6L3-59901-86799

2 vaccinations 11 coded responses 15 check-ins 11 free-text entries 3 call cases

Sex: Male
Age at first dose: 36-40
ZIP prefix: 481 / MI
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

2021-01-11
Registered in v-safe
2021-01-11
Dose 1 — Pfizer-BioNTech
2021-01-14
Survey response — days 1–6 daily, dose 1
MedDRA: Chronic fatigue syndrome, Fibromyalgia, Hospitalisation, Hypomania, Mania, Pre-existing disease, Systemic lupus erythematosus — Feeling: Good · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to work, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit, Hospitalization

Free text: Systemic reaction (other): I have had fibromyalgia, and CFS since age 19. Im now 38. I was then diagnosed with Lupus by dr (b)(6) a few years ago and he prescribed Plaquenal 200mg and i was taking it daily for approximately 1 year. The doctors on my treatment team took me ofd the hydroxychloroquin 200mg approximately one year ago. · Healthcare visit (other): I was hospitalized at (b)(6) Hospital in December due to a mild hypermanic episode. My mood affect is currently baseline.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-14
Report sent to call center — days 1–6 daily, dose 1
Be unable to work · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-15
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Good · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain

Free text: Previously stated.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-17
Survey response — days 1–6 daily, dose 1
MedDRA: Fibromyalgia — Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain

Free text: Fibromyalgia/CFS, Pelvic (Lupus in remission) I take

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-18
Survey response — day 7, dose 1
MedDRA: Attention deficit hyperactivity disorder, Fibromyalgia, Pre-existing disease, Systemic lupus erythematosus — Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain

Free text: Lupus, Fibromyalgia/CFS, ADHD Hyperactive type Axis 2

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-25
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-01
Dose 2 — Pfizer-BioNTech
2021-02-01
Survey response — day 0, dose 2
MedDRA: Pre-existing disease — Feeling: Fair · Site: Pain · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain

Free text: Lupus, Fibromyalgia, CFS, IBS-C, Pelvic Dysfunction, ADHD, Schizoaffective, Bipolar 1 mania, SAD:GAD

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-03
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to work

Adult check-in
2021-02-04
Survey response — days 1–6 daily, dose 2
MedDRA: Pre-existing disease — Feeling: Good · Site: Pain · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Lupus, Fibromyalgia, CFS, IBS-C, Rheumatic Illness With Inflammation

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-04
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-06
Survey response — days 1–6 daily, dose 2
MedDRA: Pre-existing disease — Feeling: Good · Site: Pain, Itching · Chills, Headache, Muscle or body aches, Diarrhea, Abdominal pain

Free text: Lupus, fibromyalgia, CFS, IBS-C, Pelvic Dysnergyia, Connective Tissue Disease, ADHD, Bipolar Mania Psychotic Features, Asthma

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-07
Survey response — days 1–6 daily, dose 2
MedDRA: Pre-existing disease — Feeling: Fair · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain

Free text: Dxed Lupus, fibromyalgia, CFS, Bipolar Mania , SAD,GAD,

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Survey response — day 7, dose 2
MedDRA: Pre-existing disease, Unevaluable event — Feeling: Fair · Chills, 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, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Systemic reaction (other): I have a diagnosis of lupus, fibromyalgia, CFS, IBS type C, pelvic floor dysfunction, and bipolar mania, SAD, GAD, PTSD, ADHD · Healthcare visit (other): Mt appointment is at 3:45pm with (b)(6) nurse Practitioner at (b)(6) in Wyandotte MI part of Henry Ford

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Report sent to call center — day 7, 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)
2021-02-15
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-22
Survey response — day 21, dose 2
MedDRA: Condition aggravated, Injection site pain, Irritable bowel syndrome, Pain, Pre-existing disease, Tension — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

Free text: Aggravation of fibromyalgia symptoms, noticeable flareup of IBS type C symptoms, more generalized fatigue, and overall radiating muscle pain and tension throughout body. As time goes on its gradually getting better but slowly. Got pain injection

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-01
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-03-10
Call 1 — Could Not Reach Participant
2021-03-23
Call 2 — Could Not Reach Participant
2021-03-25
Call 3 — Could Not Reach Participant
2021-05-03
Survey response — 3 months, dose 2
MedDRA: Self-medication — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

Free text: An episode of severe mania and had to be hospitalized for approximately 2 weeks. I am currently taking thorazine, cogentin, klonopin, and some vitamins.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-20
Call 1 — Could Not Reach Participant

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-11	Pfizer-BioNTech
2	2021-02-01	Pfizer-BioNTech

Call center

3 call center cases

3 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-14

Systemic reaction (other): I have had fibromyalgia, and CFS since age 19. Im now 38. I was then diagnosed with Lupus by dr (b)(6) a few years ago and he prescribed Plaquenal 200mg and i was taking it daily for approximately 1 year. The doctors on my treatment team took me ofd the hydroxychloroquin 200mg approximately one year ago.

Healthcare visit (other): I was hospitalized at (b)(6) Hospital in December due to a mild hypermanic episode. My mood affect is currently baseline.

redacted (b)(6)

2021-01-15

Systemic reaction (other): Previously stated.

2021-01-17

Systemic reaction (other): Fibromyalgia/CFS, Pelvic (Lupus in remission) I take

Release 2 — day 7, dose 1

2021-01-18

Systemic reaction (other): Lupus, Fibromyalgia/CFS, ADHD Hyperactive type Axis 2

Release 3 — day 0, dose 2

2021-02-01

Systemic reaction (other): Lupus, Fibromyalgia, CFS, IBS-C, Pelvic Dysfunction, ADHD, Schizoaffective, Bipolar 1 mania, SAD:GAD

Release 3 — days 1–6 daily, dose 2

2021-02-04

Systemic reaction (other): Lupus, Fibromyalgia, CFS, IBS-C, Rheumatic Illness With Inflammation

2021-02-06

Systemic reaction (other): Lupus, fibromyalgia, CFS, IBS-C, Pelvic Dysnergyia, Connective Tissue Disease, ADHD, Bipolar Mania Psychotic Features, Asthma

2021-02-07

Systemic reaction (other): Dxed Lupus, fibromyalgia, CFS, Bipolar Mania , SAD,GAD,

Release 3 — day 7, dose 2

2021-02-08

Systemic reaction (other): I have a diagnosis of lupus, fibromyalgia, CFS, IBS type C, pelvic floor dysfunction, and bipolar mania, SAD, GAD, PTSD, ADHD

Healthcare visit (other): Mt appointment is at 3:45pm with (b)(6) nurse Practitioner at (b)(6) in Wyandotte MI part of Henry Ford

redacted (b)(6)

Release 4 — day 21, dose 2

2021-02-22

Symptoms: Aggravation of fibromyalgia symptoms, noticeable flareup of IBS type C symptoms, more generalized fatigue, and overall radiating muscle pain and tension throughout body. As time goes on its gradually getting better but slowly. Got pain injection

Release 8 — 3 months, dose 2

2021-05-03

Symptoms: An episode of severe mania and had to be hospitalized for approximately 2 weeks. I am currently taking thorazine, cogentin, klonopin, and some vitamins.

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	Hypomania	○	✓	○
HCVO	Mania	✓	·	✓
HCVO	Unevaluable event	✓	✓	✓
SD	Condition aggravated	✓	✓	✓
SD	Injection site pain	✓	✓	✓
SD	Irritable bowel syndrome	✓	✓	✓
SD	Pain	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Tension	✓	✓	✓
SRO	Attention deficit hyperactivity disorder	○	✓	○
SRO	Chronic fatigue syndrome	✓	✓	✓
SRO	Fibromyalgia	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Systemic lupus erythematosus	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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