79U-31920-42691 · OpenVSafe

Timeline

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

2021-03-05
Dose 1 — Janssen/Johnson & Johnson
2021-03-06
Registered in v-safe
2021-03-06
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-07
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Good · Diarrhea

Free text: NASH stage 4 cirrhosis, enlarged liver and spleen, pancrease is atrophic and fatty and Ehlers Danlos Syndrome

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-08
Survey response — days 1–6 daily, dose 1
MedDRA: Ehlers-Danlos syndrome, Hepatic cirrhosis, Hepatomegaly, Migraine, Non-alcoholic steatohepatitis, Pancreatic atrophy, Pancreatic steatosis, Pre-existing disease, Splenomegaly — Feeling: Poor · Chills, Headache, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain

Free text: NASH stage 4 liver cirrhosis, enlarged liver and spleen, pancrease is atrophic and fatty, and Ehlers Danlos Syndrome. Also have migraine headaches and take Ajovy.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Diarrhea, Abdominal pain

Adult check-in
2021-03-10
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fatigue or tiredness, Diarrhea, Abdominal pain

Adult check-in
2021-03-11
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain

Adult check-in
2021-03-12
Health check-in — day 7, dose 1
Feeling: Fair · Fatigue or tiredness, Diarrhea, Abdominal pain

Adult check-in
2021-03-19
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-28
Health check-in — day 21, single dose
Feeling: Fair

Adult check-in
2021-04-02
Health check-in — day 28, single dose
Feeling: Fair

Adult check-in
2021-04-09
Health check-in — day 35, single dose
Feeling: Fair

Adult check-in
2021-04-16
Health check-in — day 42, single dose
Feeling: Fair

Adult check-in
2021-06-04
Health check-in — 3 months, dose 1
Feeling: Fair

Adult check-in
2022-03-05
Survey response — 12 months, dose 1
MedDRA: COVID-19, Cough, Nausea, Pain, Sinusitis — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Emergency room or emergency department visit

Free text: More nausea, pain and sinus infection. I also am coughing more since having covid again in February.

MedDRA releases: 2024-11 · check-in free text available
2022-03-05
Report sent to call center — 12 months, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · Emergency room or emergency department visit · 1 call case(s)
2022-03-08
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-05	Janssen/Johnson & Johnson

Call center

Reported	Outcome	VAERS-related outcome
2022-03-05	Successful 2022-03-08	Participant prefers to complete VAERS report online

Free text

Release 5 — days 1–6 daily, dose 1

2021-03-07

Systemic reaction (other): NASH stage 4 cirrhosis, enlarged liver and spleen, pancrease is atrophic and fatty and Ehlers Danlos Syndrome

2021-03-08

Systemic reaction (other): NASH stage 4 liver cirrhosis, enlarged liver and spleen, pancrease is atrophic and fatty, and Ehlers Danlos Syndrome. Also have migraine headaches and take Ajovy.

Release 11 — 12 months, dose 1

2022-03-05

Symptoms: More nausea, pain and sinus infection. I also am coughing more since having covid again in February.

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	Cough	·	·	✓
SD	COVID-19	·	·	✓
SD	Nausea	·	·	✓
SD	Pain	·	·	✓
SD	Sinusitis	·	·	✓
SRO	Ehlers-Danlos syndrome	○	✓	○
SRO	Hepatic cirrhosis	○	✓	○
SRO	Hepatomegaly	○	✓	○
SRO	Migraine	○	✓	○
SRO	Non-alcoholic steatohepatitis	○	✓	○
SRO	Pancreatic atrophy	○	✓	○
SRO	Pancreatic steatosis	○	✓	○
SRO	Pre-existing disease	✓	✓	✓
SRO	Splenomegaly	○	✓	○

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