28C-18346-09930

2 vaccinations 13 coded responses 21 check-ins 13 free-text entries 4 call cases

Sex: Female
Age at first dose: 51-55
ZIP prefix: 000
Registered: 2021-01-22

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-01-19
Dose 1 — Moderna
2021-01-22
Registered in v-safe
2021-01-22
Survey response — days 1–6 daily, dose 1
MedDRA: Herpes zoster — Feeling: Fair · Fever · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Chronic shingles is aggravated

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-23
Survey response — days 1–6 daily, dose 1
MedDRA: Condition aggravated, Pre-existing disease, Tinnitus — Feeling: Fair · Fever · Chills, Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Tinnitus from chronic shingles that have been reactivated. It's complicated because of biologic med, Xolair.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-24
Survey response — days 1–6 daily, dose 1
MedDRA: Herpes zoster, Pre-existing disease, Tinnitus — Feeling: Good · Fever · Chills, Headache, Fatigue or tiredness

Free text: Extreme tinnitus from ongoing chronic shingles, and my biologic asthma med.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-26
Health check-in — day 7, dose 1
Feeling: Good · Fever · Chills, Headache

Adult check-in
2021-02-02
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-09
Survey response — day 21, dose 1
MedDRA: Herpes zoster, Pre-existing disease, Sinusitis — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: I am on the biologic xolair for asthma. And the last 2years it has tripped out the shingles. was no surprise when this vax tripped out shingles, and it's in my head sinuses and throat. So I'm now on antibiotics for a sinus infection.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-09
Report sent to call center — day 21, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-18
Health check-in — day 28, dose 1
Feeling: Good

Adult check-in
2021-02-20
Dose 2 — Moderna
2021-02-22
Survey response — days 1–6 daily, dose 2
MedDRA: Tinnitus — Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

Free text: Tinnitus

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-23
Survey response — days 1–6 daily, dose 2
MedDRA: Tinnitus, Unevaluable event — Feeling: Fair · Site: Pain · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Tinnitus · Healthcare visit (other): Acupuncture

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-23
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-24
Survey response — days 1–6 daily, dose 2
MedDRA: Condition aggravated, Herpes zoster, Office visit, Pre-existing disease, Sinusitis, Tinnitus — Feeling: Fair · Site: Pain · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Tinnitus continues and the shingles are getting pink and trying to break out again, even with me taking one gram of valtrex twice a day for weeks prior to shot.... trying to reduce the outbreak ......I will now go to valtrex every 8 hours for at least 10 days before I reduce it to every 12 hours.... Biologic xolair makes the shingles bad and I even skipped my dose between the two vax doses. · Healthcare visit (other): Chiropractic and had to start bathroom for sinus infection and change valtrex from every 12 hours to every 8 hours hope to get my biologic in a couple of weeks since I skipped it and would not take it between the two vax doses.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-24
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-25
Survey response — days 1–6 daily, dose 2
MedDRA: Tinnitus — Feeling: Fair · Fever · Chills, Headache, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to work, Be unable to do your normal daily activities

Free text: Tinnitus

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-26
Survey response — days 1–6 daily, dose 2
MedDRA: Tinnitus — Feeling: Fair · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Diarrhea, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

Free text: Tinnitus

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-27
Survey response — day 7, dose 2
MedDRA: Cough, Productive cough, Tinnitus — Feeling: Fair · Fever · Chills, Muscle or body aches, Fatigue or tiredness, Diarrhea · Be unable to work, Be unable to do your normal daily activities

Free text: Tinnitus continues and I just realized I've had a cough for 2 days with phlegm. Productive cough is not normal for me. I suspect having skipped my asthma biologic, Xolair, has now contributed to this lung problem.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-06
Survey response — day 14, dose 2
MedDRA: Nasal congestion, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities

Free text: Nose is very stuffy, I got the biological Xolair yesterday, and it trips out my shingles for the last 28 months... Cranial internal shingles ... Cannot dc the Xolair... Skipped it so it's been 8 weeks instead of 4.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-13
Survey response — day 21, dose 2
MedDRA: Chills, Headache, Sinusitis — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Got biologic Xolair on Friday the 5th, Which was 2 weeks after vax#2... I have the worst sinus infection now... And chills and headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-13
Report sent to call center — day 21, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-20
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-03-27
Survey response — day 35, dose 2
MedDRA: Fatigue — Feeling: Fair · Be unable to do your normal daily activities

Free text: Fatigue continues, possibly could be some allergy

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-03
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-05-22
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-18
Call 1 — Left Voicemail
2021-08-21
Health check-in — 6 months, dose 2
Feeling: Fair

Adult check-in
2022-02-20
Health check-in — 12 months, dose 2
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-19	Moderna
2	2021-02-20	Moderna

Call center

4 call center cases

4 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 2 — days 1–6 daily, dose 1

2021-01-22

Systemic reaction (other): Chronic shingles is aggravated

2021-01-23

Systemic reaction (other): Tinnitus from chronic shingles that have been reactivated. It's complicated because of biologic med, Xolair.

2021-01-24

Systemic reaction (other): Extreme tinnitus from ongoing chronic shingles, and my biologic asthma med.

Release 3 — day 21, dose 1

2021-02-09

Symptoms: I am on the biologic xolair for asthma. And the last 2years it has tripped out the shingles. was no surprise when this vax tripped out shingles, and it's in my head sinuses and throat. So I'm now on antibiotics for a sinus infection.

Release 4 — days 1–6 daily, dose 2

2021-02-22

Systemic reaction (other): Tinnitus

2021-02-23

Systemic reaction (other): Tinnitus

Healthcare visit (other): Acupuncture

2021-02-24

Systemic reaction (other): Tinnitus continues and the shingles are getting pink and trying to break out again, even with me taking one gram of valtrex twice a day for weeks prior to shot.... trying to reduce the outbreak ......I will now go to valtrex every 8 hours for at least 10 days before I reduce it to every 12 hours.... Biologic xolair makes the shingles bad and I even skipped my dose between the two vax doses.

Healthcare visit (other): Chiropractic and had to start bathroom for sinus infection and change valtrex from every 12 hours to every 8 hours hope to get my biologic in a couple of weeks since I skipped it and would not take it between the two vax doses.

2021-02-25

Systemic reaction (other): Tinnitus

2021-02-26

Systemic reaction (other): Tinnitus

Release 4 — day 7, dose 2

2021-02-27

Systemic reaction (other): Tinnitus continues and I just realized I've had a cough for 2 days with phlegm. Productive cough is not normal for me. I suspect having skipped my asthma biologic, Xolair, has now contributed to this lung problem.

Release 5 — day 14, dose 2

2021-03-06

Symptoms: Nose is very stuffy, I got the biological Xolair yesterday, and it trips out my shingles for the last 28 months... Cranial internal shingles ... Cannot dc the Xolair... Skipped it so it's been 8 weeks instead of 4.

Release 5 — day 21, dose 2

2021-03-13

Symptoms: Got biologic Xolair on Friday the 5th, Which was 2 weeks after vax#2... I have the worst sinus infection now... And chills and headache

Release 6 — day 35, dose 2

2021-03-27

Symptoms: Fatigue continues, possibly could be some allergy

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
HCVO	Office visit	✓	✓	✓
HCVO	Sinusitis	✓	✓	✓
HCVO	Unevaluable event	✓	✓	✓
SD	Asthma	○	○	○
SD	Chills	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Herpes zoster	✓	✓	✓
SD	Nasal congestion	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Sinusitis	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Cough	✓	✓	✓
SRO	Herpes zoster	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Productive cough	✓	✓	✓
SRO	Tinnitus	✓	✓	✓

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