Q Anon: 01/03/20 Trust Trump’s Plan ~ Vol.204, Q Day 798

Published Covid-19 Vaccination Reports of Adverse Events.

VAERS DATA SET: 04/16/2021 - Anaphylaxis

All records containing 'anaphylaxis' in the adverse event description are shown below.

The records deemed 'serious' are at the top of the file and those are sorted by the number of days before onset. But 'serious' may relate to symptoms other than anaphylaxis, (e.g., a serious collection of symptoms, cardiac or stroke). Also, I saw a record that had moderate anaphylaxis marked 'not serious' so I kept all records in the file.

It's likely that some records used the term 'anaphylaxis' in a neutral way (e.g., 'anaphylaxis ruled out') but the portion of the records I reviewed (approx 100) did not have that notation.

Given the size of the post, I encourage all to practice using your browser's search feature to locate any terms of interest. I provide this for reference, to help show the kinds of information reported to VAERS. Note that the CDC has sharply reduced the rate at which they upload printed reports into the database, so this information is by no means complete.

I really do understand these are observations and not legal proof of responsibility or causal data.

Line	Vaccine	Onset Interval	Age	VAERS ID	Serious	Adverse Event Description
1	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1178490-1	Yes	She had no history of anaphylaxis from any cause, she had no history of reactions to vaccines or components. After about 5 minutes I checked on her and she said she was feeling very dizzy. I called management for assistance and got her ice packs for neck and forehead. I took her blood pressure and it was 150/90, HR 73. We laid her down and elevated her legs. She said that she felt some pressure in her chest but she had pulled a muscle there the day before and wasn't sure if it was related. She said the room was spinning as she continued to lay on the ground and it was not improving. Her blood pressure was taken about 5 minutes later and it was 143/85 HR 73. She said it is usually low. She had no signs of local reaction, hives, or swelling. She complained of nausea. After a few more minutes she said she was not feeling any better and was having pain in her throat and difficulty breathing. I asked her to try to take a deep breath and she was gasping for air, unable to breathe deeply. I administered epinephrine (one dose) and called 911. I rechecked blood pressure while waiting for paramedics and it was 125/80. She was taken to hospital when they arrived. Her mom arrived shortly before the ambulance and went with her. Pt never lost consciousness. Management followed up with patient this evening and patient is home and well, but the ER did classify the event as an allergic reaction.
2	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1087968-1	Yes	Patient received J&J vaccine at clinic (lot # 1805022). at approximately 1530, patient has a history of anaphylaxis and was being observed for 30 minutes. Approximately 25 minutes into the observation period the patient was noted to be lethargic, weak, was able to answer questions stated that she felt tingling in throat, numbness, tingling in extremities, back pain. Progressed to feeling itchiness and continued lethargy, was not able to answer what day it was. At that point we assissted patient in wheelchair to get on stretcher behind curtain. Patient given diphenhydramine 50 mg x 1 at 1600, patient became more lethargic and given epinephrine 0.5 mg x 1 at 1603. Vitals after epi were sbp 138, HR ?? reported as elevated, and 02 sats 98. 911 was called. Patient was also nauseous once in wheelchair and on stretcher, wretching when transferred to stretcher patients lower extremities began shaking, lasting a few seconds. Patient motioning towards throat as is if having trouble breathing. Patient remained stable until EMS arrived. I t was reported to me that patient had been cleared by her MD to receive vaccine but to be monitored for 30 minutes.
3	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1124508-1	Yes	Anaphylaxis (tongue swelling, loss of airway, required oxygen)
4	COVID19 (COVID19 (JANSSEN))	0 days	60-64 years	1091813-1	Yes	Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.
5	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1135429-1	Yes	tongue and lip swelling concerning for anaphylaxis
6	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0913445-1	Yes	Pt developed anaphylaxis, was given IM Benadryl, and was sent to the ED. Pt spent 1 night in the hospital, went home, and has come back and is in the ICU. Pt had hives, itching, chest tightness, swollen lips.
7	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0930079-1	Yes	Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
8	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0946553-1	Yes	anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
9	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0998224-1	Yes	Anaphylaxis. Epi Pen given and ambulance called. Given anaphylaxis cocktail in ER. 2:30pm: Vaccine administered 3:30pm: Headache & teeth ache which continued 7:00pm asthmatic cough which continued throughout 11:00pm fever and chills 9:00am felt generally very ill--stomach pain (more anaphylactic type pain) 10:00am nausea, severe stomach pain, diarreaha, vomiting, lungs very tight, continued coughing 11:00am excruciating stomach pain (stomach on fire) Throat felt ""thick"", feeling faint, brain fog, dizzy (These are my typical anaphylactic reactions) Epi pen administered & ambulance called Anaphylaxis symptoms returned in ER. The pain was the worst since my bowel obstructions several years ago.""
10	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0918086-1	Yes	Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
11	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0931772-1	Yes	Anaphylaxis
12	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0966954-1	Yes	Itching, chest tightness, SOB, tingling lips, loss of voice. Administered 100mg of benadryl within 5 min of symptom onset followed by Epi Pen with call to 911. Paramedics transported to ED. Patient was admitted with anaphylaxis. Used Adverse Event Emergency Policy.
13	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0995629-1	Yes	Pt. with known allergic type reaction after first dose of vaccine, discussed getting the 2nd vaccine by intensivist and pulmonologist and was advised to go ahead and get second vaccine. 1st vaccine Reaction: Itchiness of entire body, fatigue, tongue ""felt funny,"" stomach cramping. She was premedicated with Prednisone 40 mg po, Benadryl 25 mg po, Pepcid 20 mg morning of vaccine. Pt. was administered vaccine at 12:15 am and at 12:40, she started to have tongue and throat itching, swelling, voice change, H/A and abd. pain. Medical first response was called and Dr. (Anesthesia) and FNP was present on-site at 12:41 Epi 0.3 mg sq was given. Additional 50 mg IM of Benadryl was also administered. Pt. was transported to ED via wheelchair and found to have angioedema and dx of anaphylaxis. Pt. was administered Benadryl IV, Pepcid IV, Solu-Medrol IV, Epi IV was administered in the ED due to persistent angioedema. She was discharge home same day at 16:03 and asked to f/u with PCP in1-3 days. 2/2/21- Still on prednisone, pepcid and Zrytec. Tongue still feels itchy and a little swollen, but overall feeling well.""
14	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1003083-1	Yes	I had previous anaphylaxis events that were treated and did not require hospitalization. I brought epinephrine pen and premedicated with Xyzal 5mg 9 hours before and Benadryl 25mg 1.5 hours before vaccine. 20 minutes after vaccine I felt flushing, nausea, low blood pressure. They had released me from the drive through vaccination site and I was driving and felt panicky, so I pulled over. I waited 10 minutes because I wasn't sure if it was anaphylaxis or not. I felt OK after 10 minutes, so I drove to nearest ER and waited in parking lot several hours then drove home. I probably should have administered epinephrine and called 911 when I had that reaction. Continued with 25mg Benadryl every 4 hours and nightly Xyzal 5mg. The next morning (24 hours later) I woke up scratching my face. I had a diffuse sandpaper rash all over my head and neck and was very itchy. Doubled my dose of Benadryl to 50mg every 4 hours. Also took 400mg of quercetin. The itching resolved and the rash was gone the next day, which was 48 hours after vaccine. I was fatigued for several days but fatigue is my baseline as a narcoleptic plus I was taking benadryl. I continued the Benadryl for a total of 4 days. I normally do not develop rashes unless I rub against hay and I did not have any contact with hay.
15	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1074230-1	Yes	Anaphylaxis happened within 12 minutes. I was administered epinephrine at the vaccine site, as well as in the ambulance. FURTHERMORE I was administered DiphenhydrAMINE, Famotidine, solu-MEDROL at the Emergency Department. Those are just a few of what I received. When I was finally discharged I was sent home with 2 epi-pens and a 4 day dosing of Prednisone.
16	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1080851-1	Yes	Received vaccine Thursday afternoon. Waited for a half hour after receiving the vaccine, as there is a history of anaphylaxis. On the drive home lips began to swell and the lips felt numb. Patient went home and took some Benadryl which seemed to help. Friday 3/5 Patient woke and her arm was swollen at the injection site and was very painful. Patient also complained of a headache at that time. Later that same day, Patient developed a rash at the injection site and intense itching all over her body including her face. Patient went to the Medical Center ER. At ER the staff evaluated her and administered IV steroids and Benadryl and sent her home with instructions to return in worsens. Saturday Patient complained that her throat began swelling and so she went back to the ER. The ER gave more IV steroids and Benadryl, a breathing treatment (nebulizer), and gave 2 doses of epinephrine. Due to Patient's continued symptoms and gradual worsening condition the medical provider at ER felt it necessary for Patient to be admitted, however, due to the smaller size and limited resources at ER it was decided for Patient to be transported to Hospital. Patient has remained admitted at Hospital since then, and yesterday (Sunday) she required another dose of epinephrine due to tongue swelling. Patient reports that she is being given IV Benadryl and steroids, and she will not be discharged today. Today Patient is also reporting a burning sensation with urination.
17	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1085186-1	Yes	Other side effects; Anaphylaxis; Anaphylaxis; A spontaneous report was received from a nurse, concerning a 32-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 episodes of anaphylaxis (onset: 28 Jan 2021 and 29 Jan 2021) and other unspecified side effects. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date patient took her first of two planned doses. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the event of anaphylaxis (life threatening), within 30minutes after the second dose of vaccine. Hence, she received epinephrine and her condition did not improve so received a second dose of the same, also was treated with diphenhydramine and oxygen and sent home. Next day, on 29 Jan 2021, the patient again went into anaphylaxis, hence, received another epinephrine and was also given with prednisone due to which patient got better and was stable today. But, however, she still having other side effects but not anaphylaxis. The patient's clinical history says that on Sunday night she continued to be symptomatic with vaccine side effects. The patient was confirmed to be not pregnant. Treatment for event other side effects were unknwon. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events anaphylaxis (onset: 28 Jan 2021) and anaphylaxis (onset date: 29 Jan 2021) was resolved on 29 Jan 2021. The outcome of event other side effects was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
18	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1097625-1	Yes	Patient immediately developed respirtory distress and wheezing concerning for anaphylaxis. Was given an IM injection of epinephrine alone with albuterol nebs which didn't improve her symptoms. She was not responsive to 4 albuterol nebs and an epinephrine drip and ultimately require intubation and mechanical ventilation. She stabilized on the ventilator but required a MEDEVAC to a civilian hospital for ongoing care.
19	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1124345-1	Yes	HPI: patient is a 30 y.o. female with various medical conditions and various allergies who presents to the emergency department secondary to an allergic reaction following her first COVID-19 vaccination. This morning patient went to have her first Moderna COVID-19 vaccination. She was accidentally given and 3 mL instead of 0.5 mL of this vaccine. She was monitored following administration of this vaccine. Patient apparently did well and she went home. Then around 1030 she started having diffuse body itching and felt that her throat was tight. She has an epinephrine pen at home and administer this medication to herself over concerns of potential anaphylaxis. She contacted EMS who transported her to the ER. EMS gave her 25 mg of Benadryl in route. On arrival patient reports that she still feels itchy but she is no longer having any tightness in her throat. She reports that she is feeling better. Patient denies any lip swelling, tongue swelling, throat tightness, difficulty breathing, difficulty swallowing, and other related symptoms not mentioned above.
20	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0907022-1	Yes	Anaphylaxis/Angioedema Patient was given EpiPen 0.3 mg IM; Methylprednisolone 125 mg once; Diphenhydramine 25 mg IV push once; Famotidine 20 mg IV push once; Dexamethasone 10 mg IV push once Patient was intubated and put on propofol and midazolam drips for sedation
21	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0943272-1	Yes	Systemic: Anaphylaxis-Medium; symptoms lasted 1 day
22	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0945596-1	Yes	Anaphylaxis- throat tightness , nausea , rash , pruritis , chest tightness, wheezing . 9-11 called epinephrine x 2 , decade on , IV Benadryl , duo-nebs, famotidine, admission to icu high dose prednisone , nebulizers , zofran , duo-neb nebulizers
23	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0955491-1	Yes	Systemic: Anaphylaxis-Severe, Systemic: Seizure-Severe
24	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0959960-1	Yes	Admitted in Hospital for Anaphylaxis.
25	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0963267-1	Yes	Anaphylaxis, angioedema. Unresponsive to epinepherine, steroids. Patient required intubation, mechanical ventilation, and ICU admission. Patient started on high dose steroids, BID IV famotidine, nebulizer therapy, with improvement in symptoms. Pt still in ICU at time of this submission.
26	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0992035-1	Yes	Anaphylaxis: hives all over her body, lightheadedness, throat closing. Hypotension about 2 hours after the moderna was administered.. She received 2 doses of epipen before paramedics took her to the ER.
27	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1002056-1	Yes	Anaphylaxis reaction; Angioedema; Shortness of breath; Wheezing; Fast heart rate; A spontaneous report was received from a physician concerning a 44-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylaxis reaction, angioedema, shortness of breath, wheezing, and increased heart rate. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021 at 18:00, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, approximately 10 minutes after receiving her injection, the patient began to have tongue swelling. She was given diphenhydramine and epinephrine by epi pen. She went to the emergency room where she displayed symptoms including a fast heart rate, wheezing, and shortness of breath with an angioedema or anaphylaxis like appearance. She was given more epinephrine, famotidine, scheduled diphenhydramine at 50 QAs intravenously (IV), IV steroids, was intubated and placed on a ventilator. She was on the ventilator for approximately 18-20 hours following admission. She eventually responded to a high dose of dexamethasone. She was also given duonebs for her shortness of breath, regular sedation for the ventilator, and a dose of ketorolac. Consent was given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown at the time of this report.; Reporter's Comments: This case concerns a 44 year old female patient who experienced a serious unexpected event of Anaphylactic reaction. The event occurred approximately 10 minutes after first dose of the study medication administration. She was treated with epinephrine, famotidine, diphenhydramine, IV steroids, intubated and placed on a ventilator. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
28	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1021251-1	Yes	Within 1 1/2 to 2 mins after receiving vaccine pt states starting having an anaphylaxis reaction. Immediately transported to the emergency department. Pt had audible wheezes and stridor noted. Patient was given EPI pen her rt outer thigh. IV started. Pt started having relief within 30 seconds. Wheezing and stridor was decreasing. Pt was also started on a racemic epi neb. Pt placed on monitor and oxygen monitor. One hour later the symptoms of feeling ""throat was swelling off"" returned and EPI 3 mg given and another racemic treatment given. Treated with solumederol, Benadryl and Pepcid. Patient was admitted to the hospital where she remained overnight with no additional symptoms.She was released next day.""
29	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1033078-1	Yes	History of anaphylaxis to IV Taxol in her past. She did well after her first dose of the Covid vaccine, Within 10 minutes of receiving her second dose of Covid vaccine she c/o throat tightness, lightheadedness, flushed/warm sensation in her chest, C/O of SOB. She was injected with Epi, given Benadryl 25mg po, Zyrtec 10mg po. A CODE Blue was called and she was transported to the ED where she received a second Epi injection. She was monitored in the ED overnight, was given Benadryl every 6 hours, treated with prednisone and pepcid and Tylenol for headache. Was discharged from the ED the next morning and given Rx for prednisone, benadryl, pepcid for 5 days and and Epi pen.
30	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1068355-1	Yes	Hives; Nausea; A spontaneous report was received from a non HCP concerning a 45-Year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives and nausea. The patient was reported with an history of Anaphylaxis in the past. No relevant concomitant medications were reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, The patient experienced Urticaria (Hives) and Nausea with seriousness criteria of Hospitalization. Laboratory details are not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is unknown.; Reporter's Comments: This case concerns a 45-year-old female, with medical history of anaphylaxis, was hospitalized with serious unexpected events of urticaria and nausea. The events occurred the same day as the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
31	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1070813-1	Yes	anaphylaxis - throat tightness, hoarseness, coughing, trouble swallowing, nausea, dizziness, pallor, watery eyes, urinary incontinence, sense of impending doom
32	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1078928-1	Yes	First I got a headache, then I felt extra mucus in my throat. Then I started feeling compression, pressure, and pain in my diaphragm; and then the middle of my chest. Finally, I started coughing, and I wasn't able to breathe. I had told all of the nursing staff that I had anaphylaxis to the first shot, but they acted like they didn't believe me. Also, there was no EMS staff on hand this time, unlike the first time, where they were on site. I think that made the difference in my medical care, because my husband heard the nurses at the facility say they were treating me for anxiety, not anaphylaxis, despite the fact that I was getting worse. The nurses on staff didn't seem to understand or believe that a person could have anaphylaxis from the Covid injection, even though it's on record at the hospital that that's what happened the first time. It wasn't the same staff as last time, which also contributed to the problem. Once the ambulance staff got there, he took me seriously, and finally administered an EpiPen, and also put me on oxygen, which helped a little bit. that was the most comprehensive care I got that day, from someone who was actually listening to me he also took an EKG, which which was normal. When I got to Facility, the treatment wasn't as good as last time, either. Apparently they've been really busy the day before, and all of the staff seemed fatigued because of it. Nobody really checked on me, offered me even ice chips to moisten my mouth, and didn't offer me any assistance in getting to the bathroom, either. a respiratory therapist came in to give me a couple puffs on an albuterol inhaler, and I got a Benadryl shot, but nothing else. I think if I had not taken my coterie of prescriptions to stave off anaphylaxis, it would have been worse. 20 minutes before the shot I took: two aspirin, a CBD capsule, and one each of the following pills -cetirizine, benadryl, famotidine, 20 mg of prednisone, hydroxyzine. I think that's what enabled me to recover with only one EpiPen, instead of two, like last time. if there's a third Moderna shot for the varients, or a booster, I'll try to take all those pills an hour beforehand, and see if having them in my system for a longer period of time we'll make the difference. It will be nice to have no anaphylaxis, and skip the hospital trip . Since then, it's taken me about a week to recover fully, the same as after the first shot. I've had problems breathing, fatigue, muscle aches and pains, flushing, fever/chills, and in general just felt like I had the flu.
33	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1081161-1	Yes	Cardiac dysrhythmia, tachycardia, anaphylaxis
34	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1123197-1	Yes	The patient had an anaphylactic reaction. The patient experienced angioedema and could not speak. The patient presented with difficulty swallowing, shortness of breath, wheezing, and was unable to talk. As a result to the reaction the patient had to be intubated. However, the patient has a history of excessive anaphylaxis with multiple intubations.
35	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1123759-1	Yes	Anaphylaxis.
36	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1124651-1	Yes	Within 10 minutes of receiving injection in right arm I felt a BOOM flush all over my body like I just had an IV Contrast. Then I became dizzy, my heart started racing, I started cold sweats and felt tightness in my mid upper chest to the base of my throat. The ED RN on site took my BP and HR and had me lie down because I felt that I couldn't breath. She called paramedics who took my BP and HR, then did a 12 lead EKG. They transported me to the ED. I was worked up for cardiac, lung, chemistry. My troponin-HS was slightly elevated and a cardiologist was called. He did an echo on my heart, liver and right kidney -- normal. Chest X-ray was normal. A second 12 lead EKG was done, normal sinus. Hematology, Chemistry was normal. Was in the ED from 11:30 to 4:00 p.m. Advised by ED Doctor, and Cardiologist, that it seems the stress of the anaphylaxis reaction stressed the heart which caused the spill of troponin. Advised to see my cardiologist and get a stress test. I have already informed my Primary Care Doctor and he has prescribed me an EPI-PEN to carry. I have no history of allergic reactions/anaphylaxis reactions to vaccines. I am up to date with all other vaccines and just had my yearly flu shot in November 2020. This was my first allergic reaction/anaphylaxis reaction to a vaccine.
37	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0924050-1	Yes	anaphylaxis, dyspnea
38	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0947464-1	Yes	Abdominal discomfort; Abdominal pain; Lightheaded/Dizzy; Having trouble taking deep breaths/couldn't breath; Sweating; Hyperventilating; Developed blotchy skin; Shaking; Headache; Vomited; A spontaneous report (United States) was received from a health care professional concerning a 50-year-old, female patient who received Moderna's COVID-19 vaccine and experienced abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited. The patient's medical history included current conditions of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide. Concomitant products known to have been used by the patient, within two weeks prior to the event, included cefixime, ibuprofen, omeprazole, estradiol, and hydrocodone bitartrate, paracetamol. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) in their left arm for prophylaxis of COVID-19 infection. On 22 Dec 2020, the patient told a medical assistant in the waiting area that she felt ill to her stomach and she was having trouble taking deep breaths. The patient was found in a nearby bathroom sitting on the floor. She had vomited, reported she was lightheaded, couldn't breath, was shaking, had abdominal discomfort, and was sweating. It was attempted to move the patient to a wheelchair, but she did not respond well to the transfer. The patient reported the symptoms worsening: headache, abdominal pain, and developed blotch skin, hyperventilating, and was dizzy. A code blue was called and the patient was given a 0.5mg Epinephrine injection. The patient was sent to the emergency room. Treatment for the event included 0.5mg Epinepherine injection, famotidine, ondansetron HCl, prednisone 60mg, and lorazepam 1mg intravenously. Action taken with mRNA-1273 in response to the events was not provided. The events abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited were considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide, who experienced events of Abdominal discomfort, Abdominal pain, Dizziness, Dyspnoea, Hyperhidrosis, Hyperventilation, Rash macular, Tremor, Headache, and Vomiting following their first of two planned doses of mRNA-1273 (Lot number: 011J20A). The patient was found ill in the waiting room after leaving clinic prior to completing 15 minute observation time. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
39	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0961200-1	Yes	anaphylaxis - treatment ED / ICU epinephrine, famotidine, methylprednisolone
40	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0976123-1	Yes	Having Ehlers Danlos and Mast Cell Degranulation as well as Dysautonomia... Anaphylaxis is often referred to as slow roll and without the typical face swelling and rash. It is more subtle and can be harder to detect. And that was my experience: as follows: I became faint and briefly passed out within 2 minutes of injection. I stabilized quickly within a 30 minute hold although developed increasing nausea, I and med tech was satisfied that it might just be my dysautanomia. I spent the evening with severe headache vomiting as passed out again. I experienced throat tightening but not full closure. The next day I had flue like symptoms that I assume were normaland vaccine related. When this passed in the evening I again suffered nausea and dizziness, vomiting and throat tightening when I tried to eat. These symptoms were not similar to the flush feelings earlier in the day. The symptoms ebbed and waned for 2 days with increased frequency as I took chromalyn , Benadryl with some effect at first and ate with great care as not to introduce more allergens. I had increased chest pain, sweating, fainting, throat tightening became severe Benadryl was not effective. I was having trouble swallowing. I was forced to us an epi pen and call 911. This is a typical anaphylactic response for EDS< Mast Cell patients. It became clear that I could not get past this on my own and the symptoms were increasing. I started to shake with chills and feared shock as my chest pains increased. The epi pen injection and hospital visit via ambulance occurred Monday 1/25-1/26. I became very faint during the Ems intake with the techs having to hold me up to check vitals etc.. My HR dropped despite the EPi. At the ER I was given IV steroids, IV Benedryl and Potassium, tablets and fluids throughout the night, admitted for evaluation.
41	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1002482-1	Yes	Anaphylaxis
42	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1044303-1	Yes	Anaphylaxis reaction. Shot given around 9am. Around 11am symptoms appeared: extremely hot/flushed, nauseated, felt ill, difficulty swallowing. Went to pharmacist who had me sit down, within 30 seconds could not swallow. Pharmacist injected me with Epi Pen and called 911. Paramedics arrived gave more epinephrine, oxygen, started breathing treatment. Lost my voice as throat started to tighten more. Taken to Hospital where I was given Benadryl, steroids, stomach meds, more fluids and another breathing treatment since my lungs were so tight, I could only take shallow breaths. The crated my lungs, did blood work and kept me overnight for observation because I have a history of secondary reactions when I experience anaphylaxis. I was released from the hospital on 2/20/2021 at 2pm.
43	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1063860-1	Yes	Pt presented to the ED in acute anaphylaxis 20 minutes after receiving vaccine dose, in respiratory distress with stridor, wheezing, and difficulty breathing, as well as hives across her chest and arms. Pt had Epipen with her and ED staff assisted her in administering it. Pt received solu-medrol, pepcid, benadryl, and albuterol in the ED. Pt significantly improved within 1 hour and was admitted to the hospital to be monitored overnight.
44	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1069520-1	Yes	Anaphylaxis. 2 EpiPens, 50 mg Benadryl PO. Was with patient for 2 hours before ambulance arrived. Tingling and numbness to lips, tongue and mouth. Swelling of lips. Pruritis of throat. Dry unproductive cough. ""Feel like I'm being strangled"". Grogginess (may have been due to Benadryl). Disorientation. Increase in blood pressure. Increased respiratory rate and labored breathing. Left chest discomfort (non-radiating). Hoarseness. Appeared syncopal and weak.""
45	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1079818-1	Yes	Anaphylaxis. Onset 10 minutes. Initially responsive to epinephrine, subsequently not. Ultimately requiring endotracheal intubation
46	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1082469-1	Yes	20 min after dose of moderna vaccine she felt her face get hot and swollen and she felt tingling - 10 more minutes and she felt throat was swelling. Waited another 20 min. Went to ER. Got full body shakes and a full body rash. Given pred, benadryl, treated for anaphylaxis. Symptoms began to recur next day and came to PCP office
47	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1089675-1	Yes	Anaphylaxis - rash, SOB, lip swelling. Body aches. Symptoms started within 1 hr of getting vaccine.
48	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	1110900-1	Yes	full anaphylaxis including tongue and throat swelling, elevated heart rate, elevated blood pressure, delirium, face slightly swollen, shortness of breath, dizziness
49	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0924078-1	Yes	Client received vaccine at approximately 3:50pm, waited in observational area x30min. Left with husband, stated that she got a few miles down the road and starting experiencing tightness in her chest and flushing. She took 50 mg of Benadryl, 30mg of prednisone and two puffs on her inhaler. She returned to the clinic, upon assessment from nursing she looked extremely flushed and anxious, she stated that she still felt tightness and that she had a history of anaphylaxis once before and had used an epi pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse was normal, respirations normal, she continued to experience tightness and ""not able to catch my breath"", encouraged to use epi pen. She administered epi pen to right thigh at approximately 4:45PM, 911 called. Within a few minutes, she stated she was feeling better, less tightness in the chest, flushing was subsiding. BP at 190/70 at 4:52. EMS on scene at 5:03pm. Vitals normal , EKG normal. Client decided not to transport with EMS.""
50	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0975959-1	Yes	anaphylaxis (throat tightness, swelling, pruritis, GI upset, cramping, diarrhea
51	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0991187-1	Yes	Developed hives within 2 hrs/took Benadryl that night; swelling that traveled up the arm and neck in the morning with shortness of breath/used rescue inhaler at 0400 and then again at 0800; and then anaphylaxis by 0900. Treated in ED with EpiPen then IV Solumedrol, Benadryl and Famotidine. Recovered and started on prednisone taper pack starting at 6 tabs for 3 days etc. Suggested to make follow up Dr appt for one week following incident/set for Feb 8
52	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	1003479-1	Yes	About 3 PM she received her second vaccination for Covid. She states that she has a history of adverse reactions to flu vaccines that are anaphylactic like in the past. She usually premedicates with Benadryl and steroids. Today she did take 100 mg of Benadryl prior to her vaccination. Shortly after receiving the vaccine, she did feel like her throat was getting a little bit tight but she did not feel like it was true anaphylaxis. However she then felt very off. After this vaccine her throat started to feel tight, and she stated she did not feel well overall. She did have some tunnel vision and was shaky. At about 1730 her heart rate drops to the 30s, she started feeling itchy, and then she went into a coughing fit and started to feel her throat close. She received 0.3 mg IM epinephrine, 20 mg IV famotidine, 125 mg IV methylprednisone, 0.5 mL of nebulized racepinephrine, and 500 mL NS bolus. She has since recovered and is stable on room air.
53	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	1033484-1	Yes	Anaphylaxis. Used epiPen, taken to ER. Given solumedrol 125 mg, bendadryl, 25 mg IV monitored 4hours. Sent home with solumedrol dose packet and new epipen
54	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	1082334-1	Yes	No rxn to dose 1. Dose 2: @10 min had tingling of lips; at 12 min had tingling of tongue [and anxiety from the tingling]; @ 15 min had some SOB and knew this was not just anxiety. Had zero intention of being taken to ER as I could easily tx myself. Took inhalers, extra cetirizine. Did not take epi, though have several pens. @4 hour started feeling weak, severe arm pain. At 6 hours, unbearable arm pain, extreme weakness [did not take BP or pulse ox--though I can and wish I had]. Exceeding thirst, could not get water down fast enough. Reactivation of arachnoiditis symptoms. Started unusual muscle fasciculations in arms, leg, and face [face not normal for me]-took valium and baclofen. Next 36 hours unable Additional information for Item 18: next 48 hours, unable to get out of bed other than to get water. Severe HA upon waking [@16 H post injection]. Severe myalgias, but in areas of known arachnoiditis that have been quiescent for quite some time. Forgot to mention, as I find this strange: prior to going to sleep I had left eye conjunctivitis. Left eye only that still is slightly persistent and doesn't require any care [for me at least] I am currently 72 hours post. Still with HA and some fatigue, though worked today [I WAH for a population health company]. L arm is not as painful as the excruciating pain @ hour 4-16, and no need for additional acetaminophen. I have an exceedingly high pain tolerance due to the arachnoiditis, but this was the first time I took a narcotic in 5 years. 2 .5 mg oxycodone x1, then 600 mg ibuprofen x1, then 1 gm acetaminophen 2 over next 24 hours and nothing since, but it is still quite painful today. Different today than yesterday is the development of what feels like left shoulder bursitis. We'll have to see how this goes over time. There is extensive edema at the site, but not clear erythema [I'm dark skinned]. Still just can't seem to get enough water. Had my first meal last night [made chicken soup]. It's still pretty early on. I'm not even at the 72 hour mark yet, so hopefully things will settle down over the next weeks. I checked the box as life threatening because that was likely early anaphylaxis -- though at first I seriously thought at first I was just anxious because of the lip tingling. This is in defense of the fact I did not self administer epi when I became SOB. I likely should have, but know myself well and did fine without it and with asthma and allergy care. I didn't need extra albuterol after the first 24 hours [though writing this makes me feel SOB just from reliving it]. This second dose is a doozy. Hope this was helpful. I provided you guys with my cell but if you want to follow up, I use my phone for work so if you text first I cant tell you availability.
55	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0955478-1	Yes	Systemic: Anaphylaxis-Severe; symptoms lasted 1 day
56	COVID19 (COVID19 (MODERNA))	0 days	65+ years	1031115-1	Yes	syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states ""I already had this discussion with Dr.!"" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.""
