3YC-54302-02895

5 vaccinations 17 coded responses 41 check-ins 16 free-text entries 1 call case

Sex: Female
Age at first dose: 61-65
ZIP prefix: 301 / GA
Registered: 2021-03-17

Relationship: Self
Race: Black or African American
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-02-24
Dose 1 — Pfizer-BioNTech
2021-03-17
Registered in v-safe
2021-03-17
Dose 2 — Pfizer-BioNTech
2021-03-17
Survey response — day 0, dose 2
MedDRA: Blood glucose decreased, Pre-existing disease — Feeling: Fair

Free text: Hasnt bn 24 hrs yet. Recvd Vaccine @ 1150 tday. I will say with 1st shot on 2/24, my BG dropped to 45 after midnight and did so multiple times the next few days. I got Dexcom warning after 2nd shot this pm about BG approaching lows. Related?

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-18
Survey response — days 1–6 daily, dose 2
MedDRA: Blood glucose decreased, Vaccine positive rechallenge — Feeling: Poor · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Bg crashed 3 times back to back the eve of injection. Same thing with first injection. Noted on Accuchek Aviva Plus 1st time low 45. Dexcom G6 second time low 50s.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-19
Survey response — days 1–6 daily, dose 2
MedDRA: Arthritis, Blood glucose, Blood glucose decreased, Decreased appetite, Diabetes mellitus, Dizziness, Headache, Hypertension, Hypothyroidism, Inflammation, Injection site mass, Injection site nodule, Injection site pain, Injection site swelling, Pre-existing disease, Sciatica, Self-medication, Vertigo — Feeling: Fair · Site: Swelling · Headache, Fatigue or tiredness

Free text: Blood glucose in the lows more than usual. However, appetite lessened with milder headache today. Just rested tday. Headache gone. Headache much worse yesterday. Was alrdy taking 600mg of ibuprofen 2xday for arthritis and inflammation. Swelling at injection site minimal bcuz I bathed the site in alcohol immediately and evry cpla hrs day 1 and 2. Small knot, soreness. Fgot to say dizziness day 1 and some day 2. I am insulin-dep diabetic, hypertensive, vertigo, hypothyroidism and sciatica.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-03-21
Survey response — days 1–6 daily, dose 2
MedDRA: Bursitis, Pain in extremity, Pre-existing disease, Self-medication — Feeling: Good · Site: Pain, Swelling · Joint pains, Muscle or body aches

Free text: Injected arm to wrist was quite painful ystrday. More pronounced with bursitis in shldr. Icy Hot roll on helped. None today..

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-22
Survey response — days 1–6 daily, dose 2
MedDRA: Appetite disorder, Blood glucose decreased, Fatigue — Feeling: Good · Site: Pain, Swelling · Fatigue or tiredness

Free text: Since vaccineS, experiencing very low blood glucose levels primarily after bedtime and 3 to 4 times each night. Never had that before the vaccines. Maybe on occasion. Appetite seems to be affected as well. Could be bcuz of feeling tired. Tired prbly bcuz I have to keep waking up to get my BG level back up to normal. But none of this happened prior to the vaccines. May want to explore further for diabetes study.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-23
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain, Swelling · Diarrhea

Adult check-in
2021-03-24
Health check-in — day 7, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-03-31
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-07
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-14
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-04-21
Survey response — day 35, dose 2
MedDRA: Tenderness — Feeling: Fair

Free text: Noticed left underarm (both vaccines) is very tender. Didnt notice until I used vibrating massage in that area. Very tender. Otherwise, all well.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-28
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-06-16
Health check-in — 3 months, dose 2
Feeling: Poor

Adult check-in
2021-09-15
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-09-27
Dose 3 — Pfizer-BioNTech
2021-10-02
Survey response — days 1–6 daily, dose 3
MedDRA: Blood glucose fluctuation — Feeling: Fair · Headache, Muscle or body aches

Free text: Blood Glucose increased over norm 1st 3 days. Then, as b4, dropped way below norm last 2 evenings

MedDRA releases: 2024-11 · check-in free text available
2021-10-03
Survey response — days 1–6 daily, dose 3
MedDRA: Blood glucose fluctuation, Glycosylated haemoglobin increased, Reaction to previous exposure to any vaccine — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Free text: A1C 6.5 as of early Sept. Experiencing extreme BG highs and lows as with prev vaccs. Lows come on very fast and are usually at night. Have screen shots or my Dexcom records to corroborate.

MedDRA releases: 2024-11 · check-in free text available
2021-10-04
Survey response — day 7, dose 3
MedDRA: Headache, Toothache — Feeling: Good · Site: Pain · Headache

Free text: *I think headache from toothache

MedDRA releases: 2024-11 · check-in free text available
2021-10-11
Survey response — day 14, dose 3
MedDRA: Headache, Toothache — Feeling: Poor

Free text: Not Covid related. Dental pain with headache. Having trbl finding dentist that accepts my Medicare Advantage plan.

MedDRA releases: 2024-11 · check-in free text available
2021-10-18
Health check-in — day 21, dose 3
Feeling: Fair

Adult check-in
2021-10-25
Survey response — day 28, dose 3
MedDRA: Blood glucose increased, Blood pressure increased, Office visit, Pain — Feeling: Poor · Be unable to do your normal daily activities

Free text: Not Covid related. Have issues with Med Adv Plan, Dental. Need root canal, noone listed on plan accepts my plan. Extreme pain. BP and BG elevated per my PCP. FYI, I do plan to get my Zoster shot this week.

MedDRA releases: 2024-11 · check-in free text available
2021-11-01
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-11-08
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-12-27
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-03-28
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in
2022-04-06
Dose 4 — Pfizer-BioNTech
2022-04-15
Health check-in — day 7, dose 4
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2022-04-20
Survey response — day 14, dose 4
MedDRA: Abdominal discomfort, Arthralgia, Headache, Joint swelling, Office visit, Pre-existing disease — Feeling: Poor · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Symptoms: Not Covid related. A lot of joint pain and swelling. (Arthritic, prbly cold weather). Bad headache last wk; abdominal discomfort. Allergies Urgent Care visit this a.m. 4/20/22 · Healthcare visit (other): Btw, urgent care did not find a record of my 3rd Covid vaccine record of 9/27/2021. I told them. They said they didn't find it. (b)(6) Urgent Care, (b)(6)

MedDRA releases: 2024-11 · check-in free text available
2022-04-20
Report sent to call center — day 14, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-04-22
Call 1 — Left Voicemail
2022-04-22
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-04-27
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-05-04
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-05-11
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-05-18
Survey response — day 42, dose 4
MedDRA: Ear pain, Headache, Multiple allergies, Office visit, Oropharyngeal pain, Rhinorrhoea, Sneezing — Feeling: Fair

Free text: Sore throat, sneezing, headache, runny nose, earache, no temp. Went to doctor today. Allergies, but nvr had anythg but sneezing b4.

MedDRA releases: 2024-11 · check-in free text available
2022-07-06
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2022-09-27
Dose 5 — Pfizer-BioNTech
Co-administered: Shingles
2022-10-05
Survey response — 6 months, dose 4
MedDRA: Acute sinusitis, Diarrhoea, Ear pain, Feeling abnormal, Headache, Office visit, Oropharyngeal pain, Rhinorrhoea — Feeling: Poor · Be unable to do your normal daily activities

Free text: Got Covid Booster and 1st Shingrix 9/27. I have a bad headache, sore throat and earache, loose stools and runny nose but so far, no temp. Went to Immediate Care. 10/2. Diagnosed with Acute Sinusitis. Given Azithomycin K-Pak. Not working. Feel bad.

MedDRA releases: 2024-11 · check-in free text available
2022-10-09
Survey response — day 7, dose 5
MedDRA: Cough, Ear pain, Influenza virus test negative, Lacrimation increased, Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing — Feeling: Poor · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Sore throat, earache, swollen lymph nodes, coughing, sneezing, runny nose, water eyes with no temp to present. Extensive PCR test says negative covid, flu, viral and infectious via Nasal swab Oct 6 at (b)(6).

MedDRA releases: 2024-11 · check-in free text available
2022-10-11
Survey response — day 14, dose 5
MedDRA: Blood glucose increased, Blood pressure increased, Cough, Fatigue, Headache, Insomnia, Irritability, Oropharyngeal pain, Sneezing — Feeling: Poor · Be unable to do your normal daily activities

Free text: Cough, sneeze, sore throat, mild headache, elev BP and BG. Lack of sleep, exhaustion, irritability

MedDRA releases: 2024-11 · check-in free text available
2022-10-18
Health check-in — day 21, dose 5
Feeling: Fair

Adult check-in
2022-10-25
Health check-in — day 28, dose 5
Feeling: Fair

Adult check-in
2022-11-01
Health check-in — day 35, dose 5
Feeling: Fair

Adult check-in
2022-11-08
Health check-in — day 42, dose 5
Feeling: Fair

Adult check-in
2022-12-27
Health check-in — 3 months, dose 5
Feeling: Fair

Adult check-in
2023-03-28
Survey response — 6 months, dose 5
MedDRA: Asthenia, Decreased appetite, Dizziness, Increased viscosity of upper respiratory secretion, Insomnia, Malaise, Productive cough, Weight decreased — Feeling: Poor · Be unable to do your normal daily activities

MedDRA releases: 2024-11

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-24	Pfizer-BioNTech
2	2021-03-17	Pfizer-BioNTech
3	2021-09-27	Pfizer-BioNTech	No
4	2022-04-06	Pfizer-BioNTech	No
5	2022-09-27	Pfizer-BioNTech	Shingles

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 5 — day 0, dose 2

2021-03-17

Systemic reaction (other): Hasnt bn 24 hrs yet. Recvd Vaccine @ 1150 tday. I will say with 1st shot on 2/24, my BG dropped to 45 after midnight and did so multiple times the next few days. I got Dexcom warning after 2nd shot this pm about BG approaching lows. Related?

Release 5 — days 1–6 daily, dose 2

2021-03-18

Systemic reaction (other): Bg crashed 3 times back to back the eve of injection. Same thing with first injection. Noted on Accuchek Aviva Plus 1st time low 45. Dexcom G6 second time low 50s.

2021-03-19

Systemic reaction (other): Blood glucose in the lows more than usual. However, appetite lessened with milder headache today. Just rested tday. Headache gone. Headache much worse yesterday. Was alrdy taking 600mg of ibuprofen 2xday for arthritis and inflammation. Swelling at injection site minimal bcuz I bathed the site in alcohol immediately and evry cpla hrs day 1 and 2. Small knot, soreness. Fgot to say dizziness day 1 and some day 2. I am insulin-dep diabetic, hypertensive, vertigo, hypothyroidism and sciatica.

Release 6 — days 1–6 daily, dose 2

2021-03-21

Systemic reaction (other): Injected arm to wrist was quite painful ystrday. More pronounced with bursitis in shldr. Icy Hot roll on helped. None today..

2021-03-22

Systemic reaction (other): Since vaccineS, experiencing very low blood glucose levels primarily after bedtime and 3 to 4 times each night. Never had that before the vaccines. Maybe on occasion. Appetite seems to be affected as well. Could be bcuz of feeling tired. Tired prbly bcuz I have to keep waking up to get my BG level back up to normal. But none of this happened prior to the vaccines. May want to explore further for diabetes study.

Release 7 — day 35, dose 2

2021-04-21

Symptoms: Noticed left underarm (both vaccines) is very tender. Didnt notice until I used vibrating massage in that area. Very tender. Otherwise, all well.

Release 9 — days 1–6 daily, dose 3

2021-10-02

Systemic reaction (other): Blood Glucose increased over norm 1st 3 days. Then, as b4, dropped way below norm last 2 evenings

2021-10-03

Systemic reaction (other): A1C 6.5 as of early Sept. Experiencing extreme BG highs and lows as with prev vaccs. Lows come on very fast and are usually at night. Have screen shots or my Dexcom records to corroborate.

Release 9 — day 7, dose 3

2021-10-04

Systemic reaction (other): *I think headache from toothache

Release 10 — day 14, dose 3

2021-10-11

Symptoms: Not Covid related. Dental pain with headache. Having trbl finding dentist that accepts my Medicare Advantage plan.

Release 10 — day 28, dose 3

2021-10-25

Symptoms: Not Covid related. Have issues with Med Adv Plan, Dental. Need root canal, noone listed on plan accepts my plan. Extreme pain. BP and BG elevated per my PCP. FYI, I do plan to get my Zoster shot this week.

