3LX-25043-65439

3 vaccinations 20 coded responses 35 check-ins 20 free-text entries 2 call cases

Sex: Female
Age at first dose: 41-45
ZIP prefix: 379 / TN
Registered: 2021-03-13

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

2021-03-13
Registered in v-safe
2021-03-13
Dose 1 — Janssen/Johnson & Johnson
2021-03-13
Survey response — day 0, dose 1
MedDRA: Feeling abnormal, Flushing — Feeling: Good · Site: Pain · Fever · Nausea

Free text: Temporarily flushed face, brain fog

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-14
Survey response — days 1–6 daily, dose 1
MedDRA: Emotional distress — Feeling: Fair · Site: Pain, Redness · Fever · Chills, Joint pains, Fatigue or tiredness

Free text: Emotional

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-15
Survey response — days 1–6 daily, dose 1
MedDRA: Eye pain, Halo vision, Headache, Tinnitus — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness

Free text: Short ringing in ear this morning, ache behind eyes, halo headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-16
Survey response — days 1–6 daily, dose 1
MedDRA: Abdominal pain upper, Sinus disorder, Tinnitus — Feeling: Good · Site: Pain, Redness · Muscle or body aches, Abdominal pain

Free text: Short ringing in ear, some sinus (allergens are high here, so may be unrelated), stomach ache was short-lived

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Redness · Fatigue or tiredness

Adult check-in
2021-03-18
Survey response — days 1–6 daily, dose 1
MedDRA: Intermenstrual bleeding, Menstruation irregular, Tinnitus — Feeling: Good · Site: Pain · Muscle or body aches

Free text: Menstrual spotting (too early in cycle) last night, ringing in ear for a few seconds

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-19
Survey response — days 1–6 daily, dose 1
MedDRA: Angiopathy, Anxiety, Tenderness — Feeling: Good · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Have forgotten to report: Heightened anxiety level since getting vaccine, some minor possibly vascular oddness (tenderness near blood vessels at joints) sometimes

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-21
Health check-in — day 7, dose 1
Feeling: Good · Headache, Muscle or body aches

Adult check-in
2021-03-28
Survey response — day 14, dose 1
MedDRA: Abdominal discomfort, Anxiety, Fatigue, Myalgia — Feeling: Good

Free text: I had some discomfort in my stomach area. The heightened anxiety continued, as did some of the fatigue and muscle aches. Things seem to have improved, however.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-05
Survey response — day 21, single dose
MedDRA: Anxiety, Headache — Feeling: Good

Free text: Headache, continued heightened anxiety

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-11
Survey response — day 28, single dose
MedDRA: Anxiety, Arthralgia, Heavy menstrual bleeding, Myalgia — Feeling: Good

Free text: still high anxiety levels, heavier menstruation (first since vaccine), dull ache in side at times (possibly muscular, though), some joint aches, allergies (sinus)Some of this is certainly unrelated, but am providing info, just in case

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-19
Survey response — day 35, single dose
MedDRA: Anxiety, Arthralgia, Chills, Dizziness, Eye pain, Nausea, Sensory disturbance, Sinus congestion, Sinus headache, Tenderness, Tension, Tension headache, Tinnitus — Feeling: Fair

Free text: Heightened anxiety, Joint aches, Tender fingertips, Tinnitus (left), Odd face sensation, Tension/sinus headache w/pain behind eye, Shoulder/neck tension, mild sinus congestion, Vein in left thumb felt more, Some dizziness, Temporary nausea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-29
Survey response — day 42, single dose
MedDRA: Arthralgia — Feeling: Good

Free text: Not new, but still joint aches, tinnitus, and some other issues

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-09-13
Survey response — 6 months, dose 1
MedDRA: Migraine — Feeling: Good

