XZ4-28665-70216 · OpenVSafe

Timeline

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

2021-03-25
Registered in v-safe
2021-03-25
Dose 1 — Pfizer-BioNTech
2021-03-25
Survey response — 0 day, dose 1
MedDRA: Adverse reaction, Pre-existing disease — Feeling: Fair · Site: Pain · Headache, Joint pains, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-26
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-27
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease, Systemic lupus erythematosus — Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-28
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Joint pains

Adult check-in
2021-03-29
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-31
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Good · Joint pains

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-01
Health check-in — 7 day, dose 1
Feeling: Good · Joint pains

Adult check-in
2021-04-08
Survey response — 14 day, dose 1
MedDRA: Arthralgia, Medical counselling, Myalgia, Pre-existing disease — Feeling: Poor · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-08
Report sent to call center — 14 day, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-15
Dose 2 — Pfizer-BioNTech
2021-04-15
Survey response — 0 day, dose 2
MedDRA: Condition aggravated, Pre-existing disease, Reaction to previous exposure to any vaccine, Systemic lupus erythematosus — Feeling: Fair · Site: Pain · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-16
Survey response — days 1–6 daily, dose 2
MedDRA: Pre-existing disease — Feeling: Poor · Site: Pain, Redness, Swelling · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-17
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-04-18
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-19
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-04-20
Survey response — days 1–6 daily, dose 2
MedDRA: Systemic lupus erythematosus — Feeling: Good · Site: Redness, Swelling · Joint pains, Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-21
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Swelling · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-22
Health check-in — 7 day, dose 2
Feeling: Fair · Site: Redness, Swelling · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-04-29
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-05-06
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-05-13
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-05-20
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-05-27
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2022-02-09
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-25	Pfizer-BioNTech
2	2021-04-15	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-04-08	Unsuccessful

Free text

Release 6

Systemic reaction (other): I have Lupus & these symptoms could be from Lupus since I did have some joint pain in the morning before the caccine

Systemic reaction (other): Since I have Lupus, I am just assuming these symptoms are from Lupus.

Systemic reaction (other): Possibly lupus related

Release 7

Symptoms: Joint & muscle pain on s signifcant

Healthcare visit (other): I talked with my rheumatologist- will start prednisone, vax triggered a "mild" doctors words not mine, told should get second vax if possible stop prednisone if not it's ok bkz low dose

Systemic reaction (other): I have Lupus & have had lupus flare since first shot. Just finished 5 days prednisone. Will try not to take prednisone for at least 2 weeks to enhance immune response as per my doctor

Systemic reaction (other): I stopped prednisone at 4mg day before 2nd shot but started taking it again - I have Lupus

Systemic reaction (other): Lupus

Free-text releases are not linked to a specific 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	Medical counselling	✓	✓	✓
HCVO	Pre-existing disease	✓	✓	✓
SD	Arthralgia	✓	✓	✓
SD	Myalgia	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Reaction to previous exposure to any vaccine	✓	✓	✓
SRO	Systemic lupus erythematosus	✓	✓	✓

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