6SB-34016-61163

4 vaccinations 14 coded responses 52 check-ins 14 free-text entries 1 call case

Sex: Female
Age at first dose: 56-60
ZIP prefix: 198 / DE
Registered: 2021-03-28

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

2021-03-28
Registered in v-safe
2021-03-28
Dose 1 — Moderna
2021-03-28
Health check-in — day 0, dose 1
Feeling: Good · Muscle or body aches

Adult check-in
2021-03-29
Survey response — days 1–6 daily, dose 1
MedDRA: Respiratory tract congestion — Feeling: Fair · Muscle or body aches, Fatigue or tiredness

Free text: Congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Muscle or body aches

Adult check-in
2021-03-31
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-04-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-02
Survey response — days 1–6 daily, dose 1
MedDRA: Respiratory tract congestion — Feeling: Fair · Headache, Fatigue or tiredness

Free text: Congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-03
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-04
Survey response — day 7, dose 1
MedDRA: Respiratory tract congestion — Feeling: Fair · Fatigue or tiredness

Free text: Congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-11
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-04-18
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-04-25
Dose 2 — Moderna
2021-04-25
Health check-in — day 0, dose 2
Feeling: Good · Muscle or body aches

Adult check-in
2021-04-26
Survey response — days 1–6 daily, dose 2
MedDRA: Decreased appetite, Diarrhoea, Flatulence — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Lack of appetite; gas; loose stools

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-27
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Muscle or body aches

Adult check-in
2021-04-28
Survey response — days 1–6 daily, dose 2
MedDRA: Anxiety, Insomnia — Feeling: Fair · Site: Pain · Fever · Headache, Muscle or body aches, Fatigue or tiredness, Abdominal pain

Free text: For Day 1 - please add excessive insomnia and anxiety;

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-29
Survey response — days 1–6 daily, dose 2
MedDRA: Anxiety, Insomnia — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Insomnia, anxiety

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-30
Survey response — days 1–6 daily, dose 2
MedDRA: Oropharyngeal pain, Respiratory tract congestion — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Clear congestion; sore throat

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-01
Survey response — days 1–6 daily, dose 2
MedDRA: Arthralgia, Headache, Hypoaesthesia, Musculoskeletal stiffness, Pain — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Left side face feels numb; severe neck sniff ness radiating from head through shoulder

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-02
Survey response — day 7, dose 2
MedDRA: Joint stiffness, Myalgia, Pain — Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Joint stiffness; neck muscle ache radiating from top of head down through the shoulder

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-09
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-05-16
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-05-23
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-05-30
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-06-06
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-07-25
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-10-25
Survey response — 6 months, dose 2
MedDRA: Nasopharyngitis — Feeling: Good · Be unable to do your normal daily activities

Free text: A cold virus in the last week and a half unrelated to COVID.

MedDRA releases: 2024-11 · check-in free text available
2021-11-14
Dose 3 — Moderna
2021-11-14
Health check-in — day 0, dose 3
Feeling: Good · Site: Pain · None

Adult check-in
2021-11-15
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2021-11-16
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain · Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-11-17
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-11-19
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain · Headache, Muscle or body aches

Adult check-in
2021-11-20
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-11-21
Health check-in — day 7, dose 3
Feeling: Good · Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-11-28
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2021-12-05
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2021-12-12
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2021-12-21
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-12-26
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-02-15
Survey response — 3 months, dose 3
MedDRA: Office visit, Postmenopausal haemorrhage — Feeling: Good · Get care from a doctor or other healthcare professional

Free text: Symptoms: I have experienced monthly post menopausal bleeding since mid-November when I got the third booster shot. · Healthcare visit (other): Office visit, ultrasound and endometrial biopsy. Also estradiol has remained at the same level In Bioidentical hormone treatment over the past 4 months. Normally it would decline between treatments. Doctor is holding off on giving me estradiol.

