ZUH-19149-86213 · OpenVSafe

Timeline

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

2021-04-12
Registered in v-safe
2021-04-12
Dose 1 — Janssen/Johnson & Johnson
2021-04-12
Health check-in — day 0, dose 1
Feeling: Good · Diarrhea

Adult check-in
2021-04-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fever · Chills, Headache, Muscle or body aches · Be unable to do your normal daily activities

Adult check-in
2021-04-14
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-15
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-16
Survey response — days 1–6 daily, dose 1
MedDRA: Postmenopausal haemorrhage, Vaginal haemorrhage — Feeling: Good · Fatigue or tiredness

Free text: Vaginal spotting / bleeding when I thought I was six months into menopause

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-17
Survey response — days 1–6 daily, dose 1
MedDRA: Epistaxis, Haemorrhage, Menopause, Menstruation irregular — Feeling: Fair · Fatigue or tiredness · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Systemic reaction (other): I got my period after 6 months without a period and I thought I was in menopause. I also noticed my nose was bleeding a little upon waking, when I blew my nose there was some blood. · Healthcare visit (other): I am going to be seen at the gynocologist next week to check out the abnormal bleeding

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-17
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-18
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Good

Free text: Menstrual bleeding

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-19
Survey response — day 7, dose 1
MedDRA: Ear discomfort — Feeling: Good

Free text: Slight ear pressure in both ears on and off

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-26
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-02
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-05-03
Health check-in — day 21, single dose
Feeling: Good

Adult check-in
2021-05-10
Health check-in — day 28, single dose
Feeling: Good

Adult check-in
2021-05-17
Health check-in — day 35, single dose
Feeling: Good

Adult check-in
2021-05-24
Health check-in — day 42, single dose
Feeling: Good

Adult check-in
2021-07-14
Health check-in — 3 months, dose 1
Feeling: Good

Adult check-in
2021-10-11
Health check-in — 6 months, dose 1
Feeling: Good

Adult check-in
2021-10-25
Dose 2 — Moderna
2021-11-01
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-11-08
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-11-15
Survey response — day 21, dose 2
MedDRA: Ear pain — Feeling: Good

Free text: Mild ear pain in left ear

MedDRA releases: 2024-11 · check-in free text available
2021-11-22
Survey response — day 28, dose 2
MedDRA: Ear pain — Feeling: Good

Free text: Mild ear pain left ear

MedDRA releases: 2024-11 · check-in free text available
2021-11-29
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-12-06
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2022-01-24
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2022-04-25
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-10-25
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-12	Janssen/Johnson & Johnson
2	2021-10-25	Moderna	No

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 7 — days 1–6 daily, dose 1

2021-04-16

Systemic reaction (other): Vaginal spotting / bleeding when I thought I was six months into menopause

2021-04-17

Systemic reaction (other): I got my period after 6 months without a period and I thought I was in menopause. I also noticed my nose was bleeding a little upon waking, when I blew my nose there was some blood.

Healthcare visit (other): I am going to be seen at the gynocologist next week to check out the abnormal bleeding

2021-04-18

Systemic reaction (other): Menstrual bleeding

Release 7 — day 7, dose 1

2021-04-19

Systemic reaction (other): Slight ear pressure in both ears on and off

Release 10 — day 21, dose 2

2021-11-15

Symptoms: Mild ear pain in left ear

Release 10 — day 28, dose 2

2021-11-22

Symptoms: Mild ear pain left ear

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	Haemorrhage	✓	✓	✓
SD	Ear pain	·	·	✓
SRO	Ear discomfort	✓	✓	✓
SRO	Epistaxis	✓	✓	✓
SRO	Menopause	✓	✓	✓
SRO	Menstruation irregular	✓	✓	✓
SRO	Postmenopausal haemorrhage	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓
SRO	Vaginal haemorrhage	✓	✓	✓

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