ZNP-28689-52276

4 vaccinations 14 coded responses 30 check-ins 13 free-text entries 11 call cases

Sex: Female
Age at first dose: 21-25
ZIP prefix: 727 / AR
Registered: 2021-01-13

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

2021-01-13
Registered in v-safe
2021-01-13
Dose 1 — Pfizer-BioNTech
2021-01-13
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · Muscle or body aches

Adult check-in
2021-01-14
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-01-14
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-16
Survey response — days 1–6 daily, dose 1
MedDRA: Mouth ulceration, Pharyngeal ulceration, Pre-existing disease — Feeling: Poor · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: I have ulcers in my mouth and throat. Probably unrelated to the vaccine as I have had these sort my whole life.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-16
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-17
Survey response — days 1–6 daily, dose 1
MedDRA: Mouth ulceration, Oropharyngeal pain — Feeling: Fair · Fatigue or tiredness

Free text: Sore throat from the mouth ulcers

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-18
Survey response — days 1–6 daily, dose 1
MedDRA: Blister, Pharyngeal ulceration, Tongue ulceration — Feeling: Fair · Fatigue or tiredness · 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: Ulcers in my throat, under my tongue, and clear filled blister

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-18
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-19
Survey response — days 1–6 daily, dose 1
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Poor · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Ulcers in my mouth and throat are getting worse unlike any I have had before

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-22
Survey response — day 7, dose 1
MedDRA: Mouth ulceration, Pharyngeal ulceration — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Still have the ulcers in my mouth and throat

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-22
Report sent to call center — day 7, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-27
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-03
Dose 2 — Pfizer-BioNTech
2021-02-03
Health check-in — day 0, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-04
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-02-05
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy, Mouth ulceration — Feeling: Poor · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Underarm lymphnode is swollen and mouth ulcers again

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Muscle or body aches

Adult check-in
2021-02-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-09
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-10
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-02-17
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-24
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-03
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-10
Survey response — day 35, dose 2
MedDRA: Dizziness, Malaise, Nausea, Somnolence — Feeling: Poor · Be unable to do your normal daily activities

Free text: Dizziness and nausea. Im sleepy and feel unwell. Its my day off, so I am resting.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-12
Call 1 — Left Voicemail
2021-03-17
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-03-17
Call successful
Does not wish to fill out VAERS report
2021-03-17
Call successful
Does not wish to fill out VAERS report
2021-03-17
Call successful
Does not wish to fill out VAERS report
2021-03-17
Call successful
Does not wish to fill out VAERS report
2021-05-05
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-08-04
Survey response — 6 months, dose 2
MedDRA: Ageusia, Anosmia, Cough, Dyspnoea, Ear discomfort, Exposure to SARS-CoV-2, Fatigue, Headache, Illness, Oropharyngeal pain, Respiratory tract congestion — 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 · Outpatient clinic or urgent care clinic visit

Free text: Sore throat 14 days. Throat culture negative. Antibiotics. Immediately, 2nd illness: loss of taste/smell, severe congestion, shortness of breath, headache, deep nasty cough, full ears, fatigue. Roommate covid positive.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-04
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)
2021-08-15
Call 1 — Left Voicemail
2021-12-21
Dose 3 — Moderna
2022-02-03
Survey response — 12 months, dose 2
MedDRA: Migraine — 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: Migraines

MedDRA releases: 2024-11 · check-in free text available
2022-02-03
Report sent to call center — 12 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

Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-02-04
Call 1 — Could Not Reach Participant
2022-02-09
Call 2 — Could Not Reach Participant
2022-10-14
Dose 4 — Moderna
2022-10-30
Survey response — day 14, dose 4
MedDRA: Dizziness, Headache, Migraine, Pain, Pre-existing disease — 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, Emergency room or emergency department visit

Free text: Migraine, different from my usual migraines from the Tuesday after I got the shot until now. The first two days after the shot I had typical headache and body ache and dizziness.

MedDRA releases: 2024-11 · check-in free text available
2022-10-30
Report sent to call center — day 14, dose 4
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 · 1 call case(s)
2022-11-01
Call 1 — Left Voicemail
2022-11-04
Survey response — day 21, dose 4
MedDRA: Dizziness, Migraine, Office visit — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: Dizziness, migraine still going · Healthcare visit (other): Neuroscience Institute

MedDRA releases: 2024-11 · check-in free text available
2022-11-04
Report sent to call center — day 21, dose 4
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2022-11-08
Call 2 — Left Voicemail
2022-11-08
Call 3 — Left Voicemail
2022-11-08
Call 2 — Left Voicemail
2022-11-08
Call 1 — Left Voicemail
2022-11-11
Survey response — day 28, dose 4
MedDRA: Migraine — 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 · Outpatient clinic or urgent care clinic visit

Free text: Migraine does not stop

MedDRA releases: 2024-11 · check-in free text available
2022-11-11
Report sent to call center — day 28, dose 4
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)
2022-11-14
Call 3 — Left Voicemail
2022-11-14
Call X — Left Voicemail
2022-11-14
Call 3 — Left Voicemail
2022-11-14
Call 2 — Left Voicemail
2022-11-14
Call 1 — Left Voicemail
2022-11-18
Survey response — day 35, dose 4
MedDRA: Condition aggravated, Medical counselling, Migraine, Pre-existing disease — 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 · Outpatient clinic or urgent care clinic visit

Free text: My doctor thinks the migraines and associated symptoms are due to a flare up of ME/CFS caused by my immune response to the vaccine.

