XZA-10869-18635 · OpenVSafe

Timeline

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

2021-01-14
Dose 1 — Moderna
2021-01-21
Registered in v-safe
2021-01-22
Survey response — 7 day, dose 1
MedDRA: Axillary pain, Fatigue, Lymphadenopathy — Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-28
Survey response — 14 day, dose 1
MedDRA: Injection site rash, Injection site warmth, Lymphadenopathy, Office visit, Rash erythematous — 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

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-28
Report sent to call center — 14 day, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-05
Health check-in — 21 day, dose 1
Feeling: Fair

Adult check-in
2021-02-11
Dose 2 — Moderna
2021-02-18
Health check-in — 7 day, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · 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
2021-02-25
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-03-04
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-03-11
Survey response — 28 day, dose 2
MedDRA: Fatigue — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-18
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-03-25
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-05-15
Health check-in — 3 month, dose 2
Feeling: Good

Adult check-in
2021-06-09
Call successful
Does not wish to fill out VAERS report
2021-08-14
Health check-in — 6 month, dose 2
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-14	Moderna
2	2021-02-11	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-01-28	Successful 2021-06-09	Does not wish to fill out VAERS report

Free text

Release 2

Systemic reaction (other): Swollen Gland under armpit on arm where injection is given. Lump is sore and appeared yesterday, 1 week after 1st vaccination. Still swollen and sore today. Feel fatigued and concerned about swollen gland.

Release 3

Symptoms: Very swollen glands under arm of injection site, and a very large rash, that was very red and hot from top of arm to almost elbow on injection site arm. Akso felt fatigued, and had to go to Urgent Care. Was perscribed a Steriod and an antibiotic.

Release 5

Symptoms: Some Fatigue

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
SD	Fatigue	✓	✓	✓
SD	Injection site rash	✓	✓	✓
SD	Injection site warmth	✓	✓	✓
SD	Lymphadenopathy	✓	✓	✓
SD	Office visit	✓	✓	✓
SD	Rash erythematous	✓	✓	✓
SRO	Axillary pain	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Lymphadenopathy	✓	✓	✓

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