VXN-22869-03310 · OpenVSafe

Timeline

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

2021-03-25
Dose 1 — Pfizer-BioNTech
2021-04-15
Dose 2 — Pfizer-BioNTech
2021-04-16
Registered in v-safe
2021-04-16
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Swelling · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-04-17
Survey response — days 1–6 daily, dose 2
MedDRA: Chills, Peripheral coldness, Tremor — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Free text: I forgot to say yesterday (and couldn't find a way to edit) that in the first 24 hrs chills were so bad I was shaking. Got my core warm but fingers and toes were like ice.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-19
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-04-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-04-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-22
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-29
Survey response — day 14, dose 2
MedDRA: Intermenstrual bleeding, Menopause, Menstruation irregular, Pre-existing disease, Premenstrual syndrome, Vaginal haemorrhage — Feeling: Good

Free text: I had light spotting on 4/24-25.I mention it because I hear other women have been having menstrual symptoms. Also, I am in early menopause due to previous chemo, and I haven't had spotting in about 9 months, so that was unexpected.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-08
Survey response — day 21, dose 2
MedDRA: Vaginal discharge, Vaginal haemorrhage — Feeling: Good

Free text: After the spotting, there were several more days of light, discolored discharge. It seems to have cleared up now though.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-13
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-20
Survey response — day 35, dose 2
MedDRA: Intermenstrual bleeding — Feeling: Good

Free text: More spotting, almost like a very light period, lasting from last Friday through Tuesday.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-27
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-07-15
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-10-17
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-12-29
Dose 3 — Pfizer-BioNTech
2022-04-15
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-05-23
Dose 4 — Pfizer-BioNTech
2022-06-24
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-06-27
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-07-04
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-08-25
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2022-11-21
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in
2023-05-24
Health check-in — 12 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-25	Pfizer-BioNTech
2	2021-04-15	Pfizer-BioNTech
3	2021-12-29	Pfizer-BioNTech	No
4	2022-05-23	Pfizer-BioNTech	No

Free text

Release 7 — days 1–6 daily, dose 2

2021-04-17

Systemic reaction (other): I forgot to say yesterday (and couldn't find a way to edit) that in the first 24 hrs chills were so bad I was shaking. Got my core warm but fingers and toes were like ice.

Release 8 — day 14, dose 2

2021-04-29

Symptoms: I had light spotting on 4/24-25.I mention it because I hear other women have been having menstrual symptoms. Also, I am in early menopause due to previous chemo, and I haven't had spotting in about 9 months, so that was unexpected.

Release 8 — day 21, dose 2

2021-05-08

Symptoms: After the spotting, there were several more days of light, discolored discharge. It seems to have cleared up now though.

Release 8 — day 35, dose 2

2021-05-20

Symptoms: More spotting, almost like a very light period, lasting from last Friday through Tuesday.

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	Intermenstrual bleeding	✓	✓	✓
SD	Menopause	✓	✓	○
SD	Menstruation irregular	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Premenstrual syndrome	✓	✓	○
SD	Vaginal discharge	✓	✓	✓
SD	Vaginal haemorrhage	✓	✓	✓
SRO	Chills	✓	✓	✓
SRO	Peripheral coldness	✓	✓	✓
SRO	Tremor	✓	✓	✓

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