ETB-31425-99046 · OpenVSafe

Timeline

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

2021-04-10
Registered in v-safe
2021-04-10
Dose 1 — Janssen/Johnson & Johnson
2021-04-10
Health check-in — day 0, dose 1
Feeling: Fair · Site: Pain, Redness, Swelling · Headache, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2021-04-11
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting · Be unable to do your normal daily activities

Adult check-in
2021-04-12
Survey response — days 1–6 daily, dose 1
MedDRA: Dysuria — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Vomiting, Diarrhea · Be unable to do your normal daily activities

Free text: Difficulty peeing and emptying my bladder

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-13
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Fever · Chills, Headache, Nausea

Adult check-in
2021-04-14
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness, Nausea

Adult check-in
2021-04-15
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Fatigue or tiredness, Nausea

Adult check-in
2021-04-16
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Nausea · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-04-17
Health check-in — day 7, dose 1
Feeling: Good · Headache

Adult check-in
2021-04-24
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-01
Health check-in — day 21, single dose
Feeling: Good

Adult check-in
2021-05-08
Health check-in — day 28, single dose
Feeling: Good

Adult check-in
2021-05-15
Health check-in — day 35, single dose
Feeling: Good

Adult check-in
2021-05-22
Survey response — day 42, single dose
MedDRA: Hyperaesthesia, Neuralgia — Feeling: Fair · Be unable to do your normal daily activities

Free text: Nerve pain and sensitivity to touch on legs

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-10
Survey response — 3 months, dose 1
MedDRA: Abnormal uterine bleeding, Haemorrhage, Heavy menstrual bleeding, Hormone level abnormal — 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 · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: Hormonal imbalance. Four heavy periods in under six weeks, diagnosed as hemorrhage and disfunctional uterine bleeding. Ultrasound ruled out miscarriage, fibroids, and cysts. No other change to birth control and no pregnancy to affect the hormones.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-10
Report sent to call center — 3 months, dose 1
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)
2021-07-14
Call 1 — Left Voicemail
2021-10-09
Health check-in — 6 months, dose 1
Feeling: Fair

Adult check-in
2022-04-10
Health check-in — 12 months, dose 1
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-10	Janssen/Johnson & Johnson

Call center

Reported	Outcome	VAERS-related outcome
2021-07-10	Unsuccessful

Free text

Release 7 — days 1–6 daily, dose 1

2021-04-12

Systemic reaction (other): Difficulty peeing and emptying my bladder

Release 8 — day 42, single dose

2021-05-22

Symptoms: Nerve pain and sensitivity to touch on legs

Release 9 — 3 months, dose 1

2021-07-10

Symptoms: Hormonal imbalance. Four heavy periods in under six weeks, diagnosed as hemorrhage and disfunctional uterine bleeding. Ultrasound ruled out miscarriage, fibroids, and cysts. No other change to birth control and no pregnancy to affect the hormones.

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	Abnormal uterine bleeding	✓	✓	✓
SD	Haemorrhage	✓	✓	✓
SD	Heavy menstrual bleeding	✓	✓	✓
SD	Hormone level abnormal	✓	✓	✓
SD	Hyperaesthesia	✓	✓	✓
SD	Neuralgia	✓	✓	✓
SRO	Dysuria	✓	✓	✓

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