62H-42173-00244

5 vaccinations 16 coded responses 41 check-ins 16 free-text entries 6 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 064 / CT
Registered: 2021-01-30

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

2020-12-30
Dose 1 — Moderna
2021-01-27
Dose 2 — Moderna
2021-01-30
Registered in v-safe
2021-01-30
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Rash, not including the immediate area around the injection site

Adult check-in
2021-01-31
Survey response — days 1–6 daily, dose 2
MedDRA: Rash — Feeling: Good · Site: Redness, Itching · Rash, not including the immediate area around the injection site

Free text: Diffuse body rash previously described is subsiding. Wonder if Fosamax (only taken once per week, this time on Sat 1/30/21 early am, could have caused reaction

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-01
Survey response — days 1–6 daily, dose 2
MedDRA: Pruritus, Rash — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Rash is much diminished, slightly itchy

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-02
Survey response — days 1–6 daily, dose 2
MedDRA: Rash pruritic — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Major rash has subsided. Mild itching

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-03
Survey response — day 7, dose 2
MedDRA: Pruritus, Rash — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Aftermath of rash with some itching still subsiding

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-10
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-17
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-24
Health check-in — day 28, dose 2
Feeling: Good

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

Adult check-in
2021-03-10
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-28
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-28
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-11-17
Dose 3 — Moderna
2021-11-19
Survey response — days 1–6 daily, dose 3
MedDRA: Medical counselling, Rash — Feeling: Fair · Site: Pain · Fever · Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: Large area of rash on torso, bilateral, but worse on the side of injection. Worried about (b)(6), per husband, who is a physician

MedDRA releases: 2024-11 · check-in free text available
2021-11-20
Survey response — days 1–6 daily, dose 3
MedDRA: Medical counselling, Rash erythematous, Self-medication — Feeling: Good · Site: Pain · Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: My husband is a retired gastroenterologist. I took 75 mg of Benadryl last evening for rash and about 2 hours later, 2 Tylenol. Slept thru the night. Rash still diffuse and red today, but a bit less than last evening. Plan to do the same tonight

MedDRA releases: 2024-11 · check-in free text available
2021-11-20
Report sent to call center — days 1–6 daily, dose 3
Get care from a doctor or other healthcare professional

1 call case(s)
2021-11-21
Survey response — days 1–6 daily, dose 3
MedDRA: Rash — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Diffuse body Rash subsiding

MedDRA releases: 2024-11 · check-in free text available
2021-11-22
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Rash, not including the immediate area around the injection site

Adult check-in
2021-11-23
Survey response — days 1–6 daily, dose 3
MedDRA: Rash — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Rash barely visible now

MedDRA releases: 2024-11 · check-in free text available
2021-11-24
Survey response — day 7, dose 3
MedDRA: Adverse reaction — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Very slight

MedDRA releases: 2024-11 · check-in free text available
2021-12-01
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2021-12-02
Call 2 — Left Voicemail
2021-12-02
Call successful
Participant prefers to complete VAERS report online
2021-12-08
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2021-12-15
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2021-12-22
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-12-29
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-02-16
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-04-13
Dose 4 — Moderna
2022-04-19
Survey response — days 1–6 daily, dose 4
MedDRA: Blood test abnormal, Medical counselling, Rash, Unevaluable event — Feeling: Good · Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Ras clearing, but got diffuse rash for 3rd time! Went for blood word after consulting an allergist in Dec 2021 regarding allergy to vaccine. Blood work regarding allergy/rash grossly abnormal. Await direction from allergist on his return from vaca · Healthcare visit (other): Went to lab for ordered blood work

MedDRA releases: 2024-11 · check-in free text available
2022-04-19
Report sent to call center — days 1–6 daily, dose 4
Get care from a doctor or other healthcare professional

1 call case(s)
2022-04-20
Survey response — day 7, dose 4
MedDRA: Blood test abnormal, Rash pruritic — Feeling: Good · Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Rash has dissipated. Itchy not, but not drastically · Healthcare visit (other): Dr in Europe and will call on return. Allergy specific blood tests grossly abnormal, but CBC & chem profiles are normal

