KM4-27141-33113 · OpenVSafe

Timeline

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

2021-04-09
Dose 1 — Janssen/Johnson & Johnson
2021-04-13
Registered in v-safe
2021-04-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

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

Adult check-in
2021-04-15
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-16
Health check-in — day 7, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-23
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-04-30
Health check-in — day 21, single dose
Feeling: Good

Adult check-in
2021-05-07
Health check-in — day 28, single dose
Feeling: Good

Adult check-in
2021-05-14
Health check-in — day 35, single dose
Feeling: Good

Adult check-in
2021-05-21
Health check-in — day 42, single dose
Feeling: Good

Adult check-in
2021-07-09
Health check-in — 3 months, dose 1
Feeling: Good

Adult check-in
2021-10-08
Survey response — 6 months, dose 1
MedDRA: Abortion spontaneous — Feeling: Good · 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: Missed miscarriage

MedDRA releases: 2024-11 · check-in free text available
2021-10-08
Report sent to call center — 6 months, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-10-25
Dose 2 — Pfizer-BioNTech
2021-11-01
Health check-in — day 7, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-11-08
Survey response — day 14, dose 2
MedDRA: Unevaluable event — Feeling: Good · 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: I forgot to mention on my last check in that I experienced a missed miscarriage in September (before my booster dose).

MedDRA releases: 2024-11 · check-in free text available
2021-11-08
Report sent to call center — day 14, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-11-08
Call 1 — Left Voicemail
2021-11-10
Call 1 — Could Not Reach Participant
2021-11-15
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-11-15
Call 2 — Requested Callback
2021-11-15
Callback requested for
12:00PM ET
2021-11-18
Call successful
Participant prefers to complete VAERS report online
2021-11-22
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-11-29
Survey response — day 35, dose 2
MedDRA: Oropharyngeal pain — Feeling: Good

Free text: Sore throat

MedDRA releases: 2024-11 · check-in free text available
2021-12-08
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2022-01-26
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2022-04-27
Survey response — 6 months, dose 2
MedDRA: Nasal congestion, Oropharyngeal pain, Pre-existing disease, Pregnancy, Rhinorrhoea — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Sore throat, runny and stuffy nose (likely spring allergies) Nausea and fatigue (likely linked to current pregnancy)

MedDRA releases: 2024-11 · check-in free text available
2022-09-23
Dose 3 — Pfizer-BioNTech
2022-10-05
Health check-in — day 7, dose 3
Feeling: Good · None

Adult check-in
2022-10-07
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2022-10-16
Survey response — day 21, dose 3
MedDRA: Cough, Oropharyngeal pain — Feeling: Good

Free text: Sore throat and mild cough

MedDRA releases: 2024-11 · check-in free text available
2022-10-21
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2022-10-28
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2022-11-04
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-12-23
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2023-03-24
Survey response — 6 months, dose 3
MedDRA: Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea — Feeling: Good

MedDRA releases: 2024-11

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-09	Janssen/Johnson & Johnson
2	2021-10-25	Pfizer-BioNTech	No
3	2022-09-23	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-10-08	Unsuccessful
2021-11-08	Successful 2021-11-18	Participant prefers to complete VAERS report online

Free text

Release 10 — 6 months, dose 1

2021-10-08

Symptoms: Missed miscarriage

Release 10 — day 14, dose 2

2021-11-08

Symptoms: I forgot to mention on my last check in that I experienced a missed miscarriage in September (before my booster dose).

Release 10 — day 35, dose 2

2021-11-29

Symptoms: Sore throat

Release 11 — 6 months, dose 2

2022-04-27

Symptoms: Sore throat, runny and stuffy nose (likely spring allergies) Nausea and fatigue (likely linked to current pregnancy)

Release 12 — day 21, dose 3

2022-10-16

Symptoms: Sore throat and mild cough

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	Cough	·	·	✓
SD	Nasal congestion	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Pregnancy	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Unevaluable event	·	·	✓

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