MD4-11037-90326

3 vaccinations 21 coded responses 37 check-ins 21 free-text entries 0 call cases

Sex: Female
Age at first dose: 46-50
ZIP prefix: 190 / PA
Registered: 2021-02-07

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

2021-02-06
Dose 1 — Pfizer-BioNTech
2021-02-07
Registered in v-safe
2021-02-07
Survey response — days 1–6 daily, dose 1
MedDRA: Pre-existing disease — Feeling: Fair · Site: Pain, Itching · Fever · Chills, Headache, Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-08
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Chills, Fatigue or tiredness

Adult check-in
2021-02-09
Survey response — days 1–6 daily, dose 1
MedDRA: Exposure to SARS-CoV-2 — Feeling: Good · Headache, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-10
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Good · Headache, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-02-12
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-02-13
Health check-in — 7 day, dose 1
Feeling: Good · None

Adult check-in
2021-02-20
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-02-27
Dose 2 — Pfizer-BioNTech
2021-02-27
Health check-in — 0 day, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-02-28
Survey response — days 1–6 daily, dose 2
MedDRA: Musculoskeletal stiffness, Pre-existing disease, Self-medication — Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Headache, 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
2021-03-01
Survey response — days 1–6 daily, dose 2
MedDRA: Chills, Hot flush, Musculoskeletal stiffness, Self-medication — Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Headache, Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-02
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Itching · Fever · Chills, Fatigue or tiredness

Adult check-in
2021-03-03
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site bruising, Injection site pain, Injection site pruritus — Feeling: Good · Site: Pain, Itching · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-04
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site pain, Injection site pruritus — Feeling: Good · Site: Pain · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-05
Survey response — days 1–6 daily, dose 2
MedDRA: Fatigue, Injection site pain — Feeling: Good · Site: Pain · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-06
Survey response — 7 day, dose 2
MedDRA: Fatigue — Feeling: Good · Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-13
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-03-20
Survey response — 21 day, dose 2
MedDRA: Deep vein thrombosis, Pre-existing disease, Thrombosis — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-27
Health check-in — 28 day, dose 2
Feeling: Good

Adult check-in
2021-04-03
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-04-10
Survey response — 42 day, dose 2
MedDRA: Condition aggravated, Pre-existing disease, Thrombosis — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-29
Health check-in — 3 month, dose 2
Feeling: Good

Adult check-in
2021-08-28
Survey response — 6 month, dose 2
MedDRA: Cough, Respiratory tract congestion, Sneezing — Feeling: Good

MedDRA releases: 2021-09,2024-11 · check-in answers available
2021-10-29
Dose 3 — Pfizer-BioNTech
2021-10-29
Survey response — 0 day, dose 3
MedDRA: Condition aggravated, Feeling hot, Pre-existing disease, Thrombosis — Feeling: Good · Site: Pain · Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-10-30
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-10-31
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-11-01
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain · Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-11-02
Survey response — days 1–6 daily, dose 3
MedDRA: Diarrhoea, Dizziness, Hyperhidrosis — Feeling: Fair · Fever · Chills, Headache, Fatigue or tiredness, Nausea, Diarrhea · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-03
Survey response — days 1–6 daily, dose 3
MedDRA: Injection site pain, Pain, Pain in extremity — Feeling: Good · Site: Pain · Fatigue or tiredness

MedDRA releases: 2024-11 · check-in answers available
2021-11-05
Health check-in — 7 day, dose 3
Feeling: Good · Fatigue or tiredness, Diarrhea

Adult check-in
2021-11-12
Survey response — 14 day, dose 3
MedDRA: Heavy menstrual bleeding, Menstruation irregular, Office visit, Pre-existing disease, Thrombosis — Feeling: Good

MedDRA releases: 2024-11 · check-in answers available
2021-11-19
Survey response — 21 day, dose 3
MedDRA: Condition aggravated, Heavy menstrual bleeding, Menstrual clots, Menstruation delayed, Pre-existing disease, Ultrasound scan abnormal — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-26
Survey response — 28 day, dose 3
MedDRA: Cyst, Cyst rupture, Heavy menstrual bleeding, Ultrasound scan abnormal — Feeling: Good · Be unable to work or attend school

MedDRA releases: 2024-11 · check-in answers available
2021-12-03
Survey response — 35 day, dose 3
MedDRA: Cough, Fatigue, Nasopharyngitis, Rhinorrhoea — Feeling: Good

MedDRA releases: 2024-11 · check-in answers available
2021-12-10
Health check-in — 42 day, dose 3
Feeling: Good

Adult check-in
2022-01-28
Survey response — 3 month, dose 3
MedDRA: Cough, Fatigue, Headache, Productive cough, Respiratory tract congestion, Sneezing, Throat irritation — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-04-30
Survey response — 6 month, dose 3
MedDRA: Cough, Fatigue, Nasal congestion, Productive cough, Respiratory tract congestion, Sneezing — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-06	Pfizer-BioNTech
2	2021-02-27	Pfizer-BioNTech
3	2021-10-29	Pfizer-BioNTech	No

Free text

Release 3

Systemic reaction (other): I have Factor V Leiden Mutation/genetic/father side only/ diagnosed Aug 2020

Systemic reaction (other): May have indirect exposure on 2/8/21, bosss kid tested pos 2/8/21

Release 4

Systemic reaction (other): My boss received neg test result today

Systemic reaction (other): on Xarelto, normal temp for me is 97.2F; today stiff neck thru shoulder blades, Tylenol helps alleviate

Systemic reaction (other): Wax/wane chills hot flashes, mild stiffness neck-upper back, Tylenol helps

Release 5

Systemic reaction (other): Injection site past 2 days including today, feels like I was knuckle punched on top of a mosquito bite, specific site is tender and itchy

Systemic reaction (other): The itching I experienced at injection site now gone, mildest tenderness at site, and only when touched, not nearly as noticeable as earlier in week

Systemic reaction (other): Very mild tenderness at injection site, improves each day. Fatigue improves a little bit each day too

Systemic reaction (other): No itchiness or soreness at injection site at all today; still fatigued but continues to improve, not nearly as fatigued as I was when I first got 2nd shot

Release 6

Symptoms: I have Factor V Leiden mutation (blood disorder), confirmed fathers side. DVT initial diagnosis 4/25/20. I had stat US same leg that had DVT on 3/18/21 and I have new blot clot (superficial, lower left leg). Was taking 10mg Xarelto, now taking 20mg cut off by CDC

Release 7

Symptoms: Recent blood clot left leg, Dx. 3/18/2021, f/u appt 4/26/2021; I have Factor V Leiden Mutation, recent clot same leg as initial DVT diagnosis 4/25/2020.

Release 9

Symptoms: Mild congestion and sneezing, occasional dry cough

Release 10

Systemic reaction (other): Feel a little warm, no fever; I have (b)(6), 2nd dose provoked clot, left calf, was only on 10mg Xarelto at time. Today, I am on (and have been on) 20 mg Xarelto since March 2021

redacted (b)(6)

Systemic reaction (other): Sweaty/mild dizzy this AM, loose bowels/nauseous 4-6hrs, better this afternoon

Systemic reaction (other): Arm no longer hurts to move, but inject site still tender

Symptoms: Perimenopausal, LMP 4/21, about 2 months after 2nd vaccination. Menstrual cycle started again 11/9/21, heavy. I have Factor V Leiden Mutation, blood disorder. Currently 20mg Xarelto, clot in left calf provoked by 2nd dose vaccine per hematologist.

Symptoms: Heavier than normal menstrual bleeding since 11/12/21, LMP 5/18/21, passed 2 major clots 11/17/21, bleeding today minimal. Ultrasound today revealed 2cm cyst left ovary. Prior D&C 2/2020 for same reason.

Symptoms: Heavy menstrual bleeding due to simple cyst, assume one broke, and one remains, confirmed via ultrasound.

Symptoms: Feel like I have a cold, runny nose, mild cough, fatigued

Release 11

Symptoms: Jan7-9, 2022 moderate headaches, Jan 10-13, 2022 moderate headaches, scratchy throat, moderate congestion, sneezing, dry coughing & extreme fatigue through Jan 15, 2022. Jan 16-28, 2022, still cough, sometimes productive and moderate head congestion. cut off by CDC

Symptoms: Fatigue, Sneezing, dry and productive cough, lots of nasal and head congestion especially during last 30 days

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	Condition aggravated	✓	✓	✓
SD	Cough	✓	·	✓
SD	Cyst	·	·	✓
SD	Cyst rupture	·	·	✓
SD	Deep vein thrombosis	✓	✓	✓
SD	Fatigue	·	·	✓
SD	Headache	·	·	✓
SD	Heavy menstrual bleeding	·	·	✓
SD	Menstrual clots	·	·	✓
SD	Menstruation delayed	·	·	✓
SD	Menstruation irregular	·	·	✓
SD	Nasal congestion	·	·	✓
SD	Nasopharyngitis	·	·	✓
SD	Office visit	·	·	✓
SD	Pre-existing disease	✓	✓	✓
SD	Productive cough	·	·	✓
SD	Respiratory tract congestion	✓	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Sneezing	✓	·	✓
SD	Throat irritation	·	·	✓
SD	Thrombosis	✓	✓	✓
SD	Ultrasound scan abnormal	·	·	✓
SRO	Chills	✓	✓	✓
SRO	Condition aggravated	·	·	✓
SRO	Diarrhoea	·	·	✓
SRO	Dizziness	·	·	✓
SRO	Exposure to SARS-CoV-2	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Feeling hot	·	·	✓
SRO	Hot flush	✓	✓	✓
SRO	Hyperhidrosis	·	·	✓
SRO	Injection site bruising	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Injection site pruritus	✓	✓	✓
SRO	Musculoskeletal stiffness	✓	✓	✓
SRO	Pain	·	·	✓
SRO	Pain in extremity	·	·	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Thrombosis	·	·	✓
SRO	Unevaluable event	✓	✓	✓

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