ZN6-21235-44860 · OpenVSafe

Timeline

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

2021-04-02
Dose 1 — Pfizer-BioNTech
2021-04-23
Registered in v-safe
2021-04-23
Dose 2 — Pfizer-BioNTech
2021-04-24
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 · Be unable to do your normal daily activities

Adult check-in
2021-04-25
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness

Adult check-in
2021-04-26
Survey response — days 1–6 daily, dose 2
MedDRA: Tinnitus — Feeling: Poor · Site: Pain · Headache, Fatigue or tiredness, Nausea · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Tinitus, very bothring, i have to go to ER

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-26
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-27
Survey response — days 1–6 daily, dose 2
MedDRA: Depressed mood, Emergency care, Hyperacusis, Hypoacusis, Loss of personal independence in daily activities, Tinnitus — Feeling: Poor · Site: Pain · Headache, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

Free text: I started the hearing issue on the morning of 25th. whenever I talk I felt the echo on both side of my ears. I also hear the exaggeration of the sound from the outside. Basically, i feel like i am sitting in the movie theater when i talk to people. It bother me SO MUCH. I went to ER in (b)(6) on 26th, and was diagnosed as "titinus". I was prescribed the prednisone 60mg/day and for 5 days. I already took 60mg x two days for now, but didn't feel any improvement. I am so annoyed, upset, even depressed. It seriously impact my normal daily life.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-28
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Poor · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: I took the 3rd dose of prednisone today, but the symptoms of tinitus is not improved. Also, start to feel a little dizziness some times

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-29
Survey response — days 1–6 daily, dose 2
MedDRA: Dizziness, Tinnitus — Feeling: Fair

Free text: I feel the tinitus improved. The noise got a little milder. But it is still there. Hope i can recover more over next few days. Also, i feel dizzy some times, with the episode of a frw minutes. I can do work and daily activity. But the tinitus still bother me a lot

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-02
Health check-in — day 7, dose 2
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-05-09
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-05-14
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-05-21
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-28
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-06-04
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-07-25
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-10-22
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-12-30
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-02	Pfizer-BioNTech
2	2021-04-23	Pfizer-BioNTech

Call center

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

Free text

Release 8 — days 1–6 daily, dose 2

2021-04-26

Systemic reaction (other): Tinitus, very bothring, i have to go to ER

2021-04-27

Systemic reaction (other): I started the hearing issue on the morning of 25th. whenever I talk I felt the echo on both side of my ears. I also hear the exaggeration of the sound from the outside. Basically, i feel like i am sitting in the movie theater when i talk to people. It bother me SO MUCH. I went to ER in (b)(6) on 26th, and was diagnosed as "titinus". I was prescribed the prednisone 60mg/day and for 5 days. I already took 60mg x two days for now, but didn't feel any improvement. I am so annoyed, upset, even depressed. It seriously impact my normal daily life.

redacted (b)(6)

2021-04-28

Systemic reaction (other): I took the 3rd dose of prednisone today, but the symptoms of tinitus is not improved. Also, start to feel a little dizziness some times

2021-04-29

Systemic reaction (other): I feel the tinitus improved. The noise got a little milder. But it is still there. Hope i can recover more over next few days. Also, i feel dizzy some times, with the episode of a frw minutes. I can do work and daily activity. But the tinitus still bother me a lot

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
SRO	Depressed mood	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Emergency care	✓	✓	✓
SRO	Hyperacusis	✓	✓	✓
SRO	Hypoacusis	✓	✓	✓
SRO	Loss of personal independence in daily activities	✓	✓	✓
SRO	Tinnitus	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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