MedDRA releases: 2024-11 · check-in free text available
2022-11-18
Report sent to call center — day 35, dose 4
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)
2022-11-21
Call successful
Does not wish to fill out VAERS report
2022-11-21
Call successful
Does not wish to fill out VAERS report
2022-11-21
Call successful
Does not wish to fill out VAERS report
2022-11-21
Call successful
Does not wish to fill out VAERS report
2022-11-21
Call successful
Does not wish to fill out VAERS report
2022-11-21
Call successful
Does not wish to fill out VAERS report
2022-11-25
Health check-in — day 42, dose 4
Feeling: Fair

Adult check-in
2023-01-18
Survey response — 3 months, dose 4
MedDRA: Condition aggravated, Exposure to SARS-CoV-2, Pre-existing disease, SARS-CoV-2 test negative — 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 · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11
2023-01-18
Report sent to call center — 3 months, dose 4
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)
2023-01-19
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-13	Pfizer-BioNTech
2	2021-02-03	Pfizer-BioNTech
3	2021-12-21	Moderna	No
4	2022-10-14	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-01-14	Successful 2021-03-17	Does not wish to fill out VAERS report
2021-01-16	Successful 2021-03-17	Does not wish to fill out VAERS report
2021-01-18	Successful 2021-03-17	Does not wish to fill out VAERS report
2021-01-22	Successful 2021-03-17	Does not wish to fill out VAERS report
2021-08-04	Successful 2022-11-21	Does not wish to fill out VAERS report
2022-02-03	Successful 2022-11-21	Does not wish to fill out VAERS report
2022-10-30	Successful 2022-11-21	Does not wish to fill out VAERS report
2022-11-04	Successful 2022-11-21	Does not wish to fill out VAERS report
2022-11-11	Successful 2022-11-21	Does not wish to fill out VAERS report
2022-11-18	Successful 2022-11-21	Does not wish to fill out VAERS report
2023-01-18	Unsuccessful

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-16

Systemic reaction (other): I have ulcers in my mouth and throat. Probably unrelated to the vaccine as I have had these sort my whole life.

2021-01-17

Systemic reaction (other): Sore throat from the mouth ulcers

2021-01-18

Systemic reaction (other): Ulcers in my throat, under my tongue, and clear filled blister

2021-01-19

Systemic reaction (other): Ulcers in my mouth and throat are getting worse unlike any I have had before

Release 2 — day 7, dose 1

2021-01-22

Systemic reaction (other): Still have the ulcers in my mouth and throat

Release 3 — days 1–6 daily, dose 2

2021-02-05

Systemic reaction (other): Underarm lymphnode is swollen and mouth ulcers again

Release 5 — day 35, dose 2

2021-03-10

Symptoms: Dizziness and nausea. Im sleepy and feel unwell. Its my day off, so I am resting.

Release 9 — 6 months, dose 2

2021-08-04

Symptoms: Sore throat 14 days. Throat culture negative. Antibiotics. Immediately, 2nd illness: loss of taste/smell, severe congestion, shortness of breath, headache, deep nasty cough, full ears, fatigue. Roommate covid positive.

Release 11 — 12 months, dose 2

2022-02-03

Symptoms: Migraines

Release 12 — day 14, dose 4

2022-10-30

Symptoms: Migraine, different from my usual migraines from the Tuesday after I got the shot until now. The first two days after the shot I had typical headache and body ache and dizziness.

Release 12 — day 21, dose 4

2022-11-04

Symptoms: Dizziness, migraine still going

Healthcare visit (other): Neuroscience Institute

Release 12 — day 28, dose 4

2022-11-11

Symptoms: Migraine does not stop

Release 12 — day 35, dose 4

2022-11-18

Symptoms: My doctor thinks the migraines and associated symptoms are due to a flare up of ME/CFS caused by my immune response to the vaccine.

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	·	·	✓
SD	Ageusia	✓	·	✓
SD	Anosmia	✓	·	✓
SD	Condition aggravated	·	·	✓
SD	Cough	✓	·	✓
SD	Dizziness	✓	✓	✓
SD	Dyspnoea	✓	·	✓
SD	Ear discomfort	✓	·	✓
SD	Exposure to SARS-CoV-2	✓	·	✓
SD	Fatigue	✓	·	✓
SD	Headache	✓	·	✓
SD	Illness	✓	·	✓
SD	Malaise	✓	✓	✓
SD	Medical counselling	·	·	✓
SD	Migraine	·	·	✓
SD	Nausea	✓	✓	✓
SD	Oropharyngeal pain	✓	·	✓
SD	Pain	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Respiratory tract congestion	✓	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Somnolence	✓	✓	✓
SRO	Blister	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Lymphadenopathy	✓	✓	✓
SRO	Mouth ulceration	✓	✓	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Pharyngeal ulceration	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Tongue ulceration	✓	✓	✓

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