XZM-32615-25830

Timeline

1. 2021-02-01
   Dose 1 — Pfizer-BioNTech
2. 2021-02-05
   Registered in v-safe
3. 2021-02-05
   Survey response — days 1–6 daily, dose 1

   MedDRA: Office visit, Pruritus, Self-medication — Feeling: Fair · Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): My dad (b)(6) started to complain about itching on his legs on Wed Feb 3 and has increasingly gotten worse itching all over his body. Had to start taking Benadryl today. · Healthcare visit (other): Called primary physicians office and was told by LVN to start taking benedryl

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-02-05
   Report sent to call center — days 1–6 daily, dose 1

   Get care from a doctor or other healthcare professional

   1 call case(s)
5. 2021-02-07
   Survey response — days 1–6 daily, dose 1

   MedDRA: Hypersensitivity, Medical counselling, Pruritus — Feeling: Poor · Joint pains · 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: Systemic reaction (other): Allergic reaction of itching all over body on Feb 3, 2 days after injection. Had to take my dad to Urgent Care for evaluation. He also developed swelling in hands and ankles & feet. They ran blood tests and a chest X-ray. Gave him Decadron for swelling and Benedryl. They highly suspect it could be a reaction to the PFizer vaccine but cant be conclusive. Today, the itching has subsided but the swelling is quite prevalent. In addition, having pain in his arm/shoulder, same arm where injection was given but might not be related. If symptoms dont clear up we were told to go to ER. I will be taking him to his primary doctor or Urgent Care · Healthcare visit (other): Also called the on-call physician yesterday (Saturday)

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2021-02-07
   Report sent to call center — days 1–6 daily, dose 1

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

   1 call case(s)
7. 2021-02-08
   Survey response — day 7, dose 1

   MedDRA: Arthralgia, Office visit, Pruritus, Rash, Rash pruritic, Swelling, Wheezing — Feeling: Fair · Joint pains, Fatigue or tiredness · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

   Free text: As indicated yesterday, my dad developed itching and a rash 2 days after the PFizer vaccine and from there developed swelling & some wheezing. Went to Urgent Care today as he developed severe shoulder pain and a rash, and still had swelling but itching had subsided. Be advised that my dad started taking Plavix on Jan 22 and had the vaccine on Feb 1. Neither Urgent Care PA or physician we saw today can conclude whether these symptoms are Plavix or the PFizer vaccine

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-02-08
   Report sent to call center — day 7, dose 1

   Get care from a doctor or other healthcare professional

   1 call case(s)
9. 2021-02-15
   Health check-in — day 14, dose 1

   Feeling: Fair

   Adult check-in
10. 2021-02-22
    Survey response — day 21, dose 1

    MedDRA: Immunisation reaction, Medical counselling, Office visit, Pain in extremity, Peripheral swelling — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

    Free text: Symptoms: Feet are now swollen and left hand continues to be very painful. Medical PA & NP believe its from the allergic reaction caused by the PFizer vaccine. · Healthcare visit (other): Office visit on Friday Feb 19

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2021-02-22
    Report sent to call center — day 21, dose 1

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

    1 call case(s)
12. 2021-03-01
    Survey response — day 28, dose 1

    MedDRA: Emergency care, Hypotension, Immunisation reaction, Transient ischaemic attack — Feeling: Fair · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

    Free text: Symptoms: Called 911 - it appeared dad might have had a TIA or the new medication gabapentin may have excessively lowered his blood pressure. We still question if the 1st PFizer vaccine of 2/1 caused the allergic reaction (2 days after on 2/3) · Healthcare visit (other): Called 911 and was taken to hospital emergency

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-03-01
    Report sent to call center — day 28, dose 1

    Get care from a doctor or other healthcare professional

    1 call case(s)
14. 2021-03-03
    Dose 2 — Pfizer-BioNTech
15. 2021-03-08
    Health check-in — days 1–6 daily, dose 2

    Feeling: Good · None

    Adult check-in
16. 2021-03-09
    Health check-in — days 1–6 daily, dose 2

    Feeling: Good · Joint pains

    Adult check-in
17. 2021-03-10
    Health check-in — day 7, dose 2

    Feeling: Good · None

    Adult check-in
18. 2021-03-17
    Health check-in — day 14, dose 2

    Feeling: Good

    Adult check-in
19. 2021-03-24
    Health check-in — day 21, dose 2

    Feeling: Good

    Adult check-in
20. 2021-07-02
    Call successful

    Not applicable (accidental reporting or does not believe symptoms are related to vaccine)