48S-16356-05387

2 vaccinations 7 coded responses 7 check-ins 7 free-text entries 6 call cases

Sex: Female
Age at first dose: 46-50
ZIP prefix: 245 / VA
Registered: 2021-05-18

Relationship: Self
Race: American Indian or Alaska Native
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-05-13
Dose 1 — Moderna
2021-05-18
Registered in v-safe
2021-05-20
Survey response — day 7, dose 1
MedDRA: Abdominal pain upper, Chills, Crohn's disease, Decreased appetite, Headache, Pain, Pre-existing disease — Feeling: Poor · Site: Itching · Fever · Chills, Headache, Muscle or body aches, Nausea, Diarrhea, Abdominal pain · 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 had the shot on 5/13 I have crohns and Im still having stomach pains, list of appetite, chills, headaches, body aches, like Im having a crohn flare up. · Healthcare visit (other): Made an appointment with my GI. Ive been in remission for 2 yrs. i

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-20
Report sent to call center — day 7, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-27
Survey response — day 14, dose 1
MedDRA: Abdominal pain upper, Decreased appetite — Feeling: Poor · 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: Stomach pain, little appetite,

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-27
Report sent to call center — day 14, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-03
Dose 2 — Moderna
2021-06-03
Survey response — day 0, dose 2
MedDRA: Crohn's disease, Diarrhoea, Pre-existing disease — Feeling: Poor · Site: Itching · Headache, Joint pains, Muscle or body aches, Nausea, Diarrhea, Abdominal pain · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): I have crohns im having symptoms like a flare up since the first vaccine. · Healthcare visit (other): Made an appointment with GI doctor had dirrehhea so bad could not attend. Rescheduled

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-03
Survey response — day 21, dose 1
MedDRA: Abdominal pain upper, Abnormal faeces, Appetite disorder, Headache, Unevaluable event — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: Continue to have stomach pains like having a flare up. Change in my appetite. Change in my stools, and headache. · Healthcare visit (other): Doctor appointment. Waiting on blood work to come back

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-03
Report sent to call center — day 0, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-03
Report sent to call center — day 21, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-24
Survey response — day 21, dose 2
MedDRA: Gallbladder disorder, Office visit — 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

Free text: Symptoms: Appt with GI now going for ultrasound. Thinking its gallbladder no relief · Healthcare visit (other): Visit to the doctor

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-24
Report sent to call center — day 21, 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)
2021-06-30
Call 1 — Left Voicemail
2021-12-02
Survey response — 6 months, dose 2
MedDRA: Hospitalisation — 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 · Emergency room or emergency department visit, Hospitalization

Free text: I was put in the hospital 10/23 flare up. It's believed it was caused from the covid vaccine on 5/13.

MedDRA releases: 2024-11 · check-in free text available
2021-12-02
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

Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2021-12-03
Call 1 — Left Voicemail
2021-12-16
Call 2 — Could Not Reach Participant
2021-12-16
Call successful
Completed over the phone
2022-06-03
Survey response — 12 months, dose 2
MedDRA: Adverse reaction — Feeling: Good · Be unable to do your normal daily activities

Free text: Last flare up April 10, 2022

MedDRA releases: 2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-05-13	Moderna
2	2021-06-03	Moderna

Call center

6 call center cases

6 successful

VAERS report filed, before or during a call: 6

See the call center timeline

Free text

Release 8 — day 7, dose 1

2021-05-20

Systemic reaction (other): I had the shot on 5/13 I have crohns and Im still having stomach pains, list of appetite, chills, headaches, body aches, like Im having a crohn flare up.

Healthcare visit (other): Made an appointment with my GI. Ive been in remission for 2 yrs. i

Release 8 — day 14, dose 1

2021-05-27

Symptoms: Stomach pain, little appetite,

Release 8 — day 21, dose 1

2021-06-03

Symptoms: Continue to have stomach pains like having a flare up. Change in my appetite. Change in my stools, and headache.

Healthcare visit (other): Doctor appointment. Waiting on blood work to come back

Release 8 — day 0, dose 2

2021-06-03

Systemic reaction (other): I have crohns im having symptoms like a flare up since the first vaccine.

Healthcare visit (other): Made an appointment with GI doctor had dirrehhea so bad could not attend. Rescheduled

Release 9 — day 21, dose 2

2021-06-24

Symptoms: Appt with GI now going for ultrasound. Thinking its gallbladder no relief

Healthcare visit (other): Visit to the doctor

Release 10 — 6 months, dose 2

2021-12-02

Symptoms: I was put in the hospital 10/23 flare up. It's believed it was caused from the covid vaccine on 5/13.

Release 11 — 12 months, dose 2

2022-06-03

Symptoms: Last flare up April 10, 2022

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	Diarrhoea	✓	✓	✓
HCVO	Office visit	✓	✓	✓
HCVO	Pre-existing disease	✓	✓	✓
HCVO	Unevaluable event	✓	✓	✓
SD	Abdominal pain upper	✓	✓	✓
SD	Abnormal faeces	✓	✓	✓
SD	Adverse reaction	·	·	✓
SD	Appetite disorder	✓	✓	✓
SD	Decreased appetite	✓	✓	✓
SD	Gallbladder disorder	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Hospitalisation	·	·	✓
SRO	Abdominal pain upper	✓	✓	✓
SRO	Chills	✓	✓	✓
SRO	Crohn's disease	✓	✓	✓
SRO	Decreased appetite	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓

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