2YF-23425-79998

2 vaccinations 10 coded responses 17 check-ins 10 free-text entries 4 call cases

Sex: Female
Age at first dose: 51-55
ZIP prefix: 606 / IL
Registered: 2021-03-19

Relationship: Self
Race: Black or African American
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-03-17
Dose 1 — Pfizer-BioNTech
2021-03-19
Registered in v-safe
2021-03-19
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Redness, Swelling · None

Adult check-in
2021-03-20
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Redness, Swelling, Itching · None

Adult check-in
2021-03-21
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Redness, Swelling · None

Adult check-in
2021-03-22
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Redness, Swelling, Itching · None

Adult check-in
2021-03-23
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Redness · Muscle or body aches · Be unable to do your normal daily activities

Adult check-in
2021-03-24
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-04-01
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-04-07
Dose 2 — Pfizer-BioNTech
2021-04-07
Survey response — day 0, dose 2
MedDRA: Haematochezia, Nausea, Pre-existing disease, Unevaluable event, Vomiting — Feeling: Good · Site: Pain · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Last Friday, I experienced nausea and vomiting. Three days ago, I noticed blood in my stool consistent with a flare up of Crohns Disease. I had been in remission and symptom-free since September 2015. · Healthcare visit (other): I will be making an appointment with a gastroenterologist

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-07
Report sent to call center — day 0, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-08
Survey response — days 1–6 daily, dose 2
MedDRA: Decreased appetite — Feeling: Poor · Site: Pain · Chills, Headache, Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Loss of appetite

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-09
Survey response — days 1–6 daily, dose 2
MedDRA: Condition aggravated, Haematochezia — Feeling: Poor · Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Increased bloody stool

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-10
Survey response — days 1–6 daily, dose 2
MedDRA: Haematochezia — Feeling: Good

Free text: bloody stool

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-11
Survey response — days 1–6 daily, dose 2
MedDRA: Haematochezia — Feeling: Good

Free text: Bloody stool

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-13
Survey response — days 1–6 daily, dose 2
MedDRA: Haematochezia — Feeling: Good

Free text: Bloody stool

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-14
Survey response — day 7, dose 2
MedDRA: Haematochezia — Feeling: Good

Free text: Bloody stool

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-22
Survey response — day 14, dose 2
MedDRA: Frequent bowel movements, Haematochezia, Office visit, Unevaluable event — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: I continue to experience bloody stool with increasing frequency. Ive seen my gastroenterologist and am setting up appointments for testing. · Healthcare visit (other): Upper and lower GI and colonoscopy to be scheduled.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-22
Report sent to call center — day 14, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-29
Survey response — day 21, dose 2
MedDRA: Crohn's disease, Haematochezia, Office visit, Pre-existing disease — Feeling: Fair · Be unable to work, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: Increased presence of blood in stool signifying reflare of Crohns Disease. · Healthcare visit (other): Pending upper and lower GI, colonoscopy and blood work.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-29
Report sent to call center — day 21, dose 2
Be unable to work · Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-17
Survey response — day 35, dose 2
MedDRA: Chronic disease, Crohn's disease, Pre-existing disease, Rapid eye movements sleep abnormal, Unevaluable event — Feeling: Fair · 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

Free text: Symptoms: I no longer see the need to complete this survey when, FOR WEEKS, I have indicated that 10 days following my first dose I began seeing symptoms of a Crohns Disease flare up. · Healthcare visit (other): I am fully OUT of remission. Prior to my first dose, I had been in remission for over 5 years! Since no one considers this experience to be worth TALKING with me about, these surveys are a waist of my time! I will participate no further!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-17
Report sent to call center — day 35, dose 2
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)
2022-01-10
Call 1 — Could Not Reach Participant
2022-01-13
Call 2 — Could Not Reach Participant

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-17	Pfizer-BioNTech
2	2021-04-07	Pfizer-BioNTech

Call center

4 call center cases

4 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 7 — day 0, dose 2

2021-04-07

Systemic reaction (other): Last Friday, I experienced nausea and vomiting. Three days ago, I noticed blood in my stool consistent with a flare up of Crohns Disease. I had been in remission and symptom-free since September 2015.

Healthcare visit (other): I will be making an appointment with a gastroenterologist

Release 7 — days 1–6 daily, dose 2

2021-04-08

Systemic reaction (other): Loss of appetite

2021-04-09

Systemic reaction (other): Increased bloody stool

2021-04-10

Systemic reaction (other): bloody stool

2021-04-11

Systemic reaction (other): Bloody stool

2021-04-13

Systemic reaction (other): Bloody stool

Release 7 — day 7, dose 2

2021-04-14

Systemic reaction (other): Bloody stool

Release 7 — day 14, dose 2

2021-04-22

Symptoms: I continue to experience bloody stool with increasing frequency. Ive seen my gastroenterologist and am setting up appointments for testing.

Healthcare visit (other): Upper and lower GI and colonoscopy to be scheduled.

Release 8 — day 21, dose 2

2021-04-29

Symptoms: Increased presence of blood in stool signifying reflare of Crohns Disease.

Healthcare visit (other): Pending upper and lower GI, colonoscopy and blood work.

Release 8 — day 35, dose 2

2021-05-17

Symptoms: I no longer see the need to complete this survey when, FOR WEEKS, I have indicated that 10 days following my first dose I began seeing symptoms of a Crohns Disease flare up.

Healthcare visit (other): I am fully OUT of remission. Prior to my first dose, I had been in remission for over 5 years! Since no one considers this experience to be worth TALKING with me about, these surveys are a waist of my time! I will participate no further!

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	✓	✓	✓
HCVO	Pre-existing disease	·	·	✓
HCVO	Rapid eye movements sleep abnormal	○	✓	○
HCVO	Unevaluable event	✓	✓	✓
SD	Chronic disease	○	✓	○
SD	Crohn's disease	✓	✓	✓
SD	Frequent bowel movements	✓	✓	✓
SD	Haematochezia	✓	✓	✓
SD	Office visit	✓	·	✓
SD	Pre-existing disease	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Decreased appetite	✓	✓	✓
SRO	Haematochezia	✓	✓	✓
SRO	Nausea	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Vomiting	✓	✓	✓

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