HLB-29811-90482 · OpenVSafe

Timeline

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

2021-11-04
Dose 1 — Janssen/Johnson & Johnson
2021-11-06
Registered in v-safe
2021-11-06
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Rash, not including the immediate area around the injection site

Adult check-in
2021-11-08
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-11-11
Health check-in — day 7, dose 1
Feeling: Good · Headache

Adult check-in
2021-11-18
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-11-28
Survey response — day 21, single dose
MedDRA: Back pain, Chest discomfort, Diarrhoea, Headache, Loss of consciousness, Nausea, Office visit, Palpitations, Rash — Feeling: Poor · 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

Free text: Chest pressure and upper back pain 18d post followed by worst headache ever and diarrhea x4days. Urgent care visit was required. passed out after episode of nauseous and heart racing. Today rash developed on face near nose and cheeks

MedDRA releases: 2024-11 · check-in free text available
2021-11-28
Report sent to call center — day 21, single dose
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-12-06
Call 1 — Left Voicemail
2021-12-10
Survey response — day 35, single dose
MedDRA: Loss of consciousness, Palpitations — Feeling: Good

Free text: After very intense symptoms last week I had an episode where my heart was racing very fast and I ended up losing consciousness. Once I regained consciousness it seemed as though most other symptoms were drastically subsiding

MedDRA releases: 2024-11 · check-in free text available
2021-12-16
Survey response — day 42, single dose
MedDRA: Office visit, Pregnancy, Rash, Urticaria — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Rash/hives earlier in week on upper portion of abdomen just below chest. Positive pregnancy test however with initial workup by physician may be having miscarriage. Second set of labs will be completed today.

MedDRA releases: 2024-11 · check-in free text available
2021-12-16
Report sent to call center — day 42, single dose
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-12-17
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-11-04	Janssen/Johnson & Johnson	No

Call center

Reported	Outcome	VAERS-related outcome
2021-11-28	Unsuccessful
2021-12-16	Unsuccessful

Free text

Release 10 — day 21, single dose

2021-11-28

Symptoms: Chest pressure and upper back pain 18d post followed by worst headache ever and diarrhea x4days. Urgent care visit was required. passed out after episode of nauseous and heart racing. Today rash developed on face near nose and cheeks

Release 10 — day 35, single dose

2021-12-10

Symptoms: After very intense symptoms last week I had an episode where my heart was racing very fast and I ended up losing consciousness. Once I regained consciousness it seemed as though most other symptoms were drastically subsiding

Release 10 — day 42, single dose

2021-12-16

Symptoms: Rash/hives earlier in week on upper portion of abdomen just below chest. Positive pregnancy test however with initial workup by physician may be having miscarriage. Second set of labs will be completed today.

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	Back pain	·	·	✓
SD	Chest discomfort	·	·	✓
SD	Diarrhoea	·	·	✓
SD	Headache	·	·	✓
SD	Loss of consciousness	·	·	✓
SD	Nausea	·	·	✓
SD	Office visit	·	·	✓
SD	Palpitations	·	·	✓
SD	Pregnancy	·	·	✓
SD	Rash	·	·	✓
SD	Urticaria	·	·	✓

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