ZLM-29817-40989

3 vaccinations 14 coded responses 25 check-ins 14 free-text entries 6 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 029 / RI
Registered: 2021-01-14

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

2021-01-14
Registered in v-safe
2021-01-14
Dose 1 — Pfizer-BioNTech
2021-01-14
Health check-in — day 0, dose 1
Feeling: Fair · Site: Itching · Fatigue or tiredness

Adult check-in
2021-01-16
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Muscle or body aches

Adult check-in
2021-01-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-18
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-01-21
Health check-in — day 7, dose 1
Feeling: Good · Joint pains

Adult check-in
2021-01-28
Survey response — day 14, dose 1
MedDRA: Pruritus — Feeling: Fair

Free text: I have generalized itching, trunk, extremities mostly since about 4 days ago. Ive taken 25 mg Benadryl which helps but itching continues. Ive contacted allergist but no call back for 48 hrs now.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-04
Dose 2 — Pfizer-BioNTech
2021-02-04
Health check-in — day 0, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness

Adult check-in
2021-02-05
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-08
Survey response — days 1–6 daily, dose 2
MedDRA: Neck pain — Feeling: Good

Free text: Just little bit of pain around base of neck on right side I had injection on

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-09
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-10
Survey response — days 1–6 daily, dose 2
MedDRA: Arthralgia — Feeling: Good

Free text: Just little shoulder myalgia on right side above vaccine site

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

Free text: Just the soreness over R-shoulder where injection was given

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-18
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-25
Survey response — day 21, dose 2
MedDRA: Pruritus — Feeling: Fair

Free text: Very itchy all over body

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-04
Survey response — day 28, dose 2
MedDRA: Pruritus, Self-medication, Unevaluable event, Urticaria — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: I have hives bilaterally underarm and left side of neck. Ive been itching all along since first vaccine dose, but now hives development. Claritin has not worked and hives exacerbated today, waiting on PCP guidance to take Benadryl now or not. · Healthcare visit (other): Waiting for PCP to acknowledge portal communication

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-04
Report sent to call center — day 28, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-11
Survey response — day 35, dose 2
MedDRA: Chest discomfort, Headache, Office visit, Pruritus, Unevaluable event — Feeling: Poor · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: Been itching all along. Now its more pronounced - my PCP tried methylprednisone, Claritin and Benadryl. Not working, so now Singulair was added to Claritin and Benadryl. I now have really bad headaches, in addition to a heavy chest. Help plz · Healthcare visit (other): Waiting for an appt with allergist and dermatology

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

1 call case(s)
2021-03-18
Survey response — day 42, dose 2
MedDRA: Pruritus, Unevaluable event — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: The itching I sustained from day ONE post Pfizer vaccine, continues and has worsened at this time to extend under both arm pits and left neck. PCP tried m-prednisone and singulair, with no relief. Can someone reach out to me-discuss further, please? · Healthcare visit (other): Pending derm and allergist consult

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-18
Report sent to call center — day 42, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-06
Survey response — 3 months, dose 2
MedDRA: Petechiae, Rash, Rash pruritic — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Both legs developed rash like pettichiae, with itching. Derm stated Pfizer vaccine hosts at derm practice developed same symptoms as me.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-06
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-05
Survey response — 6 months, dose 2
MedDRA: Office visit, Petechiae, Rash, Symmetrical drug-related intertriginous and flexur — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Diagnosed with SDIFE by DermatÃ³logist and also evaluated by allergist for exanthem bilateral lymph nodes and pettichia-like spots on both lower estremities. Diagnosis of Symmetrical Drug related Intertriginous Flexural exanthema by Dermatologist.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-05
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-11
Call 1 — Left Voicemail
2021-08-20
Call successful
Participant prefers to complete VAERS report online
2022-02-04
Survey response — 12 months, dose 2
MedDRA: Adverse reaction, Inflammation, Office visit, Rash, Rash pruritic — Feeling: Poor · Be unable to work or attend school

Free text: I've been having rashes since second Pfizer vaccine. Since 12/14 I'm in the middle of an inflammatory response with facial and neck rash very itchy. I'm being evaluated at (b)(6) derm/rheum/immunology/neurology at this time. I'm Also having many symto

MedDRA releases: 2024-11 · check-in free text available
2022-04-21
Dose 3 — Pfizer-BioNTech
2022-04-21
Survey response — day 0, dose 3
MedDRA: Autoimmune disorder, Burning sensation, Hypoaesthesia, Neuropathy peripheral, Paraesthesia, Polyarthritis, Rash, Unevaluable event — Feeling: Poor · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain, Rash, not including the immediate area around the injection site · Be unable to work or attend school

Free text: I would like to report that I have developed an autoimmune disease aaa result of covid mRNA vaccine. I have a rash since 3/21 after second dose and now polyarthritic pain, neuropathy severe burning, tingling and numbness on hands, feet, scalp. I also

MedDRA releases: 2024-11 · check-in free text available
2022-04-23
Survey response — days 1–6 daily, dose 3
MedDRA: Office visit — Feeling: Poor · Fever · Joint pains, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: BWH 13 specialists care team

MedDRA releases: 2024-11 · check-in free text available
2022-04-23
Report sent to call center — days 1–6 daily, dose 3
Get care from a doctor or other healthcare professional

1 call case(s)
2022-04-25
Call 1 — Left Voicemail
2022-05-02
Call 2 — Could Not Reach Participant
2022-07-21
Survey response — 3 months, dose 3
MedDRA: Frustration tolerance decreased — Feeling: Fair · Be unable to work or attend school

Free text: I'm frustrated no one follow up from CDC! It's tiring writing same things over and over!

