDRA: Pruritus, Telemedicine, Urticaria — Feeling: Fair · Site: Redness, Itching · Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Systemic reaction (other): A few hives on upper inner right arms and a couple things n my back. Hives are gone, but some itching persists. · Healthcare visit (other): Virtual visit to get advice on what to take for the itching.

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

1 call case(s)
2021-03-04
Survey response — days 1–6 daily, dose 1
MedDRA: Lip swelling, Urticaria — Feeling: Fair · Site: Redness, Swelling, Itching · Rash, not including the immediate area around the injection site

Free text: Hives on inner right arm, right hip and chest and Swelling to bottom lip. Benadryl helped symptoms but not completely.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Survey response — days 1–6 daily, dose 1
MedDRA: Back pain, Lip swelling, Urticaria — Feeling: Fair · Site: Redness, Swelling, Itching · Rash, not including the immediate area around the injection site

Free text: Some hives at lower back and lip swelling. Nothing at injection site.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-06
Survey response — day 7, dose 1
MedDRA: Headache, Lip swelling, Office visit, Pruritus, Urticaria — Feeling: Good · Headache · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Systemic reaction (other): Yesterday I had to get a SoluMedrol injection for my reaction of swollen lips, hives and itching. Symptoms Resolved today. Only a mild headache today. · Healthcare visit (other): This visit was yesterday. Steroid shot given and resolved hives, itching and lip swelling.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-06
Report sent to call center — day 7, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-13
Survey response — day 14, dose 1
MedDRA: Pruritus, Rash, Urticaria — Feeling: Good

Free text: Still some itching and a few bumps or hives

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-20
Survey response — day 21, dose 1
MedDRA: Pruritus, Self-medication, Urticaria — Feeling: Fair

Free text: I am still experiencing hives almost daily. I take Benadryl for relief from the hives and itching.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-27
Dose 2 — Moderna
2021-03-27
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-03-28
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-03-30
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-01
Survey response — days 1–6 daily, dose 2
MedDRA: Urticaria, Vaccine positive rechallenge — Feeling: Fair · Diarrhea, Rash, not including the immediate area around the injection site

Free text: Ive started with hives again, like with the first vaccine. Only a few on my upper arms, not at injection site.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-03
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-11
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-20
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-24
Survey response — day 28, dose 2
MedDRA: Cough, Emergency care, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative — Feeling: Poor · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Fever, cough, Chest Congestion. Given a Covid Test in Er that was negative. Chest X-ray also done.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-24
Report sent to call center — day 28, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-01
Survey response — day 35, dose 2
MedDRA: Chills, Cough, Fatigue, Pyrexia, SARS-CoV-2 test negative — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Symptoms: Chills, fever, bad cough, fatique · Healthcare visit (other): Covid test given, was negative.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-01
Report sent to call center — day 35, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-10
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-17
Call 1 — Left Voicemail
2021-09-25
Survey response — 6 months, dose 2
MedDRA: Pruritus, Self-medication, Urticaria — Feeling: Fair

Free text: Im still getting sporadic hives and itching on various areas of my body. I self treat at home with Benadryl and topical creams.

MedDRA releases: 2024-11 · check-in free text available
2022-03-30
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-27	Moderna
2	2021-03-27	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-03-03	Unsuccessful
2021-03-06	Unsuccessful
2021-04-24	Unsuccessful
2021-05-01	Unsuccessful

Free text

Release 4 — days 1–6 daily, dose 1

2021-03-02

Systemic reaction (other): Itchy, raised red areas on inner arms, that fade away

Release 5 — days 1–6 daily, dose 1

2021-03-03

Systemic reaction (other): A few hives on upper inner right arms and a couple things n my back. Hives are gone, but some itching persists.

Healthcare visit (other): Virtual visit to get advice on what to take for the itching.

2021-03-04

Systemic reaction (other): Hives on inner right arm, right hip and chest and Swelling to bottom lip. Benadryl helped symptoms but not completely.

2021-03-05

Systemic reaction (other): Some hives at lower back and lip swelling. Nothing at injection site.

Release 5 — day 7, dose 1

2021-03-06

Systemic reaction (other): Yesterday I had to get a SoluMedrol injection for my reaction of swollen lips, hives and itching. Symptoms Resolved today. Only a mild headache today.

Healthcare visit (other): This visit was yesterday. Steroid shot given and resolved hives, itching and lip swelling.

Release 5 — day 14, dose 1

2021-03-13

Symptoms: Still some itching and a few bumps or hives

Release 6 — day 21, dose 1

2021-03-20

Symptoms: I am still experiencing hives almost daily. I take Benadryl for relief from the hives and itching.

Release 6 — days 1–6 daily, dose 2

2021-04-01

Systemic reaction (other): Ive started with hives again, like with the first vaccine. Only a few on my upper arms, not at injection site.

Release 7 — day 28, dose 2

2021-04-24

Symptoms: Fever, cough, Chest Congestion. Given a Covid Test in Er that was negative. Chest X-ray also done.

Release 8 — day 35, dose 2

2021-05-01

Symptoms: Chills, fever, bad cough, fatique

Healthcare visit (other): Covid test given, was negative.

Release 9 — 6 months, dose 2

2021-09-25

Symptoms: Im still getting sporadic hives and itching on various areas of my body. I self treat at home with Benadryl and topical creams.

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	Lip swelling	✓	✓	✓
HCVO	Office visit	✓	✓	✓
HCVO	Pruritus	✓	✓	✓
HCVO	SARS-CoV-2 test negative	✓	✓	✓
HCVO	Telemedicine	✓	✓	✓
HCVO	Urticaria	✓	✓	✓
SD	Chills	✓	✓	✓
SD	Cough	✓	✓	✓
SD	Emergency care	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Pruritus	✓	✓	✓
SD	Pyrexia	✓	✓	✓
SD	Rash	✓	✓	✓
SD	Respiratory tract congestion	✓	✓	✓
SD	SARS-CoV-2 test negative	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Urticaria	✓	✓	✓
SRO	Back pain	✓	✓	✓
SRO	Erythema	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Papule	○	✓	○
SRO	Peripheral swelling	✓	·	✓
SRO	Pruritus	✓	✓	✓
SRO	Urticaria	✓	✓	✓
SRO	Vaccine positive rechallenge	✓	✓	✓

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