ZVA-10608-79417 · OpenVSafe

Timeline

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

2020-12-28
Dose 1 — Moderna
2021-01-11
Registered in v-safe
2021-01-11
Survey response — day 14, dose 1
MedDRA: Ear infection, Ear pain, Pain in extremity — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: 1st dose: 28Dec2020. Experienced significant arm soreness for 8 days (28Dec2020-04Jan2021). Possible ear infection w/ear pain beginning 30Dec2020â€”no prior hx or suspected cause to develop this infection. Saw urgent care for tx on 07Jan2021.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-11
Report sent to call center — day 14, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-18
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-01-25
Dose 2 — Moderna
2021-01-25
Health check-in — day 0, dose 2
Feeling: Fair · Site: Pain · Muscle or body aches

Adult check-in
2021-01-26
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-01-27
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to work

Adult check-in
2021-01-28
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-01-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-02-01
Health check-in — day 7, dose 2
Feeling: Fair · Fever · Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-02-08
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-15
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-19
Call successful
Participant prefers to complete VAERS report online
2021-02-22
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-01
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-09
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-04-28
Survey response — 3 months, dose 2
MedDRA: Heavy menstrual bleeding — Feeling: Good

Free text: Prolonged + heavy menstruation Mar 9-Apr 3 (26 days on).

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-26
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-11-11
Dose 3 — Moderna
Co-administered: Flu
2022-01-26
Survey response — 12 months, dose 2
MedDRA: Accident, Concussion, Contusion, Road traffic accident — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: Shoulder contusion from downhill skiing in December 2021. Concussion from car accident in November 2021.

MedDRA releases: 2024-11 · check-in free text available
2022-01-26
Report sent to call center — 12 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · 1 call case(s)
2022-01-27
Call 1 — Left Voicemail
2022-05-14
Survey response — 6 months, dose 3
MedDRA: Dizziness, Fatigue, Nausea, Oropharyngeal pain, Paranasal sinus discomfort, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Sore throat/low fever (101Â°F)/nausea/fatigue/lightheadedness/congestion/sinus pressure for ~10 days x2 within the past month. COVID negative

MedDRA releases: 2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-28	Moderna
2	2021-01-25	Moderna
3	2021-11-11	Moderna	Flu

Call center

2 call center cases

1 successful · 1 unsuccessful

See the call center timeline

Free text

Release 1 — day 14, dose 1

2021-01-11

Symptoms: 1st dose: 28Dec2020. Experienced significant arm soreness for 8 days (28Dec2020-04Jan2021). Possible ear infection w/ear pain beginning 30Dec2020â€”no prior hx or suspected cause to develop this infection. Saw urgent care for tx on 07Jan2021.

Release 8 — 3 months, dose 2

2021-04-28

Symptoms: Prolonged + heavy menstruation Mar 9-Apr 3 (26 days on).

Release 11 — 12 months, dose 2

2022-01-26

Symptoms: Shoulder contusion from downhill skiing in December 2021. Concussion from car accident in November 2021.

Release 11 — 6 months, dose 3

2022-05-14

Symptoms: Sore throat/low fever (101Â°F)/nausea/fatigue/lightheadedness/congestion/sinus pressure for ~10 days x2 within the past month. COVID negative

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	Accident	·	·	✓
SD	Concussion	·	·	✓
SD	Contusion	·	·	✓
SD	Dizziness	·	·	✓
SD	Ear infection	✓	✓	✓
SD	Ear pain	✓	✓	✓
SD	Fatigue	·	·	✓
SD	Heavy menstrual bleeding	✓	✓	✓
SD	Medical observation	○	○	○
SD	Nausea	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pain	○	○	○
SD	Pain in extremity	✓	✓	✓
SD	Paranasal sinus discomfort	·	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Road traffic accident	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓

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