57	COVID19 (COVID19 (MODERNA))	0 days	65+ years	1075966-1	Yes	Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.
58	COVID19 (COVID19 (MODERNA))	0 days	65+ years	1082870-1	Yes	Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen glands; Blood pressure high/ changes in blood pressure; Felt faintness; Feeling hot; Fluid accumulation; Turned a dark, pinkish color/ flushed; Changes in heart rate/ heart was racing; A spontaneous report was received from a health care professional concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction/ hypersensitivity, feeling hot, fluid retention, flushing, presyncope, heart rate abnormal, swelling face, tongue felt full/ swollen tongue, hypertension, dysphagia, not feeling well/ malaise, rash, and lymphadenopathy. The patient's medical history, as provided by the reporter, included anaphylaxis to Keflex, lisinopril and sulfa drugs. Concomitant medications reported included HCTZ, diltiazem, rosuvastatin, isosorbide mono, metoprolol and pepcid. On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day patient experienced allergic reactions, feeling hot, fluid retention, flushing, presyncope, high blood pressure, swollen glands. On 26 Jan 2021, the patient was taken into the hospital and kept there for 6 hours. On 29 Jan 2021, the patient still had faintness. Her heart was racing and she did not feel well. On 04 Feb 2021, her tongue felt full and something did not feel right. The patient's vital signs included blood pressure 190/98 and later 140/80. Treatment details included Benadryl, EpiPen, Ativan, Solumedrol, steroids, and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, feeling hot, fluid retention, lymphadenopathy, and rash were considered recovered/resolved on an unknown date. The outcome of the events, flushing, and presyncope, was considered not recovered/not resolved. The outcome of the events, allergic reaction, hypertension, heart rate abnormal, swelling face, swollen tongue, malaise, and dysphagia, was not provided.; Reporter's Comments: This case concerns a 68 Y/O F who had serious unexpected hypersensitivity along with unexpected BP high, heart rate abnormal, presyncope, dysphagia, face swelling, swollen tongue, flushing, feeling hot, malaise, fluid retention, and expected rash, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Treated with Benadryl, EpiPen, steroids. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
59	COVID19 (COVID19 (MODERNA))	0 days	65+ years	1107682-1	Yes	Anaphylaxis Pulmonary embolism
60	COVID19 (COVID19 (MODERNA))	0 days	Unknown	0979264-1	Yes	Patient was given vaccine @ 10:47am, sat in observation area for about 20 minutes then reported sore throat (of sudden onset) EMS was on site and attend patient. Patient reports history of anaphylaxis x 3.
61	COVID19 (COVID19 (MODERNA))	0 days	Unknown	1021924-1	Yes	Anaphylactic shock; A spontaneous report was received from a consumer who is also a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 27 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, after the mRNA-1273 vaccine was being given, the patient noted anaphylaxis symptoms, was rushed to the hospital and hospitalized for 24 hours. Treatment information included hospitalization, epinephrine and breathing treatments. Action taken with mRNA-1273 will be discussed with her physician. The outcome of the event anaphylaxis was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient. The medical history is not provided. The patient experienced a serious unexpected event of Anaphylactic reaction on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 029L20A). Treatment included epinephrine and breathing treatments. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
62	COVID19 (COVID19 (MODERNA))	0 days	Unknown	1036031-1	Yes	Anaphylaxis; A spontaneous report was received from a consumer concerning a 61-year-old female patient who experienced anaphylaxis and Anaphylactic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 27 Jan 2021, 3 minutes prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly (arm location not provided) for prophylaxis of COVID-19 infection. On 27 Jan 2021, within 3 minutes, the patient was hospitalized for anaphylaxis. The patient reported she had never before experienced this type of reaction. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: This spontaneous report concerns a 61-year-old female patient who experienced anaphylactic reaction. The event occurred on the same day, 3 minutes after the administration of mRNA-1273 vaccine (Lot number: 030L20A, expiration date: unknown). Treatment administered was not provided and outcome is unknown. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.
63	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0917712-1	Yes	Anaphylaxis. The COVID shot was given, no reaction then. After 7 minutes, congestion, severe cough, vomiting phlegm, feeling like throat closing started happening. Code was called, Benadryl was immediately given intramuscular in the left arm, blood pressure, pulse ox was taken, and then was taken to the Emergency Department. In the ED, I was given prednisone, one EPI, anti-nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under observation for 4 hours. I was discharged after all symptoms dissipated and was given Prednisone 20 MG (3 tabs a day) to take to help my lungs. Management followed up almost immediately, everyone from the moment I had the anaphylactic reaction was quick and prepared.
64	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1029683-1	Yes	Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.
65	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1095193-1	Yes	Anaphylaxis - Throat swelled almost completely closed, wheezing, lightheadedness (nearly passed out), throat/neck and injection site were very itchy and swollen, face/eyes swelled up, turned very pale all over, heart palpitations, etc. The next day - severe, horribly painful burning sensation all throughout my body. Even clothing lightly touching my skin felt like hot razors cutting in to me. Residual swelling of the face/ arm. Migraine. For two weeks after - Very large, hard lump under my skin at the injection site. It was about the size of my hand and was very painful. After a few weeks it went away. Treatment- large amounts of benadryl. The pharmacist wanted to use an epipen and send me to the hospital, but I refused because I could still get some air in (doctor later told me that my reaction was so severe I should have gone to the hospital). I had to keep taking large amounts of benadryl for the next few days to keep the reaction down a bit.
66	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1097912-1	Yes	Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).
67	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1124030-1	Yes	Anaphylaxis
68	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1127293-1	Yes	Anaphylaxis
69	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0936011-1	Yes	Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
70	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0938868-1	Yes	-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pr
71	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0939190-1	Yes	Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
72	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0953790-1	Yes	1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.
73	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0955966-1	Yes	Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
74	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1001196-1	Yes	anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
75	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1005304-1	Yes	Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in ""icy hot,"" tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.""
76	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1019162-1	Yes	Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.
77	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1021530-1	Yes	Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxis event in my history in reaction to horse dander many years ago. As such per the guidance I remained in the waiting room for 30 minutes. After 30 minutes I had a light rash on both forearms and near the injection site on my left upper arm. I felt fine otherwise. I went up to the nurse in the monitoring room and showed her the rash. She asked if I was having trouble breathing. At the time I was not. She said I could take Benadryl for the rash as long as I had no allergy to Benadryl. I started driving home. During my drive my throat started to feel itchy and irritated. It proceeded to get worse and when I looked at my throat in the mirror it was very red and starting to be visibly swollen. I drove to the nearest hospital and checked myself in to the emergency room.
78	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1056666-1	Yes	Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021 with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
79	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1101760-1	Yes	Patient with anaphylaxis to COVID-19 vaccine. Onset of symptoms occurred five minutes after receiving vaccine. Urticarial rash occurred on chest and abdomen. Shortly after, she developed a wheeze. EMS was onsite so they administered methylprednisolone, diphenhydramine, Zofran, Phenergran and epinephrine IM. Second and third dose of epinephrine was administered due to partial response from previous doses. Patient was taken to Health care hospital for further evaluation and treatment.
80	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1105870-1	Yes	Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred to local ED. Had rebound anaphylaxis days later (3 days after) resulting in 2nd ED trip.
81	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1116808-1	Yes	No symptoms reported. Found dead seated on couch the day after vaccination (3/14/2021). Autopsy performed on 3/15/2021 showed no evidence of anaphylaxis. Cause of death = Cardiomyopathy of Obesity.
82	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1117101-1	Yes	1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to needles in the past (did not seem like it was complete syncope to all needle sticks per RN). RN offered for her to lie down, but she said she felt ok sitting. She did not endorse any history of severe allergies or reactions to injectables in the past; she was asked the necessary questions prior to vaccination. We later learned she has Crohn?s and is on immunosuppressant Imuran for this disorder. 1023ish ? walked to checkout area 1025 - While sitting at the checkout registering for her second shot she started to feel faint and checkout staff called for help 1026 - RNs were getting the BP cuff on her. She appeared obtunded and slouching in her chair- eyes closed. Gentle sternal rub and she was able to open her eyes and tell us what her name was and ask to call her dad. BP 90/58. Cold cloths placed on her neck. Continuous pulse ox monitor placed, showing 99%. 1030 - Still drowsy and diaphoretic. Able to tell us that ""she passes out when she gets shots"" C/O nausea and vomited. Still in and out of awareness. NP is site coordinator is now present and suggests taking patient by wheelchair to safer and more private area for evaluation in SR Room. Patient able to stand and transfer to wheelchair, which we did slowly and carefully. 1034 ? Now in safer and more private area SR room with NP and RN and Dr. Firemen are here and assessing the scene with medic assessing patient. Ambulance in route, about 5 - 10 minutes out per radio communication. Checking BP every 2 minutes. Now is 68/44. C/O nausea and vomited. Pulse ox won?t pick up. Patient with decreasing LOC, eyes rolling back in head, unable to maintain posture seated, and not able to describe symptoms to us (unknown if she felt itchy but no obvious cutaneous manifestations). Unable to visualize oropharynx. 1037- BP 57/40. NP administered Epi pen 0.3 mg dose to L lateral thigh due to s/s of systemic allergic reaction/anaphylaxis including 3 known body systems: hypotension (cardiovascular), vomiting (GI), and decreased LOC (neuro). No IV fluids immediately available but were preparing to obtain. Staff getting cot for patient to lie down. Provider spoke with her mom on the phone and informed her of event. Mom confirmed that she has often before passed out with vaccines and blood draws. Dad was on his way to center and rerouted to ER. 1038 - BP 68/45 Talking to medics and able to tell them she ate breakfast and that she has a hx of Crohn's and takes a monthly injection. Informed provider that her dad was on his way. EMS team here to transport to ER. We were preparing to put her on a cot so help with her blood pressure/blood flow when she started to stabilize and EMS arrived with stretcher. 1040 - BP 97/53. Patient is now alert and talking to us. Says she has had syncope in the past ?but never anything like this.? 1041 - BP 115/53. Patient still alert and talking. Oriented x 3. 1042 - Transported to ER by EMS ambulance on stretcher. DEBRIEF: Somewhat atypical (no obvious cutaneous manifestations) and rapid, severe reaction. Ddx vasovagal vs anaphylaxis. Response to epi consistent with anaphylaxis reversal. Perhaps immunosuppressant medication contributed to severity and rapidity of reaction.""
83	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0903132-1	Yes	40 year female received Pfizer-BioNTech COVID-19 Vaccine today Patient reported prior h/o severe allergic reaction to influenza vaccine with eggs preservative. She has received flu vaccine w/o egg w/o problem. Due to her prior history of severe allergic reaction/ anaphylaxis to another vaccine, in this case flu vaccine with eggs, we should proceed with caution. She was told we could defer vaccination until more information becomes available. She opted to proceed with receiving Pfizer-BioNTech COVID-19 Vaccine and be observed for 30 minute observation period. Patient developed throat tightening approximately 20 minutes after vaccination. She received EpiPen within 1 minute of symptoms and was sent to ER immediately in wheelchair by nursing staff. Patient was evaluated in ED and was hemodynamically stable. She was given IV benadryl and was stable throughout observation
84	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0923540-1	Yes	Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
85	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0936666-1	Yes	Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
86	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0947992-1	Yes	About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
87	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0968633-1	Yes	chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
88	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0974424-1	Yes	Patient reported her tongue felt tingly 5 minutes following the first dose. She reported this finding at today's visit. She said she just took a Benadryl when she got home following her first dose. I did question if she has had anaphylaxis in the past to any meds, etc, and she said no, but reported having allergic symptoms with an antibiotic. No other allergic history to vaccines, meds, etc. Patient wanted to continue with second dose of vaccine today. Vaccinated at 1615. Patient reported tongue tingling at 1640. 25mg PO Benadryl given at 1640. Patient left the clinic at 1700 stating that she felt ok to leave. She had Benadryl at home and knew who to call if symptoms worsened. Writer called the patient back on 1/26/2021 at 1100. Patient stated that at 1900 last night (1/25/2021) she had to go to the Emergency room and received 2 doses of Epinephrine. She then had to stay the night to be observed. Patient stated that she was being discharged today.
89	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0996733-1	Yes	sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from a contactable physician (patient). A 46-years-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular into right arm on 05Jan2021 at 0.3 mL, single for covid-19 immunization. Time the vaccination was reported as 10:00-10:30. Medical history included food and environmental allergies. The patient had a history of autoimmune antibodies to thyroid but with normal thyroid numbers. No medication was needed, but autoimmune antibodies was found in the past. She had a propensity for autoimmune disease, it was just not active. She was diagnosed the first time she found auto antibodies 12 years before 19Jan2021 (2009) and checks her thyroid yearly and they had been normal. She still had antibodies, but thyroid hormone levels are normal without intervention. The patient's concomitant medications included Vitamin C and Vitamin D. Historical vaccine included Pneumovax 30 days before getting the COVID vaccine (06Dec2020, 46-years-old). Her pneumonia titers were low. Historical vaccine also included flu shot, she felt sick but like everyone else, she did not consider that abnormal. She thought most people felt kind of down and it did not have long term effects. It did not require any doctor visits. She did not have a rash or anaphylaxis. The patient was a physician and well versed in terms of symptoms. By evening of 05Jan2021, she developed tinnitus, which she had never had and has been there ever since. She was on day 13 post vaccine and still having bilaterally, every day and it never went away. She had a physician visit on 12Jan2021 and hearing test performed that day. They did find sensory neuro bilateral hearing loss worse on one side, her test confirmed bilateral hearing loss at 11:00 on 12Jan2021. It was mild so far in the high frequency ranges. So, they gave option to start 14 day course of high dose steroids with steroid injections into the ear, because in some cases of acute hearing loss, it can curb or reduce it. She decided to do that. Now she was going to be on steroids. She would be temporarily immunosuppressed. She did not know if that will affect the vaccine. She had not decided if she will get second shot. It is due next week, but she was a little nervous. She was considering delaying the booster a couple months out to see if more information develops. She provided her weight as between 175 to 180lb. Right now, the hearing loss was mild and it won't be that bad, but normally, it was permanent, which would be disabling hearing loss. She was going 20Jan2021, for the steroid injection in the ear canal. That would be the first injection. She was taking oral steroids now. They would see if this limits the progression. The events outcome was not recovered.; Sender's Comments: The possible causality between the reported tinnitus/sensory neuro bilateral hearing loss and the administration of COVID-19 vaccine, BNT162B2, cannot be fully denied based on the reasonable temporal association. 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 RA, IEC, as appropriate.
90	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0998801-1	Yes	Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.
91	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1016147-1	Yes	One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
92	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1035536-1	Yes	Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62""). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. 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.""
93	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1048199-1	Yes	hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. 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 had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event ""anaphylactic reaction/ Anaphylaxis"") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.""
94	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1098011-1	Yes	Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
95	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1100482-1	Yes	Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a spontaneous report from two contactable physicians. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267), via an unspecified route of administration on 13Feb2021 at a single dose in left arm for COVID-19 immunization. Medical history included herpes Simplex I, back pain, SI joint dysfunction, difficulty sleeping and allergy to raw tomatoes. The patient's concomitant medications were not reported. On 13Feb2021, the patient experienced throat swelling, severe allergic reaction to the Pfizer vaccine, chills, sweats, nausea, the seriousness of throat swelling, severe allergic reaction was reported as hospitalization, seriousness of the other events was reported as medically significant. Under anaphylaxis that the patient has EpiPen at home for raw tomatoes Clinical course: she had a severe reaction to the first shot presenting the following side effects: chills, sweats and nausea within 5 minutes and then developed throat swelling within 10 minutes, the patient was administered with an EpiPen, Benadryl and was sent to the ER where she received Benadryl IV monitored, eventually her symptoms diminished from 10 of 10 to a 6 in a scale of 10, the patient also received Prednisone 40 mg everyday for 4 days. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. She had a virtual visit with a patient who apparently had a severe reaction after the first vaccine. It was set up in physical therapy office. HCP wants to know if it is safe for the patient to receive the second dose of the vaccine. HCP mentioned that this is her first patient who has a severe allergic reaction to the Pfizer vaccine. She was feeling better. She was told to call her doctor about getting the second shot. The bottom line is if they acted as severely as they did she would think the answer would be not to get the second. She was better. She felt fine. She has an allergy to raw tomatoes. She knows she is not supposed to have raw tomatoes. A couple of days ago she had a dressing that must have had raw tomatoes in it because she had throat swelling. The patient said what happened with Pfizer was more. She knew it when it was happening because it has happened before. She had no hypoxia. The patient reported that her pulse ox was checked and was in the high 90's. The patient was able to swallow. No drooling. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. On 23Nov2020, the patient weighed 150 pounds and her height was 66 inches. The outcome of events was recovering. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling.; Sender's Comments: Based on known safety profile and temporal association, the contribution of the suspect drug to the onset of events 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 RAs, Ethics Committees, and Investigators, as appropriate.
96	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1184295-1	Yes	Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
97	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0906733-1	Yes	anaphylaxis
98	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0906988-1	Yes	PT WAS OBSRVED IN HOLDING AREA LEANING FORWARD IN HER CHAIR ABOUT 7 MINUTES AFTER RECIEVING THE VACINE. RN ASSESSED AND NOTED: AUDIBLE WHEEZE, RESP 40/MIN, LIP SWELLING AND PT COMPLAINED OF NAUSEA. PT WAS ESCORTED TO ER IN WHEELCHAIR ACCOMPANIED BY 2 RN'S (2 MINUTE WALK) ONE HOUR LATER - AS REPORTED BY DR (ER) WORKING DIAGNOSIS - ANAPHYLAXIS / STATUS ASTHMATICUS MEDS RECIEVED: SOLUMEDROL 125, DIPHENHYDRAMINE 50MG, FAMOTIDINE 20MG --ALL IV EPINEPHERINE 0.3MG IM X1 FOLLOWED BY 0.3MG IV X 1 FOLLOWED BY 0.1MG IV X1 PT IS RECIEVING O2 - AND PROGRESSING TO BIPAP
99	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0907616-1	Yes	12-22 HPI 53-year-old female with a history of Addison's disease, anaphylactic reaction who presents to the ED complaining of hives and shortness of breath. Patient reports that 3 days ago she received the COVID-19 pfizer vaccine. She reports that since that time she has developed progressively worsening hives on her legs and arms. Approximately 1 hour ago she began to develop shortness of breath and so she presented to the ER. Patient reports a previous history of anaphylactic reactions multiple times. Denies any other acute complaints at this time. MDM Patient came in with shortness of breath and hives. Suspect allergic reaction to the COVID-19 vaccine. Patient had already taken 50 mg of Benadryl. She was given Solu-Medrol and EpiPen. She reported feeling better with improvement in the pruritus. She reports that she has had rebound reaction requiring EpiPen at 24 hours. Given the distance that she lives from adequate medical care and the possibility for recurrent severe reactions, the patient will be hospitalized for further observation. 12-23 Female with history of asthma and addison's had anaphylaxis to covid vaccine. Admitted over night to ensure that she did not rebound. Received IV Dex and this am has had no reoccurrence of hives or shortness of breath. Will discharge home on epipen, hydrocortisone prn, prednisone bid for 5 days. Return to ER or go to PCP for worsening symptoms.
100	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0916268-1	Yes	Shortly after receiving the vaccine (within 10 minutes) the patient's tongue swelled, facial redness, gasping for air. This resident was marked for a 30 minute observation due to previous anaphylaxis type reaction. Immediately administered 0.3mg epinephrine x 1 dose. Then administered 50mg IM Diphenhydramine. This treatment course resolved the adverse reaction. Patient was monitored onsite at facility. Her husband came to pick her up and take her home. Tried to reach patient several hours after but was unable to at this time.
101	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0918211-1	Yes	Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered ""no"" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.""
102	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0936612-1	Yes	anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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.
103	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0949691-1	Yes	Anaphylaxis
104	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1003206-1	Yes	Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially. ß Her symptoms mildly improved with the initial treatment. ß Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered. ß After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms. ß 1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes. ß Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 ªC (98.3 ªF) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
105	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1009995-1	Yes	Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
106	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1027078-1	Yes	Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
107	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1030126-1	Yes	Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
108	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1125420-1	Yes	- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first
109	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0904504-1	Yes	Throat closure (angioedema/anaphylaxis) requiring ambulance transport to Hospital emergency room and stay IV infusion of Benedryl, solumedrol, and Pepcid with excellent results. Observed twelve hours, then discharged.
110	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0911462-1	Yes	she is better but still not good; not to be able to breath; sore right arm; This is a spontaneous report from a contactable nurse (patient herself). A 62-year-old female patient received bnt162b2 (BNT162B2, lot EK5730), intramuscular on 18Dec2020 at single dose for immunisation. Medical history included asthma (hospitalized on Jan2020 and has not had any issues since that time, referring to her asthma) diabetes, high blood pressure, swelling, sciatica, blood cholesterol abnormal, rosacea, reflux, allergies, sinus congestion, shingles and post carpal tunnel surgery. Concomitant medications included lisinopril, hydrochlorothiazide, gabapentin, rosuvastatin, metformin, glipizide, doxycycline, sucralfate, cetirizine hydrochloride (ZYRTEC), pseudoephedrine, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and tramadol. The patient reported that she not to be able to breath (seriousness criteria-life threatening) on 22Dec2020. She woke up this morning and could not breathe and there was no reason for her to not be able to breath. She thought she may have had a reaction to the COVID vaccine. It was the only thing she could think of that might have caused her not to be able to breathe this morning. As treatment for not to be able to breath, she used Budesonide and Levosalbutamol in her nebulizer. She had sore right arm on 18Dec2020. She informed that she had done everything she can and she was better but still not good. She planned to take the second dose of the COVID Vaccine because she thought it was more important to be protected. She suspected that the vaccine was related to the events sore right arm and could not breathe. The outcome of the event not to be able to breath was recovering; for sore right arm was recovered on unknown date in Dec2020; for she is better but still not good was unknown.; Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor; a possible causal association between administration of BNT162B2 and the onset of not being able to breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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.
111	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0950759-1	Yes	Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.
112	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0940955-1	Yes	Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely 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.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown""
113	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0979082-1	Yes	Severe anaphylaxis shock, received 5 drug injections at vaccination site, transported to ER for observation. released later that evening.
114	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1054573-1	Yes	Acute onset difficulty breathing with stridor/difficulty breathing. Tx as allergic rxn/anaphylaxis. Interventions from patient included albuterol breathing treatment. EMS provided Solu-Medrol, DuoNeb breathing treatment. Continued significant stridor on presentation to emergency department. Emergency department provided IM epinephrine, IV Benadryl, IV famotidine, racemic epinephrine breathing treatment. Symptoms improved. Stridor resolved.
115	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1054886-1	Yes	Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
116	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1101682-1	Yes	Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
117	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1107266-1	Yes	she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
118	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1116803-1	Yes	Appeared unwell after vaccination. After returning home, sat down in chair and became unresponsive. Resuscitation unsuccessful. Autopsy performed 2/17/2021 showed severe hypertensive and coronary heart disease with congestive heart failure and no signs of anaphylaxis (postmortem serum tryptase = 9.2 mcg/L; RR <= 10.9).
119	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1207946-1	Yes	Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis.
120	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0908262-1	Yes	Anaphylaxis; This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received the bnt162b2 (BNT162B2; also reported as: PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included eosinophil process allergic reaction, fish, iodine and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took rabies vaccine for immunization and experienced anaphylactic reaction on an unspecified date. On 17Dec2020, the patient experienced anaphylaxis; which required hospitalization, and was assessed as medically significant. The patient was hospitalized for anaphylaxis from 18Dec2020 to an unknown date. The clinical course was reported as follows: The pharmacist called about a patient who received the COVID-19 vaccine on 17Dec2020 and started having a reaction approximately 30 minutes later. The patient used epinephrine (EPIPEN) and 50 mg of diphenhydramine hydrochloride (BENADRYL) and returned to the hospital on 18Dec2020. The patient was currently in the intensive care unit (ICU) receiving an epinephrine drip. The patient had a previous history of an anaphylactic reaction to the rabies vaccine, eosinophil process allergic reaction, fish, iodine and shellfish allergy. The patient was stabilized but continued to have reactions (not specified). The pharmacist had not seen the patient and was reaching out to Pfizer on behalf of the physicians. The pharmacist believed this had been reported by the hospital. The pharmacist had no patient information. Therapeutic measures were taken as a result of anaphylaxis. The clinical outcome of the event, anaphylaxis, was unknown. The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis due to temporal association. However patient previous history of allergic reaction cannot be excluded to have played a contributory role
121	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0951992-1	Yes	anaphylactic reaction/anaphylaxis; This is a spontaneous report from a Pfizer Sponsored Program from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EK4176), via an unspecified route of administration on 09Jan2021 at 0.3 mL, single (standard like 0.3ml by injection once to deltoid, side unknown) to prevent from getting COVID. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction/anaphylaxis on 09Jan2021. Clinical course: The patient got the vaccine while waiting to go into the watch room, to be watched for a few minutes, and she experienced anaphylactic reaction/anaphylaxis, she went down, they gave her an Epinephrine, she didn't respond to the first dose, a second dose was given in the arm where the vaccine was given, then she was picked up by an ambulance. Agent stated the caller has been on hold for almost an hour. Caller clarifies dose was given in the arm, it occurred on Saturday with the same lot. Saturday and it went away on Saturday, the patient was worried about it coming back, thus why she asked about Epinephrine pen, the patient was taken to the hospital, and given Epinephrine a couple more times, and it resolved eventually, the patient was not admitted, she went to the Emergency Department. It could have required hospitalization but would most likely say life threatening had she not been treated. Reporter seriousness for anaphylaxis is life threatening. The outcome of event was recovered on 09Jan2021. Relatedness of bnt162b2 to reaction anaphylaxis is related for primary source.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylactic reaction/anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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.
122	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0954168-1	Yes	Anaphylaxis after Covid 19 vaccine #1. Pfizer Lot # EH9899
123	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0955173-1	Yes	Anaphylaxis after Covid 19 vaccine #1. Pfizer Lot # EH9899
124	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0971556-1	Yes	Anaphylaxis; Persistent cough; This is a literature report were authors reported 21 cases listed in table 1. This is the 20th of the 21 patients. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States. As of 23Dec2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Reporting System. Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours. Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2-150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home. A 29-year-old female patient who received the 1st dose of the bnt162b2 (BNT162B2 vaccine, unknown lot number) at single dose in Dec2020 for covid-19 immunisation. Medical history included allergy to sulfa drugs. The patient had no prior history of anaphylaxis. The patient's concomitant medications were not reported. The patient experienced anaphylaxis (signs and symptoms: generalized urticaria) and persistent cough, 54 min after vaccination, in Dec2020. It was determined to be Brighton level 2 of diagnosis. The patient received treatment at emergency department and received treatment with epinephrine. At the time of the report, the outcome of the events was recovered. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-2021043915 same article/drug, different patient;US-PFIZER INC-2021043908 same article/drug, different patient;US-PFIZER INC-2021043909 same article/drug, different patient;US-PFIZER INC-2021043916 same article/drug, different patient;US-PFIZER INC-2021043911 same article/drug, different patient;US-PFIZER INC-2021043910 same article/drug, different patient;US-PFIZER INC-2021043912 same article/drug, different patient;US-PFIZER INC-2021043913 same article/drug, different patient;US-PFIZER INC-2021043914 same article/drug, different patient;US-PFIZER INC-2021043597 same article/drug, different patient
125	COVID19 (COVID19 (UNKNOWN))	0 days	65+ years	1090382-1	Yes	Patient came to emergency department after receiving second dose of COVID-19 vaccine, unknown which manufacturer as occurred prior to emergency department visit, with worsening neck pain. Wound up being treated for possible anaphylaxis and intubated. He was intubated around 12 hours after the vaccine.
126	COVID19 (COVID19 (MODERNA))	1 day	30-39 years	0950640-1	Yes	Day 1-3 after the dose flu like symptoms Day 3-7 swelling in lymph nodes on left side of body (baseball sized) took ibuprofen and Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red rash all over body and face still going on Day 16- present: severe joint pain and fever, unable to obtain any relief
127	COVID19 (COVID19 (MODERNA))	1 day	30-39 years	0952707-1	Yes	Anaphylaxis (urticaria, tongue swelling, subjective difficulty breathing) starting approx. 24hrs first moderna dose. No prior episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV, Epinepherine 0.3mg IM. Monitored in ED, complete resolution of symptoms, discharged home.
128	COVID19 (COVID19 (MODERNA))	1 day	50-59 years	0986545-1	Yes	Serious anaphylaxis started at 630 PM the day after the Moderna dose was administered . I ended up at the Medical Center ICU for two days before conditions abated and I could be discharged .
129	COVID19 (COVID19 (MODERNA))	1 day	50-59 years	1112773-1	Yes	Moderna #1 vaccine given at 130pm March 11th 2021. Pt had history of asthma and frequent nebulizer use and had it in car with her for drive-thru vaccine clinic we did at location, which has a large parking lot. We gave 80 doses. Pt checked off anaphylaxis on the intake form so Dr spoke to her and she changed it to no history of anaphylaxis and only has history of asthma. So we gave her the vaccine. About 5 minutes later in car parking lot she started to use her personal nebulizer. I saw her in passenger side of car using a personal nebulizer so I talked to her and her daughter to find out what was going on. They said she has exacerbations all the time and this was not out of ordinary for her. I checked pulse ox and did a lung exam, etc, and she was stable. She seemed baseline according to history by her and her daughter. As she seemed at baseline and clinically was comfortable and conversant whole time, and she felt better after her nebulizer, I told them to have a low threshold for going to ER or calling 911 if her asthma was worse or different than her usual symptoms. They agreed. According to daughter, she did well until about 24 hours the next day. The daughter said she was fine and she went to store and when she returned EMTs were intubating patient and apparently the patient used her epipen and called 911 herself. Approximate time of expiration was 230pm on March12th 2021.
130	COVID19 (COVID19 (MODERNA))	1 day	65+ years	0988245-1	Yes	93 y/o with complex medical history (severe COPD on oxygen, diastolic CHF, CKD3, myelofibrosis, marginal zone lymphoma of spleen with recent progression and no active treatment, chronic anemia, afib, CAD, pulmonary artery hypertension, h/o bladder cancer, hypertension, hypothyroidism, h/o bilateral PE, sick sinus syndrome s/p pacemaker, h/o Hodgkin's disease). Has had multiple hospitalizations over the last 3 months for dyspnea, most recently in 12/2020. Enrolled in palliative care. Has had multiple transfusions (most recently 01/13/21) for his chronic anemia due to myelofibrosis, and recently started on darbepoetin. No documented history of anaphylaxis to medications or prior vaccinations. He received COVID19 vaccine (Moderna) on 01/16/21. He passed away suddenly at home on 01/17/21. Symptoms: & cardiac arrest Treatment:
131	COVID19 (COVID19 (MODERNA))	1 day	65+ years	1080431-1	Yes	Narrative: 67 year-old male received his 1st COVID vaccine dose at a clinic on 2/25/21 at ~ 11:45am. No known prior COVID infection. No history of vaccine allergies or allergies to any component of the COVID vaccine. Does have history of allergic reactions including hives, angioedema or anaphylaxis to some medications (neomycin, Neosporin, bacitracin) and environmental allergens (yellow jackets, fir trees). Patient reported previously daily use of diphenhydramine (2 caps every morning) and kept an epi-pen on hand. The afternoon of 2/26/21, patient presented to his neighbor's house requesting assistance with an epi-pen. Neighbor reported significant swelling around tongue and lips, and ability to faintly speak. Neighbor administered epi-pen, but unsure if it worked, so administered a 2nd epi-pen. Within a minute or two after the 2nd dose, patient slumped over and became non-responsive. EMS was called and neighbor began CPR. EMS reported that patient was non-responsive upon arrival. A King airway was placed and a Lucas device used for chest compressions. Three rounds of epinephrine were administered during transport to the local emergency room. Patient remained unresponsive with evidence of PEA during transport. Arrival at the ER occurred ~ 4:25pm. On arrival patient noted to be unresponsive with CPR in progress. Dose of epinephrine administered ~ 3 minutes after arrival in ER. No femoral pulse palpable, cardiac monitor did show some electrical activity. Evaluation of oral cavity showed significant swelling of tongue. Additional dose of epinephrine given. Patient remained with no palpable central pulse and showed continued evidence of PEA. Patient was estimated to have been down > 45 minutes. Patient pronounced deceased at 4:59pm.
132	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	40-49 years	1045165-1	Yes	Severe Anaphylaxis onset at 3:00am. Epinephrine administered at home. Transported to ER. BP 80/40 at admission. 2nd Epinephrine administered at ER. IV fluids. BP recovered and discharged at 7:30am. Prescribed Prednisone 20mg, Famotidine 20mg, and Cetirizine 10mg.
