XVL-24562-60105 · OpenVSafe

Timeline

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

2021-03-30
Dose 1 — Pfizer-BioNTech
2021-04-02
Registered in v-safe
2021-04-02
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-04-03
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-04
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Poor · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-05
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-06
Health check-in — 7 day, dose 1
Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-13
Health check-in — 14 day, dose 1
Feeling: Poor

Adult check-in
2021-04-21
Dose 2 — Pfizer-BioNTech
2021-04-22
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Poor · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-23
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain

Adult check-in
2021-04-24
Survey response — days 1–6 daily, dose 2
MedDRA: Fatigue, Hypersomnia — Feeling: Poor · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-25
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Poor · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-26
Survey response — days 1–6 daily, dose 2
MedDRA: Arthralgia, Sleep disorder — Feeling: Poor · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-30
Survey response — 7 day, dose 2
MedDRA: Fatigue, Pain — Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-18
Health check-in — 21 day, dose 2
Feeling: Fair

Adult check-in
2021-10-20
Health check-in — 6 month, dose 2
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-30	Pfizer-BioNTech
2	2021-04-21	Pfizer-BioNTech

Free text

Release 6

Systemic reaction (other): I have hEDS.

Systemic reaction (other): Pretty sure I'm basically back to my normal pain levels..

Release 7

Systemic reaction (other): I started my period.

Systemic reaction (other): I slept for 11 hours and still feel wiped.

Systemic reaction (other): Mostly done with my period now. My temperature usually runs a little low.

Release 8

Systemic reaction (other): My joints have felt more inflamed and achy than normal, particularly my right hip and my hands. It kept me from sleeping despite being exhausted.

Systemic reaction (other): Still more tired than normal, but my pain has returned to it's usual levels..

Free-text releases are not linked to a specific 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
SRO	Arthralgia	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Hypersomnia	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Sleep disorder	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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