Z4Q-23870-32255

2 vaccinations 18 coded responses 31 check-ins 18 free-text entries 4 call cases

Sex: Female
Age at first dose: 61-65
ZIP prefix: 451 / OH
Registered: 2021-04-09

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

2021-04-09
Registered in v-safe
2021-04-09
Dose 1 — Janssen/Johnson & Johnson
2021-04-09
Health check-in — day 0, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-04-10
Survey response — days 1–6 daily, dose 1
MedDRA: Pyrexia — Feeling: Fair · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea

Free text: Fever at nine a.m. but normal two hours later.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-11
Survey response — days 1–6 daily, dose 1
MedDRA: Fatigue — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Very tired. Using cold cloths on injection site.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-12
Survey response — days 1–6 daily, dose 1
MedDRA: Diarrhoea — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Some loose stool today

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-13
Survey response — days 1–6 daily, dose 1
MedDRA: Injection site pain, Injection site warmth — Feeling: Good · Site: Pain, Redness, Swelling, Itching · Fatigue or tiredness

Free text: Injection site is warm to touch and hurts if touched

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

Free text: lightheaded but not sure related to vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-15
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Redness, Swelling · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-16
Health check-in — day 7, dose 1
Feeling: Good · Site: Redness, Swelling · Fatigue or tiredness

Adult check-in
2021-04-23
Survey response — day 14, dose 1
MedDRA: Pain in extremity, Peripheral swelling, Tinnitus — Feeling: Fair

Free text: Right ear sounds like how it is when airplane reving up to take off. I have tinnitus already for years. This new sound just once in awhile. Arm still sore and swollen just a little. Not red.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-30
Survey response — day 21, single dose
MedDRA: Balance disorder, Dizziness, Fatigue, Nausea — Feeling: Fair · Be unable to do your normal daily activities

Free text: 2 nights ago very spinning dizzy and nausea since. Not sure to do with shot? Very tired. Feel off balance.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-07
Survey response — day 28, single dose
MedDRA: Dizziness, Feeling abnormal, Nausea, Vertigo positional — Feeling: Fair · Be unable to do your normal daily activities

Free text: I had dizzy spell on 4/28 and did BPPV manuevers. Have had nausea and felt off until yesterday started feeling better. Not sure if related to vaccinne J&J on 4/9.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-14
Survey response — day 35, single dose
MedDRA: Balance disorder, Nausea, Vertigo — Feeling: Fair · Be unable to do your normal daily activities

Free text: Same as last check-in.. balance/nausea settled, then woke up with spinning again the other day. Still not sure if related to vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-21
Health check-in — day 42, single dose
Feeling: Fair

Adult check-in
2021-07-09
Survey response — 3 months, dose 1
MedDRA: Office visit, Unevaluable event — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: Ear and balance. I don't think related to vaccine as I have had similar issues in past too · Healthcare visit (other): ENT appt

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-09
Report sent to call center — 3 months, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-14
Call 1 — Left Voicemail
2021-07-14
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-10-08
Survey response — 6 months, dose 1
MedDRA: Avulsion fracture, Limb injury, Unevaluable event — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: Not related to vaccine, but, right ear tube. Also, twisted right foot...avulsion fracture inside ankle.

MedDRA releases: 2024-11 · check-in free text available
2021-10-08
Report sent to call center — 6 months, dose 1
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · 1 call case(s)
2021-10-12
Call 1 — Requested Callback
2021-10-13
Call 2 — Left Voicemail
2021-11-01
Dose 2 — Moderna
2021-11-01
Survey response — day 0, dose 2
MedDRA: Unevaluable event — Feeling: Good

Free text: Just got shot about 2 hours ago

MedDRA releases: 2024-11 · check-in free text available
2021-11-02
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness

Adult check-in
2021-11-03
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-11-04
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-11-05
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-11-06
Survey response — days 1–6 daily, dose 2
MedDRA: Malaise — Feeling: Fair · Chills, Muscle or body aches, Fatigue or tiredness, Nausea

Free text: I did not take any ibuprofen or Tylenol yesterday so wonder if that's why I feel puny today

MedDRA releases: 2024-11 · check-in free text available
2021-11-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-11-08
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-11-15
Survey response — day 14, dose 2
MedDRA: Dizziness, Ear infection, Nausea — Feeling: Good · Be unable to do your normal daily activities

Free text: Ear infection with some nausea and lightheaded

MedDRA releases: 2024-11 · check-in free text available
2021-11-22
Survey response — day 21, dose 2
MedDRA: Ear infection, Fatigue, Headache, Nausea, Neck pain — Feeling: Fair · Be unable to do your normal daily activities

Free text: Headache, neck ache, nausea and tired. Ongoing ear infection could be the problem.

MedDRA releases: 2024-11 · check-in free text available
2021-11-29
Survey response — day 28, dose 2
MedDRA: Abdominal pain upper, Nausea — Feeling: Good

Free text: Stomach ache with nausea for a couple of days.