133	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	65+ years	1006697-1	Yes	chest pain with throat irritation 1 day after receiving vaccine. no anaphylaxis. symptoms resolved.
134	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	65+ years	1104431-1	Yes	Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.
135	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	65+ years	1111305-1	Yes	suspect anaphylaxis; passed out while driving.; entire body itching; vision issue; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular Right arm on 22Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included diabetes mellitus (DM), hypertension (HTN), hypercholesterolaemia. No other vaccine in four weeks. There were other medications in two weeks. No covid prior vaccination. Clinical course reported as: Patient got vaccine with no issues. 36 hours later he developed entire body itching. He then developed vision issues and passed out while driving. He was hospitalized and no cardiac or neurologic issues were found. The reporting physician suspected anaphylaxis since patient had severe itching with the event. There were no other likely triggers found during history other than the vaccine. Events onset date reported as 23Jan2021. Events resulted in Emergency Room Visit and Physician Office Visit. Covid test type post vaccination: Nasal Swab on 06Feb2021 result: Negative. Treatment received for the events. Outcome of events was Recovered/Resolved with Sequel. Information on the lot/batch number has been requested.; Sender's Comments: A causal relationship between the events suspect anaphylaxis, passed out while driving, entire body itching, and vision issue and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 71-year-old male patient. This case will be reassessed should additional information become available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
136	COVID19 (COVID19 (UNKNOWN))	1 day	18-29 years	1177058-1	Yes	Family reports that patient had her 2nd dose of COVID-19 vaccine on 4/1, approximately 3 weeks after her first dose. Patient had one week history of ""allergy type"" symptoms. Evening of 4/1 developed ""GI symptoms and diarrhea"". Morning of 4/2 her ""neighbor came by to check on her and she stated that she was not feeling very well last night but thought she just needed some Gatorade of something...He stated that as he gave her the alka-Seltzer he told her that there was aspirin in it which apparently she has an allergy to. He stated that her response was I should be fine I do not think I'm that allergic to aspirin...5 to 10 minutes later she started to have some issues...Patient stated to her neighbor that she was having a hard time breathing and thought she needed to go to the hospital, and that maybe she was more allergic to the aspirin than she had thought...Over the 15 miles between her house and the hospital patient condition deteriorated to the point where they arrived at the hospital she is in full cardiac arrest...given ACLS protocol including epinephrine and was intubated."" ""They achieved ROSC after approximately 10 minutes."" Patient was then flown, MT emergency department to Hospital. Patient was cared for in the ICU. Patient herniated her brain the night of 4/5-4/6. ""After meeting the clinical and imaging criteria at 1605 on 4/6/2021 she was declared brain dead. Medical team suggests that patient had Samter's Triad/Triad Asthma with history of asthma, nasal polyps and allergy to aspirin. Anaphylaxis secondary to ingestion of aspirin via Alka-Seltzer.""
137	COVID19 (COVID19 (PFIZER-BIONTECH))	10-14 days	65+ years	0994731-1	Yes	[Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.
138	COVID19 (COVID19 (PFIZER-BIONTECH))	10-14 days	65+ years	1022902-1	Yes	death Narrative: 71 yo male who passed away on 1/29/2021, medical cause of death ""cholangiocarcinoma, interval between onset and death 14 months. Since patient passed away within 42 days of the covid19 vaccine administration, we are required to complete a report to VAERS. Vaccine (Pfizer) was administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Synopsis- 1/23 71 yo male presented to ED with upper GI bleed. PMH: DM, HTN, cholangiocarcinoma of biliary tract requiring recurrent paracentesis, COPD, perigastric and lower esophageal varices (not on beta blockers due to bradycardia). Pt has had 2 episodes of coffee ground emesis. Lactic 2.6, ammonia 52. Rec'd protonix, octreotide, and ceftriaxone in ED. Family has been previously encouraged to speak to palliative care but has never been willing to. GI consulted. 1/24 EGD completed. No signs of active bleed. MDs recommending hospice. CT + for small bowel ileus. 1/26 Requires placement of NG tube to suction. Palliative care consulted. 1/27 Paracentesis completed. 4100mls removed. 1/28 Pt changed to palliative status. 1/29 Pt passed away.""
139	COVID19 (COVID19 (MODERNA))	15-30 days	60-64 years	1008241-1	Yes	On 1/27/2021 was to have stress echo done with imaging -- when injected with Lumason -- I had an immediate, severe anaphylaxis shock requiring transport to hospital, intubation, and short MICU stay -- was referred to allergist who felt the PEG in Covid vaccine sensitized me to the PEG in Lumason thus resulting in severe allergy
140	COVID19 (COVID19 (PFIZER-BIONTECH))	15-30 days	30-39 years	1037040-1	Yes	Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of the thong, itchy throat, head, neck, sob. I immediately reported my symptoms to the MD that was in the room monitoring the recent vaccinated employees. Immediately he administered 50mg of Benadryl, 20mg of Pepcid, and salbutamol. I was rushed to the ED and stayed there for couple of hours headed back to my unit and then sent home by my manager.
141	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	6-17 years	1114461-1	Yes	Anaphylactoid reaction; PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject was in the open-label phase of the study when the event occurred. A 17-year-old female subject with a past medical history significant for multiple allergies with anaphylaxis received first dose of blinded therapy (BNT162;PLACEBO) on 20Nov2020 at 17:04 and second dose on 15Dec2020 at 15:16. Per protocol, the participant was unblinded and confirmed to have received placebo and subsequently received third dose of study vaccine (BNT162B2) on 25Jan2021 at 16:50, all via intramuscular route in left deltoid as single doses for COVID-19 immunization. Ongoing medical history included penicillin allergy from 2010, peanut allergy from 2004, legume allergy from 2012, chickpea allergy from 2012, chocolate allergy from 2012, flaxseed allergy from 2016, all with anaphylaxis; pollen allergy from 2007, and asthma and eczema both from 2003. Additional medical history included: tree nuts allergy from 2004 (anaphylaxis). Ongoing concomitant medications included salbutamol sulfate (PROAIR) from 2010 for asthma, epinephrine (AUVI Q) from 2005 for penicillin allergy, peanut allergy, tree nuts allergy, legume allergy, chickpea allergy, flaxseed allergy and chocolate allergy, cetirizine hydrochloride (ZYRTEC) from 2007 for pollen allergy, loratadine (CLARITIN) from 2007 for pollen allergy, and triamcinolone acetonide from 2007 for eczema. There were no concomitant vaccines administered on same date of study vaccine and no prior vaccinations (within 4 weeks prior to the first administration date of study drug). The subject experienced hives left arm on 27Jan2021 at 10:30, shortness of breath 27Jan2021 at 11:00 and a diagnosis of anaphylactoid reaction on 27Jan2021 at 10:30, which were considered as life threatening (the event was considered life-threatening as subject with known anaphylaxis with tree nuts and subject reported similar symptoms). Clinical course was reported as follows: On 27Jan2021 at 10:30 (2 days after receiving BNT162B2 injection on her left arm) the subject started developing hives on her left arm and used her epinephrine pen at 10:54 and shortly after developed shortness of breath at 11:00. The subject did not touch or consume anything new prior to developing the hives on her left arm and the shortness of breath. The subject was not seen by a school nurse and self-administered her epi-pen. The hives resolved at 11:04 and the shortness of breath resolved at 11:24. The subject denied any other symptoms and did not seek further medical attention. There were no relevant tests done. The action taken in response to the events for study vaccine (BNT162B2) was permanently withdrawn (reported as not applicable as per investigator). The subject was not dosed vaccination 4 on 17Feb2021 (Visit 102). Outcome of the events was recovered on 27Jan2021. The investigator reported that there was a reasonable possibility that the event anaphylactoid reaction was related to Dose 3 of the study vaccine (BNT162B2), but not related to dose 1 and dose 2 of blinded therapy (BNT162;PLACEBO), concomitant drugs or clinical trial procedure. Follow-up (27Jan2021 and 03Feb2021): Seriousness life-threatening justification, additional medical history (tree nuts allergy) and clinical course (did not touch or consume anything new before SAE). Follow-up (18Feb2021): New information reported includes: action taken with the blinded study vaccine. Follow-up (02Mar2021): New information reported includes: concomitant medication and action taken with the blinded study vaccine. Follow-up (11Mar2021): New information reported includes: SAE term updated to 'anaphylactoid reaction'. This is a final report for initial notification of a life threatening event. .; Sender's Comments: The event 'anaphylactoid reaction' is unlisted in the protocol's Single Reference Safety Document (IB). Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 28-FEB-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Anaphylactoid reaction.Review of the database for the PT Anaphylactoid reaction had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 29 non clinical trial cases. The information available in this report is very limited. The Company considers that there is a reasonable possibility that 'anaphylactoid reaction' is related to the study product. There is a plausible, although belated, time relationship between vaccination with BNT162b2 and onset of the event in a subject with a medical history of allergic diathesis; it is worth noting that symptoms resolved rapidly upon self-medication. From the available information for the rationale that led to attribution of a life-threatening seriousness criterion, it may not be justifiable based on past-history of anaphylaxis alone The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
142	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	18-29 years	1108043-1	Yes	Patient developed urticarial rash on 3/13/21 which began on her lower extremities and progressed to most of her body by the following day. She was seen on 3/15/21, and had no other symptoms besides the rash and was treated with zyrtec and benadryl but prescribed an Epipen (Auvi-Q) in case of worsening. The next day, 3/16/21 she awoke with swelling in her mouth and worse rash, used her Auvi-Q and called 911 and was taken to ER where she was treated for anaphylaxis with IV solumedrol,, IV fluids and IV benadryl and was sent home on Prednisone and benadryl and Pepcid.
143	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	50-59 years	0992900-1	Yes	Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
144	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	60-64 years	1089507-1	Yes	48 hours (Feb 26) after receiving the shot, I had anaphylaxis symptoms... red blotches around mouth, swelling face, swelling lips, ants-crawling feeling on face, neck and scalp. Went to Urgent Care, given benadryl and steroid shot. Rx Prednisone 20 mg x2, 5 days. Anaphylaxis happened again the next day (Feb 27) just prior to taking the first prednisone. Went back to Urgent Care, another shot. Meds kept full on allergic reactions at bay on Monday and Tuesday. Had swelling face, lips and tongue happen in Primary Care office on March 3, received another shot and increased prednisone rx to 30 mg x2, with taper. On March 5, happened again, went to ER, where doc changed timing of prednisone to 60 mg all in one dose. All in conjunction with hydroxyzine 25 mg every 12 hours and 50 mg of benadryl every six hours. Situation continues with mild swelling, itchy sensations happening just before it is time to take new meds .
145	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	40-49 years	0938524-1	Yes	first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
146	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	65+ years	1140050-1	Yes	Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a ""blockage in his throat"". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report ""cause of death is anaphylaxis"", and pt would be an OME case.""
147	COVID19 (COVID19 (PFIZER-BIONTECH))	5 days	50-59 years	1085741-1	Yes	Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
148	COVID19 (COVID19 (JANSSEN))	6 days	65+ years	1152033-1	Yes	Patient is a 69-year-old female who reports a history of hayfever who is coming in today after recent Covid vaccination with concerns of facial swelling also complaining of the rash and itching to her chest. On exam the patient has obvious facial swelling. She has what appears to be an urticarial rash on her chest. While she does have swelling around her lips and face otherwise she does not appear to have any obvious signs of airway involvement with no swelling of her tongue or uvula, she has good phonation with normal respirations without difficulty. Does not appear to be having reactive airway disease exacerbation at this time. Does not appear to have impending respiratory distress. She otherwise does have some skin changes in her bilateral lower extremities that she reports is baseline with her history of eczema. Primary concern at this time is for possible allergic reaction. Patient appears to have angioedema. Does not appear to have anaphylaxis. Other abnormalities are considered. Patient will be connected to cardiac and respiratory monitors. IV access will be obtained. The patient will be given a 1 L IV fluid bolus. She will be given Benadryl, Solu-Medrol, and famotidine. Patient be monitored for response. Labs have been ordered to evaluate. EKG as well as chest x-ray will be obtained. We will file VARES report. Chest x-ray obtained. There is no acute cardiac no acute pulmonary pathology on my interpretation. Laboratory evaluation has returned. The patient's CBC is reassuring. CMP shows a glucose of 78, otherwise reassuring without significant abnormality. Troponin within normal limits. Covid, influenza, RSV testing is negative. On repeat evaluation the patient is resting comfortably. She reports that the itching has resolved. Her face feels less uncomfortable. She has had no progression of the swelling. On repeat examination she continues to have facial swelling as well as swelling around her lips however she has no tongue swelling, no swelling within her posterior oropharynx, and her phonation continues to be normal. She and her friend were informed of the initial findings. Plan at this time is to admit for further evaluation and treatment.
149	COVID19 (COVID19 (MODERNA))	Unknown	50-59 years	0959928-1	Yes	Agitation, BlurredVision, Confusion, Anaphylaxis, UrticariaPruritus, Syncope, Pt experienced reaction three days PRIOR to first vaccine - event documentation only. Narrative: Pt has history of likely environmental allergies resulting in 4-5 mild reactions annually. Has seen allergist-immunologist in the community and has epi-pens, ranitidine and diphenhydramine. Had reaction three days PRIOR to first covid vaccine dose. She did NOT experience any untoward reaction to either dose of vaccine.
150	COVID19 (COVID19 (MODERNA))	Unknown	65+ years	1106166-1	Yes	Blood pressure up and down; Vaccine was purple and not clear in vial; A spontaneous report, was received from a consumer (patient), a 70 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced blood pressure up and down (blood pressure fluctuation), and vaccine was purple and not clear in vial (product colour issue). The patient's current conditions included allergy to dye and anaphylaxis. Concomitant medications were not reported. On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, after receiving the vaccine, the patient had her blood pressure up and down. The patient stated that the vaccine was purple and not clear in the vial on 24 Feb 2021, and still the pharmacist gave her. The patient was hospitalized for her blood pressure fluctuations. Treatment information was not provided. Action taken with second dose of mRNA-1273 in response to the events was not provided. The outcome of the event, blood pressure up and down was not reported and that of event vaccine was purple and not clear in vial was recovered on 24 Feb 2021. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded. Further information has been requested.
151	COVID19 (COVID19 (MODERNA))	Unknown	Unknown	0969615-1	Yes	High Troponin Levels; Felt dizzy; Chest felt tight; Mitral valve filling defect; Difficulty breathing; Concern of anaphylaxis; Passed out unconscious; A spontaneous report was received from a physician concerning an approximately 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect. The patient's medical history as provided by the reporter included a history of anxiety. Concomitant medication use included sertraline, buspirone, acyclovir, propranolol, hydroxyzine and lorazepam for unknown indications. On 04 Jan 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021) intramuscularly, in her left deltoid, for prophylaxis of COVID-19 infection. On 04 Jan 2020, a couple of minutes after receiving the vaccine, the patient experienced dizziness, chest felt tight, difficulty breathing, and she passed out unconscious. Due to concern of anaphylaxis, while the patient was still unconscious, she was treated with epinephrine followed by intramuscular injection of cetirizine hydrochloride. In addition, ammonia salt was used. The patient woke up briefly and passed back out. Emergency medical services (EMS) arrived and almost had to intubate the patient. The patient stayed overnight in the hospital due to lab values indicating non-ST segment elevation myocardial infraction, high troponin levels, and a mitral valve filing defect. It was noted that the patient has never had an allergy to anything, including the excipients in the Moderna vaccine. In addition, the patient had no history of loss of consciousness or anaphylaxis. Relevant laboratory tests conducted included an echocardiogram which found no issues with cardiac function and noted a mitral valve filling defect. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect was unknown.; Reporter's Comments: This case concerns a 28 year old female patient with medical history anxiety who experienced Concern of anaphylaxis , high troponin levels, dizziness, chest discomfort, difficulty breathing, loss of consciousness and Mitral valve filling defect same day after administration of the first and only dose of the mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021). Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.
152	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	18-29 years	1056642-1	Yes	anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting tight; very nauseous/sick of her stomach; rash on her chest; She could not swallow; This is a spontaneous report from a contactable consumer (parent of the patient). Information were received also from a Pfizer-sponsored program COVAX US Support. A 20-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261), via an unspecified route of administration in the left arm on 05Feb2021 09:30 at single dose for COVID-19 immunisation. Medical history included acne, allergy environmental cats dogs and latex. Adrenaline (EPIPEN) and Corticosteroid were used to treat these allergies. Due to these severe allergies, the patient had to take weekly allergy shots. Got allergy shot the day before the 2nd vaccine shot. Concomitant medication included isotretinoin (AMNESTEEM), buspirone (unknown manufacturer), calcium (unknown manufacturer), azelastine hydrochloride, fluticasone propionate (DYMISTA), gabapentin (unknown manufacturer), melatonin (unknown manufacturer), omeprazole (unknown manufacturer), estrogens conjugated, medroxyprogesterone acetate (PREMELLA), probiotics (PROBIOTICS), fluoxetine hydrochloride (PROZAC) , trazodone (unknown manufacturer), colecalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC). The patient previously took clindamycin, bactrim and corticosteroids and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249) intramuscular in left arm on 15Jan2021 at 11:00AM. It was reported that 15 minutes after receiving her second COVID-19 vaccine dose the patient developed anaphylaxis, her throat started closing up, her throat felt funny, like it was getting tight. A nurse administered her anaphylactic shot (EPI-PEN shot) and was taken to the hospital by ambulance. The patient was monitored in the Emergency Room because her blood pressure and heart rate were up, but the Emergency Room didn't give her any further treatment. The patient was discharged home on 05Feb2021. On Saturday, 06Feb2021, at 4-5AM she developed anaphylaxis again, the patient had the same throat tightening happen again. The mother gave her an Epi-Pen shot (AUVI-Q) and brought her back to the Emergency Room. While in the Emergency Room, the patient was given steroids and Pepcid, and then sent back home. On Sunday, 07Feb2021, at approximately 1:00AM she had the same throat tightening so the mother gave her an Epi-Pen shot (AUVI-Q) again, and brought her back to the Emergency Room. The patient was admitted to hospital and discharged on 09Feb2021 evening (at 16:00). At hospital the patient received some steroid shots in the hospital. The patient was given 3-125mg steroid shots, and 3-40mg steroid shots, every night she spent in the hospital, she woke up with her throat closing and she was administered 125 steroids 50 mg Diphenhydramine (BENADRYL) and 4-5 hours later 40 mg of steroids 20 mg Famotidine (PEPCID) IV. They kept IV fluids. On 10Feb2021 at 7:50AM the patient experienced throat tightness again. The mother gave her some Diphenhydramine (BENADRYL) and steroids which were prescribed at hospital. The patient started a taper dose of Prednisone 10mg tablets. She was to take 2 Prednisone 10mg tablets twice a day for 3 days, then to take 2 Prednisone 10mg tablets in the morning and 1 Prednisone 10mg tablet in the evening for 3 days; then to take 1 Prednisone 10mg tablet twice a day for 2 days, and then 1 Prednisone 10mg tablet daily for 2 days. The patient was prescribed generic Famotidine (PEPCID), 40mg, one tablet, twice a day, and generic Diphenhydramine (BENADRYL) 25mg capsules. On unknown date in feb2021 the patient gets very nauseous when her throat starts to close. She could not swallow and was sick of her stomach. She experienced a rash on her chest. The outcome of the event heart rate increased and blood pressure high was recovered, for anaphylactic reaction and throat tightness was not recovered. For the other events was unknown. The events anaphylaxis, throat tightness, heart rate increased and blood pressure were serious due to hospitalization.
153	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	40-49 years	1068260-1	Yes	Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
154	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Unknown	0960409-1	Yes	flushing/ facial flushing; Hives; felt warm; short of breath/ audibly gasping for air; wheeze; throat tightening; throat got so swollen and itchy; throat got so swollen and itchy; could not swallow; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A non-contactable consumer reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included food severe allergic reaction to influenza vaccine with eggs preservative. Concomitant medications were not reported. The patient previously took influenza vaccine and experienced severe allergic reaction to the eggs preservative. The patient received BNT162B2 vaccine and informed of prior history of severe allergic reaction to influenza vaccine with eggs preservative. She has previously received flu vaccine without egg without problem. Due to her prior history of severe allergic reaction/ anaphylaxis to another vaccine, in this case flu vaccine with eggs, it was noted to proceed with caution. She was told that the vaccination could be differed until more information became available but opted to proceed with receiving the vaccine and be observed for 30 minutes. The patient developed throat tightening approximately 20 minutes after vaccination. She received EpiPen within one minute of symptoms and was sent to the emergency room immediately in a wheel chair by Nursing staff. She was evaluated in the emergency department and was hemodynamically stable. She was given IV Benadryl and was stable throughout observation. The patient then reported that 40 minutes after injection, her throat and tongue started to feel weird and tight. The pharmacy at her work hospital gave her 25 mg Benadryl and 650mg Tylenol. At about 1 hour 45 minute after injection, her throat got so swollen and itchy to the point that she could not swallow. She went to the nearest emergency room hospital and they administered decadron and Pepcid orally, and Toradol intramuscularly. On an unspecified date, the patient also reported that 5 minutes after the vaccine administration, she developed flushing, hives, felt warm and eventually short of breath. She started to wheeze and was wheeled into the emergency room with complaint of ""cannot breathe, while holding throat and thrashing with facial flushness noted."" She took two Benadryl and had several epinephrine shots. She was discharged from the emergency room but later that day, she started to feel short of breath again. In the emergency department, she was audibly gasping for air, however had no wheezing, had a normal saturation and normal blood pressure. She had taken another dose of her EpiPen intramuscularly and diphenhydramine 50mg by mouth prior to coming. She was then admitted to the hospital for further observation. While on the floor, she started to feel short of breath again (about 9am on 18Dec2020), which required an ""RRT."" The patient received another dose of diphenhydramine IV, methylprednisolone 125mg IV and several doses of IM epinephrine and also required oxygen. She was than transferred to an ICU for further care. Outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.""
155	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1095027-1	No	Pt is here with c/o diffuse redness and itching rash which started last night; he took the J&J COVID vaccine around noon yesterday from facility; he denies any wheezing, dyspnea or SOB; denies any prior allergic reaction; no h/o anaphylaxis; Pt stated he was not provided with a hotline to call to reports vaccine reactions. Solu-Cortef 100 mg IM x1 given in the office today; will also place him on prednisone taper which he will start tomorrow morning; Zyrtec 10 mg qd also started today; pt is advised to call 911 or go to the nearest ER should he developed wheezing, SOB and difficulty breathing; he agrees with plan and voices understanding. Incident about the vaccine reported to VAERS.
156	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1097100-1	No	Anaphylaxis. High temp, swollen face, throat, eyes, chills, Required ER visit
157	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1097962-1	No	Patient developed shortness of breath, tachycardia, epigastric and chest pain. A thorough workup was performed to search for other causes and none was found, ultimately patient was treated as moderate anaphylaxis, symptoms improved with fluids, steroids, benedryl, and she was discharged with strict return precautions and outpatient followup.
158	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1102055-1	No	23 y/o female presents with nausea, vomiting, and shortness of breath since just after lunch time. SM reports 3 episodes of emesis, she ate fish for lunch. +wheezing/shortness of breath. Pt received Janssen COVID vaccine at around 0900 hours this morning. She did experience some fatigue a couple hours after vaccine. No other medications or allergies. PE pertinent for wheezing b/l on lung exam. VS normal. Due to current presentation and history suspect anaphylaxis 2/2 COVID vaccination. Pt given Epinephrine auto-injector in clinic, after which she reported resolution of wheezing and improved ability to take a full breath. Heart rate elevated to 124 BPM with BP of 142/95 and SPO2 stable at 100%, these VS subsequently normalized. Pt also given 125mg solumedrol and 50mg Benadryl both IV. Due to concern for progressive deterioration will transfer Pt to ER for improved monitoring and potential for other emergent treatment.
159	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1102479-1	No	About 40 mins after I felt my throat closing and felt like I couldn't breathe. Since then I have had several other instances of feeling similar (though none of them went to full anaphylaxis. I went to the ER Saturday and my PCP today, still for shortness of breath.
160	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1110016-1	No	Received vaccine at 0900. At 2100, chills, body aches. At 2300, itching left elbow that progressed. Seen at 0600 next day and diagnosed with hives. No anaphylaxis. However, as precaution he was given epi, solumedrol iv, and Benadryl po. Patient discharged to room. He is in setting overseas.
161	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1120716-1	No	At approximately 10:35am client had completed his 15mins observation and was ready to go home when he briefly felt his throat closing. He then called 911 and went back inside to EMT station and notified EMTs. He was then assessed and denied history of Anaphylaxis or allergies to food or meds. Assessment revealed no hives, rashes, skin flare ups, itchiness or shortness of breath. Client denied chest pain, difficulty breathing or pain throughout the body. Initial Vital signs were taken and taken every 5mins after that. He was asked to stay for 30mins. Client told 911 operator he felt safe to hang up and stay with EMT at vaccination site. Client's initial vital signs were a pulse of 112, Blood pressure of 164/92, O2 sat of 99% on room air and respirations of 24 with no signs of accessory muscle use. Due to client's vitals improving with his calmer demeanor, no additional interventions were felt to be necessary at this time. Client stated he felt better and was encouraged to follow up with his Primary Care Provider and emergency precautions were given. Vital Signs: 1035 - 164/92 (BP), 112 (HR), 99 (O2) 1040 - 160/90, 96, 99 1045 - 142/88, 94, 99 1050 - 138/88, 94, 99 1055 - 132/88, 94, 99 No medications were administered.
162	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1124073-1	No	Client complained of feeling dizzy and light headed after receiving the vaccine, He reports an allergy to Bananas which causes anaphylaxis. He does not carry an Epi Pen. Vasovagal event with no syncope. Blood pressure 87/41 pulse 78 with 02 saturation 96%. Se4cond set of vitals in 5 minutes was blood pressure 116/70 with pulse 75 and o2 saturation 98% . Released by Dr after second vitals by EMS on site. Advised to seek medical attention later if needed. Client stated understanding.
163	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1138017-1	No	ED COURSE & MEDICAL DECISION MAKING Patient is a 20 y.o. male who presents emergency department for evaluation of fevers, chills, nausea, and shortness of breath. Symptoms occurred approximately 3 to 4 hours after his Covid vaccination today. He has not felt symptomatic for symptoms related to COVID-19 prior to his vaccination. Nausea was noted without vomiting and he was given Zofran prior to arrival. No objective evidence of anaphylaxis or angioedema was noted at urgent care nor was this noted on physical examination. He does have a fever on arrival with Tylenol taken a little more then an hour prior to arrival. Chest x-ray negative for findings of COVID-19. There was no evidence of pneumonia. His blood counts were otherwise reasonable though he did have relative lymphopenia that can be described in COVID-19 infection. Metabolic profile was otherwise benign. Differential diagnosis of his fever include the possibility of a vaccine reaction though the timing is rather quick for this reaction. Certainly this remains in his differential. His he has history of asthma and felt short of breath he was given Solu-Medrol. He was given Toradol with improvement of symptoms as well as IV fluid. With differential diagnostic considerations that he may have Covid, he was swabbed and tested at bedside. With his well appearance he was ambulatory in the emergency department. He was discharged stable condition with recommendations for Tylenol and ibuprofen in the short-term. Procedures MDM CHIEF COMPLAINT Fever and Chills HPI The history is provided by the patient, medical records and the EMS personnel. Patient is a 20 y.o. male who presents emergency department with fevers, nausea, and shortness of breath. He has generally not felt well over the course of the last 8 hours after receiving his first Covid vaccination this morning at 9 AM. Fevers have been noted. He took Tylenol with 2 tablets an hour prior to arrival. He has had shortness of breath with a history of asthma. He denies productive cough, or chest pain. He denies abdominal pain, or diarrhea. He denies dysuria or frequency or hematuria. Seasonal allergies are noted without significant medication allergies. He denies a sensation of throat closing. He denies tongue or lip swelling. He was seen in urgent care and sent to the emergency department for further evaluation.
164	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1162800-1	No	A few minutes after receiving vaccine patient began to have irritation in throat and tightness in the chest. 911 was called. 50 mg of diphenhydramine was given to patient with their consent and denied any allergy to benadryl. Counseled patient that benadryl could cause drowsiness. Patient denied any history of anaphylaxis in the past. The EMTs arrived and took over care. Vitals were good per EMT's. The EMTs escorted patient from the pharmacy. Per the EMTs, the patient was advised to self-monitor at home and seek medical attention if any worsening of symptoms, and they advised the patient not to drive home, and alternate transportation was arranged.
165	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1164029-1	No	Patient is a 26 year old female who presents immediately following administration of a single dose of J&J COVID19 vaccine in the left deltoid. Patient was walking with her mother to their vehicle when she lost consciousness. Per patient?s mother, the patient has a developmental delay and can be a poor historian. Patient states that she has never experienced syncope. She denies allergies to medications and foods. She has never had a vaccine in the past. Patient denies a medical history. Patient states that she takes Concerta and Lexapro on a daily basis. She denies chest pain/tightness, shortness of breath, wheezing, swelling of the face/lips/mouth/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Vasovagal syncope with loss of consciousness. Patient not displaying active signs and symptoms of anaphylaxis. Patient was transferred to a cot and very quickly regained consciousness. Patient was A&O x 4 and in NAD. EMS was called to the scene for further evaluation due to limited resources. EMS called to the site for further evaluation due to vasovagal syncope with loss of consciousness. EMS related patient was experiencing orthostatic hypotension. EKD and blood sugar levels were within normal limits. Patient transported to ER.
166	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1179915-1	No	Patient presented himself for COVID19 Vaccine administration on 04/05/2021 at 4:10pm. Upon checking in for his appointment, he was provided with Conviva?s COVID19 vaccine screening and consent form in which he denied the following: ? Having allergies and reactions to any medication, foods, vaccines, or latex. ? Carrying an Epi-pen for emergency treatment of anaphylaxis. ? Having had a severe reaction to previous dose of this vaccine or to any of the ingredients of this vaccine. After the vaccine administration, patient was guided to the observation area for a 15-minute observatory period. At approximately 4:25 pm- patient, while in the observation area, expressed to the clinical staff member monitoring the area, that he felt lightheaded and needed to lay down, he leaned forward, and the clinical alert team was activated. Patient was lowered to the floor; a pillow was placed under his head and his feet were elevated. Vitals reported were taken in the presence of registered nurse while patient was laying on the floor. Vitals ? Glucose 97 ? Blood pressure 120/77 ? Oxygen saturation level 97% ? Pulse 72 Register nurse reports that patient was laying on the floor, alert, oriented to place, time and person. Patient never lost consciousness and within approximately 5-7 minutes he was sitting up, drinking water. At this time, patient was asked the following series of questions: ? How do you feel? As per patient, he was feeling nauseous, dizzy, and anxious. ? Are you allergic to any medications or have you had any allergic reactions to a vaccine? Patient denied having had a history of any adverse or allergic reaction to any medication or vaccines in the past. Several minutes later patient stated that he was feeling better and he was assisted to sit up. Patient stated that he was feeling fine, and able to drive. Patient was kept in the observation area an additional 15 minutes. At approximately 4:40 pm- After patient was considered stable by doctor, he was checked out. Patient was given phone numbers in case he had any clinical or general questions. At 6:00 pm- (Center Administration) called patient, he stated that he was still driving and felt fine. At 6:21 pm- Patient sent a text to Center Administrator, stating the had arrived home and was feeling fine.
167	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1182980-1	No	The patient had symptoms of light-headedness, diaphoresis, and was pale approximately 8 minutes after administration. No signs or symptoms of anaphylaxis were identified so the patient was observed and monitored. The patient then became unconscious for approximately 10-15 seconds with small jerking movements identified during this time. 911 was called and the patient was monitored until EMS arrived. Epinephrine was prepared and ready during this whole time but was not administered because the patient didn't show symptoms of anaphylaxis (trouble breathing or talking, trouble swallowing, hives, flushing etc). The time from vaccine administration to EMS arrival was approximately 20-25 minutes. The patient was able to talk and communicate clearly the entire time except during the brief unconscious period.
168	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1184213-1	No	On 04/07/21, 28 yo presented to clinic for immunization. Pt's documented allergies include codeine (rxn: rash; severity: low) since 02/06/2018. Pt had no previously documented encounters. Pt was seen at another institution on 02/06/18 for Generalized Anxiety Disorder and was prescribed sertraline 25 mg PO daily. Unknown if pt continues on this medication. On 04/07/21 at 1141, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #043A21A; Exp: 6/21/2021; NDC #59676-580-15). Immediately after injection, pt became lightheaded, dizzy, diaphoretic and ""felt like his vision was closing in"". Vitals assessed at 1145 were BP: 94/55, P: 42, O2 sats: 98%. Pt placed in Trendelenburg position with vitals BP: 116/75, HR: 43, O2 sats: 98%. Pt denied any chest pain, shortness of breath, throat swelling, skin itching or hives. Pt reported no previous reactions to vaccines and no h/o anaphylaxis. Pt did report a similar event during a previous blood draw. Pt remained in Trendelenburg x 10 minutes. At 1159, pt was repositioned to sitting with BP: 120/80, HR: 48. Pt reported a low baseline HR. After a total observation of ~20 minutes, pt was reassessed by MD and permitted to leave. Event noted as ""Symptoms are most consistent with a vasovagal reaction after J&J Covid vaccine.""""
169	COVID19 (COVID19 (JANSSEN))	0 days	18-29 years	1184279-1	No	Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Mild, Additional Details: 12:20pm\r\n24/Male fainted after administration of Janssen vaccine. No other symptoms noted. Had patient sit on the floor and elevate legs. Assessed for anaphylaxis, epinephrine was not indicated.\r\n12:24pm BP 140/75 (unsure of patients baseline, no diagnosis of hypertension). Ambulance was called. When ambulance arrived patient felt better. May have just been nervous due to needle itself, not COVID vaccine. followed up with patient 4:20pm and he states he feels perfectly normal now.
170	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1078775-1	No	Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fained a few minuies after injection. Felt hot then tried to get up and fell to the ground. She was not injured. EMS was called and evaluated her. No signs of anaphylaxis.
171	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1086309-1	No	Patient fainted about 5 minutes after receiving the vaccine. She was in the monitoring area and fell over and hit her head on the ground. I went to her aid and monitored her until the paramedics showed up. She was unconscious for a 10-15 seconds with her eyes open before regaining consciousness. IShe was not having breathing problems or other symptoms of anaphylaxis so i did not administer an epi-pen or benadryl to her. I rolled her on her side in case she became nauseas. Then the paramedics arrived and attended to her.
172	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1092985-1	No	VIS given and discussed, no concerns voiced; Pt instructed to stay in clinic area for 30 minutes after receiving vaccine due to history of anaphylaxis to latex. Patient had epi pen in her purse. Patient experienced diaphoresis and light headedness approximately 15 minutes after receiving vaccine. Was able to walk over to exam table and layed down supine position. Patient appeared pale and diaphoretic. Patient agreed to use her own epi pen from her purse. NP gave her 1 mg epinephrine with her own epi pen from her purse in her right thigh. Blood pressure checked immediately after giving epinephrine, which was 118/78. Heart rate 104; oxygen saturation 94%. Ambulance called and arrived approximately 30 minutes after patient receiving vaccine. Patient denied wanting benadryl to be given and stated she felt a lot better, but felt dizzy if she tried to sit up. Stated that she feels that way when she uses her epi pen. Ambulance arrived within 10 minutes of giving epinephrine. IV started and taken to the hospital.
173	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1125608-1	No	After receiving his vaccine client stated his throat felt ""Itchy"" and he was ""light headed"". Reclined in car seat and seen by EMS and Dr on site. Client reports he does carry and Epi Pen for a shell fish allergy that causes anaphylaxis. Blood pressure 132/88 Pulse 80 and oxygen saturation 100%. Released by Dr once feeling better, Advised to seek medical attention later if needed. Client verbalized understanding""
174	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1128608-1	No	Pt had history of anaphylaxis related to bee stings. We asked if he had ever had a reaction to another vaccine and he said no. Pt came up saying he wasn't feeling well during the observation period, within about 5-10 minutes after receiving the vaccination. He look very pale and clammy. I asked if he was ok and he shook his head. Tried to grab a chair for him and he started to collapse. With some help I was able to get him to the ground without injury. We called 911 and I grabbed an epipen. I tried to assess the patient, and he was unable to tell me if he was having any trouble breathing or if his lips/mouth/tongue was swelling. He was conscious but couldn't speak coherently. I administered the epipen to his right lateral thigh due to his history of anaphylaxis with bee stings. We were able to lay him down while waiting for the ambulance. His color started to return and he was able to respond to questions, but was still slightly confused. He did tell me at this point that he has had similar reactions after vaccines and blood work. The paramedics arrived and took the patients vitals and took him to the hospital.
175	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1148089-1	No	S:The pt walked in, is a 39 year female C/O dizzy after Janssen J&J Covid-19 Vaccine O: Appearance: alert, well appearing, and in mild distress and oriented to person, place, and time. A: Pt received Janssen J&J Covid-19 Vaccine at 1424, pt observed for 30 minutes, 1453 pt reported she had been feeling dizzy for about 10 minutes, stated she only had breakfast additional 15 minutes of observation given, 1505 stated her head felt heavy and palpitations, rash on face The patient is in need of an appointment for medical evaluation. P: 1506 Notified Doctor. 1507 Transferred via wheel chair from vaccine clinic to triage nurse clinic, accompanied by MD 1512 VO Benadryl 50mg IM, administered 1521 VO Atenolol 25mg PO, given 1605 VO Atenolol 25mg PO, 1607 given 1618 Follow up appointment with pcp per MD Future Appointments Date Time Provider Department Center 3/29/2021 10:30 AM, M.D. 1640 Pt discharged home by MD in stable condition. Pt's husband waiting for pt outside. Electronically signed 3/27/2021 4:41 PM 3:16 pm patient taken back to nurse triage due to facial rash and pressure in head > 20 minutes after receiving J&J vaccine, she then advises has palpitations, no difficulty breathing, no oral symptoms, no lip swelling, History: patient with history of systemic mastocytosis diagnosed last year and history of frequent recurrent macular erythematous rashes frequently triggered by anxiety, last more significant reaction was 1 year ago after a facial, in which she had some lip swelling without oral swelling or difficulty breathing, patient on cetirizine 10 mg by mouth once daily which she took this am, (per allergy can take up to three times daily if needed ) in past she has been given prednisone tapers, Although she states she has not had history of anaphylaxis, recent allergy referral for second opinion states ""history of anaphylaxis"" Patient denies reactive airways disease, or history of oral swelling or difficulty breathing with her reactions. Vitals: 03/27/21 1505 03/27/21 1514 03/27/21 1547 03/27/21 1602 BP: (!) 160/102 (!) 189/106 (!) 167/90 (!) 167/100 BP Patient Position: SITTING SITTING LYING LYING BP Location: LA-LEFT ARM LA-LEFT ARM LA-LEFT ARM LA-LEFT ARM Cuff Size: Standard Adult Standard Adult Standard Adult Standard Adult Pulse: 111 110 82 82 SpO2: 99% 99% 100% 100% Exam blood pressure 183/104 Pulse 100 , O2 sat: 100% on room air resp rate regular at 16-12 / min Gen: In NAD Heent: Erythematous rash macular face confluent extending to neck, cheeks, no lip swelling Oropharynx, without swelling, Lung: Clear to auscultation bilaterally, no wheezing, Cor: Regular rate at 100 beats/minute Abdomen: soft 4:36 pm - rash less prominent on face, still with erythematous macular lesions, but less dark Patient denies palpitations, headache, chest pain, dizzyness, or shortness of breath VACCINATION FOR SARS-COV-2 Note: given Plan: VACC COVID-19 , RECOMBINANT SPIKE PROTEIN-AD26, PF (JANSSEN/J&J), 0.5 ML SYSTEMIC MASTOCYTOSIS Note: has follow up with allergy URTICARIA Note: suspect triggered by anxiety, given diphenhydramine 50 mg im x 1, patient instructed to increase cetirizine as per allergy suggestion to 10 mg three times daily, contin╖e benadryl 25-50 mg q8 h as needed hives, Plan: DIPHENHYDRAMINE HCL 50 MG/ML INJ SOLN ELEVATED BP READING WO HTN DIAGNOSIS Note: atenolol 25 mg by mouth given at 3:23 pm, with blood pressure drop to 167/90 from 189/106, in 40 minutes, second dose of 25 mg by mouth given at 4:06 pm , will give atenolol 25 mg by mouth once daily to take at home for elevated blood pressure until follow up this week by primary care provider by telephone visit Plan: ATENOLOL 25 MG ORAL TAB Patient and any caregivers present are advised if there is no improvement in Her symptoms, She is to follow-up with me in the above stated time. Orders Placed This Encounter ? VACC COVID-19 , RECOMBINANT SPIKE PROTEIN-AD26, PF (JANSSEN/J&J), 0.5 ML ? Atenolol Tab 25 mg (TENORMIN) ? diphenhydrAMINE Inj 50 mg (BENADRYL) 3/27/2021 3:32 PM""
176	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1154825-1	No	felt hot, flushed, lightheaded, tight feeling around jaw and chin within 2 minutes of giving vaccine; reported feeling very nervous before getting vaccine, due to prior anaphylaxis with different type of COVID vaccine, felt sx were more likely 2/2 anxiety. after discussion of risks/benefits, given pt's history of anaphylaxis and her understandable anxiety about current vaccine and post-injection symptoms, gave 50mg PO diphenhydramine and 125mg IM Solu-Medrol. at no point did she have sensation of face, tongue, or throat swelling; shortness of breath; nausea or vomiting; syncope or pre-syncope; chest pain; skin changes such as hives. HR 80s, SpO2 98-99% on room air, and BP 160s/90s throughout time pt was symptomatic. pt felt much better after 30 minutes of observation, ambulated comfortably without dizziness or pre-syncope. after 50 minutes of observation pt felt comfortable going home with family member driving. pt was unsure whether she had epi-pen in her car or purse, so she was sent with epi-pen and family member was instructed in administration of epi-pen with trainer device. pt was escorted out without incident.
177	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1157846-1	No	Face tingling, lips swelling, throat tightening, tongue swelling (moderate anaphylaxis reaction) and rash on neck, chest and abdomen.
178	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1164868-1	No	I went to a community event (held at a church) for the COVID vaccine. After the vaccine, I wanted the 15 minutes and felt ok - just hot. I went out to my car and over the next few minutes - I was getting hotter - My face was extremely hot and flushed, and hives started developing on my arms and chest. They were burning and itching; my skin was hot to the touch. My chest felt tight and my throat felt swollen, but I was able to breathe (breathe felt a little short, but I was able to take a full breathe). I was also dizzy and felt nauseous. I went to the ER, where they treated me for anaphylaxis with Benadryl, Pepcid, Breathing treatment, and a steroid. After about an hour or so I felt fine, and the dr gave me some medications to take over the next few days.
179	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1173836-1	No	Anaphylaxis, rash, hives, 15 minutes after vaccine. Given Epipen, Benadryl 50 mg IM.
180	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1180252-1	No	32yrold patient with PMH including anxiety presented on 4/7/21 at office for J&J COVID 19 vaccine. Administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1350. After receiving vaccine, patient felt lightheaded and sweaty. At 1358, BP 81/49, HR 37, 93% RA. Patient endorsed previous reactions during immunizations previously. Other symptoms denied and no history of anaphylaxis. Patient placed in Trendelenburg position with resolution of symptoms. BP while in Trendelenburg position, 1010/58, HR 66, 98% RA. Minutes later while in sitting position, VS remained stable and BP 125/89, HR 87. Provider assessed patient and noted vasovagal reaction following vaccination. No syncope. All symptoms resolved. Patient discharged home in stable condition.
181	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1181355-1	No	Approximately 13 minutes after the vaccine was administered patient reported feeling faint. She was sweaty, shaky, hyperventilating, tingling in her fingers and reported a rapid heart rate. Patient was able to speak in full sentences and answer questions. The pharmacy team immediately called 911. The pharmacist assessed the patients symptoms and determined the patient was not experiencing anaphylaxis as she was not experiencing swelling or throat closure. No emergency medications were administered. The patient layed down on her back and elevated her feet. The EMT arrived within 5 minutes and assessed the patient. Patient was taken to the emergency department.
182	COVID19 (COVID19 (JANSSEN))	0 days	30-39 years	1182609-1	No	Administered Janssen COVID-19 vaccine to pt and had him sit in designated chairs for monitoring. A couple of minutes later he said he was feeling light-headed. We had him stay seated in the chair and I went and got the BP machine. I had the technician taking notes. Checked BP and it was 67/35 pulse 75. I advised him that we will have him lie down and elevate his feet to help increase his BP but he declined and stated that this usually happens with needles. I checked his BP again and it was 79/28 pulse 71. We gave him a bottle of water and very shortly after he expressed he was feeling much better. At no point did the patient have trouble breathing or was experiencing any symptoms of allergic reaction/anaphylaxis. I had patient stay seating for another 10 minutes and checked his BP one last time and it had come up to 110/77 pulse 79 and he expressed he was feeling back to normal.
183	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1089436-1	No	Patient received Janssen vaccine at 4pm and began having itchiness and redness at injection site at 4:10pm. At 4:23 patient was given an ice pack to apply to the area and 50mg of benadryl PO. Patient did not have SOB. At 4:28pm rash was still spreading to underarm and chest. Discussed possible future use of epinephrine due to history of anaphylaxis to spider bite, but patient had no SOB and emergency services was called at 4:34pm to assess patient. EMS arrived at 4:50pm and determined patient to be stable. Patient was given another 50mg Benadryl dose to take with him and instructions to call EMS if symptoms worsened.
184	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1096131-1	No	Pt complaint of numbness and tingling to upper lip area 30minutes after vaccine given. Pt did complete 15+ minutes of observation in the waiting area at the vaccine site. Pt did go to her car then came back into the vaccine site to report her symptoms. O2 @ 2L/min applied. Deep breathing encouraged. No s/s of anaphylaxis occurred. Respirations easy, skin warm and dry. Pt did present with increased anxiety prior to receiving the injection. No worsening of symptoms. Family on site to transport patient home. EMS was on site. No transport to local ER needed.
185	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1097761-1	No	Patient has prior allergies to other medications, never had to use epinephrine. Past allergies include: Percocet, tramadol, Toradol and latex tape. Patient stated she has some full budding numbing experience but no anaphylaxis. We gave her the J&J covid 19 vaccine and asked her to wait 30 minutes to be monitored due to her past allergies. Around 20 minutes patient let one of the pharmacist know she was feeling very flushed and dizzy. We brought her over to the side to be monitored more closely. We had patient elevate her feet to help with faint feeling and drink some water. Within 5 to 10 minutes her symptoms started worsening. Tingling sensation started going up her side of head and neck. It started moving to the front of her face. Once that happened I asked how her breathing was and she was starting to get short of breath. Soon after patients throat started to close. We administer 0.3 m of epinephrine and called 911. Pt was able to breathe a little better but within 5 minutes she was back to gasping for air, we administered another 0.3 mg of epinephrine and the paramedics arrived.
186	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1098907-1	No	Patient received vaccine and after checking on her in about 10 minutes, she reported that her tongue felt weird, kind of tingly. I said I wanted to give her benadryl and patient refused. Sat with patient and she reported no changes, just felt different and tingled a little. Patient stated that it did not feel like allergic reactions she has had in the past. Checked tongue and lips for swelling, no sign of anything like that or other signs of anaphylaxis. By the end of allotted 30 min waiting period, patient said she felt normal again. She stayed in the store for another 30 minutes and reported back that she was fine.
187	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1109226-1	No	I received my vaccine and then was told to go sit in the waiting area. After 5 minutes or so I noticed my throat feeling thick like it was swelling. I turned my head from side to side to make sure my throat was swelling (I've had anaphylaxis before). I got up and went to one of the people in the vests and they took me to the medical tent. They took my oxygen rate, blood pressure, and checked my heart rate. I was given (2) 25 mg of Diphen(Benadryl) . I was monitored till 4 pm when I was released.
188	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1134163-1	No	03/18/21- ct called-reports developed fever (103 F) evening post vaccination, this am developed angioedema-self tx w/ Claritin, midday feeling much better, -PCP aware of s/s, no further tx at this time, - day 2 evening- low grade fever, slept 11 hrs, feeling 'great today'. Hx anaphylaxis x2, 6-7th grade r/t aspirin, dx salicylate allergy, has epipen. Hx chronic hives/angioedema that can last 5-7yrs, tx w/ steroids. 3/19/21- PCP aware of s/s, no further tx at this time, last evening (day 2) low grade fever, slept 11 hrs, feeling 'great today'
189	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1164265-1	No	Scratchy throat, no complaints of shortness of breath or difficulty. No swelling. No skin redness or hives. Benadryl (25mg) solution administered with improvement after 15 minutes of observation. Educated regarding anaphylaxis. Patient left in stable condition. Confirmed she understood signs/symptoms of allergic reaction.
190	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1164475-1	No	Patient is a * year old * who received a single dose of J&J COVID 19 vaccine in the right deltoid. Immediately following administration of the vaccine, patient began experiencing the sensation of heart racing, difficulty breathing, and feelings of anxiety. Patient relates this has happened with vaccines received in the past, as she has postural orthostatic tachycardic syndrome (POTS). She feels as if this is an aggravation of her POTS. Patient states she has allergies/sensitivities to ciprofloxacin, bactrim, and sulfa drugs, but she has never needed to use epinephrine. She denies chest pain/tightness, wheezing, swelling of the face/lips/mouth/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. She does not take any medications on a daily basis. POTS aggravation. Patient was not displaying active signs and symptoms of anaphylaxis. Patient?s heart rate and breathing continued to slow down once patient was brought to a quiet place and started to enact breathing techniques. Vital signs continued to improve as patient sat. Patient encouraged to consult her PCP and inform them of their post-vaccination reaction. She was instructed to go to the emergency department if she should develop chest pain, difficulty breathing, swelling of the face/lips/airway, cramping abdominal pain with nausea and vomiting. Patient discharged to home
191	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1178316-1	No	Within 30-60 seconds of receiving the vaccine my heart started racing. No other symptoms. I alerted the nurse - she took my blood pressure and it was very high (XXX/110). EMTs were called in case I was having an allergic reaction, but I did not have any other symptoms of allergies, just a very high BP and heart rate. At this point I'm sure anxiety drove my BP higher, on top of the reaction, since I was concerned I was going to go into anaphylaxis, but the original racing heart started within one minute of the injection while I was beginning my 15 minute wait time near the injection station. I worked on regulating my breathing and with the EMTs monitoring, my BP down to a manageable but still elevated rate after about 20 minutes. I did not go to the hospital. Once I was resting at home it took about 4 hours before I felt my heart rate was at a normal level and the feeling of racing was gone. I did not have any other adverse reactions until 4/7/2021 which is the first day that the injection site (upper L arm) started aching.
192	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1182309-1	No	Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair. Vaccinator was notified that he has a history of vasovagal response with needles. This response presents itself as sweating (and possible fainting) and is alleviated by lying down. Client mentioned that previous nurse advised him to smell an alcohol pad to distract and prevent a vasovagal response, as this had worked previously on a glucose check. No medications were disclosed or history of anaphylaxis reported. With this background information, RN offered to have vaccine administered in reclined position, however client refused. RN conferred with co-lead about administration recommendations. Vaccinator then checked in with patient at 1423 to see if patient was okay and patient did not answer the question. RN then felt the client's hand and noticed hand was clammy. At 1425 the reclining chair was brought to the station and patient was transferred into chair, appearing diaphoretic. RN palpated pulse and noted patient was not tachycardia, but RN did note tachypnea and uneasiness. RN then provided distraction and promoted relaxation. Then at 1426 patient reported feeling okay and RN noted patient no longer felt clammy. At 1440 patient was asked if he would prefer if EMS should be called, patient declined and stated that he was able to drive home. Then at 1447 patient left the site appearing well, alert and oriented x3 leaving by self in private car.
193	COVID19 (COVID19 (JANSSEN))	0 days	40-49 years	1183092-1	No	The patient received a Janssen COVID vaccine on 4/8/21 at around 5:00 pm. The patient was nervous during the administration and reported never receiving a flu vaccine in the past. The common side and serious side effects were discussed with the patient. The vaccine was administered to the patient without issue. The patient and husband instructed to wait 15 minutes after the administration of the vaccine as is the recommendation per the CDC. About 5 minutes after the administration of the vaccine, the patient's husband notified the pharmacy staff that his wife was not felling well. Pharmacist responded to the patient. The patient reported shortness of breath and feeling hot and stated she was about to pass out. Pharmacist was instructed to retrieve the Epi-Pen from the immunization cart and assist. Code White was called and Division 1 staff responded and assisted. The patient was lowered to the ground and her feet were elevated. It was at this point that it was determined that the patient was not experiencing anaphylaxis based on the symptoms she was reporting and exhibiting. The patient was instructed to remove mask to help obtain better breaths and remove the patient from hyperventilation. An icepack was obtained and placed on the patients neck once she was able to sit up. The patient's symptoms improved to the point of moving to a chair. The patient sipped water and continued deep breathing. The patient's symptoms continued to improve and she was able to leave.
194	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1092507-1	No	Vax Clinic note: Approximately 10 minutes after receiving J&J vaccine c/o lips tingling and tongue feeling thick. Medicated with 10 MG cetirizine. VS o2Sat 97%, Pulse 84, BP 146/74. Pt states has had allergic reactions to IV contrast that involved tongue swelling. staets this feels similar but not as bad. o2Sat continues at 97%, Pulse 58, BP 128/68, pt trying to relax, c/o slight headache. Swellig has spread to her lips, and cheeks feeling heavy, O2Sat 97%, Pulse 75, medicated with 50mg benadryl. 911 called to transfer pt to ED for further eval. States throat is feeling tighter. And unable to swallow Epi given 11:18, daughter aware and will meet her at ED. BP 148/82, PUlse 75, O2Stat 97% swelling in tongue decreasing, throat n o longer tight, tongue still feels thick, has some hives between her eyes, and forehead. Pt transported via EMS to ED Intake ED note: 51 y.o. F here after getting J&J vaccine and 10 min. After she c/o her tongue feeling thick and lips tingling Pt given zertec Then 15 min later pt felt lips swelling and had hives around eyes and forehead Pt c/o difficulty swallowing and was rx'd with epi pen Pt has no stridor, or resp issues on arrival, able to speak in full sentences. Pt denies COVID sx 2nd ED note: Pt arrived to ED via EMS from community health center S/P Covid vaccination. About 15 minutes after receiving vaccine - felt nausea and smelled ""medicine"" followed with upper lip swelling and numbness to tongue associated with difficulty swallowing and redness to forehead. Pt alert and oriented at this time. Speaking in full sentence, drinking bottled water without any difficulty. No drooling noted. Denies SOB, chills or fever. Emergency Department Attending Attestation Note See resident/PA/student note for further details of HPI, history, exam, ED course, and diagnoses. Briefly, this is a 51 y.o. female with PMH reviewed in chart and w/ patient notable for insulin dependent diabetes, depression, prothrombin mutation, migraine, p/w concern for allergic reaction. Emesis or change in Covid vaccine today. 10 minutes after receiving the vaccine, patient reports feeling thick in her tongue with tingling in her lips. Patient was given Zertec. The minutes later, her lips began to swell up and was also noted to have new erythematous rash between her eyes and forehead. Patient was given 50 mg of Benadryl. Patient felt like she could not swallow with worsening lip swelling. She was given EpiPen and 911 was called. No stridors. No wheezing. Reports continued tingling and the numbness in her mouth but no lip swelling or tongue swelling. Denies any difficulty swallowing at this time. No wheezing. No abdominal pain or nausea. No rash at this time. Of note, patient also notes left-sided facial, arm, and leg numbness starting about 10 minutes prior to arrival to the emergency department. She reports that she has had recurrent numbness on the left side in the past, which was thought to be due to migraine versus TIA. She has had extensive work-up and multiple hospitalization for this symptom. She reports that she is allergic to iodine and gadolinium containing contrast. Denies any headache at this time though she had a mild headache after receiving the vaccine. Denies any blurry vision. Denies any weakness in her bilateral upper and lower extremities. Assessment and Plan: Vital signs notable for O2 sat of 96 to 98% on room air without tachypnea. Patient is mildly hypertensive. Patient is well-appearing speaking full sentences without any dysarthria. Pupils are equal and reactive to light. Extraocular movement intact. She notes diminished sensation to her left face, left upper extremity, and left lower extremity. Tongue is midline. Hearing is intact bilaterally. No facial droop. She has 5 out of 5 strength in bilateral upper and lower extremities. No pronator drift. Normal gait. No tongue swelling or lip swelling. No stridors. No uvula swelling. No pharyngeal or erythema. Lungs are clear to auscultation bilaterally without wheezing or rhonchi. Cardiac exam without murmurs rubs or gallops. Regular rhythm. No abdominal distention or tenderness on palpation. No CVA tenderness. 51-year-old female who is presenting to the emergency department with improving lip swelling and numbness in her mouth, raising a concern for anaphylaxis related to her Covid vaccine. Reassuringly, status post EpiPen, her symptoms are improving. However, she has new onset left-sided numbness, with without any headache. She reports that she has had this numbness in the past the last time she had the numbness on the left side was approximately 10 years ago. Her neurologic exam is only notable for diffuse numbness on her left side including her face. Differential diagnosis include migraine headache and TIA. Stroke is possible though less likely given the patient has had the same symptoms in the past with negative work-up. Will defer code stroke at this time but will emergently consult neurology. Will get labs including BMP and CBC. We will continue to monitor her from the anaphylaxis perspective. We will also give her a dose of steroid. Prednisone 60 mg by mouth given 12:29 PM NEUROLOGY CONSULT NOTE Assessment: Formulation- Diagnosis is guarded. Localization structurally would suggest subcortical (thalamic) or small brain-stem in a sensory territory on the right. Etiologies could be stroke given her vascular risk factors but seems unlikely given there is stereotypy of earlier symptomatology. Demyelinating would be another possibility as well, but again, the stereotype. Seizure unlikely because of the timing of rush from toes to body was minutes and duration of some occasions being days. Complicated migraine possible, has some risk factors, but should be treated as dx of exclusion. She does make complaint of headache, which could support. Some FND elaboration on her anxiety-ridden allergic reaction is also possible, but no objective non-structural signs to support.""
195	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1099155-1	No	While patient was sitting in chair waiting her 15 minute monitoring period in post- immunization waiting area patient fainted. Patient did not fall down or was she injured by fainting. Patient slowly rolled off chair and patients friend helped lower her to floor where patient regained her awareness . Pharmacist raced quickly to be by patient's side to monitor her vitals and to see if an allergic/ anaphylactic reaction had occured. No symptoms of an allergic reaction or anaphylaxis was observed by pharmacist. Patient quickly regained her awareness and stated that fainting is common to her when routine blood work, injections, giving blood, etc.. Patient stated that fainting is something that has occurred several times in her past. No signs of allergic reaction, redness, hives, facial swelling, cardiovascular collapse were observed by pharmacist while closely monitoring her vitals after 911 was called. EMTs and paramedics arrived quickly and after closely examining patient and talking with her it was decided by Paramedics that patient fainted due to an emotional response by patient and there was no allergic reaction or anaphylaxis to report, nor any injury sustained by patient after fainting. Patient was quickly back to normal, and she verbally declined ambulance. Patient stated that she felt fine and that she was going to do some shopping and return home to relax.
196	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1103680-1	No	Anaphylaxis; Severe Angioedema of lips, tongue, eyelids. Hypoxemic Respiratory Distress, O2 88-89% on presentation. Chest pain/tightness. Epi pen, IM, minimally responsive. Epi gtt, IV steroid, dual histamine block. IVF bolus x2L. HF O2 support, via non RB. Pt with slow response to above intervention, but remained hemodynamically stable and with improvement to respiration/oxygenation and angioedema over about 1 hour. while patient prepared for transfer to higher level of care.
197	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1111735-1	No	Pt was at outside public health vaccination clinic- but was deemed high risk and was brought to the hospital to administer it. ER nurse gave vaccine and 10-15 mins after vaccine pt started to feel dry mouth and felt her throat closing off. She stated she had had anaphylaxis in the past and this was very similar. Pt was given EpiPen and admitted to the ER for further treatment. Pt's symptoms slowly resolved. Pt was started on IV and given Benadryl 25mg IV and solumedrol 125mg IV. She was observed for 2 hours and had stable vitals and symptoms didn't return. She received 1 liter of fluids.
198	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1115632-1	No	26 minutes after receiving the vaccination, the patient developed over her left forearm, right shoulder, posterior neck, and left scalp. Upon evaluation, she had no hives or rashes. Lungs were clear on auscultation bilaterally. No shortness of breath, nausea, respiratory distress, anaphylaxis. She was given Allegra 60 mg PO times one. Her blood pressure, taking by machine, was 205/117. No dizziness, chest pain, headaches, or vision changes. Subsequent manual recheck of her blood pressure were in the 160s to 180/ 100s, and after possibly 30 minutes of monitoring with serial your blood pressure checks, her blood pressure was 172/94 manually. Her itching resolved, and she developed no other symptoms.
199	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1121333-1	No	At about 23 minutes broke out in a cold sweat. At 26 minutes, became hoarse (always my first symptom of anaphylaxis). Progressed to coughing and feeling a lump in my throat and then tightness in my chest. My blood pressure elevated to 152/100. At that point I self administered epi pen and paramedics called 911. This provided relief but after about 5 to 10 minutes the tightness in my chest and the feeling I couldn?t get a deep breath began to return and the paramedics administered two puffs of an albuteral inhaler and transported me to the hospital. At the ER, they did an EKG, started an IV and administered fluids, prednisone and Benadryl. I was discharged about 90 -120 minutes later with a prescription for 3 days of prednisone (50mg) and instructions to continue to take 25 mg oral Benadryl every 4 hours. The next morning my face and chest were red and looked like I was sunburned. My face was also swollen.
200	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1123837-1	No	Patient stated she had tingling in her face 10-15 minutes after receiving the vaccine. She thought maybe it was just her mask, but wasn't sure. She stayed an additional 15 minutes for a total of 30 minutes and at that time said it was better but still existent. She went home with understanding to call 9-1-1 if any symptoms of anaphylaxis.
201	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1137492-1	No	Anaphylaxis
202	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1157994-1	No	The patient was screened and was found to have multiple medical allergies but no allergies to any of the components to the Janssen vaccine. As a precaution, the nurses advised a 30 minute observation. She received the vaccine without complication and then was being observed and they called me over and the paramedics were also with the patient. About 17 minutes into observation, the patient started developing chest pressure (4/10), lightheadedness, and nausea. No shortness of breath, stridor, diaphoresis, back pain, abdominal pain, vomiting, neurologic changes, and any signs or symptoms of anaphylaxis. She was very anxious. Further history revealed that the patient had been discharged from the hospital 6 week prior. She initially went in for an abdominal laproscopic surgery and woke up to having 32 staples closing an abdominal incision. They had to change from a laproscopic approach to an open abdomen approach due to complications. She ended up with sepsis and a colostomy and was hospitalized for 2 weeks getting antibiotics. She lives by herself and was overwhelmed before coming into the clinic for her vaccine. The paramedics did a 12-lead ECG that showed sinus rhythm. Vital signs and blood glucose were within normal limits. The paramedics recommended that she go to the hospital to be checked out but she was very resistant and was tearful because she was traumatized from her previous hospitalization. After some time, the paramedics convinced her to go to the hospital. The paramedics hung around the emergency department and then came back once they found out that she was fine.
203	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1160487-1	No	Patient filled out vaccine consent form stating no to all questions (denying anything that might exclude her from receiving the vaccine), fever was taken (non-feverish), and signed under the bolded statement stating the patient is to wait in the pharmacy at least 15-20 minutes after receiving vaccination. Patient was then given the J&J covid-19 vaccine in left deltoid and told that it is recommended by CDC to wait in the pharmacy for 15-20 minutes after vaccination. However, the patient immediately proceeded to leave. Patient states upon getting to her car in the parking lot, she started noticing signs of anaphylaxis such as throat swelling, however patient did not come back into the pharmacy and left the premises. Patient did not report seeking any sort of treatment for her anaphylaxis side effects. Patient received vaccine on 3/30/21, did not report this event to the pharmacy until 4/2/21. Patient also states she is a registered nurse.
204	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1166406-1	No	Patient is a * year old * who received a single dose of the J&J COVID19 vaccine in the left deltoid. He states that about 20 minutes following administration of the vaccine, he started to feel numbness and tingling the left side of his face, specifically in the left cheek. He has a shellfish allergy of which he gets a similar reaction if consumed. He relates that he usually takes Benadryl and the symptoms subside. He denies history of anaphylaxis requiring epinephrine. He denies a medical history. He affirms decreased sensation in the left cheek. He denies swelling and decreased movement of the left cheek. He denies chest pain/tightness, shortness of breath, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. GEN: Alert and oriented x 4, in NAD HEAD: NCAT EYES: PERRL, EOMI, no lid ptosis noted ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry MSK: FROM, MS 5/5 NEURO: Diminished light touch sensation in the left CN 5 distribution. Motor function intact. Alert and oriented x 4, CN 2-4 and 6-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Facial Numbness, r/o Bell's Palsy. Patient was observed for 20 minutes following his 30 minute wait period. Patient was offered EMS services, but patient did not feel as if it was necessary. Patient was re-evaluated and did not display signs/symptoms of anaphylaxis. Facial sensation symptoms had stabilized by the time patient asked to leave with his wife, who would be driving their vehicle home. Vital signs stable. Patient asked to follow up with PCP and to inform them of the post-vaccination reaction. Patient instructed to go to the emergency department should he develop chest pain, shortness of breath, and swelling of the face/lips/mouth/tongue/throat, as these could be possible signs of anaphylaxis that require immediate attention. Medications administered: None. Patient self administered OTC Benadryl. Disposition: Home
205	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1166444-1	No	HPI: Patient is a * year old * who received a single dose of J&J COVID19 vaccine in the left deltoid. About 5 minutes following administration of the vaccine, patient started to develop a red and pruritic rash on the left forearm and left hand. Patient related that she has an alcohol sensitivity where she develops red and itchy skin following consumption of alcoholic beverages. She relates she also experiences cold urticaria where she develops a red, itchy rash following submersion in cold water. When this occurs, she typically takes Benadryl or Zyrtec/Claritin (depending on the time of day), of which resolves the itching and the rash subsides. She has an allergy to Bactrim. She relates a past medical history of asthma, which she takes a daily inhaler, as well as uses her rescue inhaler twice a week. She has not seen her PCP in about 1 year. She denies chest pain/tightness, shortness of breath, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam (update as needed): GEN: Alert and oriented x 4, in NAD HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Erythematous, coalescing raised papules in the distribution of the left forearm and left dorsal hand. Small, erythematous wheal on the dorsum of the left shoulder. No erythema or edema of the injection site. Skin warm and dry MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Urticarial rash. Patient was observed for 15 minutes following 30 minute observation period. During that time, the skin manifestations stabilized. Patient did not display signs/symptoms of anaphylaxis. Vital signs were stable. Patient offered evaluation by EMS, however, patient denied evaluation and preferred to go home. Patient was driven to site by significant other and self-administered OTC Benadryl. Patient asked to follow up with PCP/allergist and to inform them of the post-vaccination reaction, as well as to further discuss asthma/urticaria management. Patient instructed to go to the emergency department should she develop chest pain, shortness of breath, and swelling of the face/lips/mouth/tongue/throat, as these could be possible signs of anaphylaxis that require immediate attention. Medications administered: None. Patient self-administered OTC benadryl Disposition: Home
206	COVID19 (COVID19 (JANSSEN))	0 days	50-59 years	1170290-1	No	Administered vaccine at 12:40pm Pt during administration of vaccine started to pull away but full dose was administered, pt was nervous about the needle. After instructing pt to sit in the post vaccine chair for 15 minutes I noticed visible distress at around 12:50pm. I rushed to her aid and asked her how she was feeling and she reported feeling dizzy. I then helped her out of her chair onto the floor to ensure she would not fall and hit her head - told her to lay supine. I then asked my technician to give me the bp monitor. I then checked her bp and it was below 80/60. I informed her this could be contributing to her dizziness and then asked for consent to help raise her bp. She consented and then I told her I would be lifting her legs in the air to raise her BP. I held her legs in the air for 10 minutes or so and then reassessed her BP and it was 110/48. She started to feel better but reported feeling as if ants were all over her left arm which is where I gave her the vaccine. I assessed once again for angioedema, anaphylaxis, hives, redness, swelling, but didnt see anything. Since the pt was dizzy I did not offer her benadryl liquid but instead offered clairitin. The pt was merely having a panic attack post immunization and said she could swallow tablets and was feeling better. I gave her one clairitn tablet otc. She wanted to sit up so I assisted her to a sitting position while she was on the floor. She sat there for additional ten minutes then moved into a chair and was brought food by her husband because he said she did not have breakfast and thought that could be why she was dizzy. She was not a diabetic so I was not concerned about her BG. She said that this never happened in the past when I reviewed her PCQF form prior to giving her the vaccine. She has had zero history of syncope so this was rare for her. After an additional 10 minutes she had a bp reading of 98/60 and left the store feeling much better
207	COVID19 (COVID19 (JANSSEN))	0 days	60-64 years	1096144-1	No	Patient reported prior to administration of vaccine significant history of syncope episodes with previous vaccine injections. Placed in wheelchair prior to administration of vaccine. After vaccine given patient experienced lightheadedness and feeling hot within 1 to 2 minutes placed on cot no respiratory distress or anaphylaxis occurred symptoms persisted EMS on site now feeling better EMS recalled back to site and transported to local hospital.
208	COVID19 (COVID19 (JANSSEN))	0 days	60-64 years	1140307-1	No	Immunization was administered at 1pm, and patient started to go into anaphylaxis at 10:00pm. He swelled up, and had trouble breathing. He received epinephrine, steroids and breathing treatments in the ER.
209	COVID19 (COVID19 (JANSSEN))	0 days	60-64 years	1161064-1	No	Patient received vaccine and immediately began to feel sweaty and light-headed. She did not faint or lose consciousness. Patient received an ice pack and some cold water and began to feel better. Her blood pressure was normal and after about 10 minutes she began to feel like herself again. There was no sign of anaphylaxis or further respiratory distress.
210	COVID19 (COVID19 (JANSSEN))	0 days	60-64 years	1164480-1	No	The Pt presents with swelling of her lips 20 minutes following injection of 1 dose Janssen vaccine to the left deltoid. The Pt states that she has had anaphylaxis in the past to Macrobid, Sulfa, Amoxicillin. She has an Epipen at home but states that she has never had to use it because her symptoms develop slowly. In the past she has driven herself to the ER where she has received breathing treatments and observation. Pt denies swelling of the eyes, tongue, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting. She also denies dizziness, lightheadedness, or vision changes. The Pt also has a Hx of meningioma and SVT s/p ablation. Suspicion for anaphylaxis high due to lip swelling, wheezing, and previous episodes of delayed onset anaphylaxis. Pt drove herself today so IM injection of diphenhydramine was delayed. Upon recheck Pt?s wheezing was unchanged and lip swelling had not progressed further. Due to past episodes of SVT and no progression of current symptoms, epinephrine was on stand by but not administered. Care was transferred to EMS. Care was transferred to EMS and Pt was transported to the hospital.
211	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1075569-1	No	Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp. About 15 minutes into monitoring, the patient reported to EMS that he was feeling sweaty and had some shortness of breath. EMS reported BP to be 171/89 and pulse of 88. Patient stated that he does take blood pressure medication and reported that BP was elevated for him. EMS contacted ambulance for transport to Emergency room, patient in agreement to transport.
212	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1078117-1	No	Patient c/o throat closing, SOB, and chest pain within minutes after receiving the vaccine. Her vital signs showed tachycardia, increased respirations, and elevated blood pressure. She had a hard time speaking in full sentences. She does have a history of anaphylaxis to certain medications. She was administered epinephrine auto injector IM and brought to the emergency department by rapid response team.
213	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1095272-1	No	Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing. Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s. Lungs sounds with poor air entry, no wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events. Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD.
214	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1097880-1	No	Jansen COVID-19 Vaccine EUA I received the vaccination on 3/12/2021, about 8:30AM, at Fairgrounds. I needed the J&J vaccine, one Moderna or Pfizer as I have a history of anaphylaxis. County Public Health received about 200 does of the J&J and 800 of Moderna and Pfizer. I waited at the vaccine site about 40 minutes after the vaccine. I went home, ate, read, and became unusually sleepy so took a nap. I woke up about 2:00PM and noticed my lips and tongue were swollen, and sore. I took 2 Benadryl. The Benadryl seems to have worked as expected. I will take 2 more when I go to bed, about 11:00. I'm unusually sleepy, and my joints ache. Overall, however, I think I am experiencing a very mild reaction and I'm thankful for the vaccine. I sent my doctor a message through the patient portal, telling him of the reaction. His office is closed so he will get the message on Monday.
215	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1131609-1	No	Pt has PMH of anaphylaxis to PO sulfa drugs, red-syndrome to IV vancomycin and multiple food and environmental allergies. Physician and patient underwent shared decision making process in regards to getting vaccination. - 13:10, pt received shot. - 13:20, pt reports L orbital swelling and numbness/tingling in L upper lip. Given 50mg diphenhydramine. Lungs CTAB. Airway non-edematous. No visible abnormalities or facial edema. O2 sat 98%. HR 77. - 13:30, pt states that tingling has not subsided. Reports that symptoms are mild compared to historical allergic reactions. - 13:35 - pt discharged with instructions to take diphenhydramine Q 4-6 hours for 24 hours and to discuss reaction with PCP (pt already had appt scheduled on same day).
216	COVID19 (COVID19 (JANSSEN))	0 days	65+ years	1136537-1	No	Pt entered the monitoring area of the high-risk anaphylaxis clinic at noon for her 30 minutes of monitoring. At 12:30pm when her 30 minutes had passed and the patient was ready to leave, patient reported to RN that her tongue felt itchy and mild tingling. Evaluation of her tongue revealed no redness or swelling. Pt states she is allergic to dogs, latex, codeine, and Augmentin (severe reaction). She does have a dog at home and reacts to his dander for which she take a Benadryl nightly. Pt was given diphenhydramine 25mg PO x 1. VS = 78, 148/85, 98% O2 sat. Pt reported resolution of tongue symptoms at 12:56pm. VS 71, 159/65, 98% O2 sat. Pt discharged home in no apparent distress at 1:05pm.
217	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0907331-1	No	Employee presented for COVID 19 vaccination: Survey reviewed, no history of Anaphylaxis reaction Moderna 1st dose given today to Left arm. She immediately developed Numbness to her body, chest tightness, and abdominal discomfort. Remained Alert and oriented, voiced concerned she felt like she was going to pass out. She developed blotchy skin to chest and neck area within minutes of injection. Patient sat in a wheelchair. Vital taken: BP 140/98 Pulse 123, given water to drink, tolerated well. She quickly reported she continued with above stated ymptoms, and continued with nausea, blotchy skin, heart racing and weakness. She was given 0.3mg of Epinephrine IM to right arm and taken to the ED
218	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0910718-1	No	Warm, tingling & numbness 10 minutes post injection. Monitoring indicated elevated HR & BP. Team member released after 50 minutes. TM was driving to her clinic and developed left side numbness to her cheek, upper arm and lower left back areas. Supervisor completed incident report and had team member go to urgent care and then went to ER. TM drove herself. ER provider Dr. contacted EH and informed us that TM did not have anaphylaxis and has no known allergies. She also drew CBC, Mag, Urine pregnancy & performed a CT scan w/o contrast to rule out kidney stone. No significant findings were noted.
219	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0912285-1	No	Received Moderna vaccine, approximately 11:40AM. Onset of throat fullness, tongue fullness about 12:30 PM Mild difficulty swallowing associated. ANAPHYLAXIS, INIT - diphenhydrAMINE Injection 50 mg (BENADRYL) - EPINEPHrine (ADRENACLICK/EPIPEN) 0.3 mg/0.3 mL Injection AutoInjector; Inject 0.3 mL intramuscularly as needed for severe allergic reaction . Inject in upper thigh - predniSONE (ORASONE) 20 mg Oral Tab; Take 2 tablets by mouth daily with a meal Mild reaction. Improved with PO Benadryl. Reviewed home care, handout provided. Home epi prescribed. Prednisone 2 day course.
220	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0913570-1	No	Moderna COVID-19 Vaccine Reaction Report HPI: Reaction to vaccine administered on 12/29/2020. Moderna / 026L20A 26 year old Caucasian female with no past medical history. Healthy, physically active (marathon runner, triathlete). Occupation as a Physician Assistant. No known history of having COVID. Had IgG antibody test on 12/16/2020 at PCP office which was negative for antibodies. Has never been tested acutely for COVID. No known COVID exposure within the last 14 days. No fever, cough, or chills within the last 6 months. No history of anaphylaxis. UTD on all vaccines, including influenza and Tdap/Pertussis. No history of allergic reaction to vaccines or food. Only medication allergy was Penicillin (rash at 2 years old). Took 500mg Tylenol (prophylactically for soreness after vaccine) and vitamin D supplement along with breakfast around 10am before going to get the vaccine. I was feeling well that morning and did my normal morning workout. Vaccine administered around 11am. Within 3-5 mins, reaction started with flushing, shaking of the upper and lower extremities, and feeling weak and faint. After laying down, the shaking and flushing continued and progressed. My teeth started chattering and my jaw and neck started to feel stiff. Was given 50mg of liquid benadryl around 11:20am. Within 20-30 mins, symptoms were improving, but then, symptoms returned (around 20 minutes after the first wave resolved). The symptoms were worse in the second episode, with full body shaking, stiffness of neck, teeth chattering and jaw starting to clench. Became pale and flushed. No difficulty breathing or SOB, although my throat felt a little tight. Had difficulty speaking due to throat / jaw tightness. Unable to stand without assistance due to leg tremors/shaking/weakness. Was given 6mL Decadron IM around 12:20pm. Within 20-30 mins of Decadron administration, symptoms started to improve. I was transported to the ER by ambulance and was stable. Still felt shaky and weak. Was evaluated and given 40mg Pepcid. Symptoms continued to improve. Was observed for around 2 hours. Was discharged and sent home. Took 25mg benadryl as recommended at 4:45pm, ad 500mg Tylenol. Around 7:45pm (after eating supper), I started to feel a little flushed/faint again, and was visibly pale. Started to have mild throat/neck tightness and slight tremors in hands, but no difficulty breathing or airway swelling. No rash. Took 25 mg Benadryl at 8pm and drank plenty of fluids. Started to experience tingling in both thighs, which later moved to both calves which lasted around 8 hours. No hand or feet tingling. Tingling resolved in the morning by 7am. No leg or arm weakness. Next morning, I was feeling much better. Only symptoms in the morning were mild fatigue and mild soreness at the injection site on the left deltoid. PE: Vitals: BP slightly low ranging from 96/68 to 106/70. HR stable at around 50-60bpm. 02 sat 99%. RR around 18-20. Temp around 98 degrees F. BMI 21. Skin: Skin flushed but no hives or rash on the body or at the injection site. Mild palmar diaphoresis. No LAD. Lungs: Breathing unlabored. No throat, tongue, or tonsillar swelling. Lungs CTAB. Heart: RRR Neuro: Pupils equal. Hyper-reflexia of the bilateral lower extremities. PMHx: No past medical history / comorbidities. Last menstrual cycle 12/1/2020. No chance of pregnancy. Family history: No family history of allergic reactions to vaccines or food. No family history of anaphylaxis. Medications: Vitamin D supplement (2000 IU / day) Multivitamin Allergies: Penicillin (rash when given at 2 years of age)
221	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0916137-1	No	Dizziness and heart palpitations/elevated blood pressure 20 minutes after injection. Redness and warmth in ears and face about an hour after injection, but this subsided after another 15-20 minutes. Temperature was taken with temporal scanner and also orally. I believe the oral thermometer showed a tempature of 99.7 F (not sure if this is the exact number, but it was roughly around this). Blood pressure was taken multiple times - I think the average was around 125 / 78. A doctor came to examine me and ask about my symptoms, previous allergic reactions, history of anaphylaxis. Overall, I was monitored for about 2 hours after the initial injection, and the dizziness had subsided by then. The nurse who administered my COVID vaccine strongly recommended that staff monitor me more closely for the second dose for any adverse side effects.
222	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0921553-1	No	19 yo female received COVID Vaccines at 0930, reported to Primary care around 1200 pm with pruritus, erythema and warmth on upper extremities, chest and back. Airway intact, Lungs CTA bilar, NEURO WNL, VS wnl. Will tx for mild allergic reaction, Educated on Anaphylaxis protocol. SM v/u
223	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0921817-1	No	45-60 minutes after receiving the vaccine she had numbness on the left side of her face/cheek associated with some mild swelling to the area. Maybe some mild left tongue swelling. Normal swallowing, normal breathing. No cough. No vomiting or diarrhea. No rash. She called an urgent care who recommended Benadryl, which helped minimize the tingling sensation and swelling over the next 2 days. Over the following week she had soreness at her left jaw joint near her ear and some left eye dryness. No facial droop. Normal blinking and smiling. No facial muscle weakness noticed. She was not sick when she received the vaccine. No new medications. Tolerates NSAIDs normally without reaction. No facial fillers. Never had anaphylaxis before to anything -- foods, medications, injectables, other vaccines. No known PEG allergy. Has not used Miralax before.
224	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0929670-1	No	After vaccination, she reported to the ER. She stayed in observation for about 4 hours. States about 20 minutes afterward developed some sensation of tightness in her throat, upper chest pain, and some dizziness. Patient has a history of allergic reactions and in the past has had anaphylaxis she does carry a EpiPen. Patient took Benadryl prior to vaccine this morning and then again afterwards a total of 50 mg, did not notice any swelling of her face tongue or lip, there is no wheezing or difficulty breathing not noticed any rash or hives. Received Famotidine, methylprednisolone and IV fluids when in the ER. The next morning she was found be Covid Positive and they did not know it previous.
225	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0936075-1	No	1 hour after vaccination client complained of dizziness, swelling of right hand. No general s/s of anaphylaxis noted. Pt was given juice, crackers and asked to rest in recumbent position. Symptoms did not improve and 12.5 mg of benadryl IM given in opposite arm of injection. After 15 minutes same general symptoms present; another 12.5mg of benadryl IM given again in opposite arm of injection. Pt remained lying down and 20 min after 2nd dose of benadryl patient reported feeling improved and able to ambulate independently. And monitored in her workplace without further intervention.
226	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0940653-1	No	-Pt received COVID19 vaccine on 1/8/2021 in the morning. -Pt was initially observed for 30 minutes, given hx of anaphylaxis to Iodine. -Pt initially had no symptoms - no itchiness, itchy or watery eyes, rash, difficulty swallowing, itchy throat, swellin
227	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0940784-1	No	Anaphylaxis reaction; A spontaneous report was received from a nurse concerning her co-worker, a 28 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced anaphylaxis reaction. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 23 Dec 2020, within five minutes of vaccine administration, the patient experienced anaphylaxis reaction. The patient had symptoms of throat tightness, dizziness, nausea, weakness, and increased heart rate. Treatment for the event included an epinephrine pen On 29 Dec 2020, the nurse reported that the patient was still having some of the symptoms, including dizziness, nausea, and weakness. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis reaction, was considered not resolved. The reporter assessed the event, anaphylaxis reaction, as related to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 28 year old female patient, who experienced a serious unexpected event of anaphylactic reaction. The event occurred apparently 5 min after first dose of mRNA-1273 (Lot# unknown) vaccine administration. She was treated with epinephrine pen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
228	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0941958-1	No	Patient reported itching at injection site immediately after vaccine given. States it decreased while she was in the observation period. She states it has not resolved; she did have a bruise. Patient reported itching at injection site immediately after vaccine given. States it decreased while she was in the observation period. She states it has not resolved; she did have a bruise. She was not given any BENADRYL at the clinic and did not take anything for symptoms at home. Resolved by 2 days after injection. She denies: Feeling of impending doom, Skin symptoms present in 90% of people with anaphylaxis, including pruritus, flushing, angioedema, Confusion, disorientation, dizziness, lightheadedness, weakness, loss of consciousness, Shortness of breath, wheezing, bronchospasm, stridor, hypoxia, Hypotension, tachycardia, Nausea, vomiting, abdominal cramps, diarrhea.
229	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0944795-1	No	called to Car after vaccine due to patient not feeling well. Quick history obtained: No pmh. Not pregnant per patient. nly allergy to milk. No history of anaphylaxis. She received vaccine at 5:42. Felt lightheaded and dizzy about 5 to 10 minutes after the vaccine. She noted chest tightness and tachycardia symptoms. We transported her via gurney to our observation area. She looked sleepy and had trouble arousing her. Blood pressure is 140/80, heart rate was in the 90s to 100s. Breath sound decreased bilaterally. No lip swelling. No rash. She noted throat felt uncomfortable. Suspect anaphalxis reaction given rapid decline in status while talking with her. epic pen at bedside immediately and then due to increasing heart rate and complaints of chest discomfort gave her epipen times one. Paramedics were called prior to decision for Epipen. She noted after a minute or two her chest felt better. Monitored her and blood pressure remains stable 140/80's, heart rate initially increase to 110 and then back down to 100 about 5 minutes after the first dose. Second dose of EPI readied as Paramedics not on site yet. At about 8 minutes from EPipen dose her heart rate increase to 160 and she noted additional symptoms of chest tightness again and re-gave a second Epinephrine pen. She was more somnolent but protecting airway. Oxygen was added 2 liters after second epi pen. Her sats dropped right around second epi pen to 94% but about 2-3 minutes later back to 98%. Paramedics arrived 5 minutes after 2nd epi dose and care was transferred to them. She was transported in stable condition. Once paramedics arrived it was determined that they got a level 3 request which was not as urgent and this should have been a level 1. We reviewed how this happened and they note that our site was listed as a level 3 site due to having staff on hand. We were advised to ask for LEVEL 1 paramedics in futures. This was communicated to all Medical staff as well as the Physician of the day orientation.
230	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0946997-1	No	Pt developed itching, mild rash around injection site several minutes after injection. She also reported some itching to face bilaterally. No evidence of anaphylaxis. Symptoms improved after 1/2 hour. She refused EMS services. Band-Aid was removed and new band aid was placed on other arm where the pt then developed mild rash there as well. Suspect new allergy to bandaid adhesive. Doubt this was a reaction to the vaccine. Pt was counseled to follow up with PCP for further guidance regarding 2nd dose.
231	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0974119-1	No	Dizziness; Blood pressure 140/98; Pulse 123; Nausea; Numbness to her body; Chest tightness; Abdominal discomfort; Felt like she was going to pass out; Developed blotchy skin to chest and neck area within minutes of injection; Heart racing; Weakness; A spontaneous report was received from a consumer concerning a 29-year-old, female patient who experienced numbness, chest tightness, abdominal discomfort [Abdominal discomfort], felt like she was going to pass out, blotchy skin to chest and neck area [Rash macular], racing heart [Palpitations], weakness [Asthenia], dizziness [Dizziness], blood pressure 140/98 [Increased blood pressure], pulse 123 [Tachycardia] and nausea [Nausea]. The patient's medical history included asthma and there were no known drug allergies. Additionally, it was noted that there was no history of anaphylaxis. Concomitant product use included cetirizine and ibuprofen. On 22-Dec-2020, a short time prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A}) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Following vaccination, the patient immediately developed numbness to her body, chest tightness and abdominal discomfort. She remained alert and oriented but voiced concern that she felt like she was going to pass out. She developed blotchy skin to the chest and neck area within minutes of injection. Her vital signs included blood pressure of 140/98 and a pulse of 123. She was given water to drink which she tolerated well. She continued with symptoms of nausea, blotchy skin, heart racing and weakness. Dizziness was also reported. She was taken to the Emergency Room. Treatment for the event included epinephrine, methylprednisolone sodium succinate, diphenhydramine and lorazepam. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was reported as recovered.; Reporter's Comments: This case concerns a 29 year-old, female patient with medical history of asthma, who experienced events of numbness, chest tightness, abdominal discomfort, felt like she was going to pass out, blotchy skin to chest and neck area, racing heart, weakness, dizziness, nausea, blood pressure of 140/98 and pulse of 123. The events occurred immediately after the first and last dose of mRNA-1273 vaccine administration. The patient was taken to the Emergency Room and recovered after receiving epinephrine, methylprednisolone sodium succinate, diphenhydramine and lorazepam. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
232	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0985192-1	No	Initial adverse event occurred 25 minutes after injection. Sudden confusion, burning heat and hives and burning red rash spreading from injection site, up neck and throat and down arm to hand. 5 days after the injection, a severe allergic reaction occurred where my entire body broke into hives and a red burning rash, again starting at the injection site. Throat tightness, itchiness in scalp and groin, and difficulty concentrating (all my usual symptoms of anaphylaxis) occurred. Advised by health care provider to take Benadryl immediately and to have epi-pens on hand. Loratadine was prescribed.
233	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0985940-1	No	Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a, 23-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history included allergy to soy. No concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 23-year-old patient who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred same day (exact time not provided) after the first dose of mRNA-1273 (Lot number: 041L20A) administration. The treatment included EpiPen injection. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
234	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0986645-1	No	24 y.o. female who arrived to the emergency department for an allergic reaction after receiving the COVID-19 vaccine today. Patient states she received the first dose of the Maderna vaccine in her left arm around 0910 hours this morning. Patient waited 15 minutes afterwards and within 30 minutes was back working in the trauma unit. However, she suddenly began to experience nausea, chest tightness, palpitations, shortness of breath, throat tightness, light headed, and overall shaky. Patient states she further went down to the vaccine clinic to inform them of her symptoms in which she was prompted to come to the ED for evaluation. She was not given an Epi pen prior to arrival. Patient reports overall feeling better now with only continued tingling in her tongue and fingers, as well as feeling mildly light headed. Patient also states her throat continues to feel tight, but denies any throat swelling. Chest tightness and palpitations have since improved, only with occasional flutters in her chest similar when feeling excited. Denies nausea, rash, itchy skin, or abdominal pain. No history of anaphylaxis or allergic reactions. Patient is prescribed Nexium, but denies taking any other daily medications. Physical exam shows to be unremarkable with no rash or throat swelling/erythema. Patient does not appear in respiratory distress. Lung sounds are clear. Will order an EKG. Will administer IV Epipen and IV Benadryl. Differentials: Allergic Reaction EKG shows NSR with sinus arrhythmia. Otherwise normal with a rate of 87 bpm. Patient was observed in the ED for 3 hours with improvement of symptoms. Provided follow up instructions to clinic list. Discussed return precautions. Vital signs are stable at time of discharge Initial Vital Signs [01/28/21 1019] Blood Pressure 132/91 Heart Rate 85 Respiratory Rate 24 Temp 36.6 ªC (97.8 ªF) Temp src Oral SpO2 99 %
235	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	0991059-1	No	Received her second Moderna vaccine dosage at 3:45pm today. At 3:55pm she felt flush and tachycardic, with a dry throat and tingling lips. She is unsure if this is anxiety from vaccination or a reaction. She prophylactically took ibuprofen prior to coming in for her vaccine. No history of anaphylaxis. No history of SARS-COV-2. We called for review instructing to provide 10mg cetirizine (given at 4:02pm). Dose #1 she had experienced low grade fever, myalgias (mild) Her vital signs at 3:55pm BP 145/82; HR 113; SpO2 100%; T 98 F She appears mildly flush on her face and ears. No hives or rash. No SOB, CP, N/V/D; Vitals at 4:06 after cetirizine BP 129/85 HR 100 SpO2 100% Advised to take a second antihistamine if allergies continue when she gets home.
236	COVID19 (COVID19 (MODERNA))	0 days	18-29 years	1123110-1	No	tingling in her mouth and lips; lump in throat; dizziness; tunnel vision; shaking; headache; anaphylaxis; A spontaneous report was received from a physician concerning a 26-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Anaphylactic reaction, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness, tunnel vision and shakiness. The patient's medical history included: allergy to azithromycin and penicillin. Concomitant product use was not provided by the reporter. On 19 Feb 2021, approximately four minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 031L20A) for prophylaxis of COVID-19 infection. On 19 Feb 2021 at 14.09, the patient had tingling in their mouth and lips and a lump in their throat. The patient's heart rate noted was 130s. The patient also reported very bad headache dizziness and tunnel vision. The patient developed shakiness which was noted on exam. The reporter reported for an anaphylaxis reaction . The patient's Blood pressure reported was 156/80. At 14.29, the patient's Blood pressure reported was 176/87. Treatment information provided included EpiPen (0.3mg) given Intramuscularly to right thigh at 14.22 and supplemental O2 provided. The reporter stated ambulance was called, husband of the patient was called. Reports were given to ambulance services. The systolic BP upon transport was 168. Action taken with mRNA-1273 in response to the event(s) was Not applicable. On 19 Feb 2021, the outcome of the events, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness and tunnel vision were considered resolved and the outcome of the event, shakiness was considered not resolved. On an unknown date, the outcome of the event, Anaphylactic reaction was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
237	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0909892-1	No	pt with history of anaphylaxis to latex and fruit, presents to ED with urticarial skin reaction with itching, throat itching, cough, lightheadedness soon after receiving Covid vaccine.
238	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0911092-1	No	Pt developed hives on bilateral arms, wrist and hands. Vital signs stable, no other complaints of tongue or throat swelling. No other s/s of anaphylaxis. Pt given Benadryl 50 mg po and observed for 60 minutes. Hives resolved and patient sent home.
239	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0912099-1	No	Approx 25 minutes after vaccination, client developed mild, red, raised rash with itching on lateral left wrist distal to injection site. Client denies any other adverse signs/symptoms of angioedema or anaphylaxis 1 hour after administration of vaccine.
240	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0913595-1	No	anaphylaxis history - hands felt tingly and tight. ""Swelling"" Benadryl given iniitally bp and pulse up. last vitals are 130/89; 71; 99% and 16 Symptoms improved""
241	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0914156-1	No	tingling in neck and arm that received injection. Palpitations, blurry vision. Patient had taken zyzal and benadryl (both antihistamines) which probably caused the blurred vision. Heart rate was checked and was normal. She has a history of anaphylaxis.
242	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0914293-1	No	Patient arrived for her COVID vaccine and informed us prior to vaccine she was immunocompromised; however, her physician recommended she get the COVID vaccine. Patient received the COVID vaccine at 0920. Patient was informed to remain in the room where we were vaccinating for 30 minutes (due to immunocompromised status). , approximately 10 minutes after the vaccine was given patient started complaining of nausea. Patient escorted to exam room, and placed on exam table. Patient complains of chills, nausea, and joint pain. She stated she did not eat today; juice and a snack bar provided. Vital signs stable (BP = 108/73 - HR = 69), no apparent signs/symptoms of anaphylaxis. The doctor notified and agrees with a continued monitoring. Monitored for an additional 15 minutes, patient states she is feeling better. The nurse escorted patient to her car. She was feeling better. Unfortunately we wrote her phone number down wrong; however, we sent an email 12/30/20 am to check in. Update 12/30/20 - The patient contacted the nurse via email, she is doing well - reports bicep area is hard with mild swelling and generalized body aches.
243	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0915974-1	No	Patient came back to vaccine clinic area experiencing paresthesia in her upper and lower extremities. Every 15 minutes patient would experience decrease in pulse and increased breathing rate. Patient was monitored by vaccine clinic staff and was provided ginger ale, apple juice and candy. After approximately 20 minutes of monitoring patient went back to work station, however came back due to experiencing symptoms again. Patient was given a dose of diphenhydramine 25 mg and a nurse monitored her blood pressure which was normal. Patient was seen by provider who determined she was not experiencing anaphylaxis, therefore it would be safe to stop monitoring. Patient was counseled on visiting ER if symptoms worsened and was picked up by family member. Patient confirmed understanding.
244	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0916388-1	No	Patient reported extensive history of anaphylaxis to multiple foods. She brought her own Epi Pen to vaccine room. Pt was sitting in obersvation area for approx 25 minutes when her skin started to itch. She self-triaged to ED r/t her medical history. Pt was transported to ED by vaccine RN
245	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0916412-1	No	Moderna COVID- 19 Vaccine: Approximately five minutes after receiving vaccine reported dizziness, lightheadedness, ""weird taste"" in mouth, sensation of throat closing , and throat itching. Diphenhydramine 25 mg orally was administered and vital signs were: blood pressure- 158/96 mmHg, pulse - 88 beats per minute, oxygen saturation - 96% on room air. Patient reported throat swelling was worsening. and sensation of throat closing comes and goes. Another diphenhydramine 25 mg dose orally was administered and repeat vital signs were blood pressure - 183/91 mmHg, pulse 98 beats per minute, oxygen saturation 94% on room air. Patient was transported to the emergency department where they arrived in no acute distress. On physical exam no rash, diaphoresis, respiratory distress, or swelling of the uvula or pharynx were noted. After being observed repeat vital signs were blood pressure 125/90 mmHg, pulse 82 beats per minute, repiratory rate 16 breaths per minute, and oxygen saturation 94% on room air. No hypotension, loss of consciousness, or gastrointestinal symptoms developed. Patient diagnosed with allergic reaction, provider stated did not suspect anaphylaxis, prescribed prednisone and diphenhydramine, and patient was discharged to home stable. On follow-up visit with primary care provider the following day, patient noted to have residual throat itchiness and lightheadedness but no other symptoms and is taking prednisone and diphenhydramine as prescribed. Vital signs: blood pressure 110/68 mmHg, pulse 83 beats per minute, temperature 36.8 degrees Celcius, oxygen saturation 97% on room air.""
246	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0917221-1	No	45 minutes post vaccination, at my place of work, I got hives all over my body and my blood pressure became extremely high. It took two days of benadryl every 4 hours to get the hives to stop. No anaphylaxis.
247	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0917972-1	No	15 minutes post vaccination administration I developed tingling of the tongue and bilateral arms. I also had an increase in heart rate from 70 to 130. I felt a pounding in my chest. It felt difficult to talk to due tingling of the tongue. I took Benadryl 25 mg PO 30 minutes prior to vaccine due to history of anaphylaxis with shell fish.
248	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0918235-1	No	Patinet is a 37 y.o. female ER nurse who received her Covid vaccine just prior to arrival. While being observed at the vaccine site, she developed itching and a rash. She was brought down to the ER for evaluation. Mainly she is itchy all over. She notes a rash across her chest. But she has no cough shortness of breath wheezing. There is no problem swallowing there is no facial swelling. She does not have a history of anaphylaxis, or medication allergies. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, trouble swallowing and voice change. Eyes: Negative for redness and itching. Respiratory: Negative for cough, shortness of breath, wheezing and stridor. Musculoskeletal: Negative for myalgias. Skin: Positive for rash. Pruritus Allergic/Immunologic: Negative for environmental allergies, food allergies and immunocompromised state. Neurological: Negative for headaches. 01/04/2021- Speaking with the patient she states noticed ""hives"" accross chest, right lower extremity, and left upper extremity.""
249	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0918516-1	No	I administered the vaccine and as the patient has a history of childhood anaphylaxis to shellfish, I instructed her to wait for 30 minutes in the observation area, instead of the standard 15 minutes, It was in the observation area, where she was being observed that she began to feel ""hot and flushed"". The health staff observing will also be submitting a VAERS report, as they provided interventions to the patient.""
250	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0918990-1	No	Received Moderna vaccine at 9:00 am today and while waiting in the monitoring room, complained of feeling her heart was racing, was put on stretcher, vitals were monitored, BP noted to be 160/ 100 initially and for next 25 mins monitoring came down to to 140 -150/ 95, did not complain of shortness of breath, no rash or pruritus noted, ambulance transport was requested and husband was with patient, was transported to ED, and discussed with ED attending Dr. Followed up with pt in ED subsequently , did not have any additional symptoms and initial symptoms nearly resolved and discharged from ED subsequently at 12:30. This does not seem to be an anaphylaxis reaction, nonetheless VAERS reporting is being filed, has set her up to discuss with allergy and immunology group here.
251	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0919347-1	No	During his 15min waiting period after receiving the Moderna COVID19 vaccine, patient got somewhat anxious... tachycardic, htn, wobbly knees, felt unwell. Didn't want any intervention, but agreed to lay down. While resting, BP down to 135/65, HR to 89, looked better and calm but then after 10-15min complained that his throat felt itchy. Then said he was allergic to peanuts, but only when eaten in lg quantities. No signs of anaphylaxis, but was sent to ER for evaluation and obs. Left ER w/o getting seen.
252	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0919459-1	No	MODERNA COVID-19 VACCINE EUA Approximately 12 minutes in to the patient's 15 minute post vaccination observation period he reported new onset headache. No reported symptoms of anaphylaxis at this time; the patient was alert and oriented x4. The patient was asked to wait for an additional 15 minutes of observation. After 15 more minutes of observation, the patient continued to endorse a headache and fatigue; no additional symptoms present and the patient was alert and oriented x4. We reviewed common side effects which include headache and fatigue as well as signs of anaphylaxis. We made a plan for patient to contact PCP for any changes or concerns or to contact emergency medical services for evidence of anaphylaxis. Client was discharged from the clinic following a second 15 minute observation period with no acute change in status.
253	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0921539-1	No	Throat tightness, tongue swelling ~30 minutes following vaccine. No hx of anaphylaxis. Symptoms resolved with benadryl
254	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0921702-1	No	Patient was on a 30 min observation due to previous anaphylaxis to emgality. As she was leaving, she c/o swelling and tingling of lips and appeared anxious. We asked to stay so we can monitor her a little longer. She appeared to stabilize, then she began coughing and trying to clear her throat. She stated it seems have worsened. Epi given and she was transferred to ED.
255	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0921749-1	No	Patient completed 30 min observation (due to hx of anaphylaxis to emgality) and as she was leaving she c/o lips swelling and tingling in throat. Pt was asked to stay for further observation. A few minutes later pt began to cough and stated worsening swelling in throat. Epi given and pt transferred to ED
256	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0924525-1	No	Patient complained of tingling and numbness in left arm at completion of the 15 minute observation time. Neuro-Vascular assessment was performed by and was found to be within normal limits. Capillary refill was brisk, skin was dry and warm to touch, no localized reaction was observed at the injection site, bilateral grip was of equal strength and quality. Observation period was extended for an addition 15 minutes, with no worsening of symptoms. Patient was offered follow up examination and medical care at the in-house Urgent Care, which the patient denied any further medical treatment at that time. Patient advised to continue to monitor for neurological changes, loss of mobility or sensation, signs and symptoms of anaphylaxis and if experiencing worsening symptoms, to seek immediate emergency medical care.
257	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0927148-1	No	Within 5 minutes after Moderna dose 1 vaccine patient developed tingling around the lips and tongue. Patient has a history of anaphylaxis to Latex, and ceftriaxone. HR 86 and regular, BP 130/80, O2 96% on room air with mask on. After further evaluation patient c/o feeling winded like "" I just finished a walk pushing the stroller."" Lungs and throat sound clear. Discussed with patient the pros and cons of administering benadryl and or epi and that would require a visit to the ED for further evaluation. Patient concerned about how the drugs will affect her breast feeding. Through our conversation, the tingling of the lips and tongue has increased, patient is stable, decision made to wheel patient to the ED for evaluation.""
258	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0930003-1	No	Hx of anaphylaxis to bee stings. Rash and hives over upper chest began immediately following vaccine. Taken to ED and given IV Benadryl, Famotidine and Solu-medrol. Discharged home from ED. Recommended to not receive second dose of covid vaccine.
259	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0933608-1	No	Moderna covid vaccine administered 1720 Hx of anaphylaxis to flu shot ?about 8 years ago? (of note, was not intubated/admitted/etc) Patient requested extended monitoring due to hx. Placed in wheelchair at pharmacy station. 1730 patient states a scratch throat and itchy nose. Able to swallow water provided. 1800 patient continues to experience throat ?lump? and is clearing throat, nose itches Requests diphenhydramine-given 25mg PO x 1 ingested without issue 1830 patient complains of itchy scalp and has a red flush to chest and upper arms 1832 patient wheeled to ER by From ED note: Electrocardiogram was without acute change. The patient was observed in the emergency department, is feeling much improved. Still has a very slight sensation of a lump in her throat, but no angioedema of lips or tongue. No stridor. No shortness of breath. O2 sat is excellent at 100%. She is comfortable being discharged to home. No meds given in ED.
260	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0936072-1	No	hives, anaphylaxis, given epinephrine and Benadryl, EMS called
261	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0941469-1	No	Systemic: Anaphylaxis-Severe, Systemic: Hives across neck and face-Mild; symptoms lasted 0 days
262	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0942333-1	No	Recipient reports having an idiopathic autoimmune disorder where she can have random events where exposures can cause an increase in her histamine production resulting in rash and itching. She denied history of any previous anaphylaxis. She was advised prior to the start of the clinic to follow up with her allergist to discuss risk v. benefit of the vaccine with her condition. On the date of the clinic she reports that she consulted her allergist who encouraged her to accept the vaccine but be monitored for 30 minutes. Approximately 10 minutes after receiving the vaccine the injection site reddened, felt hot to the recipient, and was itchy. She reported the itching spread to her scalp. She verbalized this is a typical reaction that she has and that it can self resolve or improves with benadryl. It was at his time that she reported she had taken benadyl 25 mg approximately 1 hour prior to vaccination. The reaction did no spread beyond her injection site and scalp itching resolved quickly. She verbalized symptom relief with a cold pack and was under observation for 45 minutes at which time the redness decreased. She verbalized that she felt safe to leave the clinic, vital signs were stable and no signs of reaction progression or anaphylaxis. She was instructed to notify her allergist and to call 911 if symptoms worsened, as well as to notify the Primary vaccine coordinator when able to for any further issues and updates. By 1330 she called and reported she was fully back to baseline and that she was instructed by her allergist to take prednisone and that she had also taken another benadryl once she got home. She reports the allergist called it a mild reaction and ""was not concerned"".""
263	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0943386-1	No	Treated by NP attending vaccine event. HPI: Abnormal sensation in throat approx. 15 min after receiving Moderna novel coronavirus vaccine. Denies SOB, wheezes, tongue swelling. No n/v/d, no abdominal cramping, no weakness, no faintness. History of similar reaction to multiple medications. In the past when she has had this throat sensation in reaction to a medication or food, she takes 12.5 mg of oral Benadryl and finds the reaction stops or progresses to hives to posterior knees and thighs, she typically takes more Benadryl and Zantac and the reaction ceases. One episode of anaphylaxis to oral sulfa. Hx hives reaction to one injectable for RA, cannot recall the name. No hx of anaphylaxis to injectable medications. Also reports remote history of severe episodes of hives of unknown origin over a 3 week period about 10-12 years ago; her provider speculated they were stress induced. ROS: otherwise negative. PE: Constitutional - No acute distress. Speaks in full and lengthy sentences without difficulty. ENT: No oropharyngeal edema. Voice clear. No drooling. Airway patent. Neck: Supple, no LAD, no masses, no torticollis. Respiratory: CTAB, no increased WOB. Cardiac: HRRR, no murmur. A/P: Adverse rxn to vaccination, hx multiple food and drug allergies. Administer diphenhydramine 12.5 mg as she usually takes. Continue monitoring for extended period. Further intervention as needed, EM care if condition deteriorates. Report to VAERS. 0918 - diphenydramine 12.5 mg oral administered. 0930 ? reports less fullness sensation in throat. 0935 ? reports abnormal sensation is completely resolved. Lungs CTAB, no increased WOB. No hives, no n/v/d, no faintness. No oropharyngeal edema. 0940 ? patient now questioning if she has reacted to the orange Juicy Juice she drank; she has never had one before. 1020 ? continues to be asymptomatic. Lungs CTAB, no increased WOB. No hives, no n/v/d, no faintness. No oropharyngeal edema. Discussed the importance of PCP follow up to be advised on whether or not a 2nd vaccine is prudent, she plans to seek this guidance. She may opt to rec the 2nd injection at the health department if her PCP advises it is safe, has been information on how to make an appointment there. Encouraged to seek re-evaluation for new symptoms.
264	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0944261-1	No	Systemic: Anaphylaxis-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium; symptoms lasted 1 day
265	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0944398-1	No	Tachycardia (see above, tachycardia) Narrative: Recipient immediately felt ""bad"" s/p vaccination - vitals demonstrated HR 133. No other signs or symptoms of anaphylaxis. Tachycardia resolved within 1-2 minutes of rest without intervention to HR of high 70s-low 80s. BP 131/91, SpO2 98% on room air, temperature 98.4F. Recipient able to ambulate on own to exam room. Exam benign, including recipient's HR observed prior to/during/after exam to be high 70s. Tolerated oral intake without issue, no further intervention indicated. Recipient observed for 30 minutes after vaccine administration without further issue.""
266	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0944709-1	No	Anaphylaxis, hives, given epinephrine and 50mg Benadryl, EMS and fire department called
267	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0949460-1	No	11:20 - pt observed post vaccine, states she's feeling ""shaky"". Asked by nurse if she ate breakfast which she had not. Provided snack and water. 11:30 - no improvement, vitals WNL, 11:32 - pt states ""trouble breathing"", SpO2 98%, RR WNL, c/o nausea, no vomiting. 11:34 - d/t anaphylaxis hx, SOB and nausea, first dose of epi given. Called 911. 11:39 - continues to have symptoms (SOB, diaphoretic, shaking), second dose of epi given d/t no improvement. continued to monitor vital which were stable with the exception of tachypnea. 11:50 - EMS arrives, pt remained A&Ox4, report to EMS given by RN. Two used epi pens given to EMS.""
268	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0954160-1	No	Anaphylaxis severe anaphylaxis; SOB, stridor Narrative: Patient has multiple allergies including severe anaphylaxis to peanuts and a reaction to a previous flu vaccine. Patient desired COVID vaccination and was cleared by private PC to receive vaccine from Employee Health. Patient had with her her own Epi-pen and albuterol inhaler. Patient was administered vaccine and observed in the observation area. Approximately 14 minutes after vaccination physician in observation area responded to patient with stridor and code white was called. Code team responded to vaccination testing site. Upon arrival, patient seated and alert sitting using albuterol inhaler. BP 160/93, HR 97, 99% room air. She was tachypneic and in respiratory distress following the first dose of her COVID 19 vaccine. Patient gave herself OT of EPI, and then our on call team arrived. Upon arrival as noted above, she was using her albuterol inhaler, 12.5mg benadryl attempted to be given however patient with difficulty swallowing. She was taken to ED and on way 2nd dose of epinephrine given. Patient was stabilized. Follow-up: Take Prednisone for 3-5 days. Take an antihistamine like Benadryl or Zyrtec for the next 3-5 days. Also take Pepcid 20 mg 2 times daily for the next 3-5 days. Return for worsening reaction. Timeline of event: Situation: 1001 Pt was given her first Covid vaccine, staff was watching her time and at 1014 it was noticed that she was not breathing well. 1015 Code white called. 1015 Pt gave herself and dose of Epi, 1018 pt took own inhaler,1019 Benadryl 12.5 given. 1021 pt to ED for evaluation, on the way 2nd dose of Epi given- 1025 1030=pt was acode white from the area from where getting covid vaccine shots, pt states received shot at 1001 this am and with in 30 min she began to feel SOB, when pt arrived to ER respirations of stridor. pt spo2 at 99% on room air. 1045-pt has had a 20g placed by Rn in lt ac with blood draw, pt has been placed on monitor. VS WN. 1055- pt has received pepcid 20mg IV in 50ml to run over 30 min. sol-medrol 125ng ivp benadryl 50mg ivp 1100- pt now resting with warm blanket pt no longer having stridor. upper resp clear. pt spo2 at 99% ON ROOM AIR. will continue to monitor. 1120- pt states she feels much better. 1200-pt still sleeping in room. 1225- pt has been D/c to home with instructions from provider.
269	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0958335-1	No	Pt presented to COVID vaccine clinic today and developed a reaction after receiving the vaccination. Pt received the Moderna vaccine. Denies allergies or hx of anaphylaxis. Pt reported immediate flushing sensation, tingling of the tongue, and dizziness after receiving vaccination. Pt was slightly diaphoretic. VS immediately following vaccination: HR: 90 O2: 100% BP: 125/74 Pt denied SOB, difficulty swallowing, chest tightness, nausea, rash, itchiness at this time. No visible swelling. Flushing, tongue tingling, and dizziness started to resolve after laying down for 15 minutes but then quickly returned and worsened. Pt also then developed nausea, ?tongue thickness?, difficulty breathing, and tingling shooting down her arms and legs. HR: 87 O2: 99% 129/77 Code Blue called. Epi Pen injector (one dose) administered at 0951. ED code team arrived and transported patient to ED for further workup and observation. Paged Allergy
270	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0958396-1	No	Pt presented to COVID vaccine clinic today and developed a reaction after receiving the vaccination. Pt received the Moderna vaccine. Denies allergies or hx of anaphylaxis. Pt reported immediate flushing sensation, tingling of the tongue, and dizziness after receiving vaccination. Pt was slightly diaphoretic. VS immediately following vaccination: HR: 90 O2: 100% BP: 125/74 Pt denied SOB, difficulty swallowing, chest tightness, nausea, rash, itchiness at this time. No visible swelling. Flushing, tongue tingling, and dizziness started to resolve after laying down for 15 minutes but then quickly returned and worsened. Pt also then developed nausea, ?tongue thickness?, difficulty breathing, and tingling shooting down her arms and legs. HR: 87 O2: 99% 129/77 Code Blue called. Epi Pen injector (one dose) administered at 0951. ED code team arrived and transported patient to ED for further workup and observation. Paged Allergy
271	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0964108-1	No	Extreme shoulder pain in and around injection site, nausea, vomiting, body aches, fever, chills, headache. Felt as though nurse either struck the bone or I could go into anaphylaxis at time of injection. Began flu like symptoms approximately 2 hours after injection. Heavy (almost drove myself to the hospital) began 18 hours after injection. Ended approximately 35 hours later.
272	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0966610-1	No	Patient was vaccinated with the Moderna COVID-19 vaccine at facility at approximately 3:50 PM. She was then moved to the observation room per clinic. At approximately 3:59 PM, patient stated her throat was closing and that she had a rash/hives on the side of her face (on her left cheek bone) - all indicating an anaphylaxis reaction. A staff member in the observation room immediately administered 0.3 ml of Epinephrine and told the site director to call 911. After administration, patient was able to breathe and the throat swelling subsided. EMS services arrived around 4:10 PM and took patient to emergency room. Patient was able to talk and sit-up before being carried off by EMS.
273	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0967176-1	No	At approximately 1:50 pm received her vaccination. A few minutes later she exhibited signs of allergic reaction. Pharmacist attended to her, and after some questioning she exhibited signs of Anaphylaxis. At 1:56 an Epipen 0.3 mg/0.3 ml dose was administered and 911 called. At 2:00 we checked her BP and it was 132/78 and pulse 95. A few minutes later, before a second check of BP was done, the EMT took over.
274	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0967669-1	No	ANAPHYLAXIS, EPI, BenADRL TRANSPORT To ER Pt initially complained about feeling hot and then complained about weakness. Pt later developed a slight rash on the neck and complained about difficulty swallowing.
275	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0973112-1	No	Anaphylaxis; A spontaneous report was received from a consumer concerning a 34-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for COVID-19 infection prophylaxis. On 09 Jan 2021, 15 minutes after receiving the mRNA-1273 vaccination, the patient was taken to the hospital for anaphylaxis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, anaphylaxis, was unknown.; Reporter's Comments: This case concerns a patient who experienced a serious unexpected event of Anaphylaxis. The event occurred 1 day after first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
276	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0978131-1	No	Patient received her first dose of the Moderna COVID-19 Vaccine on 1/20/21 at 1531 and subsequently had complaints of closing airway (patient felt her posterior oropharynx closing up), noted stridor and hives over her torso. Of note: patient has a known history allergic reactions to foods/drugs (including anaphylaxis). Patient brought her personal epi pens with her to the vaccine clinic and self-administered an epinephrine 0.3mg dose. Nursing staff in the clinic then gave her a Benadryl 25mg and an additional epi 0.3mg dose given no improvement in symptoms after first dose. CODE BLUE activated via security officer nearby. Volunteer staff member obtained wheel chair from main lobby to transport patient to the ED at 1548. In the ED, patient was given x1 dose Solu-Medrol IV 125 mg and later cetirizine IV 10mg. Per the ED note, no airway edema, wheezing, or strider noted and patient was reported to be doing well after medications. Patient remained in the ED for observation and was discharged at 2211.
277	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0986226-1	No	1/29/2021 1000 10 minutes after Moderna COVID-19 vaccination, resident reports ""heart racing"" and pruritis. No SOB, no throat complaints, no n/v/d, abd cramping, rhinorrhea, or dizziness. On exam, NAD, lungs CTAB, HR 103, rhythm regular, no murmur; lungs CTAB, no increased WOB. No oropharyngeal edema. No difficulty speaking or swallowing, no hives.O2 sat 97% RA. 1006: Physical exam unchanged, continues to report pruritis. 25 mg benadryl PO given. 1017: physical exam unchanged, reports L side chest burning, 4/10. No other complaints. Escorted to medical for EKG, which is unremarkable and unchanged from prior: SR, rate 90 BPM, nonspec t wave abnormality. QRS 93ms, QTc 414 ms. Symptoms resolved by end of visit in medical clinic. 1325 call to cookchill LPN: resident completely asymptomatic. A/P: abnormal s/s after vaccination,No evidence of anaphylaxis. No rash ever evolved. Pruritis resolved very soon after benadryl administration. report in VAERS.""
278	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	0990127-1	No	Approximately 1 hour after injection I developed chest tightness, burning eyes, scratchy throat and hives. No anaphylaxis. If Benadryl was not taken regularly the hives would return for the first 48 hours.
279	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1031464-1	No	Anaphylaxis; Hives; A spontaneous report was received from a healthcare professional concerning a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis and hives. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021 at 4:50 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 11 Jan 2021 at 4:50 pm, after receiving the vaccine, the patient experienced anaphylaxis and hives. She was given epinephrine and 50 mg of diphenhydramine. Emergency Medical Services (EMS) and the fire department were called. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, anaphylaxis and hives, were unknown.; Reporter's Comments: This case concerns a 31 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction, a non-serious unexpected event of urticaria. The event occurred 1 day (few min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
280	COVID19 (COVID19 (MODERNA))	0 days	30-39 years	1086858-1	No	Anaphylaxis; low blood pressure; experienced flushing; nausea; A spontaneous report was received from a consumer concerning a 39-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, flushing, nausea, and low blood pressure. The patient's medical history included allergy to medications (information not reported). Concomittent meds included Xyrem (for narcolepsy/cataplexy) and Adderall (narcolepsy) On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, 20 minutes after the vaccine the patient experienced flushing. nausea, low blood pressure (reading unknown). Patient was premedicated with Benadryl and Xyzal because of known history of allergy to medications. Treatment details were not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events were reported as resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
281	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0907052-1	No	Pt with dizziness and chest pain that started about 10 minutes after getting the Moderna Covid19 vacccine. No shortness of breath, no rash, no fever, no swelling, no weakness. Feels pain in center of chest and on L side. Pt also has been having stress with work. Pain started in the R side of the chest and migrated to the L side. It improved with Nitro and Aspirin but pt states he still feels, ""fussy."" He has no symptoms of allergic reaction or anaphylaxis. Pt has no known hx of cardiac dz, nonmoker, nondrinker. His Mom has a cardiac murmur but no other known history of heart disease.""
282	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0909447-1	No	Moderna COVID-19 Vaccine Vaccine administration was okay and without issue. Patient reports having sensation of ""vice around heart"" that spontaneously resolved less than 5 minutes after injection. No anaphylaxis or shortness of breath, but sensation of tightness in chest that subsequently resolved within the 10-15 minutes after injection.""
283	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0910719-1	No	Patient reports symptoms following COVID-19 vaccine. Patient reports she had brief episode of heart racing, throat tightening, feeling lightheaded. Symptoms already improved within 1-2 minutes by the time this RN reached patient. Denies itching, hives, shortness of breath, or any other symptoms. Has history of anaphylaxis and anxiety attacks, was worried about having anxiety attack with vaccine today. BP and pulse normal on two repeat checks. Patient alert, oriented, speaking clearly and in no apparent distress. Symptoms resolved and did not return by end of patient's post-vaccination waiting period. Patient works on campus in oncology with healthcare providers nearby for help if any further symptoms.
284	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0911052-1	No	Tingling and numb feeling at back of tongue immediately after injection Weird sensation of lump in throat without anaphylaxis that got better with time
285	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0912301-1	No	In Clinic: Pt received Moderna vaccine on right arm. She immediately felt numbness and tingling sensation on both shoulders and right neck. Neck felt tight, pain and + weakness on left wrist and 4th / 5th digit. BP was 149/ 78, O2 sat 99%, pulse 82. Pt then felt nausea, dizziness, burning sensation of left thigh, ""not feeling well"". Pt abvle to move all extremities, denies SOB. Hx of allergic reaction to Reglan and compazine. Repeat Vitals: 160/74, pulse,83,O2sat 100%, 2 pm: 135/85, pulse 75, O2 sat 99% Paramedics was called and arrived at 2:11 pm. Pt to be further evaluated in ER. In ED: Gen: Patient is in NAD, non-toxic appearing, cooperative HEENT: NC/AT, MMM, no conjunctival injection, b/l sclera anicteric. Mallampati 1 oropharynx clear, no exudates, tonsils within normal limits. No edema or erythema. Neck: Supple. Cardiovascular: RRR Pulmonary/Chest: CTAB, no increased WOB, no respiratory distress, no wheezes/rhonchi/rales, chest wall tenderness. Abdominal: Soft. NT/ND, no r/g, no masses Extr/MSK: Well perfused, distal pulses intact. No tenderness. No LE edema. Back: No CVAT Neuro: No evidence of facial droop, normal speech, mentation appropriate, steady gait. Sensation intact to light touch to upper lower extremities. Cranial nerves 2-12 within normal limits. Psychiatric: Normal affect. Mood not labile nor depressed. Skin: No rashes, lesions, or wounds appreciated on exposed skin. ß ED Course & Clinical Decision Making: 43 year old female with PMHx as listed in HPI presents with intermittent numbness after receiving the coronavirus vaccination. ß - History of present illness also notable for symptoms started 20-30 minutes after receiving the coronavirus vaccination. ß - Vitals reviewed and all wnl ß - Physical exam notable for neurologically intact, no rashes, no airway abnormalities, otherwise unremakrable. ß - Given above findings, presentation is concerning for side effects from the coronavirus vaccination, electrolyte abnormality. Will check basic lab work here in the emergency department. Will give symptomatic control with 1 L of IV fluids and Zofran for the nausea. Will monitor here in the emergency department. Disposition pending clinical improvement. ß Lab work grossly unremarkable here in the emergency department. Mild hypo phos of 2.6. Electrolytes otherwise within normal limits. No leukocytosis. Hemoglobin of 10.2, no baseline but the patient does have a history of chronic anemia given uterine fibroids. ß The patient was able to ambulate with steady gait. She continues to have burning sensation to her left leg and her right arm. She will be given lidocaine patches for symptomatic control. She also be given ibuprofen 600 mg. ß Return precautions returning to the patient. At this time presentation does not appear consistent with anaphylaxis. Min presentation most consistent with side effects from coronavirus vaccination. ß Patient tolerated p.o. here in the emergency department. She was able to ambulate with steady gait. Symptoms mildly improved after lidocaine patch and ibuprofen. Return precautions given. ß Patient re-evaluated and is stable for discharge. ß At this time, suspicion is low for acute injury/illness requiring hospital admission or emergent intervention. No indication for inpatient management; No medical or surgical emergent care needed at this time. ß However, it was stressed to the patient that symptoms may persist or worsen, in which case she should be reevaluated. Patient should also get appropriate and timely follow up for further evaluation and continuation of care. The patient indicates understanding of these issues. Patient is ready for discharge. Return precautions (advised to return to ER if their symptoms persist, change, or worsen) and follow up plan reviewed with patient and understood. ß ß""
286	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0913602-1	No	Was being monitored x 30 minutes after vaccination. Approximately 15 minutes after administration, eyes began to get heavy and swell. ""My heart was racing."" Wheelchair to ED. They could not get IV access. Throat was dry. They got an IV and gave Benadryl. ""My throat starting swelling and I could not swallow."" ""I was panting and my heart was beating out of my chest."" The ED staff administered epinephrine pen via IM injection. Anaphylaxis resolved and she was monitored x 4 hours in ED. Sent home on prednisone and fomatidine.""
287	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0914494-1	No	46-year-old male in the ED between 1 and 2 hours after receiving a COVID-19 vaccine, Pfizer, in the left deltoid with concerns for an allergic reaction. His vital signs notable only for mildly elevated blood pressure but the remainder of his vitals were in the normal range. At the time of his evaluation his symptoms had fully resolved and he had no ongoing complaints. I do not think this is an allergic reaction, no evidence of angioedema or anaphylaxis. Likely vaccine side effect perhaps with some anxiety. He was offered Benadryl, and further monitoring in the emergency department however his concern is low at the time of his evaluation and he does not feel he needs any treatment or monitoring at this time. Given his overall reassuring appearance, benign exam, and resolution of his symptoms I agree. We will have him go home, take 25 mg of Benadryl and closely monitor symptoms. If he gets any return of his symptoms get back in to the ED for evaluation. I recommend that he notify the clinic where he received the vaccine about this side effect so that it can be documented. I do not see any true contraindication to receiving his second vaccine. He could premedicate with Benadryl prior to his next vaccine. An alternative option would be to request the Moderna vaccine in place of the Pfizer brand vaccine. 46-year-old male in the ED with concerns about a reaction to a COVID-19 vaccine. He presents with his wife today. He is generally healthy without any ongoing chronic health problems. He was in his normal state of health until that 1415, received a Pfizer COVID-19 vaccine in the left deltoid. About an hour after receiving the vaccine he started feeling poorly. Somewhat rapid onset of symptoms with dizziness, numbness and tingling in his arms and his legs which remained in the distal portions and was not associated with any weakness. He felt nauseous but without any vomiting. Developed chills which lasted for a few minutes and then resolved. He felt like his tongue was swollen but when his wife looked at it it appeared normal for her. There was no periorbital swelling, lip swelling, facial swelling otherwise. He did not develop a rash. His breathing was normal and he did not have any wheezing, shortness of breath. There is no chest pain or palpitations though he tells me he felt anxious. He called the on-call nurse line who instructed her to come to the ED. He has been in the emergency department for about an hour at the time of his evaluation and reports full resolution of symptoms at this time. The numbness and tingling has fully resolved. He no longer feels nauseous. He is without any complaints at this time and tells me he feels silly for coming in at this point. He is never previously had a reaction to vaccines. No previous history of anaphylaxis or angioedema. Differential diagnosis: Differential diagnosis to include vaccine side effect, allergic reaction, anxiety.
288	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0916211-1	No	30 minute monitoring required d/t reported anaphylaxis to Bee's. Tingling all over with itching sensation to the throat at 15 minute mark. No respiratory distress and PCP and pharmacy onsite gave Benadryl 25mg PO at 1145am. Tingling was slowly improving at 1200. Left with no further reaction/complaint at 1210pm.
289	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0918491-1	No	This is a 40 y.o. female who presents with abrupt onset of nausea vomiting, diarrhea, myalgias, headache about 2 hours after receiving her 1st Moderna COVID-19 vaccine at 1300 hrs.. She describes myalgias extending from the area of her left deltoid injection site over her shoulders and over her entire upper body. No neck or back pain. She describes diffuse throbbing headache with no positional component. She has had relentless nausea vomiting and retching. She has been up vomiting stomach contents to bile multiple times. She has had loose watery brown diarrhea multiple times. She describes diffuse abdominal crampy pain with increased tearing retching and vomiting. She denies any shortness of breath cough or wheezing. Voice is normal. No swallowing dysfunction or pain. No intraoral or facial swelling. She denies rash or pruritus. No arthralgias. Patient reports prior anaphylaxis with shortness of breath and tight airways, difficulty speaking and swallowing, and relationship to coconut ingestion few years prior. No other known food/nut reactions. Patient is a CNA for care at home. Last Covid test was 2 weeks ago which was negative. She reports she has been tested every 2 weeks routinely. Review of Systems Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for abdominal pain, diarrhea and nausea. Negative for vomiting. Musculoskeletal: Positive for myalgias. Negative for arthralgias, back pain and neck pain. Neurological: Positive for headaches. Negative for dizziness, weakness and numbness. Physical Exam BP 126/73 \| Pulse 120 \| Temp 37.1 ªC (98.8 ªF) \| Resp 18 \| Ht 1.575 m (5' 2"") \| Wt 68 kg (150 lb) \| SpO2 100% \| BMI 27.44 kg/mª ED Course as of Dec 30 2340 Wed Dec 30, 2020 2128 Reevaluation: Nausea improved. Abdominal cramping resolved. No further diarrhea or vomiting. Still complains of headache and muscle cramping through her upper shoulders and arm. Will remedicate with steroid and acetaminophen 2258 Reevaluation: Patient improved. Pain/myalgias improved. Headache now mild and dull. Continues with no further.nausea vomiting or diarrhea. She would like to try fluids at this time. Assuming toleration we will plan on discharge home. 2326 Reevaluation: Patient feels improved. Headache essentially gone. Taking p.o. fluids well. Discharge instructions discussed. She is very familiar with an EpiPen because of her daughter's prior use. Discharge instructions discussed. ASSESSMENT and PLAN This is a 40 y.o. female who presents with nausea vomiting diarrhea, myalgias, diffuse abdominal cramping, severe global headache, onset about 2 hours after first dose Moderna COVID-19 vaccine. Exam with intact mental status, neurologic system. Abdomen with some diffuse tenderness but no evidence of peritoneal sign. She had diffuse palpable soft tissue muscular type tenderness through her upper extremity shoulder and bilateral paraspinal back. She had no meningeal signs. She had no cardiorespiratory signs or symptoms. Her chest was clear. Voice normal. Swallowing normal. Oropharyngeal region normal. Initial ED ED management focused on rehydration, antiemetics and subsequent treatment for presumptive anaphylaxis with likely system involvement gastrointestinal and neurologic. She was treated with Solu-Medrol, famotidine and acetaminophen. She improved during ED course and did not require epinephrine. Symptoms at ED reevaluation/discharge were resolved. Clinical impression favors anaphylaxis over medication side effect given time course and abrupt onset of symptomatology and signs. She has a distant history of anaphylaxis to coconut-based product in her past. She has no history of ongoing allergic chronic history otherwise. Other organ systems appeared stable at onset and through ED course including cardiovascular and pulmonary. Plan is for discharge home with rest fluids. She will have a course of steroids/prednisone and famotidine. She was sent home with an EpiPen and understands use and precautions. Discussed ED ""return immediately if"" parameters with patient. Ongoing FOLLOW UP evaluation/care coordination via PCP recommended. Patient voices good understanding of current evaluation, follow-up & return recommendations and discharge instructions. Encounter Diagnosis Anaphylaxis due to vaccination, initial encounter Plan: -d/c home. No work next 2 days. Off work note provided -COVID-19 testing pending -rest with activity as tolerated -diet as tolerated & increased fluids as discussed -acetaminophen PRN -Prednisone 40 mg daily to finish 4 more days -Famotidine 40 mg daily to finish 4 more days -Zofran as needed (patient has at home) -Loratadine 10 mg OTC as needed -PCP f/u -ED return for interval worsening -instructions discussed & as documented""
290	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0918493-1	No	?Moderna COVID- 19 Vaccine EUA? Flu vaccine allergy discussed at length with patient prior to Moderna vaccine. Patient's arm became red and very swollen on two separate occasions after receiving flu vaccine but patient did NOT experience difficulty breathing, respiratory distress, throat swelling, shortness of breath, or anaphylaxis. Approximately 11 minutes after receiving Moderna vaccine, patient complained of warmth and redness at injection site. Immediately after this complaint, patient began to faint and complain of difficulty breathing and pain when breathing. Rapid response was called. Patient continued to complain of painful inspirations and difficulty breathing. EpiPen, albuterol inhaler, and diphenhydramine IM were administered. Patient improved and was transported to emergency room for further monitoring. Patient improved in emergency room and was discharged sooner after.
291	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0918914-1	No	Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.
292	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0919517-1	No	Diaphoresis, itchy throat. Patient has history of anaphylaxis. Received 0.3 mg epinephrine, no change in symptoms. Placed on 15L O2 via face mask. Received second dose of 0.3 mg epinephrine and 50 mg diphenhydramine. Transferred to Urgent Care, improved after transfer and was discharged to home.
293	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0921870-1	No	Patient is a 46 y.o. female. Chief Complaint Patient presents with ? Allergic reaction ß ß allergic reation to covid vaccine ß ß Patient had a covid vaccine ß Patient works for dermatology and cosmetic. The patient is a CMA Had filler injections on the face. Jaw line and Nasolabial folds on 12/29/2020 Juviderm and Define Resilin . Has had facial fillers for three to four years. No other implants or silicone in other body locations ß No history of sulfa allergy No history of anaphylaxis. ß About 120 after the Moderna vaccination, was in the car still in the parking lot got a flush feeling and got hot chest tightening, heart pounding. Weird taste in the month. Did not feel like she was going to vomit. Then got shaky. Face feels numb and swollen. Is not itchy. No hives. ß Patient husband was driving, turned around And then pulled up. The RN on the observation deck gave EPI pen in the left thigh while she was still in the car. ß ß Driving home from getting Covid vaccine. Felt flushed, weird taste in mouth, chest tightening, palpitations, face swelling. ß Is patient concerned about a specific cause for the current symptoms? Yes Covid vaccine Onset of symptoms: 2:25pm 1/3/2021. Symptoms include: hives, rash or generalized itching, throat or tongue tingling, itching, or swelling and facial swelling. Rash distribution: Face. How are symptoms changing over time? worsening. ß Patient describes symptoms as severe. Has patient tried any treatment for these symptoms? Yes epi in left thigh What makes the symptoms better? Epi made breathing better What makes the symptoms worse? nothing ß Associated symptoms: ß o Fever No ß o Sore throat No ß o Recent illness No ß o Exposure to person(s) with similar rash No ß Objective: BP 106/72 \| Pulse 77 \| Temp 97.8 ªF (36.6 ªC) (Oral) \| Resp 14 \| SpO2 97% General:well-hydrated, well nourished, no acute distress HEENT: swelling where fillers have been used around the lips, nose, cheeks Neck: nontender, no masses Lung: clear to auscultation bilaterally Heart: regular rhythm, tachycardia noted and no murmurs, clicks, or gallops. Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: flushed on face and neck and chest No urticaria No other rashes Neuro: alert, orientation normal, speech normal pupilary response normal bilaterally extraocular motions normal tongue midline no facial weakness or asymmetry we have pictures in her medical record. this appears to be a dermal filler reaction. the patient did receive epi as the first nurse who responded while she was in the car saw the facial eyelid swelling and redness and administered IM epi. Once we were able to move the patient into the clinic is was apparent that the person had no anaphylaxis symptoms. she was not itching, did not have hives, no stridor or wheezing or hypotension. she was discharge on a Medrol dose pack. advised not to get a second vaccine dose.
294	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0921974-1	No	24 minutes post shot developed itchy scratchy throat, clearing throat, dry cough, sweating, sense of impending anaphylaxis ( same feeling I get with shellfish reaction) Bp stable, o2 says dropped 88%RA, tachycardia. Epi x 1 given 50 mg IM Benadryl and O2 placed seats normalized. Symptoms did not resolve, 6 minutes later second Epi shot given. Within 3 minutes symptoms starting to resolve. 125 Iv solumedrol, and given oral pred 40 mg daily x 3 days Felt fine next day(1/3) then 1/4/2020 recurrence of symptoms ( 2nd dose pred a little late 30 hours after last dose) Gave Epi shot, Benadryl 50 mg po ( pred on board) Symptoms did not resolve but no desaturation , bp stable, tachy, persistent throat clearing and dry cough 2nd Epi shot given Iv famotidine Iv solumedrol 125 mg, symptoms resolved, albuterol helpful lungs clear Pred 40 mg daily x 3 days add famotidine bid, add cetirizine bid 1/5/2021 felt fine in am, sensation of throat swelling itching and dry cough recurred , albuterol used helped temporarily ( had already taken morning cetirizine, famotidine and pred 40 mg) Saw allergist. Says fine, breathing fine slightly tachy, lungs clear, O2 says wnl, sweaty Albuterol given, helped Laryngoscopes with ENT negative for swelling, just mild vocal cord swelling from cough Started on pred taper 40 mg daily x 3, 20 mg qd x3, 10 mg dailyx3 Add Benadryl prn Add advair bid Continue cetirizine and famotidine
295	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0925061-1	No	Anaphylaxis, CoughWheeze & UrticariaPruritus History of asthma, Epipen given with good improvement.
296	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0926738-1	No	Anaphylaxis - throat itching and Shortness of breath
297	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0927896-1	No	Initially the recipient felt tightness in her throat, which she relates is similar to past episodes of anaphylaxis .
298	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0932597-1	No	Patient reported symptoms of numbness of lower jaw and difficulty swallowing 16 minutes post vaccination. Patient was familiar with symptoms of anaphylaxis due to her history of anaphylactic reactions to both shellfish and iodine. Patient was given an Epi-Pen (self-administered) and waited for an additional 45 minutes after initial vaccination. Patient also self-administered 25mg Diphenhydramine. Patient then left clinic and was later contacted by phone by Chief Medical Officer for follow up. Pt had admitted herself to the ED and received antihistamines and steroids. She then reported that she'd felt better but will remain in ED for observation.
299	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0933766-1	No	Patient given Moderna vaccine 1455. Patient reported feeling numb tongue, dizzy and nauseous. Patient took 25 mg diphenhydramine oral. Observed at vaccine clinic. began feeling more nausea. Tongue numbness not improving, took another 25 mg diphenhydramine. Patient sent to ED - taken by PALS/RN. Arrived in ED at 1600 complaining complaining of chest tightness with tingling in her throat. Out of concern that she may have progression to anaphylaxis so 0.3 mg of epinephrine was ordered intramuscularly. Patient also given 25 mg of Benadryl IV as well as Pepcid and Solu-Medrol. Patient was observed here in the emergency department for several hours. She did have some complain of some itchiness of her skin so additional 25 mg of Benadryl was given. She also was having some persistent chest tightness and appeared quite anxious and due to concern for anxiety is possibly a contributing factor, IV Valium was given for anxiolysis. On reevaluation, symptoms have improved significantly. She was counseled in regards to use of an EpiPen and a prescription was given for this. Prescription was also given per few days of prednisone and Pepcid. Provider recommended avoiding further covid19 vaccination.
300	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0936055-1	No	patient developed hives, nausea, history of anaphylaxis, took her own 50mg Benadryl, EMS activated paramedics and took her to ER
301	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0939081-1	No	20 min post vaccination (conducted in workplace setting), patient report feeling of swelling of tongue; in her words ""thick feeling tongue."" Also reported L upper chest tenderness and ""very tired and no energy."" RN found no SOB, not appearance of swollen tongue or other angioedema, no evidence of urticaria, no respiratory distress including no wheezing. Not evidence of vasovagal response. After consultation, RN provided 12.5 mg Benadryl IM in opposite arm of vaccination. Pt remained under observation of RN and after 30 min states she feels better, previous symptoms abated, and again without evidence of anaphylaxis. Pt was released back to office 45 min after first presenting with symptoms. Pt stated ""I think I was anxious."" on departure.""
302	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0939803-1	No	patient stated her tongue was tingling similar to ""anaphylaxis"" she had previously. Please note description of her anaphylaxis events prior were to a topical application of peppermint oil before a nursing school test and she didnt react until hours later with a racing heart and tingling mouth. Told ER doctor she had similar reaction to avacados. Patient stated tongue felt zingy like touching tip to battery so we proceeded from unit to ER where she was give prednisone and bendadryl and symptoms resolved within 20 minutes. She was monitored for an hour total and released without any more symptoms.""
303	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0940490-1	No	Received injection at 0930 on 12/29/2020 and was observed for 15 minutes after injection. Around 1630 I developed a headache so I took a Fioricet as I have a history of migraines. I had a few body aches and only ate toast for supper that night. By 2330 my headache seemed to be worsening and I started experiencing a fever of 102, tremendous body aches, nausea, sore throat. At that time I took 500 mg Tylenol at 2330. By 2 am on 12/30/2020 my fever had reached 103 and I had difficulty walking as my body joints ached so bad. My headache was unbearable and I asked my husband to drive me to the ER as I could no longer take the pain. I also was hyperventilating. In the ER I was given normal saline 500 cc, Tylenol 1000 mg IV, and Zofran 4 mg IV for the nausea. I did fill prominently better thereafter, except I continued to have a headache. I was given Toradol 30 mg IV and advised not to take my Celebrex that day. The ER Doctor did call and speak with ER physician, and discussed the validity of lab testing for Covid after vaccination as well as his recommendations as to whether I should receive the second dose of the vaccine. Since I did not really have anaphylaxis, the doctor recommended that I proceed with the second vaccination with extended observation. I was discharged and instructed to take Tylenol 650 mg orally every 4 hours as needed advised for fever/analgesia.
304	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0944669-1	No	Patient developed hives and nausea, history of anaphylaxis in the past, she took her own Benadryl 50mg PO and EMS was activated, car left at site
305	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0947010-1	No	Patient to be observed for 30 minutes beginning at 1050. Patient has a history of anaphylaxis to contrast dye for CT scans. 15 min into observation at 1105, patient reported feeling dizzy. Reported history of passing out but not associated with injections or labs. Denied blurry vision. Denied feeling SOB, throat tightening, nausea. No rash noted. Patient's VS were WNL. Laid patient flat. She reported her legs felt tingly and tight. Notified Dr. Patient reported persistent dizziness and new onset nausea. Patient then developed a splotchy red rash on chest. No itchiness. Pt treated with 0.3mg epi, 50mg benadryl, and 125mg solumedrol. VS monitored continuously and 911 was called.
306	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0948410-1	No	This facility staff member received her first dose of the MODERNA COVID-19 vaccine (Lot037K20A/EXP 6/22/21) at clinic at approximately 9:15AM on 1/14/21. She initially answered ""no"" to any allergies on the VAR but revealed to the pharmacist reviewing the VAR that she had experienced an allergy to food and contrast dye that required an epi-pen and hospital attention. She did not offer additional details and explained that she had tolerated other shots (including the 2020 flu shot) without incident. I advised patient to remain for a 30 minute monitoring period post-vaccination due to history of allergic reaction. Patient presented with some anxiety before the shot and immediately started to complain of feeling ""sick"" and said she was having trouble breathing due to chest pressure. We advised patient to remove her mask and provided her with water and a trash can though no vomiting occurred. After 15-20 minutes, patient still complained of chest pressure and difficulty breathing. When asked if she was experiencing any itchiness or throat swelling, patient said she did feel some throat swelling so she was given 25MG of Benadryl. After an additional 15 minutes, patient's condition seemed unchanged (not worsening, not improving) so the facility's nursing team was called to evaluate patient. Patient said she was still experiencing difficulty breathing and throat swelling so nursing advised use of EPI-PEN and patient consented. I administered a dose of 0.3MG (LOT0FM4066/EXP 02/2022) to the right lateral thigh and nurse called for EMS. Immediately after injection, patient's eyes fluttered and she seemed to be on the verge of fainting. Nursing checked her oxygen saturation which was 100%. Patient reported no improvement after 5 minutes so another EPI-PEN 0.3MG was administered to the left lateral thigh. Nursing also gave the patient 81MG chewable aspirin due to the patient experiencing a stroke last month. EMS arrived a few minutes after the second EPI-PEN dose and patient was transported to the hospital for evaluation. Facility reported that patient went home that afternoon but did not provide details. Based on my assessment of patient's symptoms and behavior, I feel it is likely that she experienced either an acute panic attack or anaphylaxis due to vaccine administration. I called the patient today (the day after the incident) and she confirms that she received treatment for an anaphylactic reaction to the Moderna COVID shot and is doing well without any lasting adverse effects.""
307	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0950070-1	No	Pt with known anaphylaxis with prior Flu Shots x 2. Pt received COVID vaccine, dose #1 at 10:30am, checked with patient @ 10:37am who stated that she was nervous and her throat felt tight. Patient was taken to a seperate room by this RN and clinic MD. O2, pulse ox and EpiPen available. Placed pulse ox on patient, O2 sats 98%. Patient continued to complain of throat feeling tight and she was visuably getting more nervous and stated her throat felt worse. Decision was made by this RN and Clinic Doc to adminster 0.3mg of Epipen and 911 was called @ approx 10:42am. Called patients daughter and explained what happened, sat with patient until squad arrived. Squad transported to ED.
308	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0959359-1	No	Delayed anaphylaxis after receiving the vaccine. Symptoms including hives, shortness of breath, and felt like her throat was closing. Her initial symptoms included hives which began 6 hours after receiving the vaccine. This eventually progressed to anaphylaxis and she went to the ED 2 days later.
309	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0959505-1	No	Anaphylaxis - received Epi-Pen x 2 and Benadryl 50 mg - resolved.
310	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0959843-1	No	Nervous before vaccine and history of anxiety/asthma. Patient vomited x 1 after injection, experienced dizziness/shaking. BP readings: 163/85, 137/89, and 128/77. Patient received Benadryl 25 mg, Albuterol x 1, and Epi-Pen. Patient refused to go to ED - got better and left vaccine clinic with friend. Advised to monitor for signs of anaphylaxis for next 12-24 hours.
311	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0967160-1	No	Anaphylaxis. Face, lips, throat swelling. Epi in each leg. Benadryl in right arm.
312	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0977797-1	No	Several minutes after receiving Moderna COVID-19 vaccine, patient's face started to become flushed, swollen, and she had trouble breathing. This anaphylaxis reaction started at 3:40 PM . First dose of epi was given at 3:43 PM. After first dose of epi was given, patient's breathing normalized and swelling was reduced. EMS was called during this time period. At 3:49 PM, patients lips and mouth started to swell and patient couldn't breathe. At 3:50 PM, a second epi pen was given and patient could breathe easier. EMS arrived shortly after and was taken to emergency room.
313	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0980365-1	No	Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 45-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history included hypertension. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 45-year-old patient with medical history of hypertension, who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day the patient received the first dose of mRNA-1273 (Lot number: 041L20A), at an unspecified time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
314	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0985164-1	No	Presented to ED @ 0815 (approx 45 mins after 2nd Moderna vaccine) c.o. dizziness, N/V, chest pain. Patient reports throat swelling although no obvious facial/throat swelling on exam, no wheezing. Treated as anaphylaxis. Temp 36.2, BP 186/103, HR 70, RR 24, O2 sat 99. Benadryl 50mg IV, Epinephrine 0.5mg IM, Pepcid 20mg IV, Zofran 4mg IV, Solu-Medrol 125mg IV, Tylenol 1000mg po, 1L NS IV bolus. H/o covid infection ~ 3 months ago, now recovered from COVID PNA as well.
315	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0985251-1	No	Anaphylaxis. 2 minutes after injection I developed tingling of lips and tongue. 5 minutes after I couldn't speak well and developed a cough. 10 minutes after ER doc gave me pepcid 20mg and zyrtec 10mg. Cough and shortness of breath started and tongue swelling. I was then taken back to an area with team including ER doc and 2 nurses. Given benadryl liquid and ultimately epi injection. Called Ambulance and taken to Hospital where I was given more benadryl IVP, ativan, and monitoried for 8 hours. Pruritic, congestion, and difficulty talking since day of shot. this is day 2 after injection
316	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0985937-1	No	Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a, 43-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history included breast cancer. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 43-year-old patient with medical history of breast cancer, who received their first of two planned doses of mRNA-1273 (Lot 041L20A), and who experienced the serious unlisted event of anaphylaxis-like symptoms. Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
317	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0987229-1	No	Patient (DOB 09/20/77) had a reaction to the Moderna Covid-19 vaccine given on 1/29/2021. On the screening form, patient indicated she had allergies. She verbally said she had multiple allergies and had an anaphylactic reaction previously to allergy shots received in a doctor?s office. She said she does carry an Epipen. RPh counseled on the cases of anaphylaxis with the Pfizer vaccine and recommended a 30 minute monitoring period following the vaccine in accordance with CDC guidelines. Patient agreed and received the vaccine at approximately 11:30am with instructions to check back in with RPh at 12:00pm. A few minutes later (at least 5 minutes), a friend of Patient alerted RPh that patient had fainted. The friend was able to catch patient before she fell off the chair and lower her to the ground. Patient was awake and answering questions but appeared to be having trouble maintaining consciousness. She denied shortness of breath, itching, swelling, and no rash or wheezing was evident. An Epipen was available and present but not administered due to lack of respiratory symptoms. 911 was called at 11:39am with the patient?s permission. Her symptoms remained the same until EMS arrived and she left in the ambulance at 11:57am.
318	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	0991659-1	No	Pre-medicated with 25mgs Benadryl at time of vaccination 10:00am. At 6pm, started with feelings of being flushed all over body with tingling in extremities to include face, tongue, throat felt like it began to swell with voice beginning to get raspy. Begininng of chest tightness. By 7pm marked shortness of breath with increased chest tightness, more difficulty swallowing , raspy voice and oxygen saturations dropped to low 90's . Complete activity intolerance. Injection site had rash extending over entire upper arm and forearm that was hot, raised and painful. Took 50mgs Benadryl, multiple doses of rescue inhaler (albuterol) due to difficulty breathing following by steroid based inhaler (3 doses). Sx continued through night and slowly improved. At 5 am took another 25mgs of Benadryl and took repeated doses of albuterol and steroid inhaler for 48 hours. (normally don't use at all). Oxygen saturation level returned to normal within 8 hours. Rash resolved with persistent Benadryl use x 2 days. Due to lack of insurance coverage did not go to ER for Tx as recommended. I am a front line nurse so monitored at home. Contacted MD via messaging system MD has stated I cannot receive vaccine number 2 due to risk for complete anaphylaxis. Was notified my Lot was same lot OHA put notice out as having higher incident of vaccine reaction.
319	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1026008-1	No	New sensitives to face cleansers; Anaphylactic shock; A spontaneous report was received from a consumer, concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic shock and ""newsensitives to face cleansers"". The patient's medical history was not provided. Concomitant product use included face cleansers. On 08-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08-Jan-2021, approximately five minutes after receiving the vaccine, the patient experienced anaphylactic shock as evidenced by throat warm and tingling, arms was bright red and warm to touch, trouble breathing, felt like choking, and nausea. Hence, she was treated with ""epinephrine quite a few times along with steroids and ranitidine"". On 09-Jan-2021, the patient went to the hospital two more times for ""breathing issues"", however she was not admitted. On 10-Jan-2021, in the morning, the patient had ""passed out"" and was given another epinephrine injection as she went into anaphylaxis shock again. On-29 Jan-2021, the patient also reported her arm, legs and chest are ""bright red"" and ""burns"". The patient also experienced new sensitivities to the face cleansers she has used for over 12 years. Action taken with mRNA-1273 in response to the events were unknown. The events, anaphylactic shock, was considered newsensitives to face cleanser"" were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient, who experienced serious event of anaphylactic shock and non-serious event of sensitive skin. The event of anaphylactic shock occurred on the same day and re-occurred again approximately 2 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.""
320	COVID19 (COVID19 (MODERNA))	0 days	40-49 years	1049972-1	No	Patient presents for evaluation of encounter for immunization. Here for moderna COVID-19 vaccine #1. See scanned vaccination screening form and post vaccine questionnaire.@1713 Patient reports that her lungs ""felt tight"". She denies mouth swelling, facial swelling, tongue swelling, throat tightness, difficulty breathing or speaking. Denies GI distress, nausea. Denies rashes, itching or other symptoms. She denies allergies. Denies chronic conditions. Denies daily medications. She reports her only medical history is ""childhood asthma"" and does not take any medication currently. (1715) Patient escorted to exam room for privacy and monitoring. Patient able to ambulate without difficulty or distress. She reports her ""chest tightness"" is a 6 (0-10 scale). And denies other symptoms including chest pain, itching, mouth swelling, SOB. Patient reports she prefers to sit in chair, vs lying on exam table, VS monitored by RN. ROS: CONSTITUTIONAL: Negative for chills, fatigue, fever, and weight change. EYES: Negative for blurred vision, eye pain, and photophobia. E/N/T: Positive for Denies mouth, tongue swelling. Denies throat tightness.. CARDIOVASCULAR: Negative for chest pain, palpitations, tachycardia, orthopnea, and edema. RESPIRATORY: Positive for Denies cough, distress, endorses ""tight chest"". GASTROINTESTINAL: Positive for Denies nausea, vomiting, GI distress, diarrhea. INTEGUMENTARY/BREAST: Positive for Denies rashes, lesions, changes to skin.. Vitals: Current: 2/19/2021 4:48:38 PM T: 97.9 F (temporal); BP: 174/104 mm Hg (right arm, sitting); P: 81 bpm (finger clip, sitting)O2 Sat: 100 % (room air) Repeat: 5:38:26 PM BP: 182/108mm Hg (left arm, sitting, 5:17pm) 5:38:59 PM BP: 158/97mm Hg (right arm, sitting, 5:26PM) 5:40:22 PM O2 Sat: 100% (room air, 5:26PM) 5:39:56 PM P: 73bpm (finger clip, sitting, 5:26PM) Exams: Initial Exam completed by NP at 1713, 1720, 1730, 1740 and 1746. No changes from baseline GENERAL: well developed, well nourished, in no apparent distress;; well developed; well nourished; well groomed; no apparent distress EYES: lids and conjunctiva are normal; pupils and irises are normal; E/N/T: normal external ears and nose;; Hearing: grossly normal Lips, Teeth and Gums: normal; Oropharynx: normal mucosa; NECK: Neck is supple with full range of motion; RESPIRATORY: normal respiratory rate and pattern with no distress; even and unlabored, no wheezing; CARDIOVASCULAR: normal PMI placement; no thrills, heaves, or lifts; normal rate and rhythm without murmurs; normal S1 and S2 heart sounds with no S3, S4, rubs, or clicks;; normal rate; regular rhythm; irregular rhythm; Radial pulses +2 CR< 3 seconds BUE; GASTROINTESTINAL: no masses or tenderness; SKIN: no ulcerations, lesions or rashes no skin thickening, induration, or subcutaneous nodules; NEUROLOGIC: AOx3, awake, alert, calm PSYCHIATRIC: mental status: alert and oriented x 3; appropriate affect and demeanor; recent and remote memory are intact; good insight and judgement; Procedures: Encounter for immunizationBenadryl 50 mg tab given PO per, NP at 5:14pm 1. Epinephrine given IM, in the right thigh; administered by: employee; ( lot #0GM147; exp. 11/2021 ) 5:37pmVS were monitored closely by RN and NP during reaction, see chart for RN's VS **Requested RN to chart her VS: see ""Post COVID-19 Vaccination Questionnare for VS completed by employees 1714 Benadryl given PO 1726: VS: Ox 100% on RA RR 16 HR 73 BP 158/97 1731 VS: Ox 98% RA RR 16 HR 84 - patient reports chest tightness is worsening: Ordered IM epi, given by RN 1738 VS:Ox 99% RA RR 16 HR 83 BP 167/114 1742 VS: Ox 100% RA RR 16 HR 89 1746 VS: Ox 100% RA RR 16 HR 80 167/98 Plan: Encounter for immunizationvaccine given per protocol.30 minutes after vaccine, patient c/o chest tightness. PO benadryl and IM epi given per protocol, VS monitored per protocol and documented by RN and NP 1) Protocol followed for anaphylaxis 2) Patient remained stable under care. Patient AOx3, awake, no respiratory distress, talking and smiling. 3) (1537) Informed patient we are calling 911 due to administration of Epi and patient's reported symptoms. Patient refused. Re-educated to the importance of calling 911. Patient refused x 3. 4) Husband presented to drive patient to the emergency room. Re-educated to the importance of calling 911 for anaphylaxis. Patient and husband refused. Husband committed to taking patient straight to Emergency Room, and to call 911 on the way if she gets worse in any way. Patient and husband both agreed to this. 5) Educated patient that she must seem emergent medical attention for anaphylaxis. Educated patient to NOT get second vaccine. 6) (1746) Patient reports her chest tightness has gone from a 6 to a 2 (0-10 scale) 7) Patient and husband v/o and agrees to POC. 8) (1746) Patient left in stable condition, under the care and supervision of husband with plan to go straight to the Emergency Room and to call 911 immediately if anything changes or worsens. 9) Case and chart reported to Medical Director.""
321	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0909988-1	No	Anaphylaxis - epi pen X 2, transported to the ED for evaluation and further treatment.
322	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0910532-1	No	Employee has history of anaphylaxis and was in the 30 min observation. C/O dizziness. Sits on gurney at 45 degree angles. No sob, chest pain or hives. VS obtained and employee hypertensive. Under observation of RN. Able to sip on water, but continues to have HTN and dizziness. Taken to the ED for further evaluation of symptoms.
323	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0911732-1	No	At 8:50 AM she developed nausea, diffuse headache, malaise, tingling of her hands, elevated blood pressure and metal taste in mouth. She denied any trouble breathing. No swallowing difficulty, swelling of the tongue or lips observed. Subject stated she did not feel safe driving and was brought to ED by EMS. She has a history of fibromuscular dysplasia and is on aspirin and Plavix. Emergency Department ASSESSMENT and PLAN This is a 58 y.o. female who presents with vaccination side effects. She is well-appearing on exam. There is no evidence of airway swelling or anaphylaxis. Will observe. 11:34 AM Has been observed for 2 hours and her symptoms have not worsened. She did take her own dose of Tylenol for headache. She is comfortable returning home. She does have the Moderna fact sheet and we discussed signs and symptoms of when to return. She is comfortable with plan. All questions were answered.""""
324	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0914580-1	No	Employee was given the Moderna Vaccine and within 2 min employee started to feel chest discomfort, generalized tremors and light headed. The patient was given 2 doses of IM epinephrine and sent to the ER- 2:24 1st dose and 2:29 second dose. Arrived in the ER given diphenhydramine/famotidine/prednisone. RX given 0.3 IM for Epinephrine(Epi-pen)/Zyrtec and Famotidine and Predisone. Seen in ER at 2:36 - patient states to ER MD that after epinephrine she feels much better. Evaluation done and monitoring of vital sings in the ER . Doctor spent 38 minutes with patient and felt she was stable and discharged the patient home to self monitor and return to the ER at 4:28 PM. ER Doctor states no current signs of anaphylaxis, severe dehydration, live threatening emergency. Advised to follow-up with PCP in 1-2 days. Employee was called and states she feels good and has no current symptoms other than a sore arm- 12/30/2020.
325	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0914695-1	No	Patient reports that she received the 1st dose if the COVID-19 vaccine approximately 2 hours ago. She reports that she started to feel flushed about 10 minutes after the administration. After about 30 minutes started feeling better and was able to tolerate some juice. Started to drive home and became very flushed again and lightheaded. Reported back to Occupational Health and was evaluated and found to be significantly hypertensive. After further observation, patient continuing to have elevated blood pressure. Sent to the emergency department for further evaluation. Patient notes that she has had some intermittent issues with hypertension, but does not currently take medications, most recent blood pressures have been within normal limits to borderline. No prior significant allergic reactions to immunizations. Patient does note that she had an episode earlier this year of near anaphylaxis to unknown substance. Has not had recurrent issues since. No prior known history of COVID-19. No chest pain or shortness of breath. No sore throat. No difficulty swallowing. Patient medicated with IV Benadryl and normal saline. Feeling better following medication. Blood pressure improved. Return instructions provided. Patient follow up with primary care.
326	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0915676-1	No	"Tickle"" in back of throat, cough. Due to pt hx of anaphylaxis to flu vaccine, prednisone 10 mg PO given with good effect. Symptoms resolved.""
327	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0915752-1	No	Patient arrived at observation parking lot at approximately 10:55 after receiving COVID-19 Vaccine to left upper arm. Patient was stopped by observation staff and asked about any previous history of anaphylaxis. Patient denied. Patient was instructed to remain in line for 15 observation period and was instructed to set timer to phone and honk if she experienced any adverse reactions. Patient got in line. At approximately 11:00, patient honked horn. This nurse and one other nurse ran to vehicle. Patient was waving arm out of the window. Other nurse instructed to call for help and this nurse assessed patient. Patient stated ?I don?t feel good. My throat feels weird. I think it?s closing.? Initial vital sign were HR-85 and Pulse ox 98%. 1103-This nurse gave initial dose of epi to R Outer Thigh. 911 called by other staff. 1105-20G IV started to LAC. 1107-O2 given at 3L via nasal cannula. 50 mg Benadryl given via IV. Lost IV access after medication administration due to rain and being unable to secure line. 1108-2nd IV attempt was unsuccessful to LUA. 1111-O2 90%. Non rebreather applied and O2 bumped to 50L. Surgical mask applied over non rebreather. 1111-2nd dose of Epi given to R outer thigh. 1112-BP-160/70. Fire arrived on scene. 1113- 3rd IV attempt to RIJ was unsuccessful. 1116- 20G IV to R hand successful with flush. 1120- NS initiated. 1121-BP- 160/84. 1122-EMS arrived. 1126-Patient loaded into ambulance. 1131- Patient left via ambulance. Patient was alert and responsive through the entire ordeal. Patient was able to answer questions. Patient expressed relief from throat swelling after initial Epi. Pupils equal and reactive. Patient stated, ?I feel better. My throat is dry, and I feel sleepy.? Patient vocalized pain from IV attempts. After 2nd dose of Epi, patient?s hands were cold to touch and VS were not able to be read from pulse ox. Pulse obtained via palpation. Pulse was 52 after all medication administration by staff. Patient reported taking Zyrtec and duloxetine prior to coming for vaccine today. Denies any history of anaphylaxis. Patient requested this nurse call her husband. Husband notified of event per patient request.
328	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0915770-1	No	Anaphylaxis Throat swelling Difficulty swallowing
329	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0916267-1	No	A few minutes after the 15 minute observation period, patient was on her way to her car to leave, developed copper penny taste in mouth, perioral itching/tingling, and some itching/tingling on arms. She said it felt the same way it feels after she eats walnuts. Was brought to medical clinic treatment room, vital wnl, no difficulty breathing, vomiting, hives, or signs of anaphylaxis. Patient was given 10mg zyrtec (declined benadryl), and monitored for an additional 30 minutes (45 minutes after vaccination). Her symptoms were almost fully resolved (mild perioral tingling remaining only) and vital signs every 15min stayed WNL before she was discharged home. She is a healthcare worker and as an epi pen in her car and was given instructions if symptoms return, she wanted to leave and felt comfortable with plan of care.
330	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0918486-1	No	I administered the vaccine and because the patient has a history of anaphylaxis to nuts, we instructed her to stay in the observation area for 30 minutes, instead of the standard 15 minutes. Patient agreed and was monitored by medical staff in the observation area. She began to feel an adverse reaction (which will be described in further detail by Healthcare staff filling our their VAERS report), and was given supportive measures. She did not have to be transferred out of the observation area, and felt completely recovered after intervention were provided. Please see the additional VAERS report filed on this patient.
331	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0918892-1	No	About 1.5 hours after dose administration, patient began to feel lightheaded and weak, unable to stand up. He then noticed a rash on his forehead, chest, arms and back of neck. He had no swelling of the lips, tongue or throat. No shortness of breath or wheezing noted. VS 157/110, 101, 20, 97.7. Pulse ox 99% on room air. No acute distress, but a little anxious. No oropharyngeal erythema or swelling seen. Lungs clear to auscultation. Skin revealed red macular rash on the face. Other areas had faded. Benadryl 50mg po given with good effect. Weak feeling subsided quickly and hives began to fade. Repeat vitals over 30 minutes were largely unchanged. He was allowed to go home with instructions to contact his PMD and to use Benadryl 50mg po Q4H PRN. If he develops any signs/symptoms of anaphylaxis he should call 911.
332	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0920496-1	No	hx of anaphylaxis to MMR. during prolonged observation period developed sensation of heat across chest and into throat, and lip felt numb. had taken Benadryl prior to arriving to clinic. Started to improve but with concern of symptoms worsening once Benadryl wears off, he was directed to the ER by private auto. not permitted to drive himself, wife came and picked him up.
333	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0922439-1	No	Client reported mild itching in left arm approximately 10 minutes after receiving vaccine. No shortness of breath noted, alert and oriented with no known drug allergies and no history of anaphylaxis. Vital signs taken at 0705 reported as: BP 138/83, P 65 bpm, O2 99% on room air, temp 98.0 degrees Fahrenheit, all within normal limits reported from client. Stayed for 15 minutes longer and reported subsiding of itching in arm. Client discharged from area.
334	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0923230-1	No	She presents to the emergency department after receiving a COVID-19 vaccination today and having signs and symptoms of anaphylaxis. She described having sensation of swelling in her throat as well as cutaneous rash. On presentation she is also coughing very frequently. She is treated with IM epi, IV Benadryl and IV Solu-Medrol. This rapidly improved her overall symptoms. Reported per: Moderna COVID - 19 Vaccine EUA requirements
335	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0930984-1	No	55 y/o male with hx of anaphylaxis due to peanut allergy. Guardian pharmacist noted the change in facial color and alerted RN who was monitoring s/p vaccination of her observations. He was red with facial edema upon my arrival. Benadryl 25mg PO while he was still able to swallow by RN. EMS called while he took the Benadryl. After Benadryl, checked vitals ? VERY hypertensive and increasing diaphoresis; Started to wax and wane with consciousness. Administered epi pen by RN in attendance once change in level of consciousness was noted. After epi, became pale, increasing diaphoresis with change in level of consciousness. BP was lower, still hypertensive. Placed on floor by staff. While on the floor, consciousness improved. EMS arrived and assumed care.
336	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0939136-1	No	Patient with hx of drug and food allergies (nuts, dilaudid and azithromycin) with no prior history of anaphylaxis was monitored for 30 minutes post COVID-19 Moderna Vaccine and reported no post-vaccine symptoms at time of discharge from urgent care. Patient returned aproximately 45 minutes later, around 3:45p after c/o throat discomfort and sensation of throat itching/neck hives. Pt took 50mg home benadryl prior to returning. Patient was brought into observatory room with vitals: BP 125/83, Oxygen 99, HR 72, on exam was in no acute distress, no oropharyngeal edema, no respiratory distress with clear lungs, no wheezing, no hives visible. Pt was monitored for 20 additional minutes with improvement in symptoms and declined further monitoring. Patient reported she has an up to date EpiPen. She was advised low threshold for EpiPen usage and ER evaluation should patient develop any worsening symptoms. Covid Vaccine reaction clinic hotline was provided to patient. Patient agree with plan of care.
337	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0939982-1	No	Myalgia,SkinRash, Rash, HYPERtension, Pain at the insertion site, myalgia, rash to neck & back, itchiness to the throat Narrative: Developed pain at the insertion site and myalgia on 12/31/2020 1 hour after vaccination. On 01/01/21 developed rash to the neck & back and itchiness to the throat. She was seen at ER on 01/01 with a temp of 36.8 C, B/P 175/90, and HR 102. She was given Solu-u-Medrol 125mg IVP, Pepcid 20mg IVP, and Benadryl 25mg IVP. Symptoms resolved and B/P post treatment 125/80. Discharged home with Prednisone 40mg x 5day PO, Vistaril 25mg Q 6 hours PRN, and Pepcid 20mg x 5 days PO. Reports today 01/2/21 rash completely resolved. Has a history of allergic reaction to antibiotics. Reports had an anaphylaxis reaction to cephalosporin 4 years ago requiring a Epi injection in the ER. Reports history of allergic reaction to antibiotics; PCN, Macrolide, and Fluoroquinolones treated with High Dose Steroids.
338	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0949568-1	No	Received Vaccine at 1545 - Reported symptoms of throat thickening consistent with her previous anaphylaxis reactions at 1553. STAT team initiated at 1553, VSS, Benadryl 25mg PO given. Transferred to ED by Wheelchair - ED course treated with Pepcid 40mg, solumedrol 125mg and epinephrine 0.3mg IV at 1604 and given 1L bolus of 0.9 NaCl. Patient observed in the ED until all s/sx resolved. Discharged Home with 40mg Prednisone PO daily x4 days. Pt only complaint throughout was throat ""thickening"". No other s/sx per chart review.""
339	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0954800-1	No	Patient received first COVID vaccine given at 3:10 pm approximately. Patient monitored closely at approximately 3:40pm began experiencing itching on left arm by injection site and up in hairline. Noted red patches, no hives, Provider on site made aware of patient itching. No issues with breathing, swallowing able to talk in complete sentences. She was eating a snack and drinking juice without issue 3:45 pm itching both arms and upper back plus up in hairline, complained of chest being heavy. Provider assessed lung sounds lungs clear per provider 4pm this writer notes red patches under chin and on side of face, noted patient scratching their back. Checked shoulder areas hives noted. Provider over to assess. Adult Anaphylaxis Kit accessed and guidelines followed Per Provider, Dr, IM Benadryl given 25mg from Anaphylactic kit. Injection given in Right deltoid no issues noted. Per provider Epinephrine pen 0.3mg given in right upper thigh. Oxygen saturation is 99% and heart rate 121. 4:05pm Patient noted to be shaking she states ""this is normally what happens after the Epi Pen"" Blood pressure checked and was 121/71 4:15 shaking has subsided she states breathing better 4:17pm reported to RN that breathing normal and patient reports minimal itching. 4:20pm Provider spoke with patient advised to go home and rest Patient understands not recommended to have second shot. Patient was driven back to her work location by employer to get her vehicle. Provider cleared patient to drive home. Patient symptoms had resolved speaking clearly with no issues""
340	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0958623-1	No	atient presented to COVID vaccine clinic today and developed an allergic reaction after receiving the Moderna COVID-19 vaccine. Pt reports hx of allergies to sulfa and cat dander. Denies any allergies to PEG or vaccines. Denies any hx of anaphylaxis. Ten minutes after vaccine administration pt reported chest tightness, mild SOB, mild dizziness and a sensation of a ?cotton ball? in her throat. Pt reported throat sensation similar to her cat dander allergy. Pt developed slight swelling and tingline of the lower lip. Denied difficulty swallowing or nausea. HR 78. Pt placed on 2 L of O2 for SOB. Epi pen and albuterol inhaler present. Code Blue called & ED code team arrived and transported patient to ED for further workup.
341	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0966354-1	No	Within 5 minutes patient with dizziness and fast heart rate (reported by patient as in the 80s). Patient also with worsening of her baseline essential tremor (R>L). No other signs of anaphylaxis or other symptoms. Vitals taken with BP 128/68, HR 68, RR 16. Patient observed for 30 minutes with no other side effects. Discarhge in stable condition with no medications administered.
342	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0966491-1	No	Patient is a 55-year-old female who had presented to the vaccination clinic this afternoon to receive her COVID-19 vaccine. She does have a history of migraine headaches and other comorbidities as described below. Has had reactions to a number of medications, mostly narcotics as noted in her allergy list some of which could in theory be compatible with urticaria. Does not have true anaphylaxis in her history. Today at about 15 minutes after administration of her COVID-19 vaccine she began to rather precipitously developed an itchy crawling feeling in her skin, nausea with retching and some shortness of breath. She did not have the sensation of her throat closing off. Did not have coryza. Within about 10 minutes she did develop difficulty with speech that she says is typical for her migraine headache. She received, in the vaccination Clinic, epinephrine 0.3 mg subQ, 125 mg of Solu-Medrol and 50 mg of Benadryl all IV. An IV was started and a 500 mL bolus of saline was initiated. With this she was then transferred to the emergency room for further evaluation. In the emergency room she did develop chest heaviness but no palpitations. She was not dyspneic. Her nausea and vomiting by then had seem to resolve.
343	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0984397-1	No	Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 59-year-old, White, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history was not reported. No concomitant product use was reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, after vaccine administration, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 59 year old subject with unknown medical history, who experienced a serious unexpected event of Anaphylactoid reaction. The event occurred after first dose of the study medication administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
344	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0984979-1	No	Presented to ED on 1/21/21 with chest tightness and shortness of breath. Patient reports chest pain with deep inspiration. Shortness of breath started shortly after receiving vaccine on 1/20/21 and persisted into 1/21/21. Patient reports no cough, positive lightheadedness with no syncope, positive nausea with no vomiting. Per exam no fever, no rash, no tongue/mouth swelling. Emergency Department MD states does not meet threshold for anaphylaxis thus no epinephrine administered. Patient received Benadryl 50mg IV, Pepcid 20mg IVPB, Solu-Medrol 125mg IV, and 0.9% NaCl 1L IV bolus.
345	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0985428-1	No	Anaphylaxis
346	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0985695-1	No	Pt reports itchiness and swelling of her tongue. Visually inspected by paramedic onsite which confirmed oral cavity, tongue and back of throat swollen. Pt stated NO difficulty breathing or talking. Lung sounds clear as per paramedic. O2 sats 100%. 911 called to assess, pt refused care or transport. Pt made aware of potential outcomes of angioedema and anaphylaxis.
347	COVID19 (COVID19 (MODERNA))	0 days	50-59 years	0985941-1	No	Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 56-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history was not reported. No concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 56-year-old patient . The patient's medical history was not reported. The patient experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day the patient received the first dose of mRNA-1273 (Lot number: 041L20A) at an unspecified time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
348	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0910811-1	No	Patient with a history of severe anaphylaxis was observed for 30 minutes post vaccine. Right at the 30 minute mark, patient started to look pale, started with frequent throat clearing followed by sense of shortness of breath and chest tightness. 2:37p: No wheezing, good air movement, breathing was not labored, no cyanosis, no noted lip or tongue edema, able to speak. BP 160/54. P 98, O2 sat 98%. Severity of symptoms per patients = 8/10 ""tightness"" at time of medical evaluation/medical provider response. 2:38p 911 called, 2:39p epipen, benadryl 50mg oral, and solumedrol 125mg IM administered (patient tolerated well, able to swallow) 2:42p patient reports symptoms improved to ~4/10 severity O2 sat 98%, P97 2:46p , O2 96%, P 99, BP 148/52 2:48p patient reports symptoms still at ~4/10 severity/stopped improving, O2 sat 95%, p 85; discussed option of doing 2nd epipen 2:54p EMS arrived prior to administration of second epipen. Patient transported to Emergency Department for further evaluation for possible anaphylaxix""
349	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0912879-1	No	Patient (aRN ) felt dizzy was tachycardiac stayed in area for 1 hr symptoms persisted then was taken to ED there was no evidence of Anaphylaxis is. Patient stateds she was given to large of dose RN administering denies states gave 0.5 IM she was monitored for several hours because patient has cardiac history
350	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0915279-1	No	Patient was seen and given vaccine at 10:39 am. Patient remained for evaluation post vaccination due to history of anaphylaxis. At 11:10 am, patient reported a tingling sensation to upper lip and requested 12.5mg of Benadryl. Patient received medication and feeling resolved by 11:20 am. SPO2 remained steady at 98%-99% on room air.
351	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0929117-1	No	patient has a hx of anaphylaxis to pears. Within 5 minutes of vaccine developed tingling and numbness to lips and tongue. patient escorted to the emergency department for further evaluation and treatment.
352	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0947164-1	No	Pt got her COVID vaccine waited her 15 mins for observation went out to her car felt flushed face a little red and felt a slight tingling in her lip. Pt came back into the office , we put her in room 15 for observation pt was given 1000mg tylenol evaluated by Dr. advised to stay for further monitoring and observation. Pt was observed no other adverse reactions she has had anaphylaxis with compazine in the past , she does not have any other allergies at this time. Pt takes metoprolol no other medications at this time. she has COPD or asthma she does not know definitively .
353	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0952365-1	No	Patient was a 30 minute observation due to hx of anaphylaxis with bee's. 15 min post vaccination, patient stated ""Short of breath and my throat is tight"". HR 77, O2 94%, wheezy. gave 0.3 ml epi in left thigh, immediately transferred to ER""
354	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0952382-1	No	Patient being observed for 30 minutes due to hx of anaphylaxis to bee's. 15 minutes post vaccine patient stated SOB and throat tight. HR 77, O2 94%, wheezy, alert. administered 0.3ml epi in left thigh. transferred to ER
355	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0967075-1	No	16 min post Moderna COVID vaccination pt complained of nausea, dizziness, and headache. No s/s of anaphylaxis including no respiratory distress, urticaria, or angioedema. 21 min post vaccination patient given 12.5 mg diphenhydramine IM in opposite arm of injection. 35 min post vaccination and after no improvement of symptoms pt given another 12.5 mg of diphenhydramine IM. Pt under continuous observation by RN with normal O2 and HR but with BP ranging from 156/102 - 192/92. During the entire observation no s/s of acute anaphylaxis. Pt denies history of hypertension and denies medication for hypertension. 42 min post vaccination patient symptoms continued and reports chest tightness but no respiratory distress and normal O2. EMS called for transport to hospital. 45 min post vaccination EMS arrived and patient transported to hospital.
356	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0979449-1	No	Anaphylaxis within 15 minutes. Throat tightened wheezing began given Benadryl at clinic then taken to ER downstair at Hospital. Given more benadryl, then epinephrine, Decadron, then breathing treatment. once undercontrol sent home and then recommended seen by own doctor. I saw doctor on the 21st.
357	COVID19 (COVID19 (MODERNA))	0 days	60-64 years	0985939-1	No	Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning, 60-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history included rheumatoid arthritis, hypertension and allergies to diphenhydramine and meperidine. No concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 60-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 041L20A), and who experienced the serious unlisted event of anaphylaxis-like symptoms. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
358	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0909952-1	No	approx. one hour after receiving vaccine pt started having throat tightness, nausea, lips tingling, SOB and ""feeling weird"". States has had anaphylaxis in the past from nuts and uses an EPI pen. States she used her pen but did not get relief so went to ER where she received IV benadryl, tagment and steroids. EKG was abnormal. States no problems at injection site. F/U with patient appox. 7 hours after incident and pt states she is doing fine and not having any issues now.""
359	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0917941-1	No	TINGLING IN EXTREMITIES AND TONGUE, TONGUE SWELLING, MILD HTN, TREATED FOR ALLERGIC RXN WITH DIPHENHYDRAMINE 25MG IM INJECTION AND MONITORED FOR SIGNS OF ADDITIONAL ALLERGIC RXN/ANAPHYLAXIS. S/S RESOLVED S/ DIPHENHYDRAMINE AND TIME. PT WAS ALSO MILDLY HYPOCAPNIC ON ETCO2 MONITORING AND STATED THAT S/S COULD BE DUE TO MILD ANXIETY.
360	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0923078-1	No	20 minutes after receiving the vaccine, this patient began noticing a lot of swelling in her hands. She has a history of anaphylaxis to many environmental allergens as well as medications. She felt hot/ sweaty/ upper & lower extremity swelling/ gait was unsteady/ itchy swollen eyes/ headache.
361	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0923805-1	No	Received the Moderna COVID-19 vaccine 1/6/2021 at approximately 11 AM. Pt stated she does not have any history of allergy or anaphylaxis. Pt reported about 5 minutes after vaccine administration a runny nose. Pt reported she did not have a runny nose prior to administration of the vaccine. Pt notes a history of nasal problems. Pt denies difficulty swallowing, swelling of airway, difficulty breathing, itching, rash, flushing, swelling of lips, face, throat, or eyes, sensation of throat closing, change in voice, wheeze, cough, n/v/d, abd pain, dizziness, weakness. Pt confirmed she felt well other than her runny nose. Pt was observed in our observation area for 45 minutes with no progression of symptoms. Epinephrine not administered. RN consulted with medical advisor Dr. over the phone as he was off site. EMS on site. VS done by paramedic patient signed refusal with paramedic as she did not want to go to the ED. Pt was advised by RN about delayed anaphylaxis, to continue to monitor her symptoms, call 911 if additional symptoms arise. Pt declined recommendation to go the ED. Advised pt to call her PCP asap for further guidance. Advised pt there is a local urgent care she should be checked out in if she cannot get in with her PCP today. Pt verbalized understanding and agrees to the POC. 2:26 PM RN called patient to check on her and obtain additional information for VAERS form. Pt reports she is feeling well, no other symptoms developed. Pt called her doctor and is waiting for a call back.
362	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0926608-1	No	itching, chest tightness, dizziness, shortness of breath no angioedema or anaphylaxis
363	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0939137-1	No	VS: 210/100-74-98.4-98%RA. Resident called front desk and reported she wasn't feeling good after receiving COVID-19 vaccine. Seen resident immediately in apartment around 1310 accompanied by CM sitting in chair. Alert and oriented to person, place, time, and situation. Verbal and able to make needs known. Speech clear and coherent. No slurred speech or facial drooping noted. Resident received the 1st dose of Moderna COVID-19 vaccine around 1200. She was observed for 30 min by ARR staff immediately after vaccine was administered. She then went to grab coffee and went to her apartment. She did not yet eat lunch. Resident c/o feeling ""woozy"" and eyes feeling heavy/""uncomfortable"". Continued from above: Resident has a history of anaphylaxis and several allergies. Called EMS around 1320. While waiting for EMS rechecked BP several times with SBP between 200-215. She denies any SOB, numbness, tingling, or indigestion. SpO2: 97-98%RA. Resident then stated she has slight tightness/discomfort to her left chest. EMS arrived and left ARR at 1414 and sent to Medical Center.""
364	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0943504-1	No	Systemic: Anaphylaxis-Severe; symptoms lasted 1 day
365	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0943685-1	No	PT. REPORTED A BRIEF EPISODE OF ""LIGHTHEADINESS, AND TACHYCARDIA"" EMS ON SCENE EVALUATED PT. PT. REPORTS ALL SYMPTOMS RESOLVED WITHIN MINUTES, PT. ABC'S INTACT, WITH NORMAL WOB, LUNGS CLEAR, PT. SYMPTOM FREE,AND DENIES CHEST PAIN OR SOB. PT. NOT TRANSPORTED, PT. REMAINED IN OBSERVATION FOR FULL 30 MINUTES D/T HX. OF ALLERGIES, PT. DENIES HX. OF ANAPHYLAXIS.""
366	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0947674-1	No	Instant itching Localized reaction at injection site Left deltoid red dened area size of golf ball with a raised center. EMS Medic responded with Diphenhydramine 50mg Intramuscular Right Deltoid 1315 . Local EMS at site Patient declined transport to local hospital for evaluation. At 1333 patient left building. accompanied by spouse. Advised of anaphylaxis reactions to observe for and to seek medical attention immediately. Advised patient to seek counsel from her Primary MD for second vaccine.
367	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0948073-1	No	Immediate sensation of slight mental status change which resolved but within 2 minutes started to feel slightly woozy and pre-syncopal, as if anaphylaxis starting. Informed staff. Put on stretcher. Vital signs obtained. O2Sat upper 90s. BP elevated with diastolic in low 100s with sensation of pre-syncope and very slight confusion. Resolved slowly over 30 minutes to about 90% of prior mental status. Continued to feel somewhat dizzy for several hours. Went to bed early. Had very intense disturbing dreams. Very sore vaccine site. Resolved by morning. Arm soreness about 50% of day prior.
368	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0950102-1	No	Upon injection, immediately swelled up to size of golf ball, no erythema or other signs/symptoms of anaphylaxis, reports no other symptoms. 30 minutes later swelling has gone down some and seems to be healing.
369	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0959800-1	No	Pt had anaphylaxis reaction 10 minutes after administration. Sensation of light headed, could not talk, sensation of tongue swelling and throat closing. Pt was immediately given one dose of epi using standard adult epi pen, IVF, and 25mg benadryl IV. Pts vitals were always wnl, including oxygen. Pt stabilized and in 60 minutes was ready to go home wo any adverse outcome.
370	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0967219-1	No	Yesterday, she had COVID19 vaccine (believe Moderna) at 9 am, no immediate or local injection problems until 2 pm when she started itching from left wrist/ hand, up her arm to chest, back, neck, right arm and lower extremities. She took an allegra in the evening which did not help. That night she has persistent itching and shortness of breath with wheezing in her throat. This morning similar symptoms but woke with posterior headache, but over the day the rash improved receding from her legs, back, chest and remained on her chin and bilateral forearms. She was recommended to come to UCC for evaluation. - prior to the vaccine, for the past week, she reported having sore throat, wheezing in throat, shortness of breath, no coughing or diarrhea - currently being treated for h pylori, taking levofloxacin qday (has one or two more tabs) and metronidazole (has another week). She has taken metronidazole before without adverse effects and no known allergy to levofloxacin. - denies known food allergy or recent change in diet - other than dust but she does not equate this reaction to past reactions to dust, denies known environmental or contact allergy and denies recent contact with plants, nickel, new cosmetic/ personal care product use, or occupational/ home exposure to chemicals - She denies using lotion, change in soap, detergent, clothes, sheets. She lives with family who do not have similar rash. Denies history of similar skin problems or rashes. Apart from augmentin (stomach pain, vomiting), but otherwise no known food or medical allergy. - denies throat/ tongue swelling, history of severe allergic reaction or anaphylaxis
371	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0979464-1	No	Patient reported feeling flushed 6 minutes after vaccine administration. Vitals at 1513 were: BP 117/60, HR 74, O2 97%. Patient reported that symptoms resolved about five minutes later. Patient was observed for 25 minutes (she declined to stay longer) and did not develop any new or worsening symptoms. Vitals at 3:24 PM BP 107/56, HR 72, O2 98%. Reviewed s/sx anaphylaxis, advised patient to call 911 if these occur.
372	COVID19 (COVID19 (MODERNA))	0 days	65+ years	0991148-1	No	HCP was called to a patient with ""tongue swelling"". HCP asked MD for an Epi Pen and the paramedics are O2. O2 was applied at 2L per NC. . HCP approached vehicle where a 68yo white male was sitting in his vehicle on the driver side. Quick assessment revealed erythema of the face and angioedema. Pt was able to speak clearly, was CTA and had RRR. 911 was called. BP 160/90. EpiPen dose 1 was injected into right vastus lateralis and pt reported improvement at 1057. HCP asked for injectable diphenhydramine. HCP continued to monitor pt with RRR and CTA but erythema and angioedema began again along with swollen tongue so EpiPen dose 2 was injected into right vastus lateralis. 50mg IM diphenhydramine was injected into the right deltoid while fire rescue began to arrive on scene. Pt did not report difficulty breathing. Pt did report previous anaphylaxis to fire ant bites/stings and did report being allergic to bee stings. Fire rescue transported patient without difficulty. HCP called pt later that night at 2030 who reported doing better but still having tongue swelling.""
373	COVID19 (COVID19 (MODERNA))	0 days	65+ years	1047147-1	No	Patient developed erythema that started on 2/20/21 just below the vaccine site about 2 weeks after vaccination. There is no respiratory difficulty and it got wider today and a little itchy and red. There are no rashes and no signs of anaphylaxis, no GI symptoms. She also had EMG done on both upper extremities prior to this starting. I advised her to use cold compress and local / topical 1% hydrocortisone on it. To contact us if symptoms worsen and to the ER if any worsening symptoms or respiratory compromise.
374	COVID19 (COVID19 (MODERNA))	0 days	65+ years	1049475-1	No	BP 180/100 , repeat 170/90 Pulse Ox 96 While sitting in observation pt reported having an itchy area on her left wrist. Pt reported a history of CT Scan Contrast Dye and seasonal allergies. Pt was evaluated by EMS paramedic. Pt declined transport to the ED despite recommendation and education on precursor to anaphylaxis. Pt signed refusal with EMS. Pt reported she often gets itchy for no apparent reason. Pt stayed at clinic in observation for over 45 minutes with no progression of itchiness or other symptoms. . Pt was given ED precautions.
375	COVID19 (COVID19 (MODERNA))	0 days	Unknown	0924733-1	No	Anaphylaxis. Lip swelling, hives, sob, nausea. For 1 hour post Epi given.
376	COVID19 (COVID19 (MODERNA))	0 days	Unknown	0940227-1	No	anaphylaxis; A spontaneous report was received from a hospital CMO concerning a patient who was a frontline worker and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, it was reported that the frontline healthcare worker experienced anaphylaxis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting anaphylaxis. The event is possibly related to the vaccine, and additional information including temporal relationship between dosing and event and whether patient has history of anaphylaxis could provide details needed for medical assessment.
377	COVID19 (COVID19 (MODERNA))	0 days	Unknown	0940228-1	No	Anaphylaxis; A spontaneous report was received from a hospital CMO concerning a patient who was a frontline worker and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, it was reported that the frontline healthcare worker experienced anaphylaxis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a patient of unreported age and sex. The patient's medical history is not provided. The patient experienced anaphylaxis after receiving their first of two planned doses of mRNA-1273 (Lot unknown) on an unknown date. The event is possibly related to the vaccine, and additional information including temporal relationship between dosing and event and whether patient has previous history of anaphylaxis could provide details needed for medical assessment.
378	COVID19 (COVID19 (MODERNA))	0 days	Unknown	0984395-1	No	Anaphylaxis; Burning sensation in the arm; This spontaneous report was received from a consumer who was a 39-years-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced an immediate burning sensation in the arm and anaphylaxis. The patient's medical history was not provided. Concomