Z8K-64345-52582

2 vaccinations 13 coded responses 23 check-ins 13 free-text entries 0 call cases

Sex: Female
Age at first dose: 36-40
ZIP prefix: 775 / TX
Registered: 2021-01-06

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

Timeline Vaccinations Free text MedDRA terms

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 — Moderna
2021-01-06
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain, Swelling · Chills

Adult check-in
2021-01-07
Survey response — days 1–6 daily, dose 1
MedDRA: Ear pruritus, Hot flush, Pruritus, Rash, Rash macular, Self-medication, Throat irritation — Feeling: Fair · Site: Pain, Redness, Swelling · Joint pains, Diarrhea

Free text: Last night, about 630 I began to get itchy from head to toes, just random places. My face began to get hot and flush. I had a blotchy rash on my face, neck and upper chest area. My inner ears and throat began to get itchy. I took some allegraD and Tylenol.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-08
Survey response — days 1–6 daily, dose 1
MedDRA: Ear pruritus, Self-medication, Throat irritation — Feeling: Fair · Site: Redness, Itching · Joint pains

Free text: Still have inner ear and throat itchiness from the evening of my injection. Allergy medication helps but it is bothersome and doesn't fully go away.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-09
Survey response — days 1–6 daily, dose 1
MedDRA: Ear pruritus, Throat irritation — Feeling: Fair · Site: Redness · Headache, Fatigue or tiredness

Free text: Still have mild inner ear itchiness but the throat itchiness has not returned today.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-10
Survey response — days 1–6 daily, dose 1
MedDRA: Pruritus, Sinus congestion — Feeling: Good · Site: Redness · Fatigue or tiredness

Free text: Have mild sinus congestion and still have inner ear itching, but only the right ear today instead of bilateral inner ears.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-13
Survey response — day 7, dose 1
MedDRA: Lymph node pain, Lymphadenopathy — Feeling: Good · Joint pains

Free text: Left axillary lymph node is swollen and slightly tender to the touch. Noticed lymph node swelling on 1/11/21

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-21
Survey response — day 14, dose 1
MedDRA: Injection site erythema, Injection site indentation, Injection site pruritus, Injection site swelling, Injection site warmth — Feeling: Good

Free text: On 1/14 my injection site become very red, hot and swollen about a 4X4inch circle and extremely itchy. The actual injection site was noticeably indented as well. As of today, 1/21 there is no sign of the injection on my left arm &No other reactions

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-27
Survey response — day 21, dose 1
MedDRA: Lymphadenopathy — Feeling: Good

Free text: Left groin lymph nodes are swollen, again. This presented a few days after my first injection and the lymph nodes became swollen again starting yesterday 1/26/21

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-04
Dose 2 — Moderna
2021-02-05
Survey response — days 1–6 daily, dose 2
MedDRA: Inner ear disorder, Throat irritation — Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Diarrhea · Be unable to work, Be unable to do your normal daily activities

Free text: Inner ear and throat itchiness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-06
Survey response — days 1–6 daily, dose 2
MedDRA: Ear pruritus, Inner ear disorder, Self-medication, Throat irritation — Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Joint pains, Diarrhea

Free text: Still experiencing inner ear and throat itchiness. Taking Benadryl to help.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-07
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Swelling · Headache, Fatigue or tiredness, Nausea, Diarrhea

Adult check-in
2021-02-08
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-02-09
Survey response — days 1–6 daily, dose 2
MedDRA: Nasal congestion, Pruritus, Throat irritation — Feeling: Fair · Site: Pain · Headache, Nausea

Free text: Nasal congestion, itchiness in throat and inner ears

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-10
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Itching · Headache, Diarrhea

Adult check-in
2021-02-11
Health check-in — day 7, dose 2
Feeling: Fair · Site: Itching · Diarrhea

Adult check-in
2021-02-18
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-25
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-04
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-11
Survey response — day 35, dose 2
MedDRA: Arthralgia, Swelling — Feeling: Fair

