Y8X-17643-82719

2 vaccinations 6 coded responses 16 check-ins 6 free-text entries 3 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 029 / RI
Registered: 2021-01-09

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

2020-12-30
Dose 1 — Moderna
2021-01-09
Registered in v-safe
2021-01-09
Survey response — day 7, dose 1
MedDRA: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth — Feeling: Good · Site: Pain, Redness, Swelling, Itching · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: The symptoms started 7 DAYS after the injection and associated with a more severe injection reaction (red, warm, swelling, tender and itchy) than few days after vaccine that resolved completely prior to onset of symptoms 7 days later

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

1 call case(s)
2021-01-13
Survey response — day 14, dose 1
MedDRA: Chills, Erythema, Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Myalgia, Swelling — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities

Free text: One week ago today which was 7 days after receiving the first dose of the vaccine, I had the onset of a severe headache, extreme fatigue, muscle aches and chills with NEW redness, swelling, warmth, tenderness and itching at the injection site.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-13
Report sent to call center — day 14, dose 1
Be unable to work · Be unable to do your normal daily activities

1 call case(s)
2021-01-20
Survey response — day 21, dose 1
MedDRA: Fatigue, Feeling abnormal, Headache, Impaired driving ability, SARS-CoV-2 test negative, Vertigo — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

Free text: Felt poorly beginning 7 days AFTER my injection until 2 days ago. The headache and fatigue lasted 10 days and the last day with vertigo to the point I did not feel it was safe to drive. Unsure Ill get second the dose. Rapid and PCR Covid negati

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-27
Survey response — day 28, dose 1
MedDRA: Computerised tomogram abnormal, Nephrolithiasis — Feeling: Good · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: Onset of a kidney stone 1/22 verified by CTScan on 1/25 - 4 mm in mid left ureter. Doubt its related to the COVID vaccine.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-27
Report sent to call center — day 28, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-29
Dose 2 — Moderna
2021-02-02
Survey response — days 1–6 daily, dose 2
MedDRA: Chills, Headache, Myalgia, Nausea — Feeling: Good · Site: Pain, Redness, Swelling, Itching · Be unable to work, Be unable to do your normal daily activities

Free text: Had onset of headache, muscle aches, chills and nausea x 36 hrs after the injection

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-03
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Headache, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

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: Fair · Headache, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-02-12
Health check-in — day 14, dose 2
Feeling: Good

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

Adult check-in
2021-04-30
Survey response — 3 months, dose 2
MedDRA: Abdominal distension, Constipation — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

Free text: Abdominal bloating and constipation

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-29
Call 1 — Left Voicemail
2021-07-31
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-01-31
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-30	Moderna
2	2021-01-29	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-01-09	priority 2/3
2021-01-13	priority 2/3
2021-01-27	Unsuccessful

Free text

Release 1 — day 7, dose 1

2021-01-09

Systemic reaction (other): The symptoms started 7 DAYS after the injection and associated with a more severe injection reaction (red, warm, swelling, tender and itchy) than few days after vaccine that resolved completely prior to onset of symptoms 7 days later

Release 1 — day 14, dose 1

2021-01-13

Symptoms: One week ago today which was 7 days after receiving the first dose of the vaccine, I had the onset of a severe headache, extreme fatigue, muscle aches and chills with NEW redness, swelling, warmth, tenderness and itching at the injection site.

Release 2 — day 21, dose 1

2021-01-20

Symptoms: Felt poorly beginning 7 days AFTER my injection until 2 days ago. The headache and fatigue lasted 10 days and the last day with vertigo to the point I did not feel it was safe to drive. Unsure Ill get second the dose. Rapid and PCR Covid negati

Release 2 — day 28, dose 1

2021-01-27

Symptoms: Onset of a kidney stone 1/22 verified by CTScan on 1/25 - 4 mm in mid left ureter. Doubt its related to the COVID vaccine.

Release 3 — days 1–6 daily, dose 2

2021-02-02

Systemic reaction (other): Had onset of headache, muscle aches, chills and nausea x 36 hrs after the injection

Release 8 — 3 months, dose 2

2021-04-30

Symptoms: Abdominal bloating and constipation

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	Abdominal distension	✓	✓	✓
SD	Chills	✓	✓	✓
SD	Computerised tomogram abnormal	✓	✓	✓
SD	Constipation	✓	✓	✓
SD	Erythema	○	✓	○
SD	Fatigue	✓	✓	✓
SD	Feeling abnormal	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Impaired driving ability	✓	✓	✓
SD	Injection site erythema	✓	·	✓
SD	Injection site pain	✓	·	✓
SD	Injection site pruritus	✓	✓	✓
SD	Injection site swelling	✓	·	✓
SD	Injection site warmth	✓	·	✓
SD	Myalgia	✓	✓	✓
SD	Nephrolithiasis	✓	✓	✓
SD	SARS-CoV-2 test negative	✓	✓	✓
SD	Swelling	○	✓	○
SD	Vertigo	✓	✓	✓
SRO	Chills	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Injection site erythema	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Injection site pruritus	✓	✓	✓
SRO	Injection site swelling	✓	✓	✓
SRO	Injection site warmth	✓	✓	✓
SRO	Myalgia	✓	✓	✓
SRO	Nausea	✓	✓	✓

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