U2M-21362-22717

3 vaccinations 14 coded responses 27 check-ins 14 free-text entries 4 call cases

Sex: Female
Age at first dose: 41-45
ZIP prefix: 342 / FL
Registered: 2021-03-30

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

Timeline

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

2021-03-30
Registered in v-safe
2021-03-30
Dose 1 — Moderna
2021-03-30
Health check-in — day 0, dose 1
Feeling: Fair · Headache, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-03-31
Survey response — days 1–6 daily, dose 1
MedDRA: Malaise — Feeling: Poor · Site: Pain · Fever · Headache · Be unable to do your normal daily activities

Free text: Malaise

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-01
Survey response — days 1–6 daily, dose 1
MedDRA: Cough, Respiratory tract congestion — Feeling: Poor · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work

Free text: Coughing and congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-02
Survey response — days 1–6 daily, dose 1
MedDRA: Muscle twitching — Feeling: Fair · Fever · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Right eye noticeably twitching since vaccine administration.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-03
Survey response — days 1–6 daily, dose 1
MedDRA: Blepharospasm, Fatigue — Feeling: Fair · Fever · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Twitching right eye, severe fatigue,

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-04
Survey response — days 1–6 daily, dose 1
MedDRA: Blepharospasm — Feeling: Fair · Chills, Muscle or body aches, Fatigue or tiredness, Diarrhea, Rash, not including the immediate area around the injection site

Free text: Right eye twitching since Tuesdays vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-05
Survey response — days 1–6 daily, dose 1
MedDRA: Blepharospasm, Neck pain, Rhinorrhoea — Feeling: Poor · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Twitching in the right eye, neck pain, runny nose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-06
Health check-in — day 7, dose 1
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-04-13
Survey response — day 14, dose 1
MedDRA: Influenza — Feeling: Poor · Be unable to do your normal daily activities

Free text: I feel like I have the flu.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-20
Health check-in — day 21, dose 1
Feeling: Fair

Adult check-in
2021-04-27
Dose 2 — Moderna
2021-04-27
Health check-in — day 0, dose 2
Feeling: Fair · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-04-28
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site swelling — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea · Be unable to work, Be unable to do your normal daily activities

Free text: Swelling at the injections site.

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 — Feeling: Fair · Site: Pain, Redness, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea · Be unable to work, Be unable to do your normal daily activities

Free text: Light headed

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-30
Survey response — days 1–6 daily, dose 2
MedDRA: Asthenia, Dizziness — Feeling: Fair · Site: Redness, Swelling, Itching · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea · Be unable to do your normal daily activities

Free text: Dizziness. Weakness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-01
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Redness, Swelling, Itching · Fever · Headache, Joint pains, Fatigue or tiredness, Nausea, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-05-03
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Itching · Fever · Fatigue or tiredness, Nausea, Diarrhea

Adult check-in
2021-05-04
Health check-in — day 7, dose 2
Feeling: Good · Site: Itching · Headache, Joint pains, Fatigue or tiredness

Adult check-in
2021-05-11
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-05-18
Health check-in — day 21, dose 2
Feeling: Fair

Adult check-in
2021-05-25
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-06-01
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-06-08
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-07-27
Survey response — 3 months, dose 2
MedDRA: Chills, Headache, Lymphadenopathy, Myalgia, Nausea, Oropharyngeal pain — Feeling: Poor · 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: Lymphadenopathy, HA, nausea, ST, myalgias, chills

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-07-27
Report sent to call center — 3 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-05
Call 1 — Left Voicemail
2021-08-28
Dose 3 — Moderna
2021-10-28
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-11-27
Survey response — 3 months, dose 3
MedDRA: Cough, Diarrhoea, Fatigue, Lethargy, Nausea, Oropharyngeal pain, Pyrexia, Respiratory tract congestion — Feeling: Poor · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Fever, coughing, congestion, fatigue, lethargy, nausea, diarrhea, sore throat

MedDRA releases: 2024-11 · check-in free text available
2021-11-27
Report sent to call center — 3 months, dose 3
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-11-30
Call 2 — Left Voicemail
2022-02-26
Survey response — 6 months, dose 3
MedDRA: Adverse drug reaction, Blood thyroid stimulating hormone decreased, Fatigue, Hypersomnia, Malaise, SARS-CoV-2 test positive — 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: In January I tested positive for COVID-19. I have since been very fatigued and want to sleep a lot. My thyroid levels also tested the lowest in nearly 20 years. My Benlysta injections make me sicker when I take them so I cannot use them anymore.

