XVY-22216-38323

1 vaccination 12 coded responses 14 check-ins 12 free-text entries 8 call cases

Sex: Female
Age at first dose: 36-40
ZIP prefix: 109 / NY
Registered: 2021-08-20

Relationship: Self
Race: Black or African American
Ethnicity: Hispanic or Latino

Timeline

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

2021-08-20
Registered in v-safe
2021-08-20
Dose 1 — Janssen/Johnson & Johnson
2021-08-20
Health check-in — day 0, dose 1
Feeling: Fair · Site: Itching · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-08-22
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-08-23
Survey response — days 1–6 daily, dose 1
MedDRA: Arthralgia, Back pain, Neck pain, Pain in extremity — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Back pain deep below left shoulder blade, radiating to left side of neck, shoulder, and length of the arm

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-24
Survey response — days 1–6 daily, dose 1
MedDRA: Productive cough, Respiratory tract irritation, Throat clearing — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Irritated airway, like the feeling that I have something building that causes the need to clear my throat. A brief, productive cough.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-24
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-25
Survey response — days 1–6 daily, dose 1
MedDRA: Respiratory tract irritation — Feeling: Fair · Site: Pain, Redness, Swelling · Joint pains, Fatigue or tiredness, Abdominal pain

Free text: A feeling of irritation in my airway, like the menthol sensation of having a cough drop.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-27
Survey response — day 7, dose 1
MedDRA: Bronchial irritation — Feeling: Fair · Site: Pain, Swelling, Itching · Headache, Joint pains, Fatigue or tiredness · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Discomfort/ irritation in my airway

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-27
Report sent to call center — day 7, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-31
Call 2 — Could Not Reach Participant
2021-09-03
Call 3 — Could Not Reach Participant
2021-09-05
Survey response — day 14, dose 1
MedDRA: Headache, Musculoskeletal pain — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Lightning pain in right shoulderblade and left side of head

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-09-05
Report sent to call center — day 14, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-08
Call 2 — Left Voicemail
2021-09-10
Survey response — day 21, single dose
MedDRA: Arthralgia, Dyspnoea, Fatigue, Hot flush — Feeling: Poor · Be unable to do your normal daily activities

Free text: Shortness of breath, hot flashes, fatigue, joint pain

MedDRA releases: 2024-11 · check-in free text available
2021-09-17
Survey response — day 28, single dose
MedDRA: Thunderclap headache — Feeling: Fair · Be unable to do your normal daily activities

Free text: Lightning headaches are intensifying

MedDRA releases: 2024-11 · check-in free text available
2021-09-24
Survey response — day 35, single dose
MedDRA: Mixed connective tissue disease — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Mixed connective tissue disease

MedDRA releases: 2024-11 · check-in free text available
2021-09-24
Report sent to call center — day 35, single dose
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-09-27
Call 1 — Could Not Reach Participant
2021-09-30
Call 2 — Could Not Reach Participant
2021-10-01
Survey response — day 42, single dose
MedDRA: Dry eye, Foreign body sensation in eyes, Myalgia — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Muscle aches, dry/gritty eyes

MedDRA releases: 2024-11 · check-in free text available
2021-10-01
Report sent to call center — day 42, single dose
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-10-07
Call 2 — Requested Callback
2021-10-07
Call successful
Participant prefers to complete VAERS report online
2021-10-07
Call successful
Participant prefers to complete VAERS report online
2021-10-07
Call successful
Participant prefers to complete VAERS report online
2021-10-07
Call successful
Participant prefers to complete VAERS report online
2021-10-07
Call successful
Participant prefers to complete VAERS report online
2021-11-21
Survey response — 3 months, dose 1
MedDRA: Back pain, Chest discomfort, Chest pain, Discomfort, Musculoskeletal discomfort, Pneumonia — Feeling: Fair · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: I developed pneumonia when the rest of my family had a mild head cold, with lingering symptoms of pain and pressure beyond 3 weeks in the same area of my chest and back that felt discomfort after the vaccine.