Free text: Migraine

MedDRA releases: 2024-11 · check-in free text available
2021-10-29
Dose 2 — Pfizer-BioNTech
2021-10-29
Health check-in — day 0, dose 2
Feeling: Good · Site: Pain · Headache, Nausea

Adult check-in
2021-10-30
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-10-31
Survey response — days 1–6 daily, dose 2
MedDRA: Erythema, Feeling hot, Flushing, Skin tightness — Feeling: Good · Site: Pain

Free text: I could not update it, but the evening of the shit, my fave became flushed (red, tight, hot) for a few hours

MedDRA releases: 2024-11 · check-in free text available
2021-11-02
Survey response — days 1–6 daily, dose 2
MedDRA: Lethargy — Feeling: Good · Site: Pain · Fever · Chills, Headache, Fatigue or tiredness

Free text: a bit of lethargy

MedDRA releases: 2024-11 · check-in free text available
2021-11-06
Survey response — day 7, dose 2
MedDRA: Menstruation irregular — Feeling: Good · Site: Redness · Chills

Free text: Began menstrual bleeding on day 17 of cycle

MedDRA releases: 2024-11 · check-in free text available
2021-11-12
Survey response — day 14, dose 2
MedDRA: Dizziness, Menstruation irregular — Feeling: Good

Free text: Dizziness, started period two weeks early

MedDRA releases: 2024-11 · check-in free text available
2021-11-19
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-11-28
Survey response — day 28, dose 2
MedDRA: Palpitations — Feeling: Good

Free text: Heart beats strongly sometimes (perhaps unrelated, given holiday)

MedDRA releases: 2024-11 · check-in free text available
2021-12-05
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-12-12
Survey response — day 42, dose 2
MedDRA: Office visit, Swelling, Uterine leiomyoma — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Swollen uterus, likely fibroid (according to doctor)

MedDRA releases: 2024-11 · check-in free text available
2021-12-12
Report sent to call center — day 42, dose 2
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-12-15
Call 1 — Could Not Reach Participant
2021-12-22
Call 2 — Could Not Reach Participant
2022-04-29
Survey response — 6 months, dose 2
MedDRA: Uterine leiomyoma — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Diagnosed with uterine fibroid

MedDRA releases: 2024-11 · check-in free text available
2022-04-29
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-05-02
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-10-29
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-11-28
Dose 3 — Pfizer-BioNTech
2022-11-29
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

Adult check-in
2022-12-01
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2022-12-02
Survey response — days 1–6 daily, dose 3
MedDRA: Brain fog, Tinnitus — Feeling: Fair · Site: Pain · Fatigue or tiredness, Nausea

Free text: Brain fog, tinnitus

MedDRA releases: 2024-11 · check-in free text available
2022-12-07
Health check-in — day 7, dose 3
Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness

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

Adult check-in
2022-12-20
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2022-12-26
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2023-01-02
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2023-01-11
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-13	Janssen/Johnson & Johnson
2	2021-10-29	Pfizer-BioNTech	No
3	2022-11-28	Pfizer-BioNTech	No

Call center

2 call center cases

2 successful

See the call center timeline

Free text

Release 5 — day 0, dose 1

2021-03-13

Systemic reaction (other): Temporarily flushed face, brain fog

Release 5 — days 1–6 daily, dose 1

2021-03-14

Systemic reaction (other): Emotional

2021-03-15

Systemic reaction (other): Short ringing in ear this morning, ache behind eyes, halo headache

2021-03-16

Systemic reaction (other): Short ringing in ear, some sinus (allergens are high here, so may be unrelated), stomach ache was short-lived

2021-03-18

Systemic reaction (other): Menstrual spotting (too early in cycle) last night, ringing in ear for a few seconds

2021-03-19

Systemic reaction (other): Have forgotten to report: Heightened anxiety level since getting vaccine, some minor possibly vascular oddness (tenderness near blood vessels at joints) sometimes

Release 6 — day 14, dose 1

2021-03-28

Symptoms: I had some discomfort in my stomach area. The heightened anxiety continued, as did some of the fatigue and muscle aches. Things seem to have improved, however.

