4M9-20571-33316

Timeline

1. 2021-04-20
   Dose 1 — Pfizer-BioNTech
2. 2021-04-22
   Registered in v-safe
3. 2021-04-22
   Survey response — days 1–6 daily, dose 1

   MedDRA: Chest discomfort, Fatigue, Heart rate increased, Hypoaesthesia, Immediate post-injection reaction, Immunisation reaction, Injection site hypoaesthesia, Injection site paraesthesia, Medical observation, Palpitations, Paraesthesia — Feeling: Good · Site: Pain · Muscle or body aches · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

   Free text: Systemic reaction (other): Yes. I experienced an adverse reaction 10 to 15 mins after my shot on Tuesday the 20th. It was horrible. Chest discomfort, racing heart rate (high pulse), numbness/tingling from the shot site to my middle finger, below my left knee down to my left foot then crossed over to my right foot. It felt like someone was pouring sand pebbles across my chest, and it felt like someone took a pencil and drew a line from the shot site to my fingers . They had to observe me for appx 2 hours, and they administered an EKG. This experience was scary. They allowed my husband to come in the room with me. I was so afraid to sleep Tuesday night because I didnt know what was going to happen. I had major fatigue on Wednesday, but it · Healthcare visit (other): The care was done at the vaccine site at (b)(6)

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
4. 2021-04-22
   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)
5. 2021-04-23
   Survey response — days 1–6 daily, dose 1

   MedDRA: Feeling hot, Muscular weakness, Tremor — Feeling: Good · Be unable to do your normal daily activities

   Free text: Since the shot on Tuesday, I noticed that the upper left side of my body feels warm , my legs become a bit weak, and I feel like I have the shakes; no chills, no fever. It occurs every evening after 5 or 6 pm. It last for appx 2 hours then subsides. What in the world is that ?

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2021-04-24
   Survey response — days 1–6 daily, dose 1

   MedDRA: Unevaluable event — Feeling: Good

   Free text: So much better today

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-04-25
   Health check-in — days 1–6 daily, dose 1

   Feeling: Good · None

   Adult check-in
8. 2021-04-26
   Health check-in — days 1–6 daily, dose 1

   Feeling: Good · None

   Adult check-in
9. 2021-04-27
   Survey response — day 7, dose 1

   MedDRA: Axillary pain, Pain in extremity — Feeling: Good · Muscle or body aches

   Free text: I have this pain inside of my left armpit . I noticed it yesterday, but didnt think too much about. Then it became more noticeable. Its the same arm where my shot was given , but not at the site of the shot .

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
10. 2021-05-04
    Survey response — day 14, dose 1

    MedDRA: Dyspnoea — Feeling: Good

    Free text: I noticed shortness of breath for a few days while walking , however, it has subsided.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2021-05-13
    Survey response — day 21, dose 1

    MedDRA: Arthralgia, Injection site warmth, Rash macular, Self-medication, Skin burning sensation — Feeling: Good

    Free text: Sunday, May 9 burning/ heat on the left side of my neck area , upper chest , and near my collar bone. 2 red splotches / redness; no itching. Only there and no where else on my body. I used calamine lotion and it went away on Tuesday.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
12. 2021-05-20
    Survey response — day 28, dose 1

    MedDRA: Fatigue — Feeling: Good

    Free text: I noticed that Im more tired than normal; especially during and after my walk. I didnt experience that prior to my shot .

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-05-27
    Health check-in — day 35, dose 1

    Feeling: Good

    Adult check-in
14. 2021-06-01
    Survey response — day 42, dose 1

    MedDRA: Fatigue, Heart rate increased, Somnolence — Feeling: Good

    Free text: More tired/ sleepy than normal. Especially during my walks and exercise. Fast heartbeat for appx 15-20 secs. S/w cardiologist. The fast heartbeats are much better, but the exhaustion still exists.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
15. 2021-07-20
    Health check-in — 3 months, dose 1

    Feeling: Good

    Adult check-in
16. 2022-04-03
    Call 1 — Left Voicemail
17. 2023-05-03
    Call successful

    Other