ZCQ-21791-28081 · OpenVSafe

Timeline

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

2021-05-10
Dose 1 — Pfizer-BioNTech
2021-05-31
Dose 2 — Pfizer-BioNTech
2021-06-02
Registered in v-safe
2021-06-02
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness, Nausea, Diarrhea

Adult check-in
2021-06-03
Survey response — days 1–6 daily, dose 2
MedDRA: Chills, Diarrhoea, Epistaxis, Fatigue, Injection site pain, Malaise, Migraine, Pain, Pyrexia — Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness, Nausea

Free text: I wish this system would allow symptom reporting for prior days- day after shot#2, I was too sick to sign up for this. Fever, chills, body aches, tiredness, diarrhea, severe migraine headache. Only side effects with shot #1 were pain at injection site over the first night and then blood in normal nasal mucous x 3 weeks, which continues.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-04
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-06-05
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-06-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-06-07
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-06-14
Survey response — day 14, dose 2
MedDRA: Migraine, Mood swings, Pre-existing disease, Pregnancy — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: migraines (increased frequency but I did get them occasionally before)mood swingslow progesterone in 2nd trimester of pregnancy (level was fine 4 weeks ago)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-14
Report sent to call center — day 14, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-17
Call 1 — Could Not Reach Participant
2021-06-18
Call 2 — Left Voicemail
2021-06-23
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-06-28
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-07-05
Survey response — day 35, dose 2
MedDRA: Cough, Headache, Oropharyngeal pain, Rhinorrhoea — Feeling: Poor

Free text: runny nose, sore throat, cough, headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-12
Survey response — day 42, dose 2
MedDRA: Cough, Dyspnoea — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: cough, shortness of breath

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-12
Report sent to call center — day 42, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-14
Call successful
Participant prefers to complete VAERS report online
2021-08-30
Survey response — 3 months, dose 2
MedDRA: Glucose tolerance impaired — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: impaired glucose tolerance/ possible gestational diabetes

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-30
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-31
Call 1 — Left Voicemail
2021-11-29
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-05-31
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-05-10	Pfizer-BioNTech
2	2021-05-31	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-06-14	Unsuccessful
2021-07-12	Successful 2021-07-14	Participant prefers to complete VAERS report online
2021-08-30	Unsuccessful

Free text

Release 8 — days 1–6 daily, dose 2

2021-06-03

Systemic reaction (other): I wish this system would allow symptom reporting for prior days- day after shot#2, I was too sick to sign up for this. Fever, chills, body aches, tiredness, diarrhea, severe migraine headache. Only side effects with shot #1 were pain at injection site over the first night and then blood in normal nasal mucous x 3 weeks, which continues.

Release 9 — day 14, dose 2

2021-06-14

Symptoms: migraines (increased frequency but I did get them occasionally before)mood swingslow progesterone in 2nd trimester of pregnancy (level was fine 4 weeks ago)

Release 9 — day 35, dose 2

2021-07-05

Symptoms: runny nose, sore throat, cough, headache

Release 9 — day 42, dose 2

2021-07-12

Symptoms: cough, shortness of breath

Release 9 — 3 months, dose 2

2021-08-30

Symptoms: impaired glucose tolerance/ possible gestational diabetes

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	Dyspnoea	✓	✓	✓
SD	Glucose tolerance impaired	✓	·	✓
SD	Headache	✓	✓	✓
SD	Migraine	✓	✓	✓
SD	Mood swings	✓	✓	✓
SD	Oropharyngeal pain	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Pregnancy	✓	✓	✓
SD	Rhinorrhoea	✓	✓	✓
SRO	Chills	✓	✓	✓
SRO	Diarrhoea	✓	✓	✓
SRO	Epistaxis	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Malaise	✓	✓	✓
SRO	Migraine	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pyrexia	✓	✓	✓

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