BHK-13739-00172

4 vaccinations 11 coded responses 36 check-ins 11 free-text entries 2 call cases

Sex: Female
Age at first dose: 31-35
ZIP prefix: 973 / OR
Registered: 2021-05-11

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

2021-04-20
Dose 1 — Pfizer-BioNTech
2021-05-11
Registered in v-safe
2021-05-11
Dose 2 — Pfizer-BioNTech
2021-05-11
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-05-12
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-05-13
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Headache

Adult check-in
2021-05-14
Survey response — days 1–6 daily, dose 2
MedDRA: Mastitis — Feeling: Fair · Fever · Chills, Headache, Fatigue or tiredness · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Mastitis (started dating after vaccine)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-14
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-16
Survey response — days 1–6 daily, dose 2
MedDRA: Breast feeding — Feeling: Fair

Free text: Unexpected menstrual bleeding. I am 5.5 weeks postpartum and breastfeeding two children should not be having a period

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-18
Survey response — day 7, dose 2
MedDRA: Menstruation irregular — Feeling: Good

Free text: Unexpected menstrual bleeding/period

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-27
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-06-01
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-06-08
Survey response — day 28, dose 2
MedDRA: Menstruation irregular — Feeling: Good

Free text: Irregular menstrual bleeding (non-cyclical spotting, occurred last week, again this week, after an unexpected/early cycle directly after 2nd dose of vaccine)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-15
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-06-22
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-08-10
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-11-09
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-12-07
Dose 3 — Pfizer-BioNTech
2021-12-11
Survey response — days 1–6 daily, dose 3
MedDRA: Mastitis — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness

Free text: Mastitis

MedDRA releases: 2024-11 · check-in free text available
2021-12-12
Survey response — days 1–6 daily, dose 3
MedDRA: Intermenstrual bleeding, Unevaluable event — Feeling: Good

Free text: Menstrual spotting. I am 8 months postpartum, and the last time I had menstrual bleeding was after my initial vaccine doses

MedDRA releases: 2024-11 · check-in free text available
2021-12-13
Survey response — days 1–6 daily, dose 3
MedDRA: Intermenstrual bleeding, Postpartum state — Feeling: Good

Free text: Menstrual spotting. 8 months postpartum, no bleeding since earlier covid shots that correlated with menstrual bleeding at 4 weeks postpartum, and 8 weeks postpartum

MedDRA releases: 2024-11 · check-in free text available
2021-12-16
Survey response — day 7, dose 3
MedDRA: Menstruation irregular, Vaccine positive rechallenge — Feeling: Good · Abdominal pain

Free text: Menstrual bleeding. Could be related or coincidence, but I am 8 months postpartum and the only menstrual bleeding I've had had been post COVID vaccines (at 4 weeks PP and 8 weeks PP)

MedDRA releases: 2024-11 · check-in free text available
2021-12-21
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2021-12-28
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2022-01-04
Survey response — day 28, dose 3
MedDRA: Cough, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Runny nose, mild cough, sneezing. COVID PCR test was negative

MedDRA releases: 2024-11 · check-in free text available
2022-01-04
Report sent to call center — day 28, dose 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-01-05
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2022-01-13
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2022-01-20
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-03-08
Survey response — 3 months, dose 3
MedDRA: Fatigue, Headache, Rhinorrhoea — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Runny nose, headache, fatigue

MedDRA releases: 2024-11 · check-in free text available
2022-06-13
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in
2022-12-07
Survey response — 12 months, dose 3
MedDRA: COVID-19, Diarrhoea, Fatigue, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: COVID infection: fever, sore throat, body aches, diarrhea, runny nose, fatigue

MedDRA releases: 2024-11 · check-in free text available
2022-12-28
Dose 4 — Pfizer-BioNTech
Co-administered: Flu
2022-12-29
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain · Fever · Chills, Headache, Joint pains, Fatigue or tiredness, Diarrhea, Abdominal pain · Be unable to work or attend school

Adult check-in
2022-12-31
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Pain · Muscle or body aches

Adult check-in
2023-01-01
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Diarrhea

Adult check-in
2023-01-02
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Diarrhea

Adult check-in
2023-01-03
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Diarrhea

Adult check-in
2023-01-04
Health check-in — day 7, dose 4
Feeling: Good · Diarrhea

Adult check-in
2023-01-11
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2023-01-18
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2023-01-25
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2023-02-01
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2023-03-29
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-20	Pfizer-BioNTech
2	2021-05-11	Pfizer-BioNTech
3	2021-12-07	Pfizer-BioNTech	No
4	2022-12-28	Pfizer-BioNTech	Flu

Call center

2 call center cases

2 successful

See the call center timeline

Free text

Release 8 — days 1–6 daily, dose 2

2021-05-14

Systemic reaction (other): Mastitis (started dating after vaccine)

2021-05-16

Systemic reaction (other): Unexpected menstrual bleeding. I am 5.5 weeks postpartum and breastfeeding two children should not be having a period

Release 8 — day 7, dose 2

2021-05-18

Systemic reaction (other): Unexpected menstrual bleeding/period

Release 8 — day 28, dose 2

2021-06-08

Symptoms: Irregular menstrual bleeding (non-cyclical spotting, occurred last week, again this week, after an unexpected/early cycle directly after 2nd dose of vaccine)

Release 10 — days 1–6 daily, dose 3

2021-12-11

Systemic reaction (other): Mastitis

2021-12-12

Systemic reaction (other): Menstrual spotting. I am 8 months postpartum, and the last time I had menstrual bleeding was after my initial vaccine doses

2021-12-13

Systemic reaction (other): Menstrual spotting. 8 months postpartum, no bleeding since earlier covid shots that correlated with menstrual bleeding at 4 weeks postpartum, and 8 weeks postpartum

Release 10 — day 7, dose 3

2021-12-16

Systemic reaction (other): Menstrual bleeding. Could be related or coincidence, but I am 8 months postpartum and the only menstrual bleeding I've had had been post COVID vaccines (at 4 weeks PP and 8 weeks PP)

Release 10 — day 28, dose 3

2022-01-04

Symptoms: Runny nose, mild cough, sneezing. COVID PCR test was negative

Release 11 — 3 months, dose 3

2022-03-08

Symptoms: Runny nose, headache, fatigue

Release 12 — 12 months, dose 3

2022-12-07

Symptoms: COVID infection: fever, sore throat, body aches, diarrhea, runny nose, fatigue

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	Cough	·	·	✓
SD	COVID-19	·	·	✓
SD	Diarrhoea	·	·	✓
SD	Fatigue	·	·	✓
SD	Headache	·	·	✓
SD	Menstruation irregular	✓	✓	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pain	·	·	✓
SD	Pyrexia	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Sneezing	·	·	✓
SRO	Breast feeding	✓	✓	✓
SRO	Intermenstrual bleeding	·	·	✓
SRO	Mastitis	✓	✓	✓
SRO	Menstruation irregular	✓	✓	✓
SRO	Postpartum state	·	·	✓
SRO	Unevaluable event	·	·	✓
SRO	Vaccine positive rechallenge	·	·	✓

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