MedDRA releases: 2024-11 · check-in free text available
2022-04-20
Report sent to call center — day 7, dose 4
Get care from a doctor or other healthcare professional

1 call case(s)
2022-04-21
Call 1 — Requested Callback
2022-04-26
Callback requested for
09:30AM ET
2022-04-26
Call successful
Completed over the phone
2022-04-27
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-05-04
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-05-11
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-05-18
Survey response — day 35, dose 4
MedDRA: Atrial fibrillation, Office visit — Feeling: Good · Get care from a doctor or other healthcare professional

Free text: Symptoms: Diagnosed with afib. Starting on Eliquis & Toprol · Healthcare visit (other): Regular office bidit

MedDRA releases: 2024-11 · check-in free text available
2022-05-18
Report sent to call center — day 35, dose 4
Get care from a doctor or other healthcare professional

1 call case(s)
2022-05-19
Call 1 — Left Voicemail
2022-05-19
Call 1 — Left Voicemail
2022-05-19
Call 2 — Left Voicemail
2022-05-19
Call 1 — Left Voicemail
2022-05-19
Call successful
Does not wish to fill out VAERS report
2022-05-25
Survey response — day 42, dose 4
MedDRA: Atrial fibrillation, Office visit — Feeling: Good · Get care from a doctor or other healthcare professional

Free text: Symptoms: Am sure this has nothing to do with vaccine, but was diagnosed with atrial fibrillation. Now on Eliquis · Healthcare visit (other): Regular office visit with cardiologist

MedDRA releases: 2024-11 · check-in free text available
2022-05-25
Report sent to call center — day 42, dose 4
Get care from a doctor or other healthcare professional

1 call case(s)
2022-05-26
Call successful
Reported to VAERS during previous contact from GDIT
2022-07-13
Survey response — 3 months, dose 4
MedDRA: Rash — Feeling: Good

Free text: VAERS/CDC called me in May, but the young man I was explaining my 3 vaccine reactions to was not comprehending me & did not look up my history. Asked for a supervisor, but he disconnected me. Have Appt w/(b)(6) immunologist RE severe post vacc rash.

MedDRA releases: 2024-11 · check-in free text available
2022-10-13
Survey response — 6 months, dose 4
MedDRA: Atrial fibrillation — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Not sure when you last contacted me (you should say "when we last contacted you ON??), but I was diagnosed with atrial fibrillation in May 2022

MedDRA releases: 2024-11 · check-in free text available
2022-10-13
Report sent to call center — 6 months, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-10-14
Call successful
Reported to VAERS during previous contact from GDIT
2022-12-05
Dose 5 — Pfizer-BioNTech
2022-12-12
Survey response — day 7, dose 5
MedDRA: Rash, Rash pruritic, Vaccine positive rechallenge — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: 1 week since injection. Tried Pfizer this time to see if I could avoid diffuse rash. Still got body rash at 48 hours post-injection. Lasted a few days. Gone now, but slightly itchy.

MedDRA releases: 2024-11 · check-in free text available
2022-12-19
Health check-in — day 14, dose 5
Feeling: Good

Adult check-in
2022-12-26
Health check-in — day 21, dose 5
Feeling: Good

Adult check-in
2023-01-02
Health check-in — day 28, dose 5
Feeling: Good

Adult check-in
2023-01-09
Health check-in — day 35, dose 5
Feeling: Good

Adult check-in
2023-01-16
Health check-in — day 42, dose 5
Feeling: Good

Adult check-in
2023-03-06
Health check-in — 3 months, dose 5
Feeling: Good

Adult check-in
2023-06-05
Health check-in — 6 months, dose 5
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-30	Moderna
2	2021-01-27	Moderna
3	2021-11-17	Moderna	No
4	2022-04-13	Moderna	No
5	2022-12-05	Pfizer-BioNTech	No