MedDRA releases: 2024-11 · check-in free text available
2022-02-26
Report sent to call center — 6 months, dose 3
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-03-02
Call 1 — Left Voicemail
2022-08-28
Survey response — 12 months, dose 3
MedDRA: COVID-19 — Feeling: Fair · Be unable to work or attend school, 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: Positive for COVID-19 in July. Significantly impacted. Required Paxlovid for symptoms. Am still not recovered 100 %.

MedDRA releases: 2024-11 · check-in free text available
2022-08-28
Report sent to call center — 12 months, dose 3
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-08-29
Call 2 — Left Voicemail
2022-08-29
Call 1 — Left Voicemail
2022-08-29
Call 2 — Left Voicemail
2022-08-29
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-30	Moderna
2	2021-04-27	Moderna
3	2021-08-28	Moderna	No

Call center

4 call center cases

4 unsuccessful

See the call center timeline

Free text

Release 6 — days 1–6 daily, dose 1

2021-03-31

Systemic reaction (other): Malaise

2021-04-01

Systemic reaction (other): Coughing and congestion

2021-04-02

Systemic reaction (other): Right eye noticeably twitching since vaccine administration.

2021-04-03

Systemic reaction (other): Twitching right eye, severe fatigue,

2021-04-04

Systemic reaction (other): Right eye twitching since Tuesdays vaccine

2021-04-05

Systemic reaction (other): Twitching in the right eye, neck pain, runny nose

Release 7 — day 14, dose 1

2021-04-13

Symptoms: I feel like I have the flu.

Release 8 — days 1–6 daily, dose 2

2021-04-28

Systemic reaction (other): Swelling at the injections site.

2021-04-29

Systemic reaction (other): Light headed

2021-04-30

Systemic reaction (other): Dizziness. Weakness

Release 9 — 3 months, dose 2

2021-07-27

Symptoms: Lymphadenopathy, HA, nausea, ST, myalgias, chills

Release 10 — 3 months, dose 3

2021-11-27

Symptoms: Fever, coughing, congestion, fatigue, lethargy, nausea, diarrhea, sore throat

Release 11 — 6 months, dose 3

2022-02-26

Symptoms: In January I tested positive for COVID-19. I have since been very fatigued and want to sleep a lot. My thyroid levels also tested the lowest in nearly 20 years. My Benlysta injections make me sicker when I take them so I cannot use them anymore.

Release 12 — 12 months, dose 3

2022-08-28

Symptoms: Positive for COVID-19 in July. Significantly impacted. Required Paxlovid for symptoms. Am still not recovered 100 %.

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	Adverse drug reaction	·	·	✓
SD	Blood thyroid stimulating hormone decreased	·	·	✓
SD	Chills	✓	·	✓
SD	Cough	·	·	✓
SD	COVID-19	·	·	✓
SD	Diarrhoea	·	·	✓
SD	Fatigue	·	·	✓
SD	Headache	✓	·	✓
SD	Hypersomnia	·	·	✓
SD	Influenza	✓	✓	✓
SD	Lethargy	·	·	✓
SD	Lymphadenopathy	✓	·	✓
SD	Malaise	·	·	✓
SD	Myalgia	✓	·	✓
SD	Nausea	✓	·	✓
SD	Oropharyngeal pain	✓	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	SARS-CoV-2 test positive	·	·	✓
SRO	Asthenia	✓	✓	✓
SRO	Blepharospasm	✓	✓	✓
SRO	Cough	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Injection site swelling	✓	✓	✓
SRO	Malaise	✓	✓	✓
SRO	Muscle twitching	✓	✓	✓
SRO	Neck pain	✓	✓	✓
SRO	Respiratory tract congestion	✓	✓	✓
SRO	Rhinorrhoea	✓	✓	✓

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