4NN-13249-02623

3 vaccinations 8 coded responses 43 check-ins 8 free-text entries 2 call cases

Sex: Female
Age at first dose: 36-40
ZIP prefix: 407 / KY
Registered: 2021-01-11

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

2021-01-11
Registered in v-safe
2021-01-11
Dose 1 — Moderna
2021-01-11
Health check-in — day 0, dose 1
Feeling: Good · None

Adult check-in
2021-01-12
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Muscle or body aches

Adult check-in
2021-01-14
Survey response — days 1–6 daily, dose 1
MedDRA: Glossodynia, Tongue discomfort — Feeling: Good · Fatigue or tiredness

Free text: My tongue has felt like its burning and hurts since the vaccine.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-15
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-16
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-18
Health check-in — day 7, dose 1
Feeling: Fair · Headache, Fatigue or tiredness

Adult check-in
2021-01-25
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-01
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-08
Survey response — day 28, dose 1
MedDRA: Injection site pruritus — Feeling: Good

Free text: Arm has been a little itchy at the vaccine site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-15
Health check-in — day 35, dose 1
Feeling: Good

Adult check-in
2021-02-22
Dose 2 — Moderna
2021-02-22
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-02-23
Survey response — days 1–6 daily, dose 2
MedDRA: Eye irritation, Hot flush, Tremor — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Shaking feeling inside, eyes burning, face felt hot

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-24
Survey response — days 1–6 daily, dose 2
MedDRA: Neck pain, Oropharyngeal pain — Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Extreme neck pain, throat is a little sore

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-25
Survey response — days 1–6 daily, dose 2
MedDRA: Musculoskeletal stiffness, Neck pain — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Neck pain and stiffness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-26
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness, Swelling, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-02-27
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-02-28
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-03-02
Health check-in — day 7, dose 2
Feeling: Good · Site: Redness, Itching · Fatigue or tiredness

Adult check-in
2021-03-08
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-03-15
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-22
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-29
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-04-05
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-24
Survey response — 3 months, dose 2
MedDRA: Aphonia, Dysphagia, Emergency care, Odynophagia, Office visit, Oropharyngeal pain, Self-medication, Streptococcus test negative — Feeling: Good · Be unable to work, 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

Free text: Sore throat, couldnt talk, couldnt swallow Extreme painNegative for strep and covid at instant urgent care. Seeked help at the local ER the next day.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-24
Report sent to call center — 3 months, 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)
2021-08-23
Survey response — 6 months, dose 2
MedDRA: Cough, Malaise, SARS-CoV-2 test negative — 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

Free text: I feel like I have stayed sick since getting the vaccines. Ive kept a constant cough and when I get any least bit Ill it hits me hard. I have been tested for covid numerous times and been negative.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-23
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)
2021-08-25
Call 1 — Could Not Reach Participant
2021-08-30
Call 2 — Left Voicemail
2022-02-24
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-07-29
Dose 3 — Moderna
2022-07-29
Health check-in — day 0, dose 3
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2022-07-30
Survey response — days 1–6 daily, dose 3
MedDRA: Dizziness — Feeling: Poor · Site: Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Dizziness

MedDRA releases: 2024-11 · check-in free text available
2022-07-31
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain, Redness, Itching · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2022-08-01
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain, Redness, Itching · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-08-02
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain, Itching · Fatigue or tiredness

Adult check-in
2022-08-03
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Itching · Fatigue or tiredness

Adult check-in
2022-08-04
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Fatigue or tiredness

Adult check-in
2022-08-05
Health check-in — day 7, dose 3
Feeling: Good · Fatigue or tiredness

Adult check-in
2022-08-12
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2022-08-19
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2022-08-26
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2022-09-02
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2022-09-09
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-10-28
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2023-01-29
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-11	Moderna
2	2021-02-22	Moderna
3	2022-07-29	Moderna	No

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-14

Systemic reaction (other): My tongue has felt like its burning and hurts since the vaccine.

Release 3 — day 28, dose 1

2021-02-08

Symptoms: Arm has been a little itchy at the vaccine site

Release 4 — days 1–6 daily, dose 2

2021-02-23

Systemic reaction (other): Shaking feeling inside, eyes burning, face felt hot

2021-02-24

Systemic reaction (other): Extreme neck pain, throat is a little sore

2021-02-25

Systemic reaction (other): Neck pain and stiffness

Release 8 — 3 months, dose 2

2021-05-24

Symptoms: Sore throat, couldnt talk, couldnt swallow Extreme painNegative for strep and covid at instant urgent care. Seeked help at the local ER the next day.

Release 9 — 6 months, dose 2

2021-08-23

Symptoms: I feel like I have stayed sick since getting the vaccines. Ive kept a constant cough and when I get any least bit Ill it hits me hard. I have been tested for covid numerous times and been negative.

Release 12 — days 1–6 daily, dose 3

2022-07-30

Systemic reaction (other): Dizziness

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
SD	Aphonia	✓	✓	✓
SD	Cough	✓	·	✓
SD	Dysphagia	✓	✓	✓
SD	Emergency care	✓	✓	✓
SD	Injection site pruritus	✓	✓	✓
SD	Malaise	✓	·	✓
SD	Odynophagia	✓	✓	✓
SD	Office visit	✓	✓	✓
SD	Oropharyngeal pain	✓	✓	✓
SD	SARS-CoV-2 test negative	✓	·	✓
SD	Self-medication	✓	✓	✓
SD	Streptococcus test negative	✓	✓	✓
SRO	Dizziness	·	·	✓
SRO	Eye irritation	✓	✓	✓
SRO	Glossodynia	✓	✓	✓
SRO	Hot flush	✓	✓	✓
SRO	Musculoskeletal stiffness	✓	✓	✓
SRO	Neck pain	✓	✓	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Tongue discomfort	✓	✓	✓
SRO	Tremor	✓	✓	✓

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