22M-39728-67372 · OpenVSafe

Timeline

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

2021-08-19
Registered in v-safe
2021-08-19
Dose 1 — Moderna
2021-08-19
Health check-in — day 0, dose 1
Feeling: Fair · Headache, Fatigue or tiredness, Nausea

Adult check-in
2021-08-20
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Redness, Swelling · None

Adult check-in
2021-08-21
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-08-22
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-08-23
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-08-24
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-08-25
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Chills, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-08-26
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-09-02
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-09-09
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-09-16
Survey response — day 28, dose 1
MedDRA: Rash — Feeling: Fair

Free text: Random painful bumps on body.

MedDRA releases: 2024-11 · check-in free text available
2021-09-23
Health check-in — day 35, dose 1
Feeling: Good

Adult check-in
2021-09-24
Dose 2 — Moderna
2021-09-24
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-09-25
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-09-26
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-09-27
Survey response — days 1–6 daily, dose 2
MedDRA: Rash, Skin discolouration — Feeling: Fair · Site: Pain · Headache, Rash, not including the immediate area around the injection site

Free text: Since the first shot of had bumps that turned into black marks and a rash pop up on my thigh when I got my second shot.

MedDRA releases: 2024-11 · check-in free text available
2021-09-28
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Headache

Adult check-in
2021-09-29
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Rash, not including the immediate area around the injection site

Adult check-in
2021-09-30
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-10-01
Health check-in — day 7, dose 2
Feeling: Good · Rash, not including the immediate area around the injection site

Adult check-in
2021-10-08
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-10-15
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-10-22
Survey response — day 28, dose 2
MedDRA: Rash — Feeling: Good

Free text: The bumps and aftermarks are still popping up and not going away

MedDRA releases: 2024-11 · check-in free text available
2021-10-29
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-11-05
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-12-24
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2022-03-25
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-09-26
Survey response — 12 months, dose 2
MedDRA: Axillary mass, Emergency care, Rash, Skin hyperpigmentation — Feeling: Good · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Bumps still appear on the arm I received the shot, but they disappear and leave marks like hyperpigmentation. I also had a lump appear under my armpit under the same arm I got the shot in, I went to the ER, made a doctors appt for proper imaging.

MedDRA releases: 2024-11 · check-in free text available
2022-09-26
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

Emergency room or emergency department visit · 1 call case(s)
2022-09-27
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-08-19	Moderna	No
2	2021-09-24	Moderna	No

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 9 — day 28, dose 1

2021-09-16

Symptoms: Random painful bumps on body.

Release 9 — days 1–6 daily, dose 2

2021-09-27

Systemic reaction (other): Since the first shot of had bumps that turned into black marks and a rash pop up on my thigh when I got my second shot.

Release 10 — day 28, dose 2

2021-10-22

Symptoms: The bumps and aftermarks are still popping up and not going away

Release 12 — 12 months, dose 2

2022-09-26

Symptoms: Bumps still appear on the arm I received the shot, but they disappear and leave marks like hyperpigmentation. I also had a lump appear under my armpit under the same arm I got the shot in, I went to the ER, made a doctors appt for proper imaging.

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
SD	Axillary mass	·	·	✓
SD	Emergency care	·	·	✓
SD	Rash	·	·	✓
SD	Skin hyperpigmentation	·	·	✓
SRO	Rash	·	·	✓
SRO	Skin discolouration	·	·	✓

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