Free text: Joint pain and swelling, mainly my ankles but had issues with bilateral wrist joint pain.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-19
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-06
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-08-05
Survey response — 6 months, dose 2
MedDRA: Headache, Tinnitus — Feeling: Good

Free text: Severe headaches that are not related to allergies or tension, ringing in my ears occasionally.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2022-02-04
Survey response — 12 months, dose 2
MedDRA: Blood cholesterol increased — Feeling: Poor

Free text: High cholesterol

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

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-06	Moderna
2	2021-02-04	Moderna

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-07

Systemic reaction (other): Last night, about 630 I began to get itchy from head to toes, just random places. My face began to get hot and flush. I had a blotchy rash on my face, neck and upper chest area. My inner ears and throat began to get itchy. I took some allegraD and Tylenol.

2021-01-08

Systemic reaction (other): Still have inner ear and throat itchiness from the evening of my injection. Allergy medication helps but it is bothersome and doesn't fully go away.

2021-01-09

Systemic reaction (other): Still have mild inner ear itchiness but the throat itchiness has not returned today.

2021-01-10

Systemic reaction (other): Have mild sinus congestion and still have inner ear itching, but only the right ear today instead of bilateral inner ears.

Release 1 — day 7, dose 1

2021-01-13

Systemic reaction (other): Left axillary lymph node is swollen and slightly tender to the touch. Noticed lymph node swelling on 1/11/21

Release 2 — day 14, dose 1

2021-01-21

Symptoms: On 1/14 my injection site become very red, hot and swollen about a 4X4inch circle and extremely itchy. The actual injection site was noticeably indented as well. As of today, 1/21 there is no sign of the injection on my left arm &No other reactions cut off by CDC

Release 2 — day 21, dose 1

2021-01-27

Symptoms: Left groin lymph nodes are swollen, again. This presented a few days after my first injection and the lymph nodes became swollen again starting yesterday 1/26/21

Release 3 — days 1–6 daily, dose 2

2021-02-05

Systemic reaction (other): Inner ear and throat itchiness

2021-02-06

Systemic reaction (other): Still experiencing inner ear and throat itchiness. Taking Benadryl to help.

2021-02-09

Systemic reaction (other): Nasal congestion, itchiness in throat and inner ears

Release 5 — day 35, dose 2

2021-03-11

Symptoms: Joint pain and swelling, mainly my ankles but had issues with bilateral wrist joint pain.

Release 9 — 6 months, dose 2

2021-08-05

Symptoms: Severe headaches that are not related to allergies or tension, ringing in my ears occasionally.

Release 11 — 12 months, dose 2

2022-02-04

Symptoms: High cholesterol

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	Arthralgia	✓	✓	✓
SD	Blood cholesterol increased	·	·	✓
SD	Headache	✓	·	✓
SD	Injection site erythema	✓	✓	✓
SD	Injection site indentation	✓	✓	✓
SD	Injection site pruritus	✓	✓	✓
SD	Injection site swelling	✓	✓	✓
SD	Injection site warmth	✓	✓	✓
SD	Lymphadenopathy	✓	✓	✓
SD	Swelling	✓	✓	✓
SD	Tinnitus	✓	·	✓
SRO	Ear pruritus	✓	✓	✓
SRO	Feeling hot	○	○	○
SRO	Flushing	○	○	○
SRO	Hot flush	✓	✓	✓
SRO	Inner ear disorder	✓	✓	✓
SRO	Lymph node pain	✓	✓	✓
SRO	Lymphadenopathy	✓	✓	✓
SRO	Nasal congestion	✓	✓	✓
SRO	Pruritus	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Rash macular	✓	✓	✓
SRO	Respiratory tract congestion	○	○	○
SRO	Self-medication	✓	✓	✓
SRO	Sinus congestion	✓	✓	✓
SRO	Throat irritation	✓	✓	✓

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