5EM-13703-16282

4 vaccinations 8 coded responses 31 check-ins 7 free-text entries 5 call cases

Sex: Female
Age at first dose: 46-50
ZIP prefix: 275 / NC
Registered: 2021-03-25

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

2021-03-25
Registered in v-safe
2021-03-25
Dose 1 — Pfizer-BioNTech
2021-03-25
Health check-in — day 0, dose 1
Feeling: Fair · Site: Pain · None

Adult check-in
2021-03-26
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Pain, Swelling · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-03-27
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-03-28
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches · Be unable to do your normal daily activities

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

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

Adult check-in
2021-04-01
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-04-08
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-04-15
Dose 2 — Pfizer-BioNTech
2021-04-15
Health check-in — day 0, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-16
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Swelling · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-17
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site pain, Injection site pruritus — Feeling: Poor · Site: Pain, Swelling, Itching · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: The injection site began stinging as if Id gotten stung by a very potent bee yesterday and now its beginning to itch as well, just like a bad bee sting would

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-18
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Itching · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-19
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Swelling · Fatigue or tiredness

Adult check-in
2021-04-20
Survey response — days 1–6 daily, dose 2
MedDRA: Dysphonia, Vocal cord inflammation — Feeling: Fair · Site: Pain · Fatigue or tiredness

Free text: My vocal cords are inflamed so it sounds funny when I talk

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-21
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-04-22
Health check-in — day 7, dose 2
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-04-29
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-05-06
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-05-13
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-20
Survey response — day 35, dose 2
MedDRA: Urinary tract infection — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: UTI

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-20
Report sent to call center — day 35, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-27
Survey response — day 42, dose 2
MedDRA: Kidney infection, Pre-existing disease, Urinary tract disorder — Feeling: Poor · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Developed Kidney infections. I have pre-existing urinary system issues

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-27
Report sent to call center — day 42, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-15
Survey response — 3 months, dose 2
MedDRA: Gastrointestinal infection, Intestinal obstruction, Intestinal resection, Surgery — 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: Bowel obstruction and multiple infections surgery to correct obstruction (bowel resection) · Healthcare visit (other): Surgery

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-07-15
Report sent to call center — 3 months, dose 2
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

1 call case(s)
2021-07-22
Call 1 — Left Voicemail
2021-10-14
Survey response — 6 months, dose 2
MedDRA: Ankle fracture, Infection, Intestinal obstruction — 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 · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit, Hospitalization

Free text: Bowel obstruction, multiple infections, broken ankle

MedDRA releases: 2024-11 · check-in free text available
2021-10-14
Report sent to call center — 6 months, dose 2
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2021-11-05
Dose 3 — Pfizer-BioNTech
2022-04-17
Survey response — 12 months, dose 2
MedDRA: Nervous system disorder — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Neurological problems

MedDRA releases: 2024-11 · check-in free text available
2022-04-17
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-04-19
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-10-06
Dose 4 — Pfizer-BioNTech
Co-administered: Flu
2022-10-20
Health check-in — day 14, dose 4
Feeling: Fair

Adult check-in
2022-10-29
Health check-in — day 21, dose 4
Feeling: Fair

Adult check-in
2022-11-05
Health check-in — day 28, dose 4
Feeling: Fair

Adult check-in
2022-11-10
Health check-in — day 35, dose 4
Feeling: Fair

Adult check-in
2022-11-17
Health check-in — day 42, dose 4
Feeling: Fair

Adult check-in
2023-01-05
Survey response — 3 months, dose 4
MedDRA: Hernia repair — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2024-11
2023-04-06
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-25	Pfizer-BioNTech
2	2021-04-15	Pfizer-BioNTech
3	2021-11-05	Pfizer-BioNTech	No
4	2022-10-06	Pfizer-BioNTech	Flu

Call center

5 call center cases

5 successful

See the call center timeline

Free text

Release 7 — days 1–6 daily, dose 2

2021-04-17

Systemic reaction (other): The injection site began stinging as if Id gotten stung by a very potent bee yesterday and now its beginning to itch as well, just like a bad bee sting would

2021-04-20

Systemic reaction (other): My vocal cords are inflamed so it sounds funny when I talk

Release 8 — day 35, dose 2

2021-05-20

Symptoms: UTI

Release 8 — day 42, dose 2

2021-05-27

Symptoms: Developed Kidney infections. I have pre-existing urinary system issues

Release 9 — 3 months, dose 2

2021-07-15

Symptoms: Bowel obstruction and multiple infections surgery to correct obstruction (bowel resection)

Healthcare visit (other): Surgery

Release 10 — 6 months, dose 2

2021-10-14

Symptoms: Bowel obstruction, multiple infections, broken ankle

Release 11 — 12 months, dose 2

2022-04-17

Symptoms: Neurological problems

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	Surgery	✓	·	✓
SD	Ankle fracture	·	·	✓
SD	Gastrointestinal infection	✓	·	✓
SD	Hernia repair	·	·	✓
SD	Infection	·	·	✓
SD	Intestinal obstruction	✓	·	✓
SD	Intestinal resection	✓	·	✓
SD	Kidney infection	✓	✓	✓
SD	Nervous system disorder	·	·	✓
SD	Pre-existing disease	✓	✓	✓
SD	Urinary tract disorder	✓	✓	✓
SD	Urinary tract infection	✓	✓	✓
SRO	Dysphonia	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Injection site pruritus	✓	✓	✓
SRO	Vocal cord inflammation	✓	✓	✓

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