PTW-26212-35815 · OpenVSafe

Timeline

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

2021-02-25
Dose 1 — Pfizer-BioNTech
2021-02-28
Registered in v-safe
2021-02-28
Survey response — days 1–6 daily, dose 1
MedDRA: Chills, Medical counselling, Polymenorrhoea, Pyrexia — Feeling: Good · Fever · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Systemic reaction (other): Early menstrual period. It started 24 hours after I was vaccinated. I have been very regular for the last 2 years and this was the first time I got my period two weeks early. I additionally got chills and fever overnight after receiving my first dose that day. I didnt immediately register on vsafe, but I wanted to report my symptoms from then. · Healthcare visit (other): I am planning on trying to conceive in the next few months, so I have been tracking my menstrual cycle. I messaged my maternal fetal medicine physician to see what his thoughts were.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-28
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-02
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-03
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fatigue or tiredness, Nausea

Adult check-in
2021-03-04
Health check-in — day 7, dose 1
Feeling: Poor · Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-03-11
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-18
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-03-19
Dose 2 — Pfizer-BioNTech
2021-03-25
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-03-26
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-02
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-09
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-18
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-04-23
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-04-30
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-06-18
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-09-10
Call 1 — Could Not Reach Participant
2021-09-17
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-09-27
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-12-17
Dose 3 — Pfizer-BioNTech
2022-03-19
Survey response — 12 months, dose 2
MedDRA: Gestational diabetes — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Gestational diabetes

MedDRA releases: 2024-11 · check-in free text available
2022-03-19
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-03-22
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2022-09-14
Dose 4 — Pfizer-BioNTech
Co-administered: Flu
2022-09-21
Health check-in — day 7, dose 4
Feeling: Good · Site: Pain · None

Adult check-in
2022-09-28
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-10-05
Survey response — day 21, dose 4
MedDRA: Oropharyngeal pain, Upper-airway cough syndrome — Feeling: Fair

Free text: Post nasal drip for 10 days, sore throat, no fever

MedDRA releases: 2024-11 · check-in free text available
2022-10-12
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-10-19
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-10-26
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-12-16
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2023-03-15
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-25	Pfizer-BioNTech
2	2021-03-19	Pfizer-BioNTech
3	2021-12-17	Pfizer-BioNTech	No
4	2022-09-14	Pfizer-BioNTech	Flu

Call center

2 call center cases

2 successful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 4 — days 1–6 daily, dose 1

2021-02-28

Systemic reaction (other): Early menstrual period. It started 24 hours after I was vaccinated. I have been very regular for the last 2 years and this was the first time I got my period two weeks early. I additionally got chills and fever overnight after receiving my first dose that day. I didnt immediately register on vsafe, but I wanted to report my symptoms from then.

Healthcare visit (other): I am planning on trying to conceive in the next few months, so I have been tracking my menstrual cycle. I messaged my maternal fetal medicine physician to see what his thoughts were.

Release 11 — 12 months, dose 2

2022-03-19

Symptoms: Gestational diabetes

Release 12 — day 21, dose 4

2022-10-05

Symptoms: Post nasal drip for 10 days, sore throat, no fever

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	Medical counselling	✓	✓	✓
SD	Gestational diabetes	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Upper-airway cough syndrome	·	·	✓
SRO	Chills	✓	✓	✓
SRO	Polymenorrhoea	✓	✓	✓
SRO	Pyrexia	✓	✓	✓

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