Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood test, Cough, Feeling hot, Peripheral swelling
Clinical narrative: Wheezing; coughing; huge major rash; I had it with number one also but not really as bad/The caller also got the rash with the first shot; Anaphylaxis; swelled her arm up like an extra half of an inch; hot to touch; gagging; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 28Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection), dose 1 intramuscular, administered in Deltoid Left (left arm deltoid), at age 75 years, on 03Sep2021 11:00 in the morning (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes many allergies; heart condition from an unspecified date for which she was taking ELIQUIS; still has bruit in her groin and her heart doctor thought she may have an heart problem; heart surgery in Apr2021 (Apr of this year, just had surgery number 9 and tries not to do anything and is recovering from surgery, patient's doctor wants a CT of her heart but she has an allergy to dye); also has 5 herniated disks in her back, she used to be very active; patient does have underlying conditions, also an orthopedic patient and have a lot of orthopedic bone stuff also from doctor's mistake; patient had right leg paralysis and nerve damage but that was from a doctor messing up her hip surgery, messed up her leg. She cannot go around because she was paralyzed. Patient has to have special anesthesia when she has surgery. Patient has a limp and draggy foot and uses a walker. The patient's leg is independent of the others and not connected to the rest and it has a mind of its own. The patient's leg was like this prior to the vaccines. Patient was not diabetic. Patient stated that she had to wait for her heart to stabilize before she took the shot because her blood pressure has been way low, heart was finally some what stable and she is a high risk. Concomitant medications included apixaban (ELIQUIS) taken for heart condition at 5mg which is b.i.d, two times a day, 10 total so she does not have heart attack or stroke, start and stop date were not reported; menthol (BIOFREEZE) taken for an unspecified indication, start and stop date were not reported; lidocaine ointment taken for an unspecified indication, start and stop date were not reported; and also takes her normal supplements in the morning. The patient historically received flu vaccine on an unspecified date for immunisation and it makes her have a high fever and pass out. Patient stated and confirmed that she has never taken the pneumonia or Shingrex vaccine because it would kill her and will end up on the ventilator. Patient received Pfizer COVID-19 Vaccine intramuscular in the morning of 03Sep2021, left arm because she had surgery on the right arm and got it on the left arm deltoid. Both doses were administered at (pharmacy name withheld) and she had reactions with her first and second doses. Patient reported that she got the rash/mild rash on Friday night, maybe about 6 hours later, with the first shot but not as bad. She also had huge major rash with second dose, had it with number one also but not really as bad but with number two it is really bad; with number two it is much worse. The patient has had the rash since the first shot but it didn't bother her. Because She have many allergies. So, this did not surprise her. She believes that COVID-19 Vaccine caused the rash since she never had a rash before. She does have allergies, a lot of underlying allergies. But she was careful anyway all along because of her allergies. So, she knew this is the vaccine because she did not do anything different. She haven't done anything different, this is the only different thing. She knew it was the vaccine because she have taken both of them. It is just that second dose is worst, and she was thinking, and was not too sure if she should get the third one. The patient mentioned that she takes her normal supplements in the morning and so its not them. The patient stopped the BIOFREEZE and lidocaine ointment because she thought that was it but the rash was still there. Patient tried Benadryl Extra strength, 1 oz ointment (itch stopping cream, lot 2059LZ- 11 or 2069LZ- 11) and it didn't do anything. She also took Benadryl pills (allergy liquid gels 25 mg dye free lot 480646) last night from the time of reporting (27Sep2021) and it didn't touch it. The patient hasn't done anything different and is consistent because of her reactions. Normally when the caller takes Benadryl IM or IV it will knock her out but the pills didn't do anything. At the time of reporting on 28Sep2021, that night, patient was going to try the cortisone ointment because she is running out of ideas. The patient's food and liquids she drinks were the same. She has a list of 30 medications that she takes and has her allergy list and would mail it in if Pfizer would like. Patient also reported that wheezing and coughing began 10 minutes after the first dose on 03Sep2021. The first one swelled her arm up like an extra half of an inch and it was hot to touch on an unspecified date. Patient also experienced gagging on an unspecified date. Patient also mentioned that the first rash lasted 3 weeks but its worse. She is running out of ideas and is going to try cold compresses. Patient had blood work, had it with the heart surgery. But not in the past two weeks. And her blood work was perfect on Apr2021 and fine on an unspecified date. As of 28Sep2021, patient called again since she was told to call back because she needed to know what to do to feel better and what to do from here about the events. She mentioned that her mom just died so she was not thinking to clearly. As of 28Oct2021, patient reported that she had an anaphylaxis to the first dose. She stated that she is going to follow-up with her dermatologist on 03Nov2021, it was a moderate reaction to the first one, didn't go to ER, talked to doctor and treated it at home, states she was treating it with prednisone ointment. States she weaned off slowly, one day later after she stopped the medication the rash came back, all the way up to chest, welts everywhere, more wheezing. Patient also stated that she was petrified to take a new medicine because she has 40 allergies to medications. Because the patient get so sick after every vaccine she was considering not getting the booster because it is getting worse each time she gets a dose of this vaccine. She made an appointment with her PCP for later in the year but the caller's doctor doesn't care that she is having a reaction. She is a person with lots of allergies, said her symptoms are gone and added that she has been COVID negative for 2 years and is keeping good hygiene. She wanted to know if she should get the booster dose of the vaccine when she had anaphylaxis with the first two doses. And if she does not get the booster, what would be options to protect herself if 8 months will pass. She was waiting to send in the questionnaire until she was healed, still experiencing the adverse events that she had already called about it. The outcome of the events was not recovered for anaphylaxis, rash and wheezing; while unknown for all other events. The patient had her second dose of  Pfizer COVID-19 Vaccine (lot number: FE3592) on 24Sep2021.; Sender's Comments: As per available information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.