PGL-14724-46159

5 vaccinations 13 coded responses 31 check-ins 12 free-text entries 5 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 787 / TX
Registered: 2021-01-27

Relationship: Self
Race: White
Ethnicity: Hispanic or Latino

Timeline

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

2021-01-27
Registered in v-safe
2021-01-27
Dose 1 — Moderna
2021-01-27
Health check-in — 0 day, dose 1
Feeling: Good · None

Adult check-in
2021-01-28
Survey response — days 1–6 daily, dose 1
MedDRA: Gait disturbance — Feeling: Good · Site: Pain, Swelling

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-29
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Muscle or body aches

Adult check-in
2021-01-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-31
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Muscle or body aches

Adult check-in
2021-02-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-02-02
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-02-03
Health check-in — 7 day, dose 1
Feeling: Fair · None

Adult check-in
2021-02-10
Survey response — 14 day, dose 1
MedDRA: Arthralgia, Breast pain, Chest pain, Hypoaesthesia, Pain in extremity — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-17
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-02-22
Dose 2 — Moderna
2021-02-23
Survey response — days 1–6 daily, dose 2
MedDRA: Headache — Feeling: Fair · Site: Redness, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-24
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Swelling · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-02-25
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-02-26
Survey response — days 1–6 daily, dose 2
MedDRA: Postmenopausal haemorrhage — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-27
Survey response — days 1–6 daily, dose 2
MedDRA: Vaginal discharge — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-28
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Joint pains, Muscle or body aches

Adult check-in
2021-03-01
Health check-in — 7 day, dose 2
Feeling: Fair · Fever · Joint pains, Muscle or body aches

Adult check-in
2021-03-08
Survey response — 14 day, dose 2
MedDRA: Hot flush, Insomnia, Menstruation irregular — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-15
Health check-in — 21 day, dose 2
Feeling: Fair

Adult check-in
2021-03-22
Health check-in — 28 day, dose 2
Feeling: Fair

Adult check-in
2021-03-31
Survey response — 35 day, dose 2
MedDRA: Postmenopausal haemorrhage — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-31
Report sent to call center — 35 day, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-05
Health check-in — 42 day, dose 2
Feeling: Fair

Adult check-in
2021-05-24
Survey response — 3 month, dose 2
MedDRA: Unevaluable event — Feeling: Good · 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: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-24
Report sent to call center — 3 month, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-23
Survey response — 6 month, dose 2
MedDRA: Arrhythmia, Dizziness, Heart rate decreased, Presyncope — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

MedDRA releases: 2021-09,2024-11 · check-in answers available
2021-08-23
Report sent to call center — 6 month, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-25
Call 1 — Left Voicemail
2021-11-03
Dose 3 — Moderna
2022-02-22
Survey response — 12 month, dose 2
MedDRA: Cardiac arrest, Cardiac pacemaker insertion, Concussion, Dizziness, Fall — 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 · Emergency room or emergency department visit, Hospitalization

MedDRA releases: 2024-11 · check-in answers available
2022-02-22
Report sent to call center — 12 month, dose 2
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)
2022-02-23
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2022-04-14
Dose 4 — Moderna
2022-09-17
Dose 5 — Pfizer-BioNTech
Co-administered: Flu
2022-10-09
Health check-in — 21 day, dose 5
Feeling: Good

Adult check-in
2022-10-15
Health check-in — 28 day, dose 5
Feeling: Fair

Adult check-in
2022-10-22
Survey response — 35 day, dose 5
MedDRA: Arthralgia, Ligament pain, Pelvic pain, Spinal fusion surgery — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-10-29
Survey response — 42 day, dose 5
MedDRA: Flank pain, Pelvic pain, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-12-17
Health check-in — 3 month, dose 5
Feeling: Good

Adult check-in
2023-03-20
Survey response — 6 month, dose 5
MedDRA: Breast calcifications, Breast cyst, Mammogram abnormal, Ultrasound scan abnormal — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2023-03-20
Report sent to call center — 6 month, dose 5
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2023-03-21
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	2021-01-27	Moderna
2	2021-02-22	Moderna
3	2021-11-03	Moderna	No
4	2022-04-14	Moderna	No
5	2022-09-17	Pfizer-BioNTech	Flu

Call center

Reported	Outcome	VAERS-related outcome
2021-03-31	Successful	Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-05-24	Successful	Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-08-23	Successful	Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2022-02-22	Successful 2022-02-23	Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2023-03-20	Successful 2023-03-21	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Free text

Release 3

Systemic reaction (other): Left leg feels very heavy and drags

Release 4

Symptoms: My legs and pelvic floor get numb if I sit too long but I had this problem before but it is a little worse. My left arm from my breast bone to my wrist are achy.

Systemic reaction (other): Headache base of my neck and behind my eyes

Systemic reaction (other): I'm menopausal, but today is second day of light breakthrough bleeding.

Systemic reaction (other): New Brown vaginal discharge.

Release 5

Symptoms: I have had break-through menstrual bleeding on and off. Pretty light but I am 7 years post menopausal. Also hot flashes and insomnia.

Release 6

Symptoms: I have been having continuous post menopausal bleeding since mid March.

Release 8

Symptoms: 10 mm Hyperplasia of my uterine lining from ultrasound but benign findings from endometrial biopsy. No neoplasms. Scheduling D&C next.

Release 9

Symptoms: Arrhythmia, near syncope, dizzyness, low heart rate

Release 11

Symptoms: Dizzyness for 10 which led to a fall and concussion. Astystole discovered and had pacemaker put in. No stroke or heart attack.

Release 12

Symptoms: More joint and pelvic ligament pain due to fusions in spine.

Symptoms: Pelvic and flank pain due to an underlying pre-existing condition.

Free-text releases are not linked to a specific 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	Arrhythmia	✓	·	✓
SD	Arthralgia	✓	✓	✓
SD	Breast calcifications	·	·	✓
SD	Breast cyst	·	·	✓
SD	Breast pain	✓	✓	○
SD	Cardiac arrest	·	·	✓
SD	Cardiac pacemaker insertion	·	·	✓
SD	Chest pain	·	·	✓
SD	Concussion	·	·	✓
SD	Dizziness	✓	·	✓
SD	Fall	·	·	✓
SD	Flank pain	·	·	✓
SD	Heart rate decreased	✓	·	✓
SD	Hot flush	✓	✓	✓
SD	Hypoaesthesia	✓	✓	✓
SD	Insomnia	✓	✓	✓
SD	Ligament pain	·	·	✓
SD	Mammogram abnormal	·	·	✓
SD	Menstruation irregular	✓	✓	✓
SD	Pain in extremity	✓	✓	✓
SD	Pelvic pain	·	·	✓
SD	Postmenopausal haemorrhage	✓	✓	✓
SD	Pre-existing disease	·	·	✓
SD	Presyncope	✓	·	✓
SD	Spinal fusion surgery	·	·	✓
SD	Ultrasound scan abnormal	·	·	✓
SD	Unevaluable event	✓	✓	✓
SRO	Gait disturbance	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Postmenopausal haemorrhage	✓	✓	✓
SRO	Vaginal discharge	✓	✓	✓

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