Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Tremor
Clinical narrative: I also woke up in the evening drenched with sweat and chills, completely sweat; I also woke up in the evening drenched with sweat and chills, completely sweat; shaking so badly; I was that sick; First shot was February 25, the second shot was April 22nd; First shot was February 25, the second shot was April 22nd; have anaphylaxis at 30 minutes/probably something in the medication that she was allergic to; This is a spontaneous report from a contactable (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number reported as EDOL71/ENOL71, unsure) via an unspecified route of administration on 22Apr2021 12:15 pm as 2nd dose, single for covid-19 immunisation. Medical history included shortness of breath, asthma. Concomitant medications included albuterol (SALBUTAMOL) and budesonide/formoterol fumarate (inhalation aerosol). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Feb2021 at the age of 71 years for covid-19 immunisation and she did fine. Patient stated that lot number for shot 2 looked like EDOL71. It could be ENOL71. The lady didn't write it very well. It could be EN or ED. She was calling to report she had a terrible side effect and she want to document it in the data. She couldn't give that to computer right now, she didn't feel well, she had the Pfizer shot 1 and Pfizer shot 2. She had anaphylaxis at 30 minutes and almost she had crashed her car just after the highway. First shot was February 25, she did fine, the second shot was April 22nd and she had a horrible reaction at 30 min. Patient stated that the problem is they didn't asked her if she was short of breath or if she had any pulmonary complication and so on the second shot she didn't say anything and she forgot to say she has asthma and no one asked her. she forgot to say and so they had her sit in 15min observation and she was fine and she had gone out after she got her vaccination record card sign, she got in her car and 15min. Later while she was driving she went into anaphylaxis. She had to pull over, thank god she didn't hit anybody, she pulled over and parked and she had her inhaler with her so she used the inhaler and she got in the back seat for half an hour to make sure that she drove home, she did not call 911. Patient further stated that she wanted to put it in documentation, if someone is taking something for asthma that probably should not have the second shot one medication is not good enough, the second dose and she also woke up in the evening drenched with sweat and chills, completely sweat and that happened about 8 to 10 hours after the shot on 22Apr2021. After the shot at 12:15 pm and she had the sweat about 11 O'clock at night when she had to lay down and she was shaking so badly she thought she was going to call 911, she was that sick. That's scary, patient stated "I must, I did have crashed in 3 or 4 people during that." So, it was very dangerous to someone who has asthma. That was probably something in the medication that she was allergic to. Outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylaxis.