Z7P-29135-64908

6 vaccinations 11 coded responses 34 check-ins 11 free-text entries 6 call cases

Sex: Female
Age at first dose: 31-35
ZIP prefix: 481 / MI
Registered: 2021-01-07

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

2021-01-07
Registered in v-safe
2021-01-07
Dose 1 — Pfizer-BioNTech
2021-01-07
Health check-in — day 0, dose 1
Feeling: Fair · Site: Pain · None

Adult check-in
2021-01-08
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-10
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-11
Survey response — days 1–6 daily, dose 1
MedDRA: Medical counselling, Pre-existing disease — Feeling: Poor · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain, Rash, not including the immediate area around the injection site · 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: Systemic reaction (other): I do have Crohn's Disease and many of my symptoms may be due to this not the vaccine per se. · Healthcare visit (other): I messaged my Gastroenterologist through my patient portal

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-11
Report sent to call center — days 1–6 daily, dose 1
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)
2021-01-12
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Fair · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: These two symptoms are most likely due to my Crohn's Disease, rather than the vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-12
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-14
Survey response — day 7, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: I also have Crohns Disease and eczema

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-21
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-28
Dose 2 — Pfizer-BioNTech
2021-01-28
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-01-29
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-01-30
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness

Adult check-in
2021-01-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-01
Survey response — days 1–6 daily, dose 2
MedDRA: Crohn's disease, Fatigue, Pre-existing disease — Feeling: Fair · Fatigue or tiredness

Free text: I have Crohns Disease and I think the fatigue has more to do with that than the shot

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-02
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-03
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-04
Survey response — day 7, dose 2
MedDRA: Pre-existing disease — Feeling: Fair · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: I have Crohns Disease and I have an infusion coming up, so I tend to get symptoms from that around this time

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-11
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-02-18
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-22
Call 2 — Left Voicemail
2021-02-25
Survey response — day 28, dose 2
MedDRA: Fatigue, Nausea, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, Sinus pain — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities

Free text: Ive had some sinus pain, congestion, runny nose, nausea, fatigue, and a sore throat mostly only in the morning when I wake up. I have had no fever or any other problems.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-04
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-11
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-29
Health check-in — 3 months, dose 2
Feeling: Fair

Adult check-in
2021-07-29
Survey response — 6 months, dose 2
MedDRA: Abdominal pain, Arthralgia, Constipation, Crohn's disease, Diarrhoea, Fatigue, Muscle spasms, Nausea, Pre-existing disease, Pyrexia — Feeling: Poor · 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: I am having an active flare of my Crohns disease. Ive been having diarrhea, cramping, joint pain, nausea, fatigue, constipation, chronic low grade fever, and abdominal pain.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-07-29
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

1 call case(s)
2021-08-03
Call 2 — Left Voicemail
2021-08-20
Dose 3 — Pfizer-BioNTech
2021-09-30
Health check-in — day 35, dose 3
Feeling: Fair

Adult check-in
2021-10-01
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-11-19
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-01-20
Dose 4 — Pfizer-BioNTech
2022-02-18
Survey response — 6 months, dose 3
MedDRA: Arthralgia, Autoantibody positive, Crohn's disease, Pre-existing disease, Respiratory disorder, Vasculitis — Feeling: Good · 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

Free text: My Crohn's disease has been in a flare and I have developed auto-antibodies against neutrophils causing some vasculitis causing joint pain and upper respiratory problems.

MedDRA releases: 2024-11 · check-in free text available
2022-02-18
Report sent to call center — 6 months, dose 3
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 · 1 call case(s)
2022-02-24
Call 2 — Left Voicemail
2022-05-28
Dose 5 — Pfizer-BioNTech
2022-08-20
Survey response — 12 months, dose 3
MedDRA: Arthralgia, Cough, Ear pain, Fatigue, Granulomatosis with polyangiitis, Nasal ulcer, Pharyngeal ulceration — 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: Suspected granulomatosis with polyangitis: lesions in nose and throat, ear pain, coughing, fatigue, joint pain.

MedDRA releases: 2024-11 · check-in free text available
2022-08-20
Report sent to call center — 12 months, dose 3
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)
2022-08-22
Call 3 — Left Voicemail
2022-08-22
Call 2 — Left Voicemail
2022-08-22
Call 3 — Left Voicemail
2022-08-22
Call 3 — Left Voicemail
2022-08-29
Call 2 — Left Voicemail
2022-09-30
Dose 6 — Pfizer-BioNTech
2022-10-22
Survey response — day 21, dose 6
MedDRA: Crohn's disease, Pre-existing disease — Feeling: Good

Free text: I do have some flare ups of my Crohn's disease when I receive vaccines

MedDRA releases: 2024-11 · check-in free text available
2022-10-28
Health check-in — day 28, dose 6
Feeling: Good

