5GE-18013-30030

4 vaccinations 23 coded responses 42 check-ins 22 free-text entries 6 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 078 / NJ
Registered: 2021-01-08

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

2021-01-08
Registered in v-safe
2021-01-08
Dose 1 — Moderna
2021-01-08
Survey response — day 0, dose 1
MedDRA: Eye pruritus — Feeling: Good · Site: Pain

Free text: Itchy eyes, like with hay fever. No idea if there is any connection. I did take Claritin before getting the shot.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-01-10
Survey response — days 1–6 daily, dose 1
MedDRA: Lymphadenopathy, Oropharyngeal pain — Feeling: Fair · Site: Pain, Swelling · Headache, Fatigue or tiredness, Nausea

Free text: Sore throat/swollen glands

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-11
Survey response — days 1–6 daily, dose 1
MedDRA: Cough, Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea — Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Slight cough, congestion/runny nose, sore throat, swollen glands -- feel as though i have a cold

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-12
Survey response — days 1–6 daily, dose 1
MedDRA: Abdominal discomfort, Diarrhoea, Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Respiratory tract congestion — Feeling: Fair · Site: Pain · Headache

Free text: Arm pain is very mild. Congestion, sore throat, swollen glands continue. Not diarrhea, but loose stool/abdominal discomfort in morning..

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-13
Survey response — days 1–6 daily, dose 1
MedDRA: Lymphadenopathy, Migraine, Oropharyngeal pain, Respiratory tract congestion — Feeling: Good · Site: Pain · Headache

Free text: Swollen glands, congestion, sore throat, but less than day before; headache intermittent but was migrainelike and required medicine last night.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-14
Survey response — days 1–6 daily, dose 1
MedDRA: Lymphadenopathy, Oropharyngeal pain, Respiratory tract congestion — Feeling: Good · Headache

Free text: Sore throat, swollen glands. Less congestion.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-15
Survey response — day 7, dose 1
MedDRA: Lymphadenopathy, Oropharyngeal pain, Respiratory tract congestion — Feeling: Good · Headache

Free text: Decreased sore throat and swollen glands and congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-22
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-29
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-05
Dose 2 — Moderna
2021-02-05
Survey response — day 0, dose 2
MedDRA: Nasal congestion — Feeling: Good · Site: Pain · Headache

Free text: A little extra nasal congestion

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: Dizziness, Insomnia, Pyrexia, Respiratory tract congestion — Feeling: Poor · Site: Pain, Swelling · Fever · Headache, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities

Free text: Insomnia with fever overnight, slept most of day since. Congestion with dizziness.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-07
Survey response — days 1–6 daily, dose 2
MedDRA: Asthenia — Feeling: Fair · Site: Pain, Swelling · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Weakness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · Headache

Adult check-in
2021-02-09
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Itching · Nausea

Adult check-in
2021-02-10
Survey response — days 1–6 daily, dose 2
MedDRA: Abdominal discomfort — Feeling: Good · Site: Pain

Free text: GI not normal but not actual diarrhea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-11
Survey response — days 1–6 daily, dose 2
MedDRA: Dyspnoea exertional — Feeling: Good

Free text: Shortness of breath on exertion.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-12
Survey response — day 7, dose 2
MedDRA: Dyspnoea — Feeling: Good

Free text: Shortness of breath on exertion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-19
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-26
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-05
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-12
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-19
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-07
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-08-06
Survey response — 6 months, dose 2
MedDRA: Abdominal discomfort, Fatigue, Respiratory symptom, SARS-CoV-2 test negative — Feeling: Fair

Free text: Some GI upset over last couple of months. Current tiredness and mild respiratory symptoms, i assume a mild bug. (Had negative COVID test. I now have weekly tests because of work requirements.)

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-11-10
Dose 3 — Moderna
2022-02-05
Survey response — 12 months, dose 2
MedDRA: Fatigue, Pyrexia, SARS-CoV-2 test negative — Feeling: Good · Be unable to do your normal daily activities

Free text: I had low fever and tiredness several weeks ago. Similar to how I felt after 2nd shot. Routine COVID tests at work that morning and following week were negative.

