2ZS-23562-50487

1 vaccination 8 coded responses 9 check-ins 8 free-text entries 5 call cases

Sex: Female
Age at first dose: 46-50
ZIP prefix: 211 / MD
Registered: 2021-02-09

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

2021-02-06
Dose 1 — Moderna
2021-02-09
Registered in v-safe
2021-02-10
Survey response — days 1–6 daily, dose 1
MedDRA: Dyspnoea, Hypervolaemia, Office visit — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · 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): Fluid volume overload and shortness of breath · Healthcare visit (other): I saw my PCP but considered going to the ED

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-10
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)
2021-02-11
Survey response — days 1–6 daily, dose 1
MedDRA: Generalised oedema, Oedema, Unevaluable event — Feeling: Poor · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Be unable to do your normal daily activities

Free text: Pitting BLE Edema

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-12
Survey response — days 1–6 daily, dose 1
MedDRA: Oedema peripheral — Feeling: Poor · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Diarrhea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

Free text: BLE Edema

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-13
Survey response — day 7, dose 1
MedDRA: Oedema peripheral — Feeling: Poor · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

Free text: BLE Edema

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-20
Survey response — day 14, dose 1
MedDRA: Hepatitis, Hospitalisation, Oedema peripheral, Splenomegaly — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Hospitalization

Free text: Hospitalized for enlarged spleen, liver and BLE Edema

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-20
Report sent to call center — day 14, dose 1
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)
2021-02-27
Survey response — day 21, dose 1
MedDRA: Arthralgia, Hospitalisation, Hypertension, Oedema peripheral, Splenomegaly, Swelling — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Hospitalization

Free text: Symptoms: Lower extremity edema, hypertension, enlarged spleen, joint pain and swelling. · Healthcare visit (other): ED a S wasnt home. Next day I was hospitalised IP for 3 days and have had 3 MD office follow ups since.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-27
Report sent to call center — day 21, dose 1
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)
2021-03-06
Survey response — day 28, dose 1
MedDRA: Hypertension, Liver disorder, Oedema peripheral, Splenomegaly — Feeling: Poor · Be unable to work, 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: Enlarged Spleen and Liver, HTN, BLE Edema

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-06
Report sent to call center — day 28, dose 1
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)
2021-03-20
Survey response — day 42, dose 1
MedDRA: Fatigue, Feeling abnormal, Headache, Hepatomegaly, Immunisation reaction, Medical counselling, Splenomegaly — Feeling: Poor · Be unable to work, 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: Same but no improvement enlarged liver and spleen, headaches, extreme fatigue and brain fog I was advised by my MD not to get the 2nd dose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-20
Report sent to call center — day 42, dose 1
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)
2021-05-10
Health check-in — 3 months, dose 1
Feeling: Poor

Adult check-in
2021-07-18
Call 1 — Could Not Reach Participant
2021-07-22
Call 2 — Could Not Reach Participant

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-06	Moderna

Call center

5 call center cases

5 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 4 — days 1–6 daily, dose 1

2021-02-10

Systemic reaction (other): Fluid volume overload and shortness of breath

Healthcare visit (other): I saw my PCP but considered going to the ED

2021-02-11

Systemic reaction (other): Pitting BLE Edema

2021-02-12

Systemic reaction (other): BLE Edema

Release 4 — day 7, dose 1

2021-02-13

Systemic reaction (other): BLE Edema

Release 4 — day 14, dose 1

2021-02-20

Symptoms: Hospitalized for enlarged spleen, liver and BLE Edema

Release 4 — day 21, dose 1

2021-02-27

Symptoms: Lower extremity edema, hypertension, enlarged spleen, joint pain and swelling.

Healthcare visit (other): ED a S wasnt home. Next day I was hospitalised IP for 3 days and have had 3 MD office follow ups since.

Release 5 — day 28, dose 1

2021-03-06

Symptoms: Enlarged Spleen and Liver, HTN, BLE Edema

Release 6 — day 42, dose 1

2021-03-20

Symptoms: Same but no improvement enlarged liver and spleen, headaches, extreme fatigue and brain fog I was advised by my MD not to get the 2nd dose

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	Hospitalisation	✓	✓	✓
HCVO	Office visit	✓	✓	✓
SD	Arthralgia	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Feeling abnormal	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Hepatitis	✓	✓	✓
SD	Hepatomegaly	✓	✓	✓
SD	Hospitalisation	✓	✓	✓
SD	Hypertension	✓	✓	✓
SD	Immunisation reaction	✓	✓	✓
SD	Liver disorder	✓	✓	✓
SD	Medical counselling	✓	✓	✓
SD	Oedema peripheral	✓	✓	✓
SD	Splenomegaly	✓	✓	✓
SD	Swelling	✓	✓	✓
SRO	Dyspnoea	✓	✓	✓
SRO	Generalised oedema	○	✓	○
SRO	Hypervolaemia	✓	✓	✓
SRO	Oedema	✓	·	✓
SRO	Oedema peripheral	✓	✓	✓
SRO	Unevaluable event	○	✓	○

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