MedDRA releases: 2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-14	Pfizer-BioNTech
2	2021-02-04	Pfizer-BioNTech
3	2022-04-21	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-03-04	Successful	Participant prefers to complete VAERS report online
2021-03-11	Successful	Participant prefers to complete VAERS report online
2021-03-18	Successful	Participant prefers to complete VAERS report online
2021-05-06	Successful	Participant prefers to complete VAERS report online
2021-08-05	Successful 2021-08-20	Participant prefers to complete VAERS report online
2022-04-23	Unsuccessful

Free text

Release 3 — day 14, dose 1

2021-01-28

Symptoms: I have generalized itching, trunk, extremities mostly since about 4 days ago. Ive taken 25 mg Benadryl which helps but itching continues. Ive contacted allergist but no call back for 48 hrs now.

Release 3 — days 1–6 daily, dose 2

2021-02-08

Systemic reaction (other): Just little bit of pain around base of neck on right side I had injection on

Release 4 — days 1–6 daily, dose 2

2021-02-10

Systemic reaction (other): Just little shoulder myalgia on right side above vaccine site

Release 4 — day 7, dose 2

2021-02-11

Systemic reaction (other): Just the soreness over R-shoulder where injection was given

Release 4 — day 21, dose 2

2021-02-25

Symptoms: Very itchy all over body

Release 5 — day 28, dose 2

2021-03-04

Symptoms: I have hives bilaterally underarm and left side of neck. Ive been itching all along since first vaccine dose, but now hives development. Claritin has not worked and hives exacerbated today, waiting on PCP guidance to take Benadryl now or not.

Healthcare visit (other): Waiting for PCP to acknowledge portal communication

Release 5 — day 35, dose 2

2021-03-11

Symptoms: Been itching all along. Now its more pronounced - my PCP tried methylprednisone, Claritin and Benadryl. Not working, so now Singulair was added to Claritin and Benadryl. I now have really bad headaches, in addition to a heavy chest. Help plz

Healthcare visit (other): Waiting for an appt with allergist and dermatology

Release 5 — day 42, dose 2

2021-03-18

Symptoms: The itching I sustained from day ONE post Pfizer vaccine, continues and has worsened at this time to extend under both arm pits and left neck. PCP tried m-prednisone and singulair, with no relief. Can someone reach out to me-discuss further, please? cut off by CDC

Healthcare visit (other): Pending derm and allergist consult

Release 8 — 3 months, dose 2

2021-05-06

Symptoms: Both legs developed rash like pettichiae, with itching. Derm stated Pfizer vaccine hosts at derm practice developed same symptoms as me.

Release 9 — 6 months, dose 2

2021-08-05

Symptoms: Diagnosed with SDIFE by DermatÃ³logist and also evaluated by allergist for exanthem bilateral lymph nodes and pettichia-like spots on both lower estremities. Diagnosis of Symmetrical Drug related Intertriginous Flexural exanthema by Dermatologist. cut off by CDC

Release 11 — 12 months, dose 2

2022-02-04

Symptoms: I've been having rashes since second Pfizer vaccine. Since 12/14 I'm in the middle of an inflammatory response with facial and neck rash very itchy. I'm being evaluated at (b)(6) derm/rheum/immunology/neurology at this time. I'm Also having many symto cut off by CDC

redacted (b)(6)

Release 11 — day 0, dose 3

2022-04-21

Systemic reaction (other): I would like to report that I have developed an autoimmune disease aaa result of covid mRNA vaccine. I have a rash since 3/21 after second dose and now polyarthritic pain, neuropathy severe burning, tingling and numbness on hands, feet, scalp. I also cut off by CDC

Release 11 — days 1–6 daily, dose 3

2022-04-23

Healthcare visit (other): BWH 13 specialists care team

Release 12 — 3 months, dose 3

2022-07-21

Symptoms: I'm frustrated no one follow up from CDC! It's tiring writing same things over and over!

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	·	·	✓
HCVO	Unevaluable event	✓	✓	✓
SD	Adverse reaction	·	·	✓
SD	Chest discomfort	✓	✓	✓
SD	Frustration tolerance decreased	·	·	✓
SD	Headache	✓	✓	✓
SD	Inflammation	·	·	✓
SD	Office visit	✓	✓	✓
SD	Petechiae	✓	✓	✓
SD	Pruritus	✓	✓	✓
SD	Rash	✓	✓	✓
SD	Rash pruritic	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Symmetrical drug-related intertriginous and flexur	✓	·	✓
SD	Urticaria	✓	✓	✓
SRO	Arthralgia	✓	✓	✓
SRO	Autoimmune disorder	·	·	✓
SRO	Burning sensation	·	·	✓
SRO	Hypoaesthesia	·	·	✓
SRO	Neck pain	✓	✓	✓
SRO	Neuropathy peripheral	·	·	✓
SRO	Paraesthesia	·	·	✓
SRO	Polyarthritis	·	·	✓
SRO	Rash	·	·	✓
SRO	Unevaluable event	·	·	✓

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