ZAZ-12226-22608

1 vaccination 10 coded responses 15 check-ins 10 free-text entries 7 call cases

Sex: Female
Age at first dose: 41-45
ZIP prefix: 320 / FL
Registered: 2021-08-24

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

2021-08-23
Dose 1 — Janssen/Johnson & Johnson
2021-08-24
Registered in v-safe
2021-08-24
Survey response — days 1–6 daily, dose 1
MedDRA: Office visit — Feeling: Good · Site: Pain · Abdominal pain · Get care from a doctor or other healthcare professional

Free text: OBGYN consult

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-24
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-25
Survey response — days 1–6 daily, dose 1
MedDRA: Intermenstrual bleeding — Feeling: Fair · Site: Pain · Joint pains, Diarrhea, Abdominal pain · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Spotting / menstrual bleeding 5 days before start of cycle

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-25
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-26
Survey response — days 1–6 daily, dose 1
MedDRA: Dysmenorrhoea, Heavy menstrual bleeding — Feeling: Fair · Headache, Abdominal pain · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Heavy menstruation outside of my normal cycle and cramping

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-26
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-27
Survey response — days 1–6 daily, dose 1
MedDRA: Heavy menstrual bleeding — Feeling: Fair · Site: Pain · Abdominal pain · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Heavy menstrual bleeding in advance of cycle start

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-27
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-28
Survey response — days 1–6 daily, dose 1
MedDRA: Menstruation irregular — Feeling: Good · Headache, Diarrhea, Abdominal pain

Free text: Menstrual bleeding before cycle

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-29
Survey response — days 1–6 daily, dose 1
MedDRA: Menstruation irregular — Feeling: Fair · Site: Pain · Fatigue or tiredness, Abdominal pain · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Menstruation before cycle start

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-29
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-30
Survey response — day 7, dose 1
MedDRA: Dysgeusia, Menstruation irregular — Feeling: Fair · Abdominal pain · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Menstrual bleeding in advance of cycle and metallic taste in mouth

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-30
Report sent to call center — day 7, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-01
Call 2 — Left Voicemail
2021-09-02
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2021-09-02
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2021-09-02
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2021-09-02
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2021-09-02
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2021-09-06
Survey response — day 14, dose 1
MedDRA: Dysgeusia, Immediate post-injection reaction — Feeling: Good

Free text: 20 min after the shot I noticed a metallic taste in my mouth. It hasnt gone away. Im still experiencing a metallic taste in my mouth at all times.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-09-13
Survey response — day 21, single dose
MedDRA: Self-medication, Urticaria — Feeling: Fair

Free text: On Friday I broke out in hives on my back. I took Benadryl and it was gone the next day.

MedDRA releases: 2024-11 · check-in free text available
2021-09-20
Health check-in — day 28, single dose
Feeling: Fair

Adult check-in
2021-09-27
Health check-in — day 35, single dose
Feeling: Good

Adult check-in
2021-10-04
Health check-in — day 42, single dose
Feeling: Fair

Adult check-in
2021-11-22
Health check-in — 3 months, dose 1
Feeling: Fair

Adult check-in
2022-02-21
Health check-in — 6 months, dose 1
Feeling: Fair

Adult check-in
2022-08-23
Survey response — 12 months, dose 1
MedDRA: Hot flush, Menstruation irregular, Night sweats, Office visit — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Missed period, hot flashes, night sweats · Healthcare visit (other): Primary care

MedDRA releases: 2024-11 · check-in free text available
2022-08-23
Report sent to call center — 12 months, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call 1 — Left Voicemail
2022-08-24
Call successful
Participant prefers to complete VAERS report online
2022-09-02
Call successful
Reported to VAERS voluntarily prior to GDIT contact

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-08-23	Janssen/Johnson & Johnson	No

Call center

Reported	Outcome	VAERS-related outcome
2021-08-24	Successful 2021-09-02	Reported to VAERS voluntarily prior to GDIT contact
2021-08-25	Successful 2021-09-02	Reported to VAERS voluntarily prior to GDIT contact
2021-08-26	Successful 2022-09-02	Reported to VAERS voluntarily prior to GDIT contact
2021-08-27	Successful 2021-09-02	Reported to VAERS voluntarily prior to GDIT contact
2021-08-29	Successful 2021-09-02	Reported to VAERS voluntarily prior to GDIT contact
2021-08-30	Successful 2021-09-02	Reported to VAERS voluntarily prior to GDIT contact
2022-08-23	Successful 2022-08-24	Participant prefers to complete VAERS report online

Free text

Release 9 — days 1–6 daily, dose 1

2021-08-24

Healthcare visit (other): OBGYN consult

2021-08-25

Systemic reaction (other): Spotting / menstrual bleeding 5 days before start of cycle

2021-08-26

Systemic reaction (other): Heavy menstruation outside of my normal cycle and cramping

2021-08-27

Systemic reaction (other): Heavy menstrual bleeding in advance of cycle start

2021-08-28

Systemic reaction (other): Menstrual bleeding before cycle

2021-08-29

Systemic reaction (other): Menstruation before cycle start

Release 9 — day 7, dose 1

2021-08-30

Systemic reaction (other): Menstrual bleeding in advance of cycle and metallic taste in mouth

Release 9 — day 14, dose 1

2021-09-06

Symptoms: 20 min after the shot I noticed a metallic taste in my mouth. It hasnt gone away. Im still experiencing a metallic taste in my mouth at all times.

Release 9 — day 21, single dose

2021-09-13

Symptoms: On Friday I broke out in hives on my back. I took Benadryl and it was gone the next day.

Release 12 — 12 months, dose 1

2022-08-23

Symptoms: Missed period, hot flashes, night sweats

Healthcare visit (other): Primary care

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	Office visit	✓	·	✓
SD	Dysgeusia	✓	·	✓
SD	Hot flush	·	·	✓
SD	Immediate post-injection reaction	✓	·	✓
SD	Menstruation irregular	·	·	✓
SD	Night sweats	·	·	✓
SD	Self-medication	·	·	✓
SD	Urticaria	·	·	✓
SRO	Dysgeusia	✓	·	✓
SRO	Dysmenorrhoea	✓	·	✓
SRO	Heavy menstrual bleeding	✓	·	✓
SRO	Intermenstrual bleeding	✓	·	✓
SRO	Menstruation irregular	✓	·	✓

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