XZG-38993-63791 · OpenVSafe

Timeline

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

2020-12-30
Dose 1 — Moderna
2021-01-01
Registered in v-safe
2021-01-01
Survey response — days 1–6 daily, dose 1
MedDRA: Contusion, Injection site erythema — Feeling: Fair · Chills

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-02
Survey response — days 1–6 daily, dose 1
MedDRA: Contusion — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-03
Survey response — days 1–6 daily, dose 1
MedDRA: Oedema peripheral, Skin discolouration — Feeling: Fair · Site: Swelling

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-04
Survey response — days 1–6 daily, dose 1
MedDRA: Contusion, Erythema, Oedema peripheral — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-05
Survey response — days 1–6 daily, dose 1
MedDRA: Oedema peripheral, Skin discolouration — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-06
Survey response — 7 day, dose 1
MedDRA: Oedema peripheral, Skin discolouration — Feeling: Fair · Site: Swelling

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-13
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-01-21
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-01-27
Health check-in — 28 day, dose 1
Feeling: Good

Adult check-in
2021-01-28
Dose 2 — Moderna
2021-01-29
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site bruising, Skin discolouration — Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-30
Survey response — days 1–6 daily, dose 2
MedDRA: Contusion — Feeling: Fair · Site: Pain · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-31
Survey response — days 1–6 daily, dose 2
MedDRA: Contusion — Feeling: Good · Site: Redness · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-01
Survey response — days 1–6 daily, dose 2
MedDRA: Contusion, Reaction to previous exposure to any vaccine — Feeling: Good · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-02
Survey response — days 1–6 daily, dose 2
MedDRA: Contusion, Lymphadenopathy — Feeling: Good · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-03
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy — Feeling: Good · Site: Swelling · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-04
Survey response — 7 day, dose 2
MedDRA: Skin discolouration — Feeling: Good · Site: Swelling · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-11
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-02-18
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-07-29
Health check-in — 6 month, dose 2
Feeling: Fair

Adult check-in
2021-11-12
Dose 3 — Moderna
2022-01-28
Health check-in — 12 month, dose 2
Feeling: Good

Adult check-in
2022-05-13
Survey response — 6 month, dose 3
MedDRA: Tinnitus — Feeling: Good

MedDRA releases: 2024-11 · check-in answers available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-30	Moderna
2	2021-01-28	Moderna
3	2021-11-12	Moderna	No

Free text

Release 1

Systemic reaction (other): Left Axillary Region was notable discolored(Bruise coloration) greater than 10 cm in length at 48 hours post immunization. Actual injection site: no reaction, 2 inches below erythema present.

Systemic reaction (other): Left Axillary Bruised region is beginning to lighten in color.

Systemic reaction (other): Swelling to Left Axillary area, same arm as injection site. Visible discoloration greater than 10 cm present.

Systemic reaction (other): Left Axillary Region remains swollen and red/ purple bruise appearance area greater than 10cm remains, bruise appearance in the left Axillary region remains present.

Systemic reaction (other): Left Axillary region not as dark as before, remains slightly swollen.

Systemic reaction (other): Continued swelling on Left Axillary Area( Left Arm was used for inoculation). Discoloration is fading out a bit today, outline is still visible.

Release 3

Systemic reaction (other): Left Axillary darkened region returned, identical to Reaction noted post 1st injection. Affected area appears as bruise in color.Experienced Insomnia post 2nd injection. .

Systemic reaction (other): Left Axillary Region greater than 10 cm, marquise shape. Bruised appearance. Shape is the exact same as post 1st injection.

Systemic reaction (other): Left Axillary area bruised, greater than 10 cm .

Systemic reaction (other): Left Axillary site remains bruised in appearance. Same shape as post First injection. Greater than 10 cm in size.

Systemic reaction (other): Left axillary region bruised in appearance same experience as post first injection.

Systemic reaction (other): Left Axillary site remains reddened, swelling to left Axillary lymph nodes.

Systemic reaction (other): Left Axillary site remains discolored, beginning to fade.

Release 11

Symptoms: Occasional/ short lasting tinnitus

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	Tinnitus	·	·	✓
SRO	Contusion	✓	✓	✓
SRO	Erythema	✓	✓	✓
SRO	Injection site bruising	✓	✓	✓
SRO	Injection site erythema	✓	✓	✓
SRO	Lymphadenopathy	✓	✓	✓
SRO	Oedema peripheral	✓	✓	✓
SRO	Reaction to previous exposure to any vaccine	✓	✓	✓
SRO	Skin discolouration	✓	✓	✓
SRO	Swelling	○	○	○

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