MedDRA releases: 2024-11 · check-in free text available
2022-05-13
Dose 4 — Moderna
2022-05-13
Health check-in — day 0, dose 4
Feeling: Good · Site: Pain · None

Adult check-in
2022-05-14
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain, Swelling · Fever · Headache, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2022-05-15
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Pain · None

Adult check-in
2022-05-16
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Pain · None

Adult check-in
2022-05-17
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-05-18
Survey response — days 1–6 daily, dose 4
MedDRA: Abdominal pain — Feeling: Fair · Abdominal pain

Free text: Abdominal pain likely related to non-COVID or vaccine issue

MedDRA releases: 2024-11 · check-in free text available
2022-05-19
Survey response — days 1–6 daily, dose 4
MedDRA: Diverticulitis, Medical counselling, Office visit — Feeling: Fair · Abdominal pain · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Being treated for diverticulitis, seemingly unrelated to vaccine · Healthcare visit (other): Testing and doctor visit May 18, phone followup May 19

MedDRA releases: 2024-11 · check-in free text available
2022-05-19
Report sent to call center — days 1–6 daily, dose 4
Get care from a doctor or other healthcare professional

1 call case(s)
2022-05-20
Survey response — day 7, dose 4
MedDRA: Abdominal pain, Diverticulitis — Feeling: Fair · Abdominal pain

Free text: Abdominal pain is from diverticulitis diagnosed this week but almost certainly not related to vaccine

MedDRA releases: 2024-11 · check-in free text available
2022-05-20
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-05-27
Survey response — day 14, dose 4
MedDRA: Clostridium difficile infection, Diverticulitis, Hospitalisation — 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 · Emergency room or emergency department visit, Hospitalization

Free text: I am in the hospital for IV antibiotics for diverticulitis and being treated for c diff.

MedDRA releases: 2024-11 · check-in free text available
2022-05-27
Report sent to call center — day 14, dose 4
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2022-05-31
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-03
Survey response — day 21, dose 4
MedDRA: Clostridium difficile infection, Diverticulum, Drug hypersensitivity, Fungal infection, Hospitalisation — 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: I was in hospital for diverticulosis. Developed c diff, had allergic reaction to antibiotic, got yeast infection. Seems coincidental, not related to vaccine.

MedDRA releases: 2024-11 · check-in free text available
2022-06-03
Report sent to call center — day 21, dose 4
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)
2022-06-07
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-06-10
Health check-in — day 28, dose 4
Feeling: Fair

Adult check-in
2022-06-17
Survey response — day 35, dose 4
MedDRA: Clostridium difficile infection — 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 · Outpatient clinic or urgent care clinic visit

Free text: Recurrence of c diff

MedDRA releases: 2024-11 · check-in free text available
2022-06-17
Report sent to call center — day 35, dose 4
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)
2022-06-21
Call 1 — Left Voicemail
2022-06-24
Health check-in — day 42, dose 4
Feeling: Fair

Adult check-in
2022-08-12
Survey response — 3 months, dose 4
MedDRA: Fatigue, Oropharyngeal pain, Pre-existing disease, Respiratory tract congestion, Retinal detachment, SARS-CoV-2 test positive — Feeling: Good · 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, Outpatient clinic or urgent care clinic visit

Free text: Positive covid test. Congestion, sore throat, tiredness. Unrelated to covud: recurrent c diff and partially detatched retina.

MedDRA releases: 2024-11 · check-in free text available
2022-08-12
Report sent to call center — 3 months, dose 4
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 · Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-08-15
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-08-15
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-11-11
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in
2023-05-13
Survey response — 12 months, dose 4
MedDRA: Asthma, Cough, Pre-existing disease, Pyrexia, Respiratory tract congestion, Respiratory tract infection viral, Wheezing — Feeling: Good · 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

MedDRA releases: 2024-11
2023-05-13
Report sent to call center — 12 months, dose 4
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)
2023-05-15
Call 1 — Requested Callback
2023-05-18
Callback requested for
10:00AM ET
2023-05-18
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-08	Moderna
2	2021-02-05	Moderna
3	2021-11-10	Moderna	No
4	2022-05-13	Moderna	No

Call center

6 call center cases

6 successful

See the call center timeline

Free text

Release 1 — day 0, dose 1

2021-01-08

Systemic reaction (other): Itchy eyes, like with hay fever. No idea if there is any connection. I did take Claritin before getting the shot.

Release 1 — days 1–6 daily, dose 1

2021-01-10

Systemic reaction (other): Sore throat/swollen glands

2021-01-11

Systemic reaction (other): Slight cough, congestion/runny nose, sore throat, swollen glands -- feel as though i have a cold

2021-01-12

Systemic reaction (other): Arm pain is very mild. Congestion, sore throat, swollen glands continue. Not diarrhea, but loose stool/abdominal discomfort in morning..

2021-01-13

Systemic reaction (other): Swollen glands, congestion, sore throat, but less than day before; headache intermittent but was migrainelike and required medicine last night.

2021-01-14

Systemic reaction (other): Sore throat, swollen glands. Less congestion.

Release 2 — day 7, dose 1

2021-01-15

Systemic reaction (other): Decreased sore throat and swollen glands and congestion

Release 3 — day 0, dose 2

2021-02-05

Systemic reaction (other): A little extra nasal congestion

Release 3 — days 1–6 daily, dose 2

2021-02-06

Systemic reaction (other): Insomnia with fever overnight, slept most of day since. Congestion with dizziness.

2021-02-07

Systemic reaction (other): Weakness

2021-02-10

Systemic reaction (other): GI not normal but not actual diarrhea

Release 4 — days 1–6 daily, dose 2

2021-02-11

Systemic reaction (other): Shortness of breath on exertion.

Release 4 — day 7, dose 2

2021-02-12

Systemic reaction (other): Shortness of breath on exertion

Release 9 — 6 months, dose 2

2021-08-06

Symptoms: Some GI upset over last couple of months. Current tiredness and mild respiratory symptoms, i assume a mild bug. (Had negative COVID test. I now have weekly tests because of work requirements.)

Release 11 — 12 months, dose 2

2022-02-05

Symptoms: I had low fever and tiredness several weeks ago. Similar to how I felt after 2nd shot. Routine COVID tests at work that morning and following week were negative.

Release 11 — days 1–6 daily, dose 4

2022-05-18

Systemic reaction (other): Abdominal pain likely related to non-COVID or vaccine issue

2022-05-19

Systemic reaction (other): Being treated for diverticulitis, seemingly unrelated to vaccine

Healthcare visit (other): Testing and doctor visit May 18, phone followup May 19

Release 11 — day 7, dose 4

2022-05-20

Systemic reaction (other): Abdominal pain is from diverticulitis diagnosed this week but almost certainly not related to vaccine

Release 11 — day 14, dose 4

2022-05-27

Symptoms: I am in the hospital for IV antibiotics for diverticulitis and being treated for c diff.

Release 11 — day 21, dose 4

2022-06-03

Symptoms: I was in hospital for diverticulosis. Developed c diff, had allergic reaction to antibiotic, got yeast infection. Seems coincidental, not related to vaccine.

Release 12 — day 35, dose 4

2022-06-17

Symptoms: Recurrence of c diff

Release 12 — 3 months, dose 4

2022-08-12

Symptoms: Positive covid test. Congestion, sore throat, tiredness. Unrelated to covud: recurrent c diff and partially detatched retina.

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	Medical counselling	·	·	✓
HCVO	Office visit	·	·	✓
SD	Abdominal discomfort	✓	·	✓
SD	Adverse drug reaction	·	·	○
SD	Asthma	·	·	✓
SD	Clostridium difficile infection	·	·	✓
SD	Cough	·	·	✓
SD	Diverticulitis	·	·	✓
SD	Diverticulum	·	·	✓
SD	Drug hypersensitivity	·	·	✓
SD	Fatigue	✓	·	✓
SD	Fungal infection	·	·	✓
SD	Hospitalisation	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory symptom	✓	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Respiratory tract infection viral	·	·	✓
SD	Retinal detachment	·	·	✓
SD	SARS-CoV-2 test negative	✓	·	✓
SD	SARS-CoV-2 test positive	·	·	✓
SD	Wheezing	·	·	✓
SRO	Abdominal discomfort	✓	✓	✓
SRO	Abdominal pain	·	·	✓
SRO	Asthenia	✓	✓	✓
SRO	Axillary pain	○	○	○
SRO	Cough	✓	✓	✓
SRO	Diarrhoea	✓	✓	✓
SRO	Diverticulitis	·	·	✓
SRO	Dizziness	✓	✓	✓
SRO	Dyspnoea	✓	✓	✓
SRO	Dyspnoea exertional	✓	✓	✓
SRO	Eye pruritus	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Lymphadenopathy	✓	✓	✓
SRO	Migraine	✓	✓	✓
SRO	Nasal congestion	✓	✓	✓
SRO	Nasopharyngitis	✓	✓	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Pyrexia	✓	✓	✓
SRO	Respiratory tract congestion	✓	✓	✓
SRO	Rhinorrhoea	✓	✓	✓

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