XVE-10880-39397 · OpenVSafe

Timeline

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

2021-02-01
Dose 1 — Pfizer-BioNTech
2021-02-23
Dose 2 — Pfizer-BioNTech
2021-02-25
Registered in v-safe
2021-02-25
Survey response — days 1–6 daily, dose 2
MedDRA: Hypoaesthesia, Neuropathy peripheral — Feeling: Good · Headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-26
Survey response — days 1–6 daily, dose 2
MedDRA: Asthenia, Dizziness, Dry mouth, Hypoaesthesia, Neuralgia, Paralysis, Skin warm, Tongue discomfort — Feeling: Poor · Site: Pain · Muscle or body aches · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-27
Survey response — days 1–6 daily, dose 2
MedDRA: Abdominal pain upper, Back pain, Burning sensation, Chest discomfort, Emergency care, Feeling hot, Hyperhidrosis, Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia, Paraesthesia oral, Throat tightness, Tongue discomfort, Tongue dry, Tremor — Feeling: Poor · Site: Pain · Fever · Muscle or body aches, Fatigue or tiredness, Abdominal pain · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-27
Report sent to call center — days 1–6 daily, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-28
Survey response — days 1–6 daily, dose 2
MedDRA: Asthenia, Heart rate increased, Hypoaesthesia, Limb discomfort, Muscular weakness, Neuralgia, Self-medication, Skin burning sensation, Tongue discomfort, Tongue dry — Feeling: Fair · Site: Pain · Muscle or body aches, Abdominal pain · 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: Limb discomfort, Muscular weakness, Paraesthesia, Paraesthesia oral — Feeling: Fair · Site: Pain · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-02
Survey response — 7 day, dose 2
MedDRA: Burning sensation, Limb discomfort — Feeling: Fair · Site: Pain · Muscle or body aches

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

Adult check-in
2021-03-16
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-08-24
Health check-in — 6 month, dose 2
Feeling: Good

Adult check-in
2021-09-08
Call 1 — Could Not Reach Participant
2021-09-13
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-01	Pfizer-BioNTech
2	2021-02-23	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-02-27	Unsuccessful

Free text

Release 4

Systemic reaction (other): Neuropathy pain in hands and feet with slight numbness

Systemic reaction (other): My mouth is dry. My tongue feel like its been burn with some thing hot. I felt dizziness and weakness. My skin feel hot on my back and arms . I feel Nerve pain in my arms, hands and feet with numbness or mild paralysis

Systemic reaction (other): Still have pain on the left side of my stomach area and back a little today . Last night I have tremor. I was sweating under neck and top my chest . I still feel like my tongue is burn my something hot and my is dry but I still have taste. My skin feel hot on my back , arms and thighs. I got a tingle in my groin area and lips . I feel pressure in both my hands and feet. I got numbness and weakness in a few toes on both feet and both hands . The pinky toes and fingers. Still got tight in my throat and chest area . Went the ER

Systemic reaction (other): My heart rates was high for an hour . I still skin my skin burning along my arm with Neuropathy pain and pressure. My left calf muscle feel funny . Weakness and numbness with the smaller digits of the my hands and feet. Tongue still scorch and my is dry but I still have taste . Taking a narco and Ibuprofen for pain in intervals. It help with the pain and I am drinking of water to have my system because my mouth stay dry

Systemic reaction (other): Only symptoms the last 24 hours are my tongue still feel burned or scorch. Still feel pressure in my feet and hands with slight weakness of my limbs . Tingling in hands, feet , lips and every now again in my crotch area and thigh. I dont know if I have an allergic reaction to the vaccine or it just the symptoms I am having .

Systemic reaction (other): My arms feel slightly weighed with pressure and with burning sensation down both arms

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
SRO	Abdominal pain upper	✓	✓	✓
SRO	Asthenia	✓	✓	✓
SRO	Back pain	✓	✓	✓
SRO	Burning sensation	✓	✓	✓
SRO	Chest discomfort	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Dry mouth	✓	✓	✓
SRO	Emergency care	✓	✓	✓
SRO	Feeling hot	✓	✓	✓
SRO	Heart rate increased	✓	✓	✓
SRO	Hyperhidrosis	✓	✓	✓
SRO	Hypoaesthesia	✓	✓	✓
SRO	Limb discomfort	✓	✓	✓
SRO	Muscular weakness	✓	✓	✓
SRO	Neuralgia	✓	✓	✓
SRO	Neuropathy peripheral	✓	✓	✓
SRO	Paraesthesia	✓	✓	✓
SRO	Paraesthesia oral	✓	✓	✓
SRO	Paralysis	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Skin burning sensation	✓	✓	✓
SRO	Skin warm	✓	✓	✓
SRO	Throat tightness	✓	✓	✓
SRO	Tongue discomfort	✓	✓	✓
SRO	Tongue dry	✓	✓	✓
SRO	Tremor	✓	✓	✓

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