Z8L-13083-69537

6 vaccinations 11 coded responses 33 check-ins 10 free-text entries 8 call cases

Sex: Female
Age at first dose: 61-65
ZIP prefix: 801 / CO
Registered: 2020-12-30

Relationship: Self
Race: White
Ethnicity: Hispanic or Latino

Timeline

Registration Vaccinations Survey responses Call reports Cases without a report Call attempts Call successful Pregnancy survey

2020-12-30
Registered in v-safe
2020-12-30
Dose 1 — Moderna
2020-12-30
Survey response — day 0, dose 1
MedDRA: Dizziness — Feeling: Fair · Site: Pain · Fever · Chills, Nausea · Be unable to do your normal daily activities

Free text: Light headed

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-30
Report sent to call center — day 0, dose 1
Be unable to do your normal daily activities

1 call case(s)
2020-12-31
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Muscle or body aches · Be unable to do your normal daily activities

Adult check-in
2020-12-31
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Swelling · Fatigue or tiredness

Adult check-in
2021-01-02
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-04
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-05
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-06
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-01-13
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-20
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-01-27
Dose 2 — Moderna
2021-01-29
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work

Adult check-in
2021-01-30
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Redness, Swelling · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Be unable to work

Adult check-in
2021-01-31
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Itching · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work

Adult check-in
2021-02-01
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Fever · Chills, Joint pains, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-02-02
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work

Adult check-in
2021-02-03
Health check-in — day 7, dose 2
Feeling: Fair · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work

Adult check-in
2021-02-10
Survey response — day 14, dose 2
MedDRA: Pruritus — Feeling: Fair · Be unable to do your normal daily activities

Free text: Severe itching

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-17
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-24
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-03
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-10
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-28
Survey response — 3 months, dose 2
MedDRA: Lymphadenopathy — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Large cervical adenopathy

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-28
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-14
Call 1 — Requested Callback
2021-06-17
Call successful
Does not wish to fill out VAERS report
2021-07-28
Survey response — 6 months, dose 2
MedDRA: Biopsy liver abnormal, SARS-CoV-2 antibody test negative — Feeling: Fair · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: 6/21/21 per liver biopsy had acute rejection. Symptoms started after 2 nd dose of Menactra.Also, had a negative level of the spike protein antibody to COVID 4 weeks after the 2nd dose.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-07-28
Report sent to call center — 6 months, dose 2
Be unable to work or attend school · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-06
Call successful
Does not wish to fill out VAERS report
2021-09-18
Dose 3 — Moderna
2021-10-23
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-10-30
Health check-in — day 42, dose 3
Feeling: Fair

Adult check-in
2021-12-18
Survey response — 3 months, dose 3
MedDRA: Clostridium difficile infection — Feeling: Fair · Be unable to work or attend school

Free text: C diff infection.

MedDRA releases: 2024-11 · check-in free text available
2022-03-08
Dose 4 — Moderna
2022-03-19
Survey response — 6 months, dose 3
MedDRA: COVID-19, Clostridium difficile infection — Feeling: Good · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: C. Diff infection early March and COVID mid- January

MedDRA releases: 2024-11 · check-in free text available
2022-03-19
Report sent to call center — 6 months, dose 3
Be unable to work or attend school · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-03-22
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-04-15
Survey response — day 35, dose 4
MedDRA: Clostridium difficile infection, Pre-existing disease, Rheumatoid arthritis — Feeling: Fair · Be unable to do your normal daily activities

Free text: Increase RA symptoms and C. Difficile infection.

MedDRA releases: 2024-11 · check-in free text available
2022-04-19
Survey response — day 42, dose 4
MedDRA: Arthralgia, Clostridium difficile infection, Rheumatoid arthritis — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: C. Difficile infections and worsening RA pain..

MedDRA releases: 2024-11 · check-in free text available
2022-04-19
Report sent to call center — day 42, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-04-22
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-09
Survey response — 3 months, dose 4
MedDRA: Clostridium difficile infection, Gastroenteritis — 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 · Outpatient clinic or urgent care clinic visit

Free text: Recurrent C. Difficille gastroenteritis.

MedDRA releases: 2024-11 · check-in free text available
2022-06-09
Report sent to call center — 3 months, dose 4
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-06-10
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-07-08
Dose 5 — Pfizer-BioNTech
2022-09-07
Health check-in — 6 months, dose 4
Feeling: Fair

Adult check-in
2022-10-04
Dose 6 — Moderna
2022-10-07
Survey response — 3 months, dose 5
MedDRA: Hospitalisation, Pyelonephritis, Surgery — Feeling: Good · Be unable to work or attend school, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit, Hospitalization

Free text: Had a surgery and pyelonephritis. Hospitalized for both in September.

MedDRA releases: 2024-11 · check-in free text available
2022-10-07
Report sent to call center — 3 months, dose 5
Be unable to work or attend school · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2022-10-10
Call successful
Not applicable - Accidental Reporting
2023-01-06
Health check-in — 6 months, dose 5
Feeling: Good

Adult check-in
2023-04-11
Survey response — 6 months, dose 6
MedDRA: Cerebrospinal fluid leakage, Spinal fusion surgery — Feeling: Fair · Be unable to work or attend school

MedDRA releases: 2024-11

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-30	Moderna
2	2021-01-27	Moderna
3	2021-09-18	Moderna	No
4	2022-03-08	Moderna	No
5	2022-07-08	Pfizer-BioNTech	No
6	2022-10-04	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2020-12-30	Successful	Does not wish to fill out VAERS report
2020-12-31	Successful	Does not wish to fill out VAERS report
2021-04-28	Successful 2021-06-17	Does not wish to fill out VAERS report
2021-07-28	Successful 2021-08-06	Does not wish to fill out VAERS report
2022-03-19	Successful 2022-03-22	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-04-19	Successful 2022-04-22	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-09	Successful 2022-06-10	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-10-07	Successful 2022-10-10	Not applicable - Accidental Reporting

Free text

Release 1 — day 0, dose 1

2020-12-30

Systemic reaction (other): Light headed

Release 4 — day 14, dose 2

2021-02-10

Symptoms: Severe itching

Release 8 — 3 months, dose 2

2021-04-28

Symptoms: Large cervical adenopathy

Release 9 — 6 months, dose 2

2021-07-28

Symptoms: 6/21/21 per liver biopsy had acute rejection. Symptoms started after 2 nd dose of Menactra.Also, had a negative level of the spike protein antibody to COVID 4 weeks after the 2nd dose.

Release 10 — 3 months, dose 3

2021-12-18

Symptoms: C diff infection.

Release 11 — 6 months, dose 3

2022-03-19

Symptoms: C. Diff infection early March and COVID mid- January

Release 11 — day 35, dose 4

2022-04-15

Symptoms: Increase RA symptoms and C. Difficile infection.

Release 11 — day 42, dose 4

2022-04-19

Symptoms: C. Difficile infections and worsening RA pain..

Release 11 — 3 months, dose 4

2022-06-09

Symptoms: Recurrent C. Difficille gastroenteritis.

Release 12 — 3 months, dose 5

2022-10-07

Symptoms: Had a surgery and pyelonephritis. Hospitalized for both in September.

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
SD	Arthralgia	·	·	✓
SD	Biopsy liver abnormal	✓	·	✓
SD	Cerebrospinal fluid leakage	·	·	✓
SD	Clostridium difficile infection	·	·	✓
SD	COVID-19	·	·	✓
SD	Gastroenteritis	·	·	✓
SD	Hospitalisation	·	·	✓
SD	Lymphadenopathy	✓	✓	✓
SD	Pre-existing disease	·	·	✓
SD	Pruritus	✓	✓	✓
SD	Pyelonephritis	·	·	✓
SD	Rheumatoid arthritis	·	·	✓
SD	SARS-CoV-2 antibody test negative	✓	·	✓
SD	Spinal fusion surgery	·	·	✓
SD	Surgery	·	·	✓
SRO	Dizziness	✓	✓	✓

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