6VE-19328-12207

Timeline

1. 2021-05-24
   Dose 1 — Pfizer-BioNTech
2. 2021-06-10
   Registered in v-safe
3. 2021-06-10
   Survey response — day 14, dose 1

   MedDRA: Balance disorder, Deafness neurosensory, Office visit, Sudden hearing loss — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit, Hospitalization

   Free text: Symptoms: Sudden sensorineural hearing loss, equilibrium is off. Off balance. · Healthcare visit (other): ENT appointment

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-06-10
   Report sent to call center — day 14, dose 1

   Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

   1 call case(s)
5. 2021-06-14
   Dose 2 — Pfizer-BioNTech
6. 2021-06-14
   Survey response — day 0, dose 2

   MedDRA: Deafness unilateral, Ear discomfort — Feeling: Fair · Site: Pain

   Free text: Not yet. But I still am unable to heart out of my left ear.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-06-15
   Survey response — days 1–6 daily, dose 2

   MedDRA: Unevaluable event — Feeling: Fair · Site: Pain · Fatigue or tiredness

   Free text: A little such to the stomach

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-06-16
   Survey response — days 1–6 daily, dose 2

   MedDRA: Deafness — Feeling: Fair

   Free text: Still unable to hear from the first shot

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-06-17
   Survey response — days 1–6 daily, dose 2

   MedDRA: Deafness, Emergency care, Fluid retention, Office visit, Wheezing — Feeling: Fair · Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): Unable to hear out of left ear. Fluid in lungs, wheezing. · Healthcare visit (other): PCP doctor and ENT specialist along with two ER visits

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
10. 2021-06-17
    Report sent to call center — days 1–6 daily, dose 2

    Get care from a doctor or other healthcare professional

    1 call case(s)
11. 2021-06-18
    Survey response — days 1–6 daily, dose 2

    MedDRA: Balance disorder, Deafness, Emergency care, Office visit — Feeling: Poor · Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

    Free text: Systemic reaction (other): Still unable to hear. Balance is off. Went to the ER and had to get a antibiotic shot and prescription. Balance is off too. · Healthcare visit (other): Primary care visit and ENT

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-06-18
    Report sent to call center — days 1–6 daily, dose 2

    Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

    1 call case(s)
13. 2021-06-22
    Call 1 — Left Voicemail