CLN-13570-23511 · OpenVSafe

Timeline

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

2021-11-23
Dose 1 — Pfizer-BioNTech
2021-12-01
Registered in v-safe
2021-12-01
Health check-in — day 7, dose 1
Feeling: Fair · Headache, Fatigue or tiredness

Adult check-in
2021-12-09
Health check-in — day 14, dose 1
Feeling: Fair

Adult check-in
2021-12-14
Dose 2 — Pfizer-BioNTech
2021-12-14
Survey response — day 0, dose 2
MedDRA: Intermenstrual bleeding — Feeling: Fair · Site: Pain · Fatigue or tiredness

Free text: Potential disruption of normal menses. Had increased days of spotting after 1st dose

MedDRA releases: 2024-11 · check-in free text available
2021-12-15
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-12-21
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-12-30
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2022-01-04
Survey response — day 21, dose 2
MedDRA: Pregnancy — Feeling: Fair · Be unable to do your normal daily activities

Free text: Weakness and nausea from pregnancy

MedDRA releases: 2024-11 · check-in free text available
2022-01-11
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2022-01-18
Survey response — day 35, dose 2
MedDRA: Pain — Feeling: Fair

Free text: Sore body could be from a massage i had completed yesterday or from travel

MedDRA releases: 2024-11 · check-in free text available
2022-01-25
Survey response — day 42, dose 2
MedDRA: Abortion spontaneous, Foetal cardiac disorder, Ultrasound foetal abnormal, Unevaluable event — 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: Symptoms: Miscarriage at 9 weeks and 6 days. No cardiac activity at ultrasound. LMP was 11/16. Very concerned that the vaccine could have caused this miscarriage since the doses were so early in pregnancy. · Healthcare visit (other): Scheduled D&C

MedDRA releases: 2024-11 · check-in free text available
2022-01-25
Report sent to call center — day 42, dose 2
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)
2022-01-26
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-11-23	Pfizer-BioNTech	No
2	2021-12-14	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2022-01-25	Successful 2022-01-26	Participant prefers to complete VAERS report online

Free text

Release 10 — day 0, dose 2

2021-12-14

Systemic reaction (other): Potential disruption of normal menses. Had increased days of spotting after 1st dose

Release 10 — day 21, dose 2

2022-01-04

Symptoms: Weakness and nausea from pregnancy

Release 10 — day 35, dose 2

2022-01-18

Symptoms: Sore body could be from a massage i had completed yesterday or from travel

Release 11 — day 42, dose 2

2022-01-25

Symptoms: Miscarriage at 9 weeks and 6 days. No cardiac activity at ultrasound. LMP was 11/16. Very concerned that the vaccine could have caused this miscarriage since the doses were so early in pregnancy.

Healthcare visit (other): Scheduled D&C

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	Unevaluable event	·	·	✓
SD	Abortion spontaneous	·	·	✓
SD	Foetal cardiac disorder	·	·	✓
SD	Pain	·	·	✓
SD	Pregnancy	·	·	✓
SD	Ultrasound foetal abnormal	·	·	✓
SRO	Intermenstrual bleeding	·	·	✓

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