MedDRA releases: 2024-11 · check-in free text available
2021-12-06
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-12-13
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2022-01-31
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2022-05-02
Survey response — 6 months, dose 2
MedDRA: Colitis, Emergency care, Office visit — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Colitis · Healthcare visit (other): ER and followed up with doctor, then gastro

MedDRA releases: 2024-11 · check-in free text available
2022-05-02
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2022-05-03
Call 1 — Left Voicemail
2022-11-01
Survey response — 12 months, dose 2
MedDRA: Blood glucose decreased, Blood glucose increased, COVID-19, Muscle spasms, Office visit, Pain in extremity — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: My sugar levels too high and can't seem to get back on track. Was off meds for it awhile due to low levels after COVID. Also, leg pain with Charley horses. · Healthcare visit (other): Primary care doctor visits

MedDRA releases: 2024-11 · check-in free text available
2022-11-01
Report sent to call center — 12 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2022-11-02
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-11-02
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-11-02
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-09	Janssen/Johnson & Johnson
2	2021-11-01	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-07-09	Successful 2021-07-14	Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-10-08	Successful 2022-11-02	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-05-02	Successful 2022-11-02	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-11-01	Successful 2022-11-02	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Free text

Release 7 — days 1–6 daily, dose 1

2021-04-10

Systemic reaction (other): Fever at nine a.m. but normal two hours later.

2021-04-11

Systemic reaction (other): Very tired. Using cold cloths on injection site.

2021-04-12

Systemic reaction (other): Some loose stool today

2021-04-13

Systemic reaction (other): Injection site is warm to touch and hurts if touched

2021-04-14

Systemic reaction (other): lightheaded but not sure related to vaccine

Release 7 — day 14, dose 1

2021-04-23

Symptoms: Right ear sounds like how it is when airplane reving up to take off. I have tinnitus already for years. This new sound just once in awhile. Arm still sore and swollen just a little. Not red.

Release 8 — day 21, single dose

2021-04-30

Symptoms: 2 nights ago very spinning dizzy and nausea since. Not sure to do with shot? Very tired. Feel off balance.

Release 8 — day 28, single dose

2021-05-07

Symptoms: I had dizzy spell on 4/28 and did BPPV manuevers. Have had nausea and felt off until yesterday started feeling better. Not sure if related to vaccinne J&J on 4/9.

Release 8 — day 35, single dose

2021-05-14

Symptoms: Same as last check-in.. balance/nausea settled, then woke up with spinning again the other day. Still not sure if related to vaccine

Release 9 — 3 months, dose 1

2021-07-09

Symptoms: Ear and balance. I don't think related to vaccine as I have had similar issues in past too

Healthcare visit (other): ENT appt

Release 10 — 6 months, dose 1

2021-10-08

Symptoms: Not related to vaccine, but, right ear tube. Also, twisted right foot...avulsion fracture inside ankle.

Release 10 — day 0, dose 2

2021-11-01

Systemic reaction (other): Just got shot about 2 hours ago

Release 10 — days 1–6 daily, dose 2

2021-11-06

Systemic reaction (other): I did not take any ibuprofen or Tylenol yesterday so wonder if that's why I feel puny today

Release 10 — day 14, dose 2

2021-11-15

Symptoms: Ear infection with some nausea and lightheaded

Release 10 — day 21, dose 2

2021-11-22

Symptoms: Headache, neck ache, nausea and tired. Ongoing ear infection could be the problem.

Release 10 — day 28, dose 2

2021-11-29

Symptoms: Stomach ache with nausea for a couple of days.

Release 11 — 6 months, dose 2

2022-05-02

Symptoms: Colitis

Healthcare visit (other): ER and followed up with doctor, then gastro

Release 12 — 12 months, dose 2

2022-11-01

Symptoms: My sugar levels too high and can't seem to get back on track. Was off meds for it awhile due to low levels after COVID. Also, leg pain with Charley horses.

Healthcare visit (other): Primary care doctor visits

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	Emergency care	·	·	✓
HCVO	Office visit	✓	✓	✓
SD	Abdominal pain upper	·	·	✓
SD	Avulsion fracture	·	·	✓
SD	Balance disorder	✓	✓	✓
SD	Blood glucose decreased	·	·	✓
SD	Blood glucose increased	·	·	✓
SD	Colitis	·	·	✓
SD	COVID-19	·	·	✓
SD	Dizziness	✓	✓	✓
SD	Ear infection	·	·	✓
SD	Fatigue	✓	✓	✓
SD	Feeling abnormal	✓	✓	✓
SD	Headache	·	·	✓
SD	Limb injury	·	·	✓
SD	Muscle spasms	·	·	✓
SD	Nausea	✓	✓	✓
SD	Neck pain	·	·	✓
SD	Pain in extremity	✓	✓	✓
SD	Peripheral swelling	✓	✓	✓
SD	Tinnitus	✓	✓	✓
SD	Unevaluable event	✓	✓	✓
SD	Vertigo	✓	✓	✓
SD	Vertigo positional	✓	✓	✓
SRO	Diarrhoea	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Injection site warmth	✓	✓	✓
SRO	Malaise	·	·	✓
SRO	Pyrexia	✓	✓	✓
SRO	Unevaluable event	·	·	✓

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