VPR-17233-53078 · OpenVSafe

Timeline

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

2021-02-16
Dose 1 — Moderna
2021-02-22
Registered in v-safe
2021-02-22
Survey response — days 1–6 daily, dose 1
MedDRA: Adverse reaction — Feeling: Good · Diarrhea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-23
Survey response — 7 day, dose 1
MedDRA: Insomnia — Feeling: Fair · Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-02
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-03-09
Survey response — 21 day, dose 1
MedDRA: Postmenopausal haemorrhage — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-17
Dose 2 — Moderna
2021-03-18
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Fair · Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-19
Survey response — days 1–6 daily, dose 2
MedDRA: Amenorrhoea — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-03-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-03-22
Survey response — days 1–6 daily, dose 2
MedDRA: Insomnia — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-23
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · None

Adult check-in
2021-03-24
Survey response — 7 day, dose 2
MedDRA: Insomnia — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-01
Survey response — 14 day, dose 2
MedDRA: Intermenstrual bleeding — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-07
Health check-in — 21 day, dose 2
Feeling: Fair

Adult check-in
2021-04-14
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-04-22
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-04-29
Survey response — 42 day, dose 2
MedDRA: Hospitalisation, Unevaluable event — Feeling: Fair · 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
2021-04-29
Report sent to call center — 42 day, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-18
Survey response — 3 month, dose 2
MedDRA: Condition aggravated, Herpes zoster, Pre-existing disease, Stress — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-09-17
Health check-in — 6 month, dose 2
Feeling: Fair

Adult check-in
2022-03-20
Survey response — 12 month, dose 2
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Good

MedDRA releases: 2024-11 · check-in answers available
2022-04-12
Call successful
Completed over the phone

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-16	Moderna
2	2021-03-17	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-04-29	Successful 2022-04-12	Completed over the phone

Free text

Release 4

Systemic reaction (other): I had the Covid shot on Tuesday and have not slept soundly since Thursday. I wake up during the night around 2 and again at 4. I have not changed anything with my diet or my habits. The only change is the vaccination.

Systemic reaction (other): I am still not sleeping. I woke up after 5 hours of sleep at 2:07 am.

Release 5

Symptoms: I am 66 and I got a menstrual period. It has been 15 years since my last one. No cramps or pain. It came as a complete shock.

Systemic reaction (other): My period started again and I am 66. I have not had a period in 15 years.

Systemic reaction (other): My period stopped.

Release 6

Systemic reaction (other): Hard time sleeping.

Systemic reaction (other): I am having a hard time sleeping.

Symptoms: I started spotting again.

Release 8

Symptoms: I had a D&C due to the break through bleeding to check for cancer (it was nagative), but I have random sleeping issues.

Healthcare visit (other): d&C was done at a hospital

Release 9

Symptoms: My shingles are breaking are breaking out in greater frequency. My shingles are triggered by stress and lately the smallest thing makes them break out.

Release 11

Symptoms: Shingles are breaking out again more often.

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	Hospitalisation	✓	✓	✓
SD	Condition aggravated	✓	✓	✓
SD	Herpes zoster	✓	✓	✓
SD	Intermenstrual bleeding	✓	✓	✓
SD	Postmenopausal haemorrhage	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Stress	✓	✓	✓
SD	Unevaluable event	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Amenorrhoea	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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