Release 11 — day 14, dose 4

2022-04-20

Symptoms: Not Covid related. A lot of joint pain and swelling. (Arthritic, prbly cold weather). Bad headache last wk; abdominal discomfort. Allergies Urgent Care visit this a.m. 4/20/22

Healthcare visit (other): Btw, urgent care did not find a record of my 3rd Covid vaccine record of 9/27/2021. I told them. They said they didn't find it. (b)(6) Urgent Care, (b)(6)

redacted (b)(6)

Release 11 — day 42, dose 4

2022-05-18

Symptoms: Sore throat, sneezing, headache, runny nose, earache, no temp. Went to doctor today. Allergies, but nvr had anythg but sneezing b4.

Release 12 — 6 months, dose 4

2022-10-05

Symptoms: Got Covid Booster and 1st Shingrix 9/27. I have a bad headache, sore throat and earache, loose stools and runny nose but so far, no temp. Went to Immediate Care. 10/2. Diagnosed with Acute Sinusitis. Given Azithomycin K-Pak. Not working. Feel bad.

Release 12 — day 7, dose 5

2022-10-09

Systemic reaction (other): Sore throat, earache, swollen lymph nodes, coughing, sneezing, runny nose, water eyes with no temp to present. Extensive PCR test says negative covid, flu, viral and infectious via Nasal swab Oct 6 at (b)(6).

redacted (b)(6)

Release 12 — day 14, dose 5

2022-10-11

Symptoms: Cough, sneeze, sore throat, mild headache, elev BP and BG. Lack of sleep, exhaustion, irritability

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	Abdominal discomfort	·	·	✓
SD	Acute sinusitis	·	·	✓
SD	Arthralgia	·	·	✓
SD	Asthenia	·	·	✓
SD	Blood glucose increased	·	·	✓
SD	Blood pressure increased	·	·	✓
SD	Cough	·	·	✓
SD	Decreased appetite	·	·	✓
SD	Diarrhoea	·	·	✓
SD	Dizziness	·	·	✓
SD	Ear pain	·	·	✓
SD	Fatigue	·	·	✓
SD	Feeling abnormal	·	·	✓
SD	Headache	·	·	✓
SD	Increased viscosity of upper respiratory secretion	·	·	✓
SD	Insomnia	·	·	✓
SD	Irritability	·	·	✓
SD	Joint swelling	·	·	✓
SD	Malaise	·	·	✓
SD	Multiple allergies	·	·	✓
SD	Office visit	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pain	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Productive cough	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Sneezing	·	·	✓
SD	Tenderness	✓	✓	✓
SD	Toothache	·	·	✓
SD	Weight decreased	·	·	✓
SRO	Appetite disorder	✓	✓	✓
SRO	Arthritis	✓	✓	✓
SRO	Blood glucose	○	✓	○
SRO	Blood glucose decreased	✓	✓	✓
SRO	Blood glucose fluctuation	·	·	✓
SRO	Bursitis	✓	✓	✓
SRO	Cough	·	·	✓
SRO	Decreased appetite	✓	✓	✓
SRO	Diabetes mellitus	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Ear pain	·	·	✓
SRO	Fatigue	✓	✓	✓
SRO	Glycosylated haemoglobin increased	·	·	✓
SRO	Headache	✓	✓	✓
SRO	Hypertension	✓	✓	✓
SRO	Hypothyroidism	✓	✓	✓
SRO	Inflammation	✓	✓	✓
SRO	Influenza virus test negative	·	·	✓
SRO	Injection site mass	○	✓	○
SRO	Injection site nodule	✓	·	✓
SRO	Injection site pain	✓	✓	✓
SRO	Injection site swelling	✓	✓	✓
SRO	Lacrimation increased	·	·	✓
SRO	Lymphadenopathy	·	·	✓
SRO	Oropharyngeal pain	·	·	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Reaction to previous exposure to any vaccine	·	·	✓
SRO	Rhinorrhoea	·	·	✓
SRO	SARS-CoV-2 test negative	·	·	✓
SRO	Sciatica	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Sneezing	·	·	✓
SRO	Toothache	·	·	✓
SRO	Vaccine positive rechallenge	✓	✓	✓
SRO	Vertigo	✓	✓	✓

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