4FH-14592-05259 · OpenVSafe

Timeline

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

2021-03-17
Dose 1 — Pfizer-BioNTech
2021-03-19
Registered in v-safe
2021-03-19
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Joint pains, Fatigue or tiredness

Adult check-in
2021-03-20
Survey response — days 1–6 daily, dose 1
MedDRA: Irregular sleep phase, Poor quality sleep — Feeling: Good · Fatigue or tiredness

Free text: Irregular/restless sleep periods (4 hour intervals)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-21
Survey response — days 1–6 daily, dose 1
MedDRA: Insomnia — Feeling: Good · Fatigue or tiredness

Free text: Insomnia; only able to sleep for 4 hours

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-22
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-03-23
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-24
Health check-in — day 7, dose 1
Feeling: Good · Diarrhea

Adult check-in
2021-03-31
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-04-07
Dose 2 — Pfizer-BioNTech
2021-04-07
Health check-in — day 0, dose 2
Feeling: Good · Headache

Adult check-in
2021-04-08
Survey response — days 1–6 daily, dose 2
MedDRA: Adverse reaction — Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Free text: Symptoms were much less intense than after first dose.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-09
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-10
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-11
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-12
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-13
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-14
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-24
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-29
Survey response — day 21, dose 2
MedDRA: Arthralgia, Fatigue, Pyrexia, Reaction to previous exposure to any vaccine, Self-medication, Somnolence — Feeling: Good · Be unable to do your normal daily activities

Free text: Took an antihistamine (Zyrtec) for what I thought was allergies but later developed mild fever, drowsiness, sore joints and systemic fatigue as I did after initial vaccine shot. Symptoms resolved completely w/in 24 hours.

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

Adult check-in
2021-05-12
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-05-19
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-07-09
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-10-06
Survey response — 6 months, dose 2
MedDRA: Menstruation irregular, Polymenorrhoea — Feeling: Good

Free text: Irregular menstrual cycle for past two months. Cycle was 2-3 weeks apart instead of 4-5 and it was definitely NOT spotting. This is my third month so I don't know if the short menstrual cycles will persist.

MedDRA releases: 2024-11 · check-in free text available
2022-04-11
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-17	Pfizer-BioNTech
2	2021-04-07	Pfizer-BioNTech

Free text

Release 6 — days 1–6 daily, dose 1

2021-03-20

Systemic reaction (other): Irregular/restless sleep periods (4 hour intervals)

2021-03-21

Systemic reaction (other): Insomnia; only able to sleep for 4 hours

Release 7 — days 1–6 daily, dose 2

2021-04-08

Systemic reaction (other): Symptoms were much less intense than after first dose.

Release 8 — day 21, dose 2

2021-04-29

Symptoms: Took an antihistamine (Zyrtec) for what I thought was allergies but later developed mild fever, drowsiness, sore joints and systemic fatigue as I did after initial vaccine shot. Symptoms resolved completely w/in 24 hours.

Release 10 — 6 months, dose 2

2021-10-06

Symptoms: Irregular menstrual cycle for past two months. Cycle was 2-3 weeks apart instead of 4-5 and it was definitely NOT spotting. This is my third month so I don't know if the short menstrual cycles will persist.

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	Arthralgia	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Menstruation irregular	·	·	✓
SD	Polymenorrhoea	·	·	✓
SD	Pyrexia	✓	✓	✓
SD	Reaction to previous exposure to any vaccine	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Somnolence	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Irregular sleep phase	✓	✓	✓
SRO	Poor quality sleep	✓	✓	✓

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