Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis reaction (itching, rash, tingling, insomnia); This is a spontaneous report from a contactable Nurse. This 75-years-old female Nurse (patient) reported herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an intramuscular route of administration, administered in arm left on 09Apr2021 09:45 at age of 75-year-old at a single dose for COVID-19 immunization. Medical history included ongoing hypertension and patient was diagnosed with high blood pressure probably 30 years ago. Patient reported that she was put on amlodipine because her other blood pressure medication wasn't keeping her blood pressure down. patient unable to provide details for blood pressure medication she took before amlodipine, ongoing reflux gastritis patient reported that she was diagnosed with acid reflux 25 years ago, ongoing osteoporosis patient was diagnosed with osteoporosis 3.5 years ago, ongoing scoliosis patient was diagnosed with scoliosis as a child when she was 11 years old. Patient reported that she had surgery 3.5 years ago and her spine was fused from T3 to her coccyx. Patient reported that when she was diagnosed with scoliosis, the doctors back then said that surgery was too drastic. Patient reported that an orthopedic back specialist advised her parents not to let anyone touch the caller, ongoing blood cholesterol increased patient was diagnosed with high cholesterol a year and a half ago, hysterectomy from an unknown date and unknown if ongoing Caller reported that she had a hysterectomy when she was 40. Family Medical History Relevant: Caller reported that she has a grandson that has a severe reaction to tree nuts. Caller reported that her grandson is the only one in her family that she knows of that has a severe allergy to something specific. The patient did not have a history of any previous allergies to specific products or any conditions indicative of an allergy. Concomitant medications included calcium taken for hysterectomy from an unspecified start date and ongoing, esomeprazole taken for reflux gastritis from an unspecified start date and ongoing, Atorvastatin taken for blood cholesterol from an unspecified start date and ongoing, losartan potassium taken for blood pressure measurement from an unspecified start date and ongoing, amlodipine besylate taken for blood pressure measurement from an unspecified start date and ongoing, alendronate sodium taken for osteoporosis from an unspecified start date to Apr2021. Calcium: Caller reported that she has been taking Calcium for years. Fosamax: Caller reported that her doctor cancelled the Fosamax because it was causing a problem with reflux, burning and so forth. Caller reported that her physician is trying to get her one something that is given by an infusion once a year to replace the Fosamax. Caller reported that she took the Fosamax in the morning with water, no food, and didn't lay down afterward. Caller reported that she knew that it would cause problems if she laid down after taking the Fosamax. Fosamax Product Info: NDC: 69097-224-16, Lot Number: GC00501, Expiration Date: Apr2023. Caller reported that she used another medication for 2 years before Fosamax that was given via injection that can only be given for 2 years. Losartan: Caller reported that she was on another blood pressure medication and the pharmacy called and told the caller to stop taking that blood pressure medicine. Caller reported that the pharmacy informed her that they had gotten reports that her blood medication was bad medication. Caller reported that she received the medication and phone call from the Pharmacy. Caller reported that the pharmacy instructed her not to take any more of the blood pressure medication and to go back to her doctor and have him prescribe something else. Caller reported that the pharmacy informed her that the product had something in it that is not good for your health. Caller was queried for details on her old blood pressure medication. Caller reported that she threw the medication in the trash because the pharmacy explained that it could be deadly to her health. Caller unable to provide details of the blood pressure medication she took before Losartan. Scoliosis: Caller reported that her brother found out that there are surgeons that are taking care of scoliosis in older patients at the hospital. Caller reported that she had the surgery done and it has allowed her to have her life back because she was going down very fast in what she could do. Caller reported that the pain was just too much at times. Caller reported that her quality of life was poor and now it's very good. Caller reported that she didn't go to see her physician for the rash or itching, she just took Benadryl and waited it out. The patient did not receive any recent vaccines for any other conditions prior to the event being reported, the patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer BIONTECH COVID-19 Vaccine prior to the event being reported, the patient did not received any other vaccines around the time of the Pfizer BIONTECH COVID-19 Vaccine vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced anaphylaxis reaction, (itching all over just severely from head to toe, small rash on back, lips tingle a little) on 09Apr2021, patient itching so bad she couldn't sleep. Patient reported that she received her first dose of the Pfizer Covid-19 vaccine on 09Apr2021. She was supposed to have her second dose of the Covid-19 vaccine today, 07May2021, but she called and cancelled the appointment. The lady that gave the caller the Covid-19 vaccine called her wondering why she had cancelled her appointment. Patient had a reaction from the first dose of the Covid-19 vaccine where she was itching all over just severely from head to toe. Patient was miserable and took Benadryl. Patient reported that the Benadryl helped her get to sleep. Patient reported that she also had a small rash on her back that she put Benadryl cream on. Patient reported that the rash lasted 2 days or so. Patient reported that she has a little itching now but it's nothing, the itching could be just normal for her. Patient reported that for 2 days the itching was not normal at all, it was severe itching. Patient reported that she didn't know if she should even have the second dose of the Covid-19 vaccine following her reaction to the first dose. Patient reported that she called the pharmacist who instructed the caller to call her physician. Caller reported that she called her physician and he informed the Patient that there is not enough information for him to be able to tell the caller what she should do. Caller reported that she asked her physician if she took a Benadryl before she went to get the second dose of the Covid-19 vaccine and took someone with her to the vaccination facility, would that be enough. Patient reported that her physician informed her that he would definitely recommend that the caller take Benadryl if she gets the second dose of the COVID-19 vaccine, but would not tell the caller whether or not she should get the second dose. Patient reported that she didn't know how long you had to decide to get the second dose of the Covid-19 vaccine or not. Caller reported that someone told her that you have 3 weeks after the first dose of the Covid-19 vaccine and 3 weeks after you're supposed to have the second dose. Caller inquired how much longer she has to decide whether or not to get the second dose of the Covid-19 vaccine. Patient reported that the itching began about 5 hours after she received the first dose of the Covid-19 vaccine on 09Apr2021 and the itching was severe for at least 2 days. Patient he has itched a little here and there, patient is always out in the yard doing something. Patient nose itched so bad that she couldn't stand it, not having any trouble with breathing and lips tingled a little and she wondered if that was just from itching. Patient was trying to use her knowledge to figure all of this out on her own. Caller reported that's all she could figure out and it was mainly severe itching. Patient had no swelling of the lips and no difficulty swallowing or breathing. Patient couldn't sleep due to the itching, so she would say that the itching was at least almost definitely medically significant, patient reported that it wasn't life or death, the itching was just annoying. Patient was constantly just scratching her head a little and she feels a little itchy at places. Patient did not know if in the past she has been itchy before but she doesn't think that she has. Small rash on back: Caller reported that when the severe itching began, there was one place on her back that she started scratching. Caller reported that she had her husband look at her back and he informed her that there was a little rash back there. Patient reported that her husband stated the rash was probably about 5 inches but only maybe 2 inches the other way. Caller reported that the rash was not a big area. Patient didn't have her husband look at the rash after that. Caller reported that when she took Benadryl orally, the itching stopped and she just let it go. Caller reported that she did have her husband look the other day and the rash was no longer there, itching, rash, tingling, insomnia was diagnosis as anaphylaxis. The patient did not required medical intervention, the patient did not visit in the Emergency Department or physician office, not hospitalized and not admitted to an Intensive Care Unit. Seriousness of the event was reported as always serious, medically significant. The outcome of event was recovering.  Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylactic reaction and the suspect drug BNT162B2.