Adult check-in
2022-11-04
Health check-in — day 35, dose 6
Feeling: Fair

Adult check-in
2022-11-11
Health check-in — day 42, dose 6
Feeling: Fair

Adult check-in
2022-12-30
Survey response — 3 months, dose 6
MedDRA: Haematocrit decreased, Haemoglobin decreased, Red blood cell count decreased, Sacroiliitis — 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

Free text: Low red blood cell count, hemoglobin, and hematocrit. Sacroilitis

MedDRA releases: 2024-11 · check-in free text available
2022-12-30
Report sent to call center — 3 months, dose 6
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 · 1 call case(s)
2023-01-03
Call 1 — Left Voicemail
2023-01-03
Call 1 — Left Voicemail
2023-01-03
Call 1 — Left Voicemail
2023-01-03
Call 1 — Left Voicemail
2023-01-03
Call 1 — Left Voicemail
2023-01-03
Call 1 — Left Voicemail
2023-03-31
Health check-in — 6 months, dose 6
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-07	Pfizer-BioNTech
2	2021-01-28	Pfizer-BioNTech
3	2021-08-20	Pfizer-BioNTech	No
4	2022-01-20	Pfizer-BioNTech	No
5	2022-05-28	Pfizer-BioNTech	No
6	2022-09-30	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-01-11	Unsuccessful
2021-01-12	Unsuccessful
2021-07-29	Unsuccessful
2022-02-18	Unsuccessful
2022-08-20	Unsuccessful
2022-12-30	Unsuccessful

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-11

Systemic reaction (other): I do have Crohn's Disease and many of my symptoms may be due to this not the vaccine per se.

Healthcare visit (other): I messaged my Gastroenterologist through my patient portal

2021-01-12

Systemic reaction (other): These two symptoms are most likely due to my Crohn's Disease, rather than the vaccine

Release 2 — day 7, dose 1

2021-01-14

Systemic reaction (other): I also have Crohns Disease and eczema

Release 3 — days 1–6 daily, dose 2

2021-02-01

Systemic reaction (other): I have Crohns Disease and I think the fatigue has more to do with that than the shot

Release 3 — day 7, dose 2

2021-02-04

Systemic reaction (other): I have Crohns Disease and I have an infusion coming up, so I tend to get symptoms from that around this time

Release 4 — day 28, dose 2

2021-02-25

Symptoms: Ive had some sinus pain, congestion, runny nose, nausea, fatigue, and a sore throat mostly only in the morning when I wake up. I have had no fever or any other problems.

Release 9 — 6 months, dose 2

2021-07-29

Symptoms: I am having an active flare of my Crohns disease. Ive been having diarrhea, cramping, joint pain, nausea, fatigue, constipation, chronic low grade fever, and abdominal pain.

Release 11 — 6 months, dose 3

2022-02-18

Symptoms: My Crohn's disease has been in a flare and I have developed auto-antibodies against neutrophils causing some vasculitis causing joint pain and upper respiratory problems.

Release 12 — 12 months, dose 3

2022-08-20

Symptoms: Suspected granulomatosis with polyangitis: lesions in nose and throat, ear pain, coughing, fatigue, joint pain.

Release 12 — day 21, dose 6

2022-10-22

Symptoms: I do have some flare ups of my Crohn's disease when I receive vaccines

Release 12 — 3 months, dose 6

2022-12-30

Symptoms: Low red blood cell count, hemoglobin, and hematocrit. Sacroilitis

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	Medical counselling	✓	✓	✓
HCVO	Telemedicine	○	○	○
SD	Abdominal pain	✓	·	✓
SD	Arthralgia	✓	·	✓
SD	Autoantibody positive	·	·	✓
SD	Constipation	✓	·	✓
SD	Cough	·	·	✓
SD	Crohn's disease	✓	·	✓
SD	Diarrhoea	✓	·	✓
SD	Ear pain	·	·	✓
SD	Fatigue	✓	✓	✓
SD	Granulomatosis with polyangiitis	·	·	✓
SD	Haematocrit decreased	·	·	✓
SD	Haemoglobin decreased	·	·	✓
SD	Muscle spasms	✓	·	✓
SD	Nasal ulcer	·	·	✓
SD	Nausea	✓	✓	✓
SD	Oropharyngeal pain	✓	✓	✓
SD	Pharyngeal ulceration	·	·	✓
SD	Pre-existing disease	✓	·	✓
SD	Pyrexia	✓	·	✓
SD	Red blood cell count decreased	·	·	✓
SD	Respiratory disorder	·	·	✓
SD	Respiratory tract congestion	✓	✓	✓
SD	Rhinorrhoea	✓	✓	✓
SD	Sacroiliitis	·	·	✓
SD	Sinus pain	✓	✓	✓
SD	Vasculitis	·	·	✓
SRO	Crohn's disease	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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