XX5-39538-42435 · OpenVSafe

Timeline

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

2021-03-03
Dose 1 — Moderna
2021-03-13
Registered in v-safe
2021-03-13
Survey response — 7 day, dose 1
MedDRA: Rash, Rash erythematous, Rash papular, Rash pruritic — Feeling: Fair · Site: Redness, Swelling, Itching · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-17
Survey response — 14 day, dose 1
MedDRA: Back pain, Flank pain, Herpes dermatitis, Herpes zoster, Office visit, Oral herpes zoster, Oral pain, Pre-existing disease, Pruritus, Stomatitis — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-17
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)
2021-03-26
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-03-30
Dose 2 — Moderna
2021-03-31
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Redness, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-04-01
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling · Headache, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-04-02
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy — Feeling: Fair · Site: Pain, Swelling, Itching · Muscle or body aches, Nausea, Diarrhea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-03
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy — Feeling: Good · Site: Swelling · Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-06
Health check-in — 7 day, dose 2
Feeling: Good · Site: Itching · None

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

Adult check-in
2021-10-29
Dose 3 — Moderna
2021-10-29
Health check-in — 0 day, dose 3
Feeling: Good · None

Adult check-in
2021-10-30
Survey response — days 1–6 daily, dose 3
MedDRA: Injection site warmth — Feeling: Good · Site: Pain, Redness, Swelling · Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2024-11 · check-in answers available
2021-10-31
Survey response — days 1–6 daily, dose 3
MedDRA: Injection site warmth — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-01
Survey response — days 1–6 daily, dose 3
MedDRA: Injection site warmth — Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-02
Survey response — days 1–6 daily, dose 3
MedDRA: Oropharyngeal pain — Feeling: Poor · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-03
Survey response — days 1–6 daily, dose 3
MedDRA: Cough, Oropharyngeal pain — Feeling: Poor · Site: Redness, Itching · Fever · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-04
Survey response — days 1–6 daily, dose 3
MedDRA: Sinusitis — Feeling: Poor · Site: Itching · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-05
Health check-in — 7 day, dose 3
Feeling: Poor · Site: Redness · Fever · Chills, Fatigue or tiredness, Nausea, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-11-19
Health check-in — 21 day, dose 3
Feeling: Good

Adult check-in
2021-11-26
Health check-in — 28 day, dose 3
Feeling: Good

Adult check-in
2022-03-08
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-03	Moderna
2	2021-03-30	Moderna
3	2021-10-29	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-03-17	Unsuccessful

Free text

Release 5

Systemic reaction (other): Raised red bumps on trunk area like Shingles. Hurt and itch

Symptoms: Shingles since 2nd day after Moderna vaccine. Pain and itching started on 2nd day on right back side/flank.Sores surfaced 9 days after vaccine. Spreading currently. Also since 2nd day several mouth sores/herpes.

Healthcare visit (other): PCP office visit prescribe Valtrex for Shingles

Release 6

Systemic reaction (other): Swollen lymph nodes

Systemic reaction (other): Mild Swollen Lymph Nodes

Release 10

Systemic reaction (other): Injection site hot

Systemic reaction (other): Injection area hot

Systemic reaction (other): Injection site hot

Systemic reaction (other): Sore throat

Systemic reaction (other): Sore throat, coughing

Systemic reaction (other): Sinus infection

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	Office visit	✓	✓	✓
HCVO	Pre-existing disease	✓	✓	○
SD	Back pain	✓	✓	○
SD	Flank pain	·	·	✓
SD	Herpes dermatitis	✓	✓	○
SD	Herpes zoster	✓	✓	✓
SD	Oral herpes zoster	·	·	✓
SD	Oral pain	✓	✓	○
SD	Pruritus	✓	✓	○
SD	Stomatitis	·	·	✓
SRO	Cough	·	·	✓
SRO	Injection site warmth	·	·	✓
SRO	Lymphadenopathy	✓	✓	✓
SRO	Oropharyngeal pain	·	·	✓
SRO	Rash	✓	✓	✓
SRO	Rash erythematous	✓	✓	✓
SRO	Rash papular	✓	✓	✓
SRO	Rash pruritic	✓	✓	✓
SRO	Sinusitis	·	·	✓

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