3GF-11115-19587

2 vaccinations 9 coded responses 23 check-ins 9 free-text entries 6 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 629 / IL
Registered: 2021-01-29

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

2021-01-26
Dose 1 — Moderna
2021-01-29
Registered in v-safe
2021-01-29
Survey response — days 1–6 daily, dose 1
MedDRA: Medical counselling, Unevaluable event — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): My INR shot up from 2.5 one week ago to 5.8 today. I have no change in my diet, medications, or anything. · Healthcare visit (other): Additional laboratory testing

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-29
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-30
Survey response — days 1–6 daily, dose 1
MedDRA: Blood test, International normalised ratio increased, Medical counselling — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): As reported yesterday, my INR shot up from in-range 2.5 to a 5.8 on 1/29/21. My 1st (Moderna) vaccine was 1/26/21. There has been no change in diet, medications, etc. Could the vaccine cause this jump to a critical INR level? · Healthcare visit (other): Phone, then laboratory for blood tests

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-30
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-01
Survey response — days 1–6 daily, dose 1
MedDRA: International normalised ratio increased, Laboratory test, Medical counselling — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): As reported in previous check-ins, my INR shot up from a stable level of 2.5 to a CRITICAL level of 5.8. The ONLY change in critcal parameters was the fact that I received my first vaccination on 1/26/21. Could this be a direct reaction? I need a response prior to my second vaccination · Healthcare visit (other): Lab work, phone calls

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-01
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)
2021-02-02
Survey response — day 7, dose 1
MedDRA: Unevaluable event — Feeling: Fair

Free text: Moderna called me regarding my critical INR jump post vaccine. Thank you.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-09
Health check-in — day 14, dose 1
Feeling: Fair

Adult check-in
2021-02-16
Health check-in — day 21, dose 1
Feeling: Fair

Adult check-in
2021-02-23
Health check-in — day 28, dose 1
Feeling: Fair

Adult check-in
2021-03-02
Health check-in — day 35, dose 1
Feeling: Fair

Adult check-in
2021-03-03
Dose 2 — Moderna
2021-03-03
Survey response — day 0, dose 2
MedDRA: Heart rate increased, Heart rate irregular, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities

Free text: High heart rate 110s to 132 thus far, irregular heartbeat (understand I do have afib on & off, but not high heart rate. I just had the shot about 9 am this morning.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-04
Survey response — days 1–6 daily, dose 2
MedDRA: Heart rate increased — Feeling: Fair · Site: Pain

Free text: High heart rate reported yesterday has slowly decreased today and at 2:16 CST dropped below 100 to 90's & high 80's.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · None

Adult check-in
2021-03-07
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · None

Adult check-in
2021-03-08
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · None

Adult check-in
2021-03-09
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · None

Adult check-in
2021-03-10
Health check-in — day 7, dose 2
Feeling: Fair · None

Adult check-in
2021-03-17
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-03-24
Health check-in — day 21, dose 2
Feeling: Fair

Adult check-in
2021-03-31
Survey response — day 28, dose 2
MedDRA: Atrial fibrillation, Heart rate increased, Pre-existing disease — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit, Hospitalization

Free text: ER/Hospitalization due to Heart Rate in the 190s due to AFibrillation with a rapid ventricular response (RVR). My AFib is a pre-existing condition.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-31
Report sent to call center — day 28, dose 2
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-07
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-04-14
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-05-28
Call successful
Participant prefers to complete VAERS report online
2021-06-03
Health check-in — 3 months, dose 2
Feeling: Fair

Adult check-in
2021-09-03
Survey response — 6 months, dose 2
MedDRA: Condition aggravated, Office visit, Pre-existing disease — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: Worsening of my preexisting conditions unrelated to the vaccine. · Healthcare visit (other): Regular in person dr sppts

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-09-03
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-08
Call successful
Does not wish to fill out VAERS report
2022-03-03
Survey response — 12 months, dose 2
MedDRA: Atrial fibrillation, Office visit, Sinusitis — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Repeated Sinus infections, 99.5 % Afib instead of random occurrences · Healthcare visit (other): Periodic appts with my regular doctors

MedDRA releases: 2024-11 · check-in free text available
2022-03-03
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2022-03-08
Call successful
Does not wish to fill out VAERS report

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-26	Moderna
2	2021-03-03	Moderna

Call center

6 call center cases

6 successful

See the call center timeline

Free text

Release 3 — days 1–6 daily, dose 1

2021-01-29

Systemic reaction (other): My INR shot up from 2.5 one week ago to 5.8 today. I have no change in my diet, medications, or anything.

Healthcare visit (other): Additional laboratory testing

2021-01-30

Systemic reaction (other): As reported yesterday, my INR shot up from in-range 2.5 to a 5.8 on 1/29/21. My 1st (Moderna) vaccine was 1/26/21. There has been no change in diet, medications, etc. Could the vaccine cause this jump to a critical INR level?

Healthcare visit (other): Phone, then laboratory for blood tests

2021-02-01

Systemic reaction (other): As reported in previous check-ins, my INR shot up from a stable level of 2.5 to a CRITICAL level of 5.8. The ONLY change in critcal parameters was the fact that I received my first vaccination on 1/26/21. Could this be a direct reaction? I need a response prior to my second vaccination

Healthcare visit (other): Lab work, phone calls

Release 3 — day 7, dose 1

2021-02-02

Systemic reaction (other): Moderna called me regarding my critical INR jump post vaccine. Thank you.

Release 5 — day 0, dose 2

2021-03-03

Systemic reaction (other): High heart rate 110s to 132 thus far, irregular heartbeat (understand I do have afib on & off, but not high heart rate. I just had the shot about 9 am this morning.

Release 5 — days 1–6 daily, dose 2

2021-03-04

Systemic reaction (other): High heart rate reported yesterday has slowly decreased today and at 2:16 CST dropped below 100 to 90's & high 80's.

Release 6 — day 28, dose 2

2021-03-31

Symptoms: ER/Hospitalization due to Heart Rate in the 190s due to AFibrillation with a rapid ventricular response (RVR). My AFib is a pre-existing condition.

Release 9 — 6 months, dose 2

2021-09-03

Symptoms: Worsening of my preexisting conditions unrelated to the vaccine.

Healthcare visit (other): Regular in person dr sppts

Release 11 — 12 months, dose 2

2022-03-03

Symptoms: Repeated Sinus infections, 99.5 % Afib instead of random occurrences

Healthcare visit (other): Periodic appts with my regular doctors

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	Blood test	✓	✓	✓
HCVO	Laboratory test	✓	✓	✓
HCVO	Medical counselling	✓	✓	✓
HCVO	Office visit	✓	·	✓
SD	Atrial fibrillation	✓	✓	✓
SD	Condition aggravated	✓	·	✓
SD	Heart rate increased	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Sinusitis	·	·	✓
SRO	Heart rate increased	✓	✓	✓
SRO	Heart rate irregular	✓	✓	✓
SRO	International normalised ratio increased	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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