MedDRA releases: 2024-11 · check-in free text available
2021-11-21
Report sent to call center — 3 months, dose 1
Be unable to work or attend school · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-11-23
Call 2 — Could Not Reach Participant
2021-12-01
Call 3 — Could Not Reach Participant
2022-02-18
Survey response — 6 months, dose 1
MedDRA: Dizziness, Dyspnoea, Palpitations — Feeling: Fair · Be unable to work or attend school, 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: Dizziness, shortness of breath, heart palpitations

MedDRA releases: 2024-11 · check-in free text available
2022-02-18
Report sent to call center — 6 months, dose 1
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-02-21
Call 1 — Left Voicemail
2022-08-20
Survey response — 12 months, dose 1
MedDRA: Chest discomfort, Dizziness, Fatigue, Myocardial infarction, Vision blurred — Feeling: Fair · Be unable to work or attend school, 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, Emergency room or emergency department visit, Hospitalization

Free text: Symptoms of heart attacks Feeling of fiberglass in chest Extreme dizziness and fatigue Blurred visio

MedDRA releases: 2024-11 · check-in free text available
2022-08-20
Report sent to call center — 12 months, dose 1
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2022-08-22
Call 1 — Left Voicemail
2022-08-22
Call 1 — Left Voicemail
2022-08-22
Call 1 — Left Voicemail
2022-08-22
Call 1 — Left Voicemail
2022-08-22
Call 1 — Left Voicemail
2022-08-22
Call 2 — Left Voicemail
2022-08-22
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-08-20	Janssen/Johnson & Johnson	No

Call center

Reported	Outcome	VAERS-related outcome
2021-08-24	Successful 2021-10-07	Participant prefers to complete VAERS report online
2021-08-27	Successful 2021-10-07	Participant prefers to complete VAERS report online
2021-09-05	Successful 2021-10-07	Participant prefers to complete VAERS report online
2021-09-24	Successful 2021-10-07	Participant prefers to complete VAERS report online
2021-10-01	Successful 2021-10-07	Participant prefers to complete VAERS report online
2021-11-21	Unsuccessful
2022-02-18	Unsuccessful
2022-08-20	Unsuccessful

Free text

Release 9 — days 1–6 daily, dose 1

2021-08-23

Systemic reaction (other): Back pain deep below left shoulder blade, radiating to left side of neck, shoulder, and length of the arm

2021-08-24

Systemic reaction (other): Irritated airway, like the feeling that I have something building that causes the need to clear my throat. A brief, productive cough.

2021-08-25

Systemic reaction (other): A feeling of irritation in my airway, like the menthol sensation of having a cough drop.

Release 9 — day 7, dose 1

2021-08-27

Systemic reaction (other): Discomfort/ irritation in my airway

Release 9 — day 14, dose 1

2021-09-05

Symptoms: Lightning pain in right shoulderblade and left side of head

Release 9 — day 21, single dose

2021-09-10

Symptoms: Shortness of breath, hot flashes, fatigue, joint pain

Release 9 — day 28, single dose

2021-09-17

Symptoms: Lightning headaches are intensifying

Release 9 — day 35, single dose

2021-09-24

Symptoms: Mixed connective tissue disease

Release 9 — day 42, single dose

2021-10-01

Symptoms: Muscle aches, dry/gritty eyes

Release 10 — 3 months, dose 1

2021-11-21

Symptoms: I developed pneumonia when the rest of my family had a mild head cold, with lingering symptoms of pain and pressure beyond 3 weeks in the same area of my chest and back that felt discomfort after the vaccine.

Release 11 — 6 months, dose 1

2022-02-18

Symptoms: Dizziness, shortness of breath, heart palpitations

Release 12 — 12 months, dose 1

2022-08-20

Symptoms: Symptoms of heart attacks Feeling of fiberglass in chest Extreme dizziness and fatigue Blurred visio

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	Arthralgia	·	·	✓
SD	Back pain	·	·	✓
SD	Chest discomfort	·	·	✓
SD	Chest pain	·	·	✓
SD	Discomfort	·	·	✓
SD	Dizziness	·	·	✓
SD	Dry eye	·	·	✓
SD	Dyspnoea	·	·	✓
SD	Fatigue	·	·	✓
SD	Foreign body sensation in eyes	·	·	✓
SD	Headache	✓	·	✓
SD	Hot flush	·	·	✓
SD	Mixed connective tissue disease	·	·	✓
SD	Musculoskeletal discomfort	·	·	✓
SD	Musculoskeletal pain	✓	·	✓
SD	Myalgia	·	·	✓
SD	Myocardial infarction	·	·	✓
SD	Palpitations	·	·	✓
SD	Pneumonia	·	·	✓
SD	Thunderclap headache	·	·	✓
SD	Vision blurred	·	·	✓
SRO	Arthralgia	✓	·	✓
SRO	Back pain	✓	·	✓
SRO	Bronchial irritation	✓	·	✓
SRO	Neck pain	✓	·	✓
SRO	Pain in extremity	✓	·	✓
SRO	Productive cough	✓	·	✓
SRO	Respiratory tract irritation	✓	·	✓
SRO	Throat clearing	✓	·	✓

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