ZQX-15691-83536 · OpenVSafe

Timeline

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

2021-01-06
Registered in v-safe
2021-01-06
Dose 1 — Pfizer-BioNTech
2021-01-06
Health check-in — 0 day, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-01-07
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-08
Survey response — days 1–6 daily, dose 1
MedDRA: Heart rate irregular — Feeling: Good · Abdominal pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Abdominal pain

Adult check-in
2021-01-10
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Abdominal pain

Adult check-in
2021-01-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Abdominal pain

Adult check-in
2021-01-12
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-13
Health check-in — 7 day, dose 1
Feeling: Good · None

Adult check-in
2021-01-21
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-01-27
Dose 2 — Pfizer-BioNTech
2021-02-03
Survey response — 7 day, dose 2
MedDRA: Gastrooesophageal reflux disease — Feeling: Good · Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-10
Survey response — 14 day, dose 2
MedDRA: Condition aggravated, Gastrooesophageal reflux disease, Pre-existing disease — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-17
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-02-24
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-03-03
Survey response — 35 day, dose 2
MedDRA: Pain — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-10
Survey response — 42 day, dose 2
MedDRA: Formication, Pain — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-28
Health check-in — 3 month, dose 2
Feeling: Good

Adult check-in
2021-07-30
Health check-in — 6 month, dose 2
Feeling: Good

Adult check-in
2021-11-16
Dose 3 — Moderna
2022-01-27
Survey response — 12 month, dose 2
MedDRA: Gastrointestinal disorder — Feeling: Fair

MedDRA releases: 2024-11 · check-in answers available
2022-09-07
Dose 4 — Moderna
2022-09-22
Survey response — 14 day, dose 4
MedDRA: Urine output increased — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2022-09-22
Report sent to call center — 14 day, dose 4
Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-09-23
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2023-03-08
Survey response — 6 month, dose 4
MedDRA: Blood glucose increased, Blood thyroid stimulating hormone increased, Pre-existing disease — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2023-03-08
Report sent to call center — 6 month, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2023-03-09
Call successful
Participant prefers to complete VAERS report online

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-06	Pfizer-BioNTech
2	2021-01-27	Pfizer-BioNTech
3	2021-11-16	Moderna	No
4	2022-09-07	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2022-09-22	Successful 2022-09-23	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2023-03-08	Successful 2023-03-09	Participant prefers to complete VAERS report online

Free text

Release 1

Systemic reaction (other): Occasinal ectopic heart beat

Release 3

Systemic reaction (other): Acid Reflux

Release 4

Symptoms: Never had acid reflux symptoms before, and I started having reflux issue right after 2nd dose. I dont think it is related to vaccine and is most likely coincidental. I also have preexisting spine-related pain/neurological issues which has worsened. cut off by CDC

Release 5

Symptoms: Increased Pain

Symptoms: Pain, creeping and crawling sensations

Release 11

Symptoms: Gastrointestinal symptoms.

Release 12

Symptoms: Increased urine output volume.

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	Blood glucose increased	·	·	✓
SD	Blood thyroid stimulating hormone increased	·	·	✓
SD	Condition aggravated	✓	✓	✓
SD	Formication	✓	✓	✓
SD	Gastrointestinal disorder	·	·	✓
SD	Gastrooesophageal reflux disease	✓	✓	✓
SD	Pain	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Urine output increased	·	·	✓
SRO	Gastrooesophageal reflux disease	✓	✓	✓
SRO	Heart rate irregular	✓	✓	✓

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