5LE-28338-50771

4 vaccinations 16 coded responses 48 check-ins 15 free-text entries 2 call cases

Sex: Female
Age at first dose: 31-35
ZIP prefix: 041 / ME
Registered: 2020-12-23

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Timeline

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

2020-12-23
Registered in v-safe
2020-12-23
Dose 1 — Pfizer-BioNTech
2020-12-23
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2020-12-24
Survey response — days 1–6 daily, dose 1
MedDRA: Erythema, Musculoskeletal stiffness, Peripheral coldness, Peripheral swelling — Feeling: Good · Site: Pain

Free text: Intolerance to cold in my fingers...outside x1 hour with gloves on in 45 degree weather (seasonally warm), and fingers were freezing, red, and puffy/stiff. No idea if this is vaccine related or just a new thing for me, resolved after going inside and warming up but reoccurred during second outdoor outing

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2020-12-26
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2020-12-27
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-28
Survey response — days 1–6 daily, dose 1
MedDRA: Rash, Rash macular — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Scattered red, flat, pinpoint to trunk, not itchy or painful

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-29
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2020-12-30
Health check-in — day 7, dose 1
Feeling: Good · Headache, Fatigue or tiredness

Adult check-in
2021-01-06
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-13
Dose 2 — Pfizer-BioNTech
2021-01-13
Health check-in — day 0, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-14
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-15
Survey response — days 1–6 daily, dose 2
MedDRA: Rash, Rash erythematous, Rhinorrhoea — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

Free text: Runny nose. Rash scattered red pinpoint to trunk, same as on day 5 after first vaccine. Not itchy or painful. Rash did not cross midline and was opposite from injection side with second dose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-15
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities

1 call case(s)
2021-01-16
Survey response — days 1–6 daily, dose 2
MedDRA: Cough — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: Cough

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-17
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-01-18
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-21
Survey response — day 7, dose 2
MedDRA: Lymphadenopathy — Feeling: Fair · Headache, Fatigue or tiredness

Free text: Swollen glands upper body vaccine side

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-27
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-03
Survey response — day 21, dose 2
MedDRA: Orthostatic hypotension — Feeling: Good

Free text: Since vaccine 1 I have had frequent orthostatic hypotension. This started the night after my first vaccine and improved about a week after and has since remained steady occurring 1-2x per day. Did not appear to improve or worsen after second dose.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-10
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-02-17
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-02-24
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-14
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-14
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-11-22
Dose 3 — Pfizer-BioNTech
2021-11-25
Survey response — days 1–6 daily, dose 3
MedDRA: Lymphadenopathy — Feeling: Good

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2021-11-26
Survey response — days 1–6 daily, dose 3
MedDRA: Lymphadenopathy — Feeling: Good

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2021-11-27
Survey response — days 1–6 daily, dose 3
MedDRA: Lymphadenopathy — Feeling: Good

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2021-11-28
Survey response — days 1–6 daily, dose 3
MedDRA: Lymphadenopathy — Feeling: Good

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2021-11-29
Health check-in — day 7, dose 3
Feeling: Good · None

Adult check-in
2021-12-06
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2021-12-13
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2021-12-20
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2021-12-27
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2022-01-03
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-02-21
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-05-25
Survey response — 6 months, dose 3
MedDRA: Infertility — Feeling: Good

Free text: Infertility

MedDRA releases: 2024-11 · check-in free text available
2022-10-02
Dose 4 — Pfizer-BioNTech
2022-10-03
Survey response — days 1–6 daily, dose 4
MedDRA: Lymphadenopathy — Feeling: Fair · Site: Pain, Swelling · Muscle or body aches, Fatigue or tiredness

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2022-10-04
Survey response — days 1–6 daily, dose 4
MedDRA: Lymphadenopathy — Feeling: Good · Site: Pain · Fatigue or tiredness

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2022-10-05
Survey response — days 1–6 daily, dose 4
MedDRA: Lymphadenopathy — Feeling: Fair · Site: Pain · Fatigue or tiredness

Free text: Swollen lymph nodes, improving

MedDRA releases: 2024-11 · check-in free text available
2022-10-06
Survey response — days 1–6 daily, dose 4
MedDRA: Lymphadenopathy — Feeling: Fair · Fatigue or tiredness

Free text: Swollen lymph nodes

MedDRA releases: 2024-11 · check-in free text available
2022-10-07
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-10-09
Health check-in — day 7, dose 4
Feeling: Good · None

Adult check-in
2022-10-16
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-10-23
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-10-30
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-11-06
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-11-13
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2023-01-01
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2023-04-04
Survey response — 6 months, dose 4
MedDRA: Adenomyosis, Endometriosis — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11
2023-04-04
Report sent to call center — 6 months, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2023-04-05
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-23	Pfizer-BioNTech
2	2021-01-13	Pfizer-BioNTech
3	2021-11-22	Pfizer-BioNTech	No
4	2022-10-02	Pfizer-BioNTech	No

Call center

2 call center cases

1 unsuccessful · 1 priority 2/3 (triaged and no follow up)

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2020-12-24

Systemic reaction (other): Intolerance to cold in my fingers...outside x1 hour with gloves on in 45 degree weather (seasonally warm), and fingers were freezing, red, and puffy/stiff. No idea if this is vaccine related or just a new thing for me, resolved after going inside and warming up but reoccurred during second outdoor outing

2020-12-28

Systemic reaction (other): Scattered red, flat, pinpoint to trunk, not itchy or painful

Release 2 — days 1–6 daily, dose 2

2021-01-15

Systemic reaction (other): Runny nose. Rash scattered red pinpoint to trunk, same as on day 5 after first vaccine. Not itchy or painful. Rash did not cross midline and was opposite from injection side with second dose

2021-01-16

Systemic reaction (other): Cough

Release 2 — day 7, dose 2

2021-01-21

Systemic reaction (other): Swollen glands upper body vaccine side

Release 3 — day 21, dose 2

2021-02-03

Symptoms: Since vaccine 1 I have had frequent orthostatic hypotension. This started the night after my first vaccine and improved about a week after and has since remained steady occurring 1-2x per day. Did not appear to improve or worsen after second dose.