45Z-27087-72315

5 vaccinations 14 coded responses 64 check-ins 14 free-text entries 6 call cases

Sex: Female
Age at first dose: 61-65
ZIP prefix: 925 / CA
Registered: 2021-03-04

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

Registered dependents

RCN-42068-30038 Other · Male · 2021-08-24

Timeline

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

2021-03-02
Dose 1 — Pfizer-BioNTech
2021-03-04
Registered in v-safe
2021-03-04
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness, Nausea

Adult check-in
2021-03-05
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-03-06
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Nausea

Adult check-in
2021-03-07
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-03-08
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-09
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-03-16
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-23
Survey response — day 21, dose 1
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Fair · Be unable to do your normal daily activities

Free text: I have MCTD, my symptoms are in line with a general flare of my autoimmune disease.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-24
Dose 2 — Pfizer-BioNTech
2021-03-24
Survey response — day 0, dose 2
MedDRA: Nasal congestion, Throat irritation — Feeling: Poor · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Free text: Throat irritation, stuffy nose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-25
Survey response — days 1–6 daily, dose 2
MedDRA: Musculoskeletal stiffness, Throat irritation — Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Stiff neck and throat irritation.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-26
Survey response — days 1–6 daily, dose 2
MedDRA: Musculoskeletal stiffness, Pharyngeal swelling — Feeling: Fair · Site: Pain, Redness, Itching · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Free text: Stiff neck, sensation of swelling in my throat - but not severe.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-27
Survey response — days 1–6 daily, dose 2
MedDRA: Musculoskeletal stiffness — Feeling: Good · Site: Pain, Redness, Itching · Muscle or body aches, Fatigue or tiredness

Free text: Stiff neck

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-28
Survey response — days 1–6 daily, dose 2
MedDRA: Musculoskeletal stiffness — Feeling: Good · Site: Pain, Redness, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Stiff neck

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-29
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-03-30
Survey response — days 1–6 daily, dose 2
MedDRA: Pre-existing disease — Feeling: Poor · Site: Pain, Redness, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain

Free text: I have autoimmune disease, so the symptoms may not be related to getting the vaccine.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-31
Health check-in — day 7, dose 2
Feeling: Fair · Site: Pain, Redness, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-04-07
Survey response — day 14, dose 2
MedDRA: Balance disorder, Coordination abnormal, Dry eye, Dysaesthesia, Dyspnoea, Muscular weakness, Paraesthesia, Pre-existing disease, Vision blurred — Feeling: Good

Free text: I have MCTD and Im having various symptoms related to that. SOB, muscle weakness, paresthesia. dyesthesia, balance and coordination problems, blurry vision/dry eyes.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-14
Survey response — day 21, dose 2
MedDRA: Condition aggravated, Dysaesthesia, Dyspepsia, Insomnia, Muscle spasms, Office visit, Paraesthesia, Pre-existing disease, Respiration abnormal, Vision blurred — Feeling: Poor · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: I have NCTD and am experiencing a flare that includes problems with breathing, digestion, paresthesia, dyesthesia, insomnia, muscle spans and blurry vision. · Healthcare visit (other): In person appointment and diagnostic tests (chest x-ray, pulmonary function test, and sleep study have been scheduled.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-14
Report sent to call center — day 21, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-21
Survey response — day 28, dose 2
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: I continue to have an exacerbation of breathing difficulties and insomnia. May be related to lung disease secondary to MCTD.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-21
Report sent to call center — day 28, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-28
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-05-05
Survey response — day 42, dose 2
MedDRA: Condition aggravated, Pre-existing disease, Respiratory disorder — 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

Free text: Increased breathing problems related to ACOS (I have MCTD)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-05
Report sent to call center — day 42, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-23
Survey response — 3 months, dose 2
MedDRA: Condition aggravated, Pre-existing disease — 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, Outpatient clinic or urgent care clinic visit

Free text: Exacerbation from my MCTD.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-23
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)
2021-06-26
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2021-06-28
Call 1 — Left Voicemail
2021-06-29
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2021-06-29
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2021-06-29
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-08-24
Dose 3 — Pfizer-BioNTech
2021-08-24
Health check-in — day 0, dose 3
Feeling: Good · Site: Pain · Headache

Adult check-in
2021-08-25
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain, Redness · Headache

Adult check-in
2021-08-26
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Headache

Adult check-in
2021-08-27
Health check-in — days 1–6 daily, dose 3
Feeling: Good · None

Adult check-in
2021-08-28
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Itching · None

Adult check-in
2021-08-29
Health check-in — days 1–6 daily, dose 3
Feeling: Good · None

Adult check-in
2021-08-30
Health check-in — days 1–6 daily, dose 3
Feeling: Good · None

Adult check-in
2021-08-31
Health check-in — day 7, dose 3
Feeling: Good · None

Adult check-in
2021-09-07
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2021-09-14
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2021-09-21
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2021-09-28
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-10-05
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-11-23
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-02-22
Survey response — 6 months, dose 3
MedDRA: Myositis, Neuritis, Pre-existing disease, Secretion discharge — 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, Outpatient clinic or urgent care clinic visit

Free text: Massive amounts of mucus production in my airway, and inflammation of muscles and nerves. But I have Mixed Connective Tissue Disease, so it probably all related to that.

MedDRA releases: 2024-11 · check-in free text available
2022-02-22
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 · Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-02-23
Call 1 — Left Voicemail
2022-03-28
Dose 4 — Pfizer-BioNTech
2022-03-30
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain, Redness · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2022-03-31
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain, Redness, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2022-04-01
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2022-04-02
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Redness, Swelling, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2022-04-03
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Swelling, Itching · Headache

Adult check-in
2022-04-04
Health check-in — day 7, dose 4
Feeling: Good · Site: Itching · Headache

Adult check-in
2022-04-11
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-04-18
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-04-25
Health check-in — day 28, dose 4
Feeling: Fair

Adult check-in
2022-05-02
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-05-09
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-06-27
Health check-in — 3 months, dose 4
Feeling: Fair

Adult check-in
2022-09-26
Survey response — 6 months, dose 4
MedDRA: COVID-19 — 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: COVID August 2022

MedDRA releases: 2024-11 · check-in free text available
2022-09-26
Report sent to call center — 6 months, dose 4
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)
2022-09-28
Call 2 — Left Voicemail
2022-09-28
Call 1 — Left Voicemail
2023-01-20
Dose 5 — Pfizer-BioNTech
2023-01-20
Health check-in — day 0, dose 5
Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2023-01-21
Health check-in — days 1–6 daily, dose 5
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2023-01-22
Health check-in — days 1–6 daily, dose 5
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2023-01-23
Health check-in — days 1–6 daily, dose 5
Feeling: Fair · Site: Pain, Redness, Swelling, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2023-01-24
Health check-in — days 1–6 daily, dose 5
Feeling: Good · Site: Redness, Swelling, Itching · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2023-01-25
Health check-in — days 1–6 daily, dose 5
Feeling: Good · Site: Pain, Swelling, Itching · Headache, Fatigue or tiredness

Adult check-in
2023-01-26
Health check-in — days 1–6 daily, dose 5
Feeling: Good · Site: Itching · Headache, Fatigue or tiredness

Adult check-in
2023-01-27
Health check-in — day 7, dose 5
Feeling: Good · Site: Itching · Fatigue or tiredness

Adult check-in
2023-02-03
Health check-in — day 14, dose 5
Feeling: Good

Adult check-in
2023-02-10
Health check-in — day 21, dose 5
Feeling: Good

Adult check-in
2023-02-17
Health check-in — day 28, dose 5
Feeling: Good

Adult check-in
2023-02-24
Health check-in — day 35, dose 5
Feeling: Good

Adult check-in
2023-03-03
Health check-in — day 42, dose 5
Feeling: Good

Adult check-in
2023-04-21
Health check-in — 3 months, dose 5
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-02	Pfizer-BioNTech
2	2021-03-24	Pfizer-BioNTech
3	2021-08-24	Pfizer-BioNTech	No
4	2022-03-28	Pfizer-BioNTech	No
5	2023-01-20	Pfizer-BioNTech	No

Call center

6 call center cases

4 successful · 2 unsuccessful

See the call center timeline

Free text

Release 6 — day 21, dose 1

2021-03-23

Symptoms: I have MCTD, my symptoms are in line with a general flare of my autoimmune disease.

Release 6 — day 0, dose 2

2021-03-24

Systemic reaction (other): Throat irritation, stuffy nose

Release 6 — days 1–6 daily, dose 2

2021-03-25

Systemic reaction (other): Stiff neck and throat irritation.

2021-03-26

Systemic reaction (other): Stiff neck, sensation of swelling in my throat - but not severe.

2021-03-27

Systemic reaction (other): Stiff neck

2021-03-28

Systemic reaction (other): Stiff neck

2021-03-30

Systemic reaction (other): I have autoimmune disease, so the symptoms may not be related to getting the vaccine.

Release 7 — day 14, dose 2

2021-04-07

Symptoms: I have MCTD and Im having various symptoms related to that. SOB, muscle weakness, paresthesia. dyesthesia, balance and coordination problems, blurry vision/dry eyes.

Release 7 — day 21, dose 2

2021-04-14

Symptoms: I have NCTD and am experiencing a flare that includes problems with breathing, digestion, paresthesia, dyesthesia, insomnia, muscle spans and blurry vision.

Healthcare visit (other): In person appointment and diagnostic tests (chest x-ray, pulmonary function test, and sleep study have been scheduled.

Release 7 — day 28, dose 2

2021-04-21

Symptoms: I continue to have an exacerbation of breathing difficulties and insomnia. May be related to lung disease secondary to MCTD.

Release 8 — day 42, dose 2

2021-05-05

Symptoms: Increased breathing problems related to ACOS (I have MCTD)

Release 9 — 3 months, dose 2

2021-06-23

Symptoms: Exacerbation from my MCTD.

Release 11 — 6 months, dose 3

2022-02-22

Symptoms: Massive amounts of mucus production in my airway, and inflammation of muscles and nerves. But I have Mixed Connective Tissue Disease, so it probably all related to that.

Release 12 — 6 months, dose 4

2022-09-26

Symptoms: COVID August 2022

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	Office visit	✓	✓	✓
SD	Balance disorder	✓	✓	✓
SD	Condition aggravated	✓	✓	✓
SD	Coordination abnormal	✓	✓	✓
SD	COVID-19	·	·	✓
SD	Dry eye	✓	✓	✓
SD	Dysaesthesia	✓	✓	✓
SD	Dyspepsia	✓	·	✓
SD	Dyspnoea	✓	✓	✓
SD	Insomnia	✓	✓	✓
SD	Muscle spasms	✓	✓	✓
SD	Muscular weakness	✓	✓	✓
SD	Myositis	·	·	✓
SD	Neuritis	·	·	✓
SD	Paraesthesia	✓	✓	✓
SD	Pre-existing disease	✓	✓	✓
SD	Respiration abnormal	✓	✓	✓
SD	Respiratory disorder	✓	✓	✓
SD	Secretion discharge	·	·	✓
SD	Vision blurred	✓	✓	✓
SRO	Musculoskeletal stiffness	✓	✓	✓
SRO	Nasal congestion	✓	✓	✓
SRO	Pharyngeal swelling	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Throat irritation	✓	✓	✓

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