Release 6 — day 21, single dose

2021-04-05

Symptoms: Headache, continued heightened anxiety

Release 7 — day 28, single dose

2021-04-11

Symptoms: still high anxiety levels, heavier menstruation (first since vaccine), dull ache in side at times (possibly muscular, though), some joint aches, allergies (sinus)Some of this is certainly unrelated, but am providing info, just in case

Release 7 — day 35, single dose

2021-04-19

Symptoms: Heightened anxiety, Joint aches, Tender fingertips, Tinnitus (left), Odd face sensation, Tension/sinus headache w/pain behind eye, Shoulder/neck tension, mild sinus congestion, Vein in left thumb felt more, Some dizziness, Temporary nausea

Release 8 — day 42, single dose

2021-04-29

Symptoms: Not new, but still joint aches, tinnitus, and some other issues

Release 9 — 6 months, dose 1

2021-09-13

Symptoms: Migraine

Release 10 — days 1–6 daily, dose 2

2021-10-31

Systemic reaction (other): I could not update it, but the evening of the shit, my fave became flushed (red, tight, hot) for a few hours

2021-11-02

Systemic reaction (other): a bit of lethargy

Release 10 — day 7, dose 2

2021-11-06

Systemic reaction (other): Began menstrual bleeding on day 17 of cycle

Release 10 — day 14, dose 2

2021-11-12

Symptoms: Dizziness, started period two weeks early

Release 10 — day 28, dose 2

2021-11-28

Symptoms: Heart beats strongly sometimes (perhaps unrelated, given holiday)

Release 10 — day 42, dose 2

2021-12-12

Symptoms: Swollen uterus, likely fibroid (according to doctor)

Release 11 — 6 months, dose 2

2022-04-29

Symptoms: Diagnosed with uterine fibroid

Release 12 — days 1–6 daily, dose 3

2022-12-02

Systemic reaction (other): Brain fog, tinnitus

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	Abdominal discomfort	✓	✓	✓
SD	Anxiety	✓	✓	✓
SD	Arthralgia	✓	✓	✓
SD	Chills	✓	✓	✓
SD	Dizziness	✓	✓	✓
SD	Eye pain	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Heavy menstrual bleeding	✓	✓	✓
SD	Menstruation irregular	·	·	✓
SD	Migraine	·	·	✓
SD	Myalgia	✓	✓	✓
SD	Nausea	✓	✓	✓
SD	Office visit	·	·	✓
SD	Palpitations	·	·	✓
SD	Sensory disturbance	✓	✓	✓
SD	Sinus congestion	✓	✓	✓
SD	Sinus headache	✓	✓	✓
SD	Swelling	·	·	✓
SD	Tenderness	✓	✓	✓
SD	Tension	✓	✓	✓
SD	Tension headache	✓	✓	✓
SD	Tinnitus	✓	✓	✓
SD	Uterine leiomyoma	·	·	✓
SRO	Abdominal pain upper	✓	✓	✓
SRO	Angiopathy	✓	✓	✓
SRO	Anxiety	✓	✓	✓
SRO	Brain fog	·	·	✓
SRO	Emotional distress	✓	✓	✓
SRO	Erythema	·	·	✓
SRO	Eye pain	✓	✓	✓
SRO	Feeling abnormal	✓	✓	✓
SRO	Feeling hot	·	·	✓
SRO	Flushing	✓	✓	✓
SRO	Halo vision	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Intermenstrual bleeding	✓	✓	✓
SRO	Lethargy	·	·	✓
SRO	Menstruation irregular	✓	✓	✓
SRO	Sinus disorder	✓	✓	✓
SRO	Skin tightness	·	·	✓
SRO	Tenderness	✓	✓	✓
SRO	Tinnitus	✓	✓	✓

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