3GT-43356-30114

4 vaccinations 6 coded responses 32 check-ins 5 free-text entries 0 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 804 / CO
Registered: 2021-01-16

Relationship: Self
Race: N/A
Ethnicity: Not Hispanic or Latino

Timeline Vaccinations Free text MedDRA terms

Timeline

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

2021-01-15
Dose 1 — Moderna
2021-01-16
Registered in v-safe
2021-01-16
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Joint pains

Adult check-in
2021-01-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-18
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache, Muscle or body aches

Adult check-in
2021-01-21
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache

Adult check-in
2021-01-24
Survey response — day 7, dose 1
MedDRA: Peripheral swelling — Feeling: Good · Site: Redness, Itching · Headache

Free text: Swollen lower legs

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-29
Survey response — day 14, dose 1
MedDRA: Abdominal discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Peripheral swelling, Pre-existing disease, Similar reaction on previous exposure to drug — Feeling: Good

Free text: Large red spot around injection site - grew from about 6 cm in diameter to 8 cm. Get redder and itchy then began to fade, accompanied by some slight pain. Intestinal distress, swollen leg. Much like reaction I used to have to monthly allergy shots.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-05
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-12
Dose 2 — Moderna
2021-02-12
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-02-13
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-02-14
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site erythema — Feeling: Fair · Site: Redness, Swelling · Headache, Diarrhea

Free text: Redness around previous injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-15
Survey response — days 1–6 daily, dose 2
MedDRA: Dizziness, Peripheral swelling — Feeling: Fair · Site: Redness · Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: One episode of light headed-ness. Swollen lower calves continue from first injection.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-16
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Swelling · Rash, not including the immediate area around the injection site

Adult check-in
2021-02-17
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Headache, Rash, not including the immediate area around the injection site

Adult check-in
2021-02-18
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Rash, not including the immediate area around the injection site

Adult check-in
2021-02-19
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-02-26
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-03-05
Survey response — day 21, dose 2
MedDRA: Peripheral swelling, Weight increased — Feeling: Good

Free text: Swollen lower part of calf continues and weight gain has not resolved or improved.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-12
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-19
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-26
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-14
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-08-15
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-10-27
Dose 3 — Moderna
Co-administered: Flu
2022-02-14
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-04-14
Dose 4 — Pfizer-BioNTech
2022-04-25
Health check-in — day 7, dose 4
Feeling: Good · None

Adult check-in
2022-04-28
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-05-05
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-05-12
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-05-21
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-05-26
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-07-14
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2022-10-13
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in
2023-04-14
Survey response — 12 months, dose 4
MedDRA: Ageusia, Anosmia — Feeling: Good

MedDRA releases: 2024-11

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-15	Moderna
2	2021-02-12	Moderna
3	2021-10-27	Moderna	Flu
4	2022-04-14	Pfizer-BioNTech	No

Free text

Release 2 — day 7, dose 1

2021-01-24

Systemic reaction (other): Swollen lower legs

Release 3 — day 14, dose 1

2021-01-29

Symptoms: Large red spot around injection site - grew from about 6 cm in diameter to 8 cm. Get redder and itchy then began to fade, accompanied by some slight pain. Intestinal distress, swollen leg. Much like reaction I used to have to monthly allergy shots. cut off by CDC

Release 4 — days 1–6 daily, dose 2

2021-02-14

Systemic reaction (other): Redness around previous injection site

2021-02-15

Systemic reaction (other): One episode of light headed-ness. Swollen lower calves continue from first injection.

Release 5 — day 21, dose 2

2021-03-05

Symptoms: Swollen lower part of calf continues and weight gain has not resolved or improved.

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 discomfort	✓	✓	✓
SD	Ageusia	·	·	✓
SD	Anosmia	·	·	✓
SD	Injection site erythema	✓	✓	✓
SD	Injection site pain	✓	✓	✓
SD	Injection site pruritus	✓	✓	✓
SD	Peripheral swelling	✓	✓	✓
SD	Pre-existing disease	✓	·	✓
SD	Similar reaction on previous exposure to drug	○	✓	○
SD	Weight increased	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Injection site erythema	✓	✓	✓
SRO	Peripheral swelling	✓	✓	✓

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