XYL-13623-81159 · OpenVSafe

Timeline

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

2021-04-14
Dose 1 — Pfizer-BioNTech
2021-05-05
Dose 2 — Pfizer-BioNTech
2021-05-06
Registered in v-safe
2021-05-06
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Diarrhea, Abdominal pain · Be unable to work

Adult check-in
2021-05-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Muscle or body aches

Adult check-in
2021-05-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-05-09
Survey response — days 1–6 daily, dose 2
MedDRA: Hot flush — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-11
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-05-12
Health check-in — 7 day, dose 2
Feeling: Good · None

Adult check-in
2021-05-20
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-05-26
Survey response — 21 day, dose 2
MedDRA: Burning sensation, Herpes zoster, Immediate post-injection reaction, Pruritus, Rash pruritic, Skin burning sensation — Feeling: Good · 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
2021-05-26
Report sent to call center — 21 day, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-04
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-06-10
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-06-17
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-08-04
Survey response — 3 month, dose 2
MedDRA: Migraine — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

MedDRA releases: 2021-09,2024-11 · check-in answers available
2021-08-04
Report sent to call center — 3 month, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-13
Call 1 — Left Voicemail
2021-11-24
Dose 3 — Moderna
2022-05-05
Health check-in — 12 month, dose 2
Feeling: Good

Adult check-in
2022-05-25
Survey response — 6 month, dose 3
MedDRA: Malaise, Oropharyngeal pain, Pain — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-11-27
Health check-in — 12 month, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-14	Pfizer-BioNTech
2	2021-05-05	Pfizer-BioNTech
3	2021-11-24	Moderna	No

Call center

Reported	Outcome	VAERS-related outcome
2021-05-26	Unsuccessful
2021-08-04	Unsuccessful

Free text

Release 8

Systemic reaction (other): After my first shot, I started having hot flashes similar to those during menopause.

Symptoms: Since shortly after my second vaccine I had itchy and burning section of skin on right side of my back. I also have a rash on my right toe that burns and itches. I believe it is a shingles outbreak.

Release 9

Symptoms: Migraine headaches

Release 11

Symptoms: I was sick with sore throat and body aches for 3 days. My child had same symptoms and had negative covid test from health care provider.

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	Burning sensation	✓	✓	✓
SD	Herpes zoster	✓	✓	✓
SD	Immediate post-injection reaction	✓	✓	✓
SD	Malaise	·	·	✓
SD	Migraine	✓	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pain	·	·	✓
SD	Pruritus	✓	✓	✓
SD	Rash pruritic	✓	✓	✓
SD	Skin burning sensation	✓	✓	✓
SRO	Hot flush	✓	✓	✓

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