TL6-20193-43538

1 vaccination 10 coded responses 13 check-ins 10 free-text entries 2 call cases

Sex: Female
Age at first dose: 31-35
ZIP prefix: 352 / AL
Registered: 2021-08-10

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

2021-08-10
Registered in v-safe
2021-08-10
Dose 1 — Janssen/Johnson & Johnson
2021-08-10
Survey response — day 0, dose 1
MedDRA: Paranasal sinus discomfort — Feeling: Good · Site: Pain · Fatigue or tiredness

Free text: Some sinus pressure

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-11
Survey response — days 1–6 daily, dose 1
MedDRA: Office visit, Pregnancy, Thrombosis, Vaginal haemorrhage — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Systemic reaction (other): Pregnant (1st trimester)- spotting and blood clots passed · Healthcare visit (other): OB visit for concern regarding possible miscarriage

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

1 call case(s)
2021-08-13
Survey response — days 1–6 daily, dose 1
MedDRA: Bloody discharge, Fatigue, Myalgia, Neuralgia, Pregnancy, Sciatica — Feeling: Good · Muscle or body aches, Fatigue or tiredness, Nausea

Free text: Still having some very light blood tinged discharge. Experience fatigue and muscles are sore. Experiencing a slight nerve twinge down the backs of my legs and a little in my left ankle. Could be sciatic nerves from pregnancy.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-13
Call 1 — Left Voicemail
2021-08-13
Call successful
Participant prefers to complete VAERS report online
2021-08-14
Survey response — days 1–6 daily, dose 1
MedDRA: Office visit, Vaginal haemorrhage — Feeling: Fair · Fatigue or tiredness

Free text: Still having light blood tinged discharge occasionally. Being treated by OB with supplementing progesterone.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-15
Survey response — days 1–6 daily, dose 1
MedDRA: Pain in jaw — Feeling: Good · Fatigue or tiredness

Free text: Soreness in jaw. Could be from clenching but unsure.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-16
Survey response — days 1–6 daily, dose 1
MedDRA: Human chorionic gonadotropin abnormal, Pregnancy, Progesterone abnormal — Feeling: Fair · Fatigue or tiredness

Free text: Got blood results back and my progesterone and HCG levels are not increasing now. I may lose this pregnancy

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-17
Health check-in — day 7, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-08-24
Survey response — day 14, dose 1
MedDRA: Headache — Feeling: Fair

Free text: Headache today

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-31
Health check-in — day 21, single dose
Feeling: Fair

Adult check-in
2021-09-07
Survey response — day 28, single dose
MedDRA: Abortion spontaneous — Feeling: Fair

Free text: My baby did not grow and heartbeat not detected at 7 weeks. Miscarriage on Sept. 1st.

MedDRA releases: 2024-11 · check-in free text available
2021-09-18
Survey response — day 35, single dose
MedDRA: Abortion spontaneous, Abortion spontaneous incomplete, Emergency care, Human chorionic gonadotropin increased, Vaginal haemorrhage — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: Had increased and abnormal vaginal bleeding from miscarriage and had to go to ER on 9/13. Diagnosed Incomplete miscarriage. Bleeding has slowed since then and HCG levels are down in the 300 range.

MedDRA releases: 2024-11 · check-in free text available
2021-09-18
Report sent to call center — day 35, single dose
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-20
Call 1 — Left Voicemail
2021-09-23
Health check-in — day 42, single dose
Feeling: Good

Adult check-in
2021-11-10
Survey response — 3 months, dose 1
MedDRA: Abortion spontaneous — Feeling: Good

Free text: Miscarriage September 1, 2021.

MedDRA releases: 2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-08-10	Janssen/Johnson & Johnson	No

Call center

Reported	Outcome	VAERS-related outcome
2021-08-11	Successful 2021-08-13	Participant prefers to complete VAERS report online
2021-09-18	Unsuccessful	Reported to VAERS voluntarily prior to GDIT contact

Free text

Release 9 — day 0, dose 1

2021-08-10

Systemic reaction (other): Some sinus pressure

Release 9 — days 1–6 daily, dose 1

2021-08-11

Systemic reaction (other): Pregnant (1st trimester)- spotting and blood clots passed

Healthcare visit (other): OB visit for concern regarding possible miscarriage

2021-08-13

Systemic reaction (other): Still having some very light blood tinged discharge. Experience fatigue and muscles are sore. Experiencing a slight nerve twinge down the backs of my legs and a little in my left ankle. Could be sciatic nerves from pregnancy.

2021-08-14

Systemic reaction (other): Still having light blood tinged discharge occasionally. Being treated by OB with supplementing progesterone.

2021-08-15

Systemic reaction (other): Soreness in jaw. Could be from clenching but unsure.

2021-08-16

Systemic reaction (other): Got blood results back and my progesterone and HCG levels are not increasing now. I may lose this pregnancy

Release 9 — day 14, dose 1

2021-08-24

Symptoms: Headache today

Release 9 — day 28, single dose

2021-09-07

Symptoms: My baby did not grow and heartbeat not detected at 7 weeks. Miscarriage on Sept. 1st.

Release 9 — day 35, single dose

2021-09-18

Symptoms: Had increased and abnormal vaginal bleeding from miscarriage and had to go to ER on 9/13. Diagnosed Incomplete miscarriage. Bleeding has slowed since then and HCG levels are down in the 300 range.

Release 10 — 3 months, dose 1

2021-11-10

Symptoms: Miscarriage September 1, 2021.

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	Abortion spontaneous	·	·	✓
SD	Abortion spontaneous incomplete	·	·	✓
SD	Emergency care	·	·	✓
SD	Headache	✓	·	✓
SD	Human chorionic gonadotropin increased	·	·	✓
SD	Vaginal haemorrhage	·	·	✓
SRO	Bloody discharge	✓	·	✓
SRO	Fatigue	✓	·	✓
SRO	Human chorionic gonadotropin abnormal	✓	·	✓
SRO	Human chorionic gonadotropin increased	○	·	○
SRO	Myalgia	✓	·	✓
SRO	Neuralgia	✓	·	✓
SRO	Office visit	✓	·	✓
SRO	Pain in jaw	✓	·	✓
SRO	Paranasal sinus discomfort	✓	·	✓
SRO	Pregnancy	✓	·	✓
SRO	Progesterone abnormal	✓	·	✓
SRO	Progesterone increased	○	·	○
SRO	Sciatica	✓	·	✓
SRO	Thrombosis	✓	·	✓
SRO	Vaginal haemorrhage	✓	·	✓

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