MedDRA releases: 2024-11 · check-in free text available
2022-02-15
Report sent to call center — 3 months, dose 3
Get care from a doctor or other healthcare professional

1 call case(s)
2022-02-17
Call successful
Participant prefers to complete VAERS report online
2022-04-30
Dose 4 — Moderna
2022-05-02
Survey response — days 1–6 daily, dose 4
MedDRA: Periorbital swelling — Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Swollen under eyes

MedDRA releases: 2024-11 · check-in free text available
2022-05-03
Survey response — days 1–6 daily, dose 4
MedDRA: No adverse event, Postmenopausal haemorrhage — Feeling: Good · Site: Pain

Free text: Post menopausal bleeding on day 3 after 4th booster; previously experienced 4 months of post menopausal bleeding after 3rd booster in Nov 2021; uterine ultrasound and biopsy in Feb 2022 resulted in no cancerous cells or other potential causes

MedDRA releases: 2024-11 · check-in free text available
2022-05-04
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Pain · Joint pains, Muscle or body aches

Adult check-in
2022-05-05
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Joint pains, Muscle or body aches

Adult check-in
2022-05-06
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Joint pains, Muscle or body aches

Adult check-in
2022-05-07
Health check-in — day 7, dose 4
Feeling: Good · Joint pains, Muscle or body aches

Adult check-in
2022-05-14
Health check-in — day 14, dose 4
Feeling: Fair

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

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

Adult check-in
2022-06-04
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-06-11
Survey response — day 42, dose 4
MedDRA: Discharge, Respiratory tract congestion — Feeling: Fair · Be unable to do your normal daily activities

Free text: Congestion and drainage

MedDRA releases: 2024-11 · check-in free text available
2022-07-31
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2022-10-29
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in
2023-05-02
Health check-in — 12 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-28	Moderna
2	2021-04-25	Moderna
3	2021-11-14	Moderna	No
4	2022-04-30	Moderna	No

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 6 — days 1–6 daily, dose 1

2021-03-29

Systemic reaction (other): Congestion

2021-04-02

Systemic reaction (other): Congestion

Release 6 — day 7, dose 1

2021-04-04

Systemic reaction (other): Congestion

Release 8 — days 1–6 daily, dose 2

2021-04-26

Systemic reaction (other): Lack of appetite; gas; loose stools

2021-04-28

Systemic reaction (other): For Day 1 - please add excessive insomnia and anxiety;

2021-04-29

Systemic reaction (other): Insomnia, anxiety

2021-04-30

Systemic reaction (other): Clear congestion; sore throat

2021-05-01

Systemic reaction (other): Left side face feels numb; severe neck sniff ness radiating from head through shoulder

Release 8 — day 7, dose 2

2021-05-02

Systemic reaction (other): Joint stiffness; neck muscle ache radiating from top of head down through the shoulder

Release 10 — 6 months, dose 2

2021-10-25

Symptoms: A cold virus in the last week and a half unrelated to COVID.

Release 11 — 3 months, dose 3

2022-02-15

Symptoms: I have experienced monthly post menopausal bleeding since mid-November when I got the third booster shot.

Healthcare visit (other): Office visit, ultrasound and endometrial biopsy. Also estradiol has remained at the same level In Bioidentical hormone treatment over the past 4 months. Normally it would decline between treatments. Doctor is holding off on giving me estradiol.

Release 11 — days 1–6 daily, dose 4

2022-05-02

Systemic reaction (other): Swollen under eyes

2022-05-03

Systemic reaction (other): Post menopausal bleeding on day 3 after 4th booster; previously experienced 4 months of post menopausal bleeding after 3rd booster in Nov 2021; uterine ultrasound and biopsy in Feb 2022 resulted in no cancerous cells or other potential causes

Release 12 — day 42, dose 4

2022-06-11

Symptoms: Congestion and drainage

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	Office visit	·	·	✓
SD	Discharge	·	·	✓
SD	Nasopharyngitis	·	·	✓
SD	Postmenopausal haemorrhage	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SRO	Anxiety	✓	✓	✓
SRO	Arthralgia	✓	✓	✓
SRO	Decreased appetite	✓	✓	✓
SRO	Diarrhoea	✓	✓	✓
SRO	Flatulence	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Hypoaesthesia	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Joint stiffness	✓	✓	✓
SRO	Musculoskeletal stiffness	✓	✓	✓
SRO	Myalgia	✓	✓	✓
SRO	No adverse event	·	·	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Periorbital swelling	·	·	✓
SRO	Postmenopausal haemorrhage	·	·	✓
SRO	Respiratory tract congestion	✓	✓	✓

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