2ND-15294-16325

5 vaccinations 7 coded responses 27 check-ins 7 free-text entries 4 call cases

Sex: Female
Age at first dose: 61-65
ZIP prefix: 044 / ME
Registered: 2022-05-17

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

2021-03-26
Dose 1 — Moderna
2021-04-23
Dose 2 — Moderna
2021-12-29
Dose 3 — Moderna
2022-05-17
Registered in v-safe
2022-05-17
Dose 4 — Pfizer-BioNTech
2022-05-17
Health check-in — day 0, dose 4
Feeling: Fair · Site: Pain · Fatigue or tiredness

Adult check-in
2022-05-18
Survey response — days 1–6 daily, dose 4
MedDRA: Pruritus — Feeling: Fair · Site: Pain · Chills, Fatigue or tiredness, Diarrhea · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Itching

MedDRA releases: 2024-11 · check-in free text available
2022-05-19
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-05-20
Survey response — days 1–6 daily, dose 4
MedDRA: Urinary incontinence — Feeling: Fair · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Urinary I continence

MedDRA releases: 2024-11 · check-in free text available
2022-05-21
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Pain · Chills, Fatigue or tiredness

Adult check-in
2022-05-22
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-05-23
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-05-24
Health check-in — day 7, dose 4
Feeling: Fair · Chills, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2022-05-31
Health check-in — day 14, dose 4
Feeling: Fair

Adult check-in
2022-06-07
Survey response — day 21, dose 4
MedDRA: Impaired healing, Oedema peripheral, Pain in extremity, Peripheral swelling, Skin ulcer, Skin ulcer 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

Free text: Painful left lower leg with swelling/edema. Sores on lower right leg with excessive bleeding and failure to heal.

MedDRA releases: 2024-11 · check-in free text available
2022-06-07
Report sent to call center — day 21, dose 4
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-06-08
Call 1 — Left Voicemail
2022-06-14
Survey response — day 28, dose 4
MedDRA: Emergency care, Hypoaesthesia, International normalised ratio increased, Oedema peripheral, Unevaluable event — 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: Symptoms: My lower left leg is numb and has pitting oedema from knee to toes. I also had an INR of greater than 10 and had to be treated at the emergency department. · Healthcare visit (other): Ultrasound to r/o clots

MedDRA releases: 2024-11 · check-in free text available
2022-06-14
Report sent to call center — day 28, dose 4
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 · 1 call case(s)
2022-06-15
Call 2 — Left Voicemail
2022-06-15
Call 1 — Left Voicemail
2022-06-21
Survey response — day 35, dose 4
MedDRA: Fall, Hypoaesthesia, Medical counselling, Oedema peripheral, Office visit, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: I'm having problems with oedema and numbness in my lower legs, related to my peripheral neuropathy and a recent fall. I called in today to speak to one of your staff: my doctor doesn't believe these problems have anything to do with my Covid vaccine. · Healthcare visit (other): Visit with PCP

MedDRA releases: 2024-11 · check-in free text available
2022-06-21
Report sent to call center — day 35, dose 4
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2022-06-21
Call 3 — Left Voicemail
2022-06-21
Call 2 — Left Voicemail
2022-06-21
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-21
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-22
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-29
Survey response — day 42, dose 4
MedDRA: Condition aggravated, International normalised ratio fluctuation, Office visit, Pre-existing disease — Feeling: Fair · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Symptoms: Worsening oedema in both lower legs. Very unstable INR. · Healthcare visit (other): Primary care physician

MedDRA releases: 2024-11 · check-in free text available
2022-06-29
Report sent to call center — day 42, dose 4
Get care from a doctor or other healthcare professional

Emergency room or emergency department visit · 1 call case(s)
2022-06-30
Call 1 — Left Voicemail
2022-09-22
Dose 5 — Moderna
2022-09-23
Health check-in — days 1–6 daily, dose 5
Feeling: Fair · Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-09-24
Health check-in — days 1–6 daily, dose 5
Feeling: Fair · Fatigue or tiredness

Adult check-in
2022-09-25
Health check-in — days 1–6 daily, dose 5
Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-09-26
Health check-in — days 1–6 daily, dose 5
Feeling: Good · Muscle or body aches, Fatigue or tiredness

Adult check-in
2022-09-27
Health check-in — days 1–6 daily, dose 5
Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2022-09-28
Health check-in — days 1–6 daily, dose 5
Feeling: Good · Fatigue or tiredness

Adult check-in
2022-09-29
Health check-in — day 7, dose 5
Feeling: Good · Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-10-06
Health check-in — day 14, dose 5
Feeling: Good

Adult check-in
2022-10-13
Health check-in — day 21, dose 5
Feeling: Good

Adult check-in
2022-10-20
Health check-in — day 28, dose 5
Feeling: Good

Adult check-in
2022-10-27
Health check-in — day 35, dose 5
Feeling: Fair

Adult check-in
2022-11-03
Health check-in — day 42, dose 5
Feeling: Fair

Adult check-in
2022-12-22
Survey response — 3 months, dose 5
MedDRA: Fatigue — Feeling: Good · Be unable to do your normal daily activities

Free text: Extreme fatigue

MedDRA releases: 2024-11 · check-in free text available
2023-03-24
Health check-in — 6 months, dose 5
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-26	Moderna	No
2	2021-04-23	Moderna	No
3	2021-12-29	Moderna	No
4	2022-05-17	Pfizer-BioNTech	No
5	2022-09-22	Moderna	No

Call center

4 call center cases

3 successful · 1 unsuccessful

See the call center timeline

Free text

Release 11 — days 1–6 daily, dose 4

2022-05-18

Systemic reaction (other): Itching

2022-05-20

Systemic reaction (other): Urinary I continence

Release 11 — day 21, dose 4

2022-06-07

Symptoms: Painful left lower leg with swelling/edema. Sores on lower right leg with excessive bleeding and failure to heal.

Release 12 — day 28, dose 4

2022-06-14

Symptoms: My lower left leg is numb and has pitting oedema from knee to toes. I also had an INR of greater than 10 and had to be treated at the emergency department.

Healthcare visit (other): Ultrasound to r/o clots

Release 12 — day 35, dose 4

2022-06-21

Symptoms: I'm having problems with oedema and numbness in my lower legs, related to my peripheral neuropathy and a recent fall. I called in today to speak to one of your staff: my doctor doesn't believe these problems have anything to do with my Covid vaccine. cut off by CDC

Healthcare visit (other): Visit with PCP

Release 12 — day 42, dose 4

2022-06-29

Symptoms: Worsening oedema in both lower legs. Very unstable INR.

Healthcare visit (other): Primary care physician

Release 12 — 3 months, dose 5

2022-12-22

Symptoms: Extreme fatigue

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	·	·	✓
HCVO	Unevaluable event	·	·	✓
SD	Condition aggravated	·	·	✓
SD	Emergency care	·	·	✓
SD	Fall	·	·	✓
SD	Fatigue	·	·	✓
SD	Hypoaesthesia	·	·	✓
SD	Impaired healing	·	·	✓
SD	International normalised ratio fluctuation	·	·	✓
SD	International normalised ratio increased	·	·	✓
SD	Medical counselling	·	·	✓
SD	Oedema peripheral	·	·	✓
SD	Pain in extremity	·	·	✓
SD	Peripheral swelling	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Skin ulcer	·	·	✓
SD	Skin ulcer haemorrhage	·	·	✓
SRO	Pruritus	·	·	✓
SRO	Urinary incontinence	·	·	✓

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