Z8K-46263-08196 · OpenVSafe

Timeline

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

2021-02-05
Dose 1 — Moderna
2021-03-05
Dose 2 — Moderna
2021-03-07
Registered in v-safe
2021-03-07
Survey response — days 1–6 daily, dose 2
MedDRA: Adverse reaction — Feeling: Good · Site: Pain · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Sx were present on 3/6/21

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-08
Survey response — days 1–6 daily, dose 2
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Good · Site: Pain, Redness, Swelling, Itching

Free text: On 2/6 the day after the shot I had a flare of uveitis in one eye. As I am on prednisone drops for control of this the next scheduled drop resolved the problem.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-09
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site erythema, Injection site induration, Injection site rash — Feeling: Good · Site: Redness, Itching · Rash, not including the immediate area around the injection site

Free text: On the first injection of 2/5/21 I had intermittent erythema for about 3 weeks.. Initially for the first 3 days there was no erythema . Then on about day 11 there was a 15cm area of erythema and induration. This resolved slowly and then there was erythema with some satellite lesions extending nearly to the ante cubital fossa. Both episodes of erythema seemed to be preceded my me rubbing my arm as it was pruritic.. I think in both cases of erythema I activated a reaction by messaging the arm!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-10
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-03-11
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-13
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-03-19
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-03-26
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-02
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-04-09
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-04-16
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-04
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-09-03
Survey response — 6 months, dose 2
MedDRA: Office visit, Pre-existing disease — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Symptoms: At my 3 mos check with my Dermatologist for a h/o melanoma in March my right labia minora disappeared and I had lichen sclerosis. I have a h/o autoimmunity. Modera shots were 2/5, 3/5. A friend developed Pitariasis Rubor Pilaris after #2 inj. · Healthcare visit (other): Dermatologist

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-09-03
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-09
Call 1 — Could Not Reach Participant
2021-09-14
Call 2 — Could Not Reach Participant
2022-03-05
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-05	Moderna
2	2021-03-05	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-09-03	Unsuccessful

Free text

Release 5 — days 1–6 daily, dose 2

2021-03-07

Systemic reaction (other): Sx were present on 3/6/21

2021-03-08

Systemic reaction (other): On 2/6 the day after the shot I had a flare of uveitis in one eye. As I am on prednisone drops for control of this the next scheduled drop resolved the problem.

2021-03-09

Systemic reaction (other): On the first injection of 2/5/21 I had intermittent erythema for about 3 weeks.. Initially for the first 3 days there was no erythema . Then on about day 11 there was a 15cm area of erythema and induration. This resolved slowly and then there was erythema with some satellite lesions extending nearly to the ante cubital fossa. Both episodes of erythema seemed to be preceded my me rubbing my arm as it was pruritic.. I think in both cases of erythema I activated a reaction by messaging the arm!

Release 9 — 6 months, dose 2

2021-09-03

Symptoms: At my 3 mos check with my Dermatologist for a h/o melanoma in March my right labia minora disappeared and I had lichen sclerosis. I have a h/o autoimmunity. Modera shots were 2/5, 3/5. A friend developed Pitariasis Rubor Pilaris after #2 inj. cut off by CDC

Healthcare visit (other): Dermatologist

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	✓	·	✓
SD	Office visit	✓	·	✓
SD	Pre-existing disease	✓	·	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Injection site erythema	✓	✓	✓
SRO	Injection site induration	✓	✓	✓
SRO	Injection site rash	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓

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