RZX-13185-39726 · OpenVSafe

Timeline

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

2021-03-31
Registered in v-safe
2021-03-31
Dose 1 — Pfizer-BioNTech
2021-03-31
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-04-01
Survey response — days 1–6 daily, dose 1
MedDRA: Insomnia — Feeling: Poor · Site: Pain · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work

Free text: Inability to sleep last night

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-02
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-04-03
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-04
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache

Adult check-in
2021-06-30
Survey response — 3 months, dose 1
MedDRA: Fatigue — Feeling: Good

Free text: Fatigue

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2022-04-03
Survey response — 12 months, dose 1
MedDRA: Abortion spontaneous — 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 · Outpatient clinic or urgent care clinic visit

Free text: We had a miscarriage in July 2021 at 6 weeks along.

MedDRA releases: 2024-11 · check-in free text available
2022-04-03
Report sent to call center — 12 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

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-04-06
Call 1 — Could Not Reach Participant
2022-04-12
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-31	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2022-04-03	Successful 2022-04-12	Participant prefers to complete VAERS report online

Free text

Release 6 — days 1–6 daily, dose 1

2021-04-01

Systemic reaction (other): Inability to sleep last night

Release 9 — 3 months, dose 1

2021-06-30

Symptoms: Fatigue

Release 11 — 12 months, dose 1

2022-04-03

Symptoms: We had a miscarriage in July 2021 at 6 weeks along.

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	Abortion spontaneous	·	·	✓
SD	Fatigue	✓	✓	✓
SRO	Insomnia	✓	✓	✓

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