HBP-27905-45062

Timeline

1. 2021-05-12
   Dose 1 — Pfizer-BioNTech
2. 2021-05-13
   Registered in v-safe
3. 2021-05-13
   Survey response — days 1–6 daily, dose 1

   MedDRA: Asthenia, Dizziness, Dyspnoea, Gait disturbance, Immediate post-injection reaction, Muscle twitching, Seizure, Tremor — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

   Free text: Seizure (yesterday, 25 min after injection,) twitching, major weakness, short of breath, hands shaking, dizzy, can't walk without collapsing

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-05-14
   Survey response — days 1–6 daily, dose 1

   MedDRA: Asthenia, Dysstasia, Gait inability, Mobility decreased — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: I still can't walk or stand without falling, or lift anything heavy. Very weak, chair/bed ridden still.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
5. 2021-05-15
   Survey response — days 1–6 daily, dose 1

   MedDRA: Asthenia, Seizure — Feeling: Poor · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: Half hour seizure around 3am, still can't walk/stand due to severe weakness

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2021-05-16
   Survey response — days 1–6 daily, dose 1

   MedDRA: Asthenia, Dysstasia, Gait disturbance — Feeling: Poor · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: Weakness, still can't walk or stand unsupported without falling

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-05-17
   Survey response — days 1–6 daily, dose 1

   MedDRA: Asthenia, Fall, Syncope — Feeling: Fair · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

   Free text: Weakness/falling/collapsing

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-05-19
   Survey response — day 7, dose 1

   MedDRA: Asthenia, Fall, Gait disturbance — Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

   Free text: Still can't walk more than a few steps without falling. Still weak, though can lift a milk jug now.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-05-26
   Survey response — day 14, dose 1

   MedDRA: Asthenia, Fall, Gait disturbance, Mobility decreased, Physiotherapy, Walking aid user — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

   Free text: Symptoms: Frequent falls a couple days ago. Weakness was so bad last week that I was barely able to make it in to the physical therapist, and they had to escort me out with a gait belt. Using a walker now, though seem slightly stronger each day. · Healthcare visit (other): Physical therapist, took ten minutes to get up the ramp into the building and almost didn't make it at all. He said it was too unsafe for me to try to come back or do therapy at present due to the weakness and risk of falling.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
10. 2021-05-26
    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)
11. 2021-06-04
    Survey response — day 21, dose 1

    MedDRA: Asthenia, Mobility decreased, Walking aid user — Feeling: Poor · Be unable to work, Be unable to do your normal daily activities

    Free text: Weakness so bad one evening I couldn't lift my own head unsupported. Using a walker now to get around.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-06-11
    Survey response — day 28, dose 1

    MedDRA: Asthenia, Back pain, Fall, Feeling cold, Gait disturbance, Hot flush, Unevaluable event — Feeling: Poor · 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: Symptoms: Weakness seems to be worsening again - even with my walker I often collapse in the house. Back pain can be severe. Have had several hard falls and get stuck until assisted up. Hot/cold flashes are back. · Healthcare visit (other): We had planned to get my lab blood draw done today, and possibly go to the emergency room, but I've been too wiped out and weak to even get out of the door.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-06-11
    Report sent to call center — day 28, dose 1

    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)
14. 2021-06-21
    Call 1 — Left Voicemail
15. 2021-06-23
    Survey response — day 42, dose 1

    MedDRA: Brain fog, Mobility decreased, Muscle spasms, Pain — Feeling: Poor · Be unable to work or attend school, Be unable to do your normal daily activities

    Free text: Relapse yesterday, bedridden a lot of the day. Left arm is now spazzing at times like legs sometimes do and twisting or going backwards from what I'm trying to do. More mental fog and pain.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
16. 2021-08-11
    Survey response — 3 months, dose 1

    MedDRA: Hypoaesthesia, Mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia — Feeling: Poor · Be unable to do your normal daily activities

    Free text: Severe numbness/tingling in arms in addition to the weakness and all the other symptoms I reported before. Fortunately it only lasted a couple of days, but has come on and off. It's very painful, and when it happens I can't easily move my arms.

    MedDRA releases: 2021-09,2024-11 · check-in free text available
17. 2021-11-11
    Survey response — 6 months, dose 1

    MedDRA: Pregnancy — Feeling: Fair · Be unable to do your normal daily activities

    Free text: Pregnancy + nausea, the nausea is pretty bad and worse than I had with my last three kids

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