3NU-30793-06169

3 vaccinations 8 coded responses 16 check-ins 8 free-text entries 6 call cases

Sex: Female
Age at first dose: 61-65
ZIP prefix: 140 / NY
Registered: 2021-01-11

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

2021-01-08
Dose 1 — Moderna
2021-01-11
Registered in v-safe
2021-01-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-12
Survey response — days 1–6 daily, dose 1
MedDRA: Headache, Nasal congestion, Rhinorrhoea — Feeling: Fair

Free text: Nasal congestion, runny nose, very mild headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache

Adult check-in
2021-01-14
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-15
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-01-22
Survey response — day 14, dose 1
MedDRA: Condition aggravated, Supraventricular tachycardia — Feeling: Good

Free text: Don't know if it's related or not, but have had more runs of SVT since the vaccine. My SVT has been well controlled, but had been noticing it acting up a bit. 1/19/21 it was most noticable and I began to wonder if there was a relationship. Ok now.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-29
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-05
Dose 2 — Moderna
2021-02-19
Survey response — day 14, dose 2
MedDRA: Dyspnoea exertional, Office visit, Palpitations, Tachycardia — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Tachycardia, palpitations anddyspnea with exertion. Caffeine was d/c'd 12 days after dose one without any improvement. Saw PCP and am currently wearing a holter monitor. The vaxwas the only thing different in my life. Sx started soon after # 1. · Healthcare visit (other): Urgent office visit at PCP

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-19
Report sent to call center — day 14, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-26
Survey response — day 21, dose 2
MedDRA: Crohn's disease, Dyspnoea exertional, Pre-existing disease, Supraventricular tachycardia — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Crohn's started flaring. It had been in remission (with chronic meds) for several (+) years.SVT much improved, but dyspnea with exertion continues, although it too is improving.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-26
Report sent to call center — day 21, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-05
Survey response — day 28, dose 2
MedDRA: Crohn's disease, Office visit, Pre-existing disease, Tachycardia — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Crohn's flare, in addition to issues with tachycardia. In a look back, both issues became symptomatic within the week after dose #1. · Healthcare visit (other): Urgent visit with the Dr.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Report sent to call center — day 28, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-12
Survey response — day 35, dose 2
MedDRA: Crohn's disease, Office visit, Pre-existing disease — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Crohn's flare persists. Attempted colonoscopy. Need changes in treatment plan. Tachycardia and DOE is improving though :) · Healthcare visit (other): Office visit and procedure.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-12
Report sent to call center — day 35, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-19
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-05-07
Survey response — 3 months, dose 2
MedDRA: Crohn's disease, Office visit, Pre-existing disease, Tachycardia — Feeling: Good · Get care from a doctor or other healthcare professional

Free text: Symptoms: My Crohn's flare continues, but is finally showing signs of improvement after a change in the biological drug treatment.It took 9 weeks for my SVT to return to baseline.I will be VERY cautious if I need to consider a booster vaccine!! · Healthcare visit (other): Office visits. Infusion treatment.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-07
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-16
Call 1 — Left Voicemail
2021-08-08
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-08-27
Dose 3 — Moderna
2021-11-26
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-02-25
Survey response — 6 months, dose 3
MedDRA: Deep vein thrombosis, Pulmonary embolism, Spinal cord neoplasm, Spinal operation — Feeling: Fair · Be unable to work or attend school, 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: Diagnosed with a spinal cord tumor on 12/26/22, bilateral PE and Lt DVT. Blood thinners until spinal surgery 3/4/22

MedDRA releases: 2024-11 · check-in free text available
2022-02-25
Report sent to call center — 6 months, dose 3
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2022-02-28
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-08	Moderna
2	2021-02-05	Moderna
3	2021-08-27	Moderna	No

Call center

6 call center cases

6 unsuccessful

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-12

Systemic reaction (other): Nasal congestion, runny nose, very mild headache

Release 2 — day 14, dose 1

2021-01-22

Symptoms: Don't know if it's related or not, but have had more runs of SVT since the vaccine. My SVT has been well controlled, but had been noticing it acting up a bit. 1/19/21 it was most noticable and I began to wonder if there was a relationship. Ok now. cut off by CDC

Release 4 — day 14, dose 2

2021-02-19

Symptoms: Tachycardia, palpitations anddyspnea with exertion. Caffeine was d/c'd 12 days after dose one without any improvement. Saw PCP and am currently wearing a holter monitor. The vaxwas the only thing different in my life. Sx started soon after # 1. cut off by CDC

Healthcare visit (other): Urgent office visit at PCP

Release 4 — day 21, dose 2

2021-02-26

Symptoms: Crohn's started flaring. It had been in remission (with chronic meds) for several (+) years.SVT much improved, but dyspnea with exertion continues, although it too is improving.

Release 5 — day 28, dose 2

2021-03-05

Symptoms: Crohn's flare, in addition to issues with tachycardia. In a look back, both issues became symptomatic within the week after dose #1.

Healthcare visit (other): Urgent visit with the Dr.

Release 5 — day 35, dose 2

2021-03-12

Symptoms: Crohn's flare persists. Attempted colonoscopy. Need changes in treatment plan. Tachycardia and DOE is improving though :)

Healthcare visit (other): Office visit and procedure.

Release 8 — 3 months, dose 2

2021-05-07

Symptoms: My Crohn's flare continues, but is finally showing signs of improvement after a change in the biological drug treatment.It took 9 weeks for my SVT to return to baseline.I will be VERY cautious if I need to consider a booster vaccine!!

Healthcare visit (other): Office visits. Infusion treatment.

Release 11 — 6 months, dose 3

2022-02-25

Symptoms: Diagnosed with a spinal cord tumor on 12/26/22, bilateral PE and Lt DVT. Blood thinners until spinal surgery 3/4/22

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	Condition aggravated	✓	✓	✓
SD	Crohn's disease	✓	✓	✓
SD	Deep vein thrombosis	·	·	✓
SD	Dyspnoea exertional	✓	✓	✓
SD	Office visit	✓	✓	✓
SD	Palpitations	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Pulmonary embolism	·	·	✓
SD	Spinal cord neoplasm	·	·	✓
SD	Spinal operation	·	·	✓
SD	Supraventricular tachycardia	✓	✓	✓
SD	Tachycardia	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Nasal congestion	✓	✓	✓
SRO	Rhinorrhoea	✓	✓	✓
SRO	Unevaluable event	○	○	○

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