53E-30761-72684

2 vaccinations 12 coded responses 22 check-ins 12 free-text entries 8 call cases

Sex: Female
Age at first dose: 41-45
ZIP prefix: 009 / PR
Registered: 2021-04-15

Relationship: Self
Race: White
Ethnicity: N/A

Timeline

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

2021-04-15
Registered in v-safe
2021-04-15
Dose 1 — Pfizer-BioNTech
2021-04-15
Survey response — day 0, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Site: Pain · Joint pains, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Rheumatoid arthritis.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-16
Survey response — days 1–6 daily, dose 1
MedDRA: Ear pain — Feeling: Poor · Site: Pain · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Ear pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-17
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Swelling · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-18
Survey response — days 1–6 daily, dose 1
MedDRA: Cyst, Inflammation — Feeling: Fair · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Severely inflamated cyst near shoulder on same side as injection site.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-19
Survey response — days 1–6 daily, dose 1
MedDRA: Injection site abscess — Feeling: Poor · Site: Pain · Joint pains, Muscle or body aches · Be unable to work, Be unable to do your normal daily activities

Free text: Surgical scar (epidermal cyst) near the injection site, potential abscess forming.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-20
Survey response — days 1–6 daily, dose 1
MedDRA: Abscess, Abscess limb, Incisional drainage — Feeling: Poor · Fever · Muscle or body aches, Fatigue or tiredness · 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&D in abscess on left shoulder · Healthcare visit (other): Ambulatory Surgical - I&D

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-20
Report sent to call center — days 1–6 daily, 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)
2021-04-21
Survey response — days 1–6 daily, dose 1
MedDRA: Inflammation, Pain — Feeling: Poor · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Significant pain and inflammation in surgical site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-22
Survey response — day 7, dose 1
MedDRA: Procedural site reaction — Feeling: Fair · Fever · Muscle or body aches

Free text: Surgical site pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-29
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-06
Dose 2 — Pfizer-BioNTech
2021-05-06
Health check-in — day 0, dose 2
Feeling: Fair · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-05-07
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-05-08
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Swelling · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-05-09
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-05-10
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Swelling, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-05-11
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work

Adult check-in
2021-05-12
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · 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

Adult check-in
2021-05-12
Report sent to call center — days 1–6 daily, 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)
2021-05-13
Health check-in — day 7, dose 2
Feeling: Poor · Joint pains, Muscle or body aches, Fatigue or tiredness · 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

Adult check-in
2021-05-13
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)
2021-05-20
Survey response — day 14, dose 2
MedDRA: Inflammation — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Acute inflation of the upper chest, shoulders and ribs.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-20
Report sent to call center — day 14, 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)
2021-05-27
Survey response — day 21, dose 2
MedDRA: Condition aggravated, Inflammation, Pain, Pre-existing disease, Rheumatoid arthritis — Feeling: Poor · 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: I am having a severe auto-inflammatory episode in my upper body (shoulders, armpits, chest wall, ribs). Unprecedented in magnitude, level of inflammation, pain and duration of the episode relative to 12 years of having RA and HS. High dose of steroid

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-27
Report sent to call center — day 21, 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)
2021-06-03
Survey response — day 28, dose 2
MedDRA: Arthritis, Inflammation, Self-medication — Feeling: Poor · 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: Continued inflammation of joints, axilliary area and ribs. Taking a 2-week course of prednisone and anti-inflammatory medicatiion. Reactive arthritis assumed as the source of the inflammation.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-03
Report sent to call center — day 28, 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)
2021-06-10
Survey response — day 35, dose 2
MedDRA: Autoinflammatory disease, Cyst, Inflammation, Pre-existing disease, Rheumatoid arthritis, Surgery — 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, Outpatient clinic or urgent care clinic visit

Free text: The auto-inflammatory response caused a severe RA flare, inflammation of the rib-cage and of a cyst in the back. Surgical intervention was required for the cyst, in addition to prophylactic antibiotics, and oral and injected steroids.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-10
Report sent to call center — day 35, 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)
2021-06-17
Survey response — day 42, dose 2
MedDRA: Inflammation — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: Continued auto-inflammatory reaction ribs, shoulders and hips. Improving with Oralia be injected steroid treatment.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-17
Report sent to call center — day 42, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-17
Call 1 — Left Voicemail
2021-06-17
Call 1 — Left Voicemail
2021-06-17
Call 1 — Left Voicemail
2021-06-17
Call 1 — Left Voicemail
2021-06-17
Call 1 — Left Voicemail
2021-06-17
Call 1 — Left Voicemail
2021-06-17
Call 1 — Left Voicemail
2021-06-24
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-15	Pfizer-BioNTech
2	2021-05-06	Pfizer-BioNTech

Call center

8 call center cases

1 successful · 7 unsuccessful

See the call center timeline

Free text

Release 7 — day 0, dose 1

2021-04-15

Systemic reaction (other): Rheumatoid arthritis.

Release 7 — days 1–6 daily, dose 1

2021-04-16

Systemic reaction (other): Ear pain

2021-04-18

Systemic reaction (other): Severely inflamated cyst near shoulder on same side as injection site.

2021-04-19

Systemic reaction (other): Surgical scar (epidermal cyst) near the injection site, potential abscess forming.

2021-04-20

Systemic reaction (other): I&D in abscess on left shoulder

Healthcare visit (other): Ambulatory Surgical - I&D

2021-04-21

Systemic reaction (other): Significant pain and inflammation in surgical site

Release 7 — day 7, dose 1

2021-04-22

Systemic reaction (other): Surgical site pain

Release 8 — day 14, dose 2

2021-05-20

Symptoms: Acute inflation of the upper chest, shoulders and ribs.

Release 8 — day 21, dose 2

2021-05-27

Symptoms: I am having a severe auto-inflammatory episode in my upper body (shoulders, armpits, chest wall, ribs). Unprecedented in magnitude, level of inflammation, pain and duration of the episode relative to 12 years of having RA and HS. High dose of steroid cut off by CDC

Release 8 — day 28, dose 2

2021-06-03

Symptoms: Continued inflammation of joints, axilliary area and ribs. Taking a 2-week course of prednisone and anti-inflammatory medicatiion. Reactive arthritis assumed as the source of the inflammation.

Release 9 — day 35, dose 2

2021-06-10

Symptoms: The auto-inflammatory response caused a severe RA flare, inflammation of the rib-cage and of a cyst in the back. Surgical intervention was required for the cyst, in addition to prophylactic antibiotics, and oral and injected steroids.

Release 9 — day 42, dose 2

2021-06-17

Symptoms: Continued auto-inflammatory reaction ribs, shoulders and hips. Improving with Oralia be injected steroid treatment.

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	Abscess	✓	✓	○
HCVO	Incisional drainage	·	·	✓
SD	Arthritis	✓	✓	✓
SD	Autoinflammatory disease	✓	✓	✓
SD	Condition aggravated	✓	✓	✓
SD	Cyst	✓	✓	✓
SD	Inflammation	✓	✓	✓
SD	Pain	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Rheumatoid arthritis	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Surgery	✓	·	✓
SRO	Abscess	✓	✓	○
SRO	Abscess limb	·	·	✓
SRO	Cyst	✓	✓	✓
SRO	Ear pain	✓	✓	✓
SRO	Incisional drainage	·	·	✓
SRO	Inflammation	✓	✓	✓
SRO	Injection site abscess	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Procedural site reaction	✓	✓	✓

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