Call center

6 call center cases

6 successful

VAERS report filed, before or during a call: 4

See the call center timeline

Free text

Release 3 — days 1–6 daily, dose 2

2021-01-31

Systemic reaction (other): Diffuse body rash previously described is subsiding. Wonder if Fosamax (only taken once per week, this time on Sat 1/30/21 early am, could have caused reaction

2021-02-01

Systemic reaction (other): Rash is much diminished, slightly itchy

2021-02-02

Systemic reaction (other): Major rash has subsided. Mild itching

Release 3 — day 7, dose 2

2021-02-03

Systemic reaction (other): Aftermath of rash with some itching still subsiding

Release 10 — days 1–6 daily, dose 3

2021-11-19

Systemic reaction (other): Large area of rash on torso, bilateral, but worse on the side of injection. Worried about (b)(6), per husband, who is a physician

redacted (b)(6)

2021-11-20

Healthcare visit (other): My husband is a retired gastroenterologist. I took 75 mg of Benadryl last evening for rash and about 2 hours later, 2 Tylenol. Slept thru the night. Rash still diffuse and red today, but a bit less than last evening. Plan to do the same tonight

2021-11-21

Systemic reaction (other): Diffuse body Rash subsiding

2021-11-23

Systemic reaction (other): Rash barely visible now

Release 10 — day 7, dose 3

2021-11-24

Systemic reaction (other): Very slight

Release 11 — days 1–6 daily, dose 4

2022-04-19

Systemic reaction (other): Ras clearing, but got diffuse rash for 3rd time! Went for blood word after consulting an allergist in Dec 2021 regarding allergy to vaccine. Blood work regarding allergy/rash grossly abnormal. Await direction from allergist on his return from vaca cut off by CDC

Healthcare visit (other): Went to lab for ordered blood work

Release 11 — day 7, dose 4

2022-04-20

Systemic reaction (other): Rash has dissipated. Itchy not, but not drastically

Healthcare visit (other): Dr in Europe and will call on return. Allergy specific blood tests grossly abnormal, but CBC & chem profiles are normal

Release 11 — day 35, dose 4

2022-05-18

Symptoms: Diagnosed with afib. Starting on Eliquis & Toprol

Healthcare visit (other): Regular office bidit

Release 11 — day 42, dose 4

2022-05-25

Symptoms: Am sure this has nothing to do with vaccine, but was diagnosed with atrial fibrillation. Now on Eliquis

Healthcare visit (other): Regular office visit with cardiologist

Release 12 — 3 months, dose 4

2022-07-13

Symptoms: VAERS/CDC called me in May, but the young man I was explaining my 3 vaccine reactions to was not comprehending me & did not look up my history. Asked for a supervisor, but he disconnected me. Have Appt w/(b)(6) immunologist RE severe post vacc rash. cut off by CDC

redacted (b)(6)

Release 12 — 6 months, dose 4

2022-10-13

Symptoms: Not sure when you last contacted me (you should say "when we last contacted you ON??), but I was diagnosed with atrial fibrillation in May 2022

Release 12 — day 7, dose 5

2022-12-12

Systemic reaction (other): 1 week since injection. Tried Pfizer this time to see if I could avoid diffuse rash. Still got body rash at 48 hours post-injection. Lasted a few days. Gone now, but slightly itchy.

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	Blood test abnormal	·	·	✓
HCVO	Medical counselling	·	·	✓
HCVO	Office visit	·	·	✓
HCVO	Rash erythematous	·	·	✓
HCVO	Self-medication	·	·	✓
HCVO	Unevaluable event	·	·	✓
SD	Atrial fibrillation	·	·	✓
SD	Rash	·	·	✓
SRO	Adverse reaction	·	·	✓
SRO	Blood test abnormal	·	·	✓
SRO	Medical counselling	·	·	✓
SRO	Pruritus	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Rash pruritic	✓	✓	✓
SRO	Vaccine positive rechallenge	·	·	✓

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