ZGX-16344-57246 · OpenVSafe

Timeline

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

2021-03-22
Dose 1 — Pfizer-BioNTech
2021-04-14
Registered in v-safe
2021-04-14
Dose 2 — Pfizer-BioNTech
2021-04-14
Survey response — day 0, dose 2
MedDRA: Sinus pain — Feeling: Fair · Site: Pain · Headache

Free text: Sinus pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-15
Survey response — days 1–6 daily, dose 2
MedDRA: Sinus pain — Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Sinus pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-16
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-17
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-04-18
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-04-21
Health check-in — day 7, dose 2
Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-28
Survey response — day 14, dose 2
MedDRA: Condition aggravated, Pre-existing disease, Rheumatoid arthritis — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities

Free text: My RA has flared and so has my MRSA infection. I dont think it has anything to do with the vaccine. Just coincidence.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-05
Survey response — day 21, dose 2
MedDRA: Bronchitis, Pre-existing disease, Rheumatoid arthritis — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities

Free text: My RA has gotten worse and Im starting to get bronchitis.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-12
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-07-14
Health check-in — 3 months, dose 2
Feeling: Fair

Adult check-in
2021-10-13
Survey response — 6 months, dose 2
MedDRA: Condition aggravated, Fatigue, Malaise, Office visit, Pre-existing disease — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: I have been feeling very fatigued and generally unwell. My GP did blood tests which showed a very high Epstein Barr Panel. My doctor indicated that it probably meant that I had a reactivation of mono. · Healthcare visit (other): Several doctor appointments. I'm still not feeling well.

MedDRA releases: 2024-11 · check-in free text available
2021-10-13
Report sent to call center — 6 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2021-11-16
Call 1 — Could Not Reach Participant
2021-11-19
Call 2 — Could Not Reach Participant
2022-04-17
Survey response — 12 months, dose 2
MedDRA: Epstein-Barr virus infection, Fatigue — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Epstein Barr Syndrome - extreme tiredness

MedDRA releases: 2024-11 · check-in free text available
2022-04-17
Report sent to call center — 12 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-04-19
Call 1 — Requested Callback
2022-04-19
Callback requested for
01:15PM ET
2022-04-19
Call successful
Does not wish to fill out VAERS report

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-22	Pfizer-BioNTech
2	2021-04-14	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-10-13	Successful	Does not wish to fill out VAERS report
2022-04-17	Successful 2022-04-19	Does not wish to fill out VAERS report

Free text

Release 7 — day 0, dose 2

2021-04-14

Systemic reaction (other): Sinus pain

Release 7 — days 1–6 daily, dose 2

2021-04-15

Systemic reaction (other): Sinus pain

Release 8 — day 14, dose 2

2021-04-28

Symptoms: My RA has flared and so has my MRSA infection. I dont think it has anything to do with the vaccine. Just coincidence.

Release 8 — day 21, dose 2

2021-05-05

Symptoms: My RA has gotten worse and Im starting to get bronchitis.

Release 10 — 6 months, dose 2

2021-10-13

Symptoms: I have been feeling very fatigued and generally unwell. My GP did blood tests which showed a very high Epstein Barr Panel. My doctor indicated that it probably meant that I had a reactivation of mono.

Healthcare visit (other): Several doctor appointments. I'm still not feeling well.

Release 11 — 12 months, dose 2

2022-04-17

Symptoms: Epstein Barr Syndrome - extreme tiredness

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	Malaise	·	·	✓
HCVO	Office visit	·	·	✓
SD	Bronchitis	✓	✓	✓
SD	Condition aggravated	✓	✓	✓
SD	Epstein-Barr virus infection	·	·	✓
SD	Fatigue	·	·	✓
SD	Malaise	·	·	✓
SD	Office visit	·	·	✓
SD	Pre-existing disease	✓	✓	✓
SD	Rheumatoid arthritis	✓	✓	✓
SRO	Sinus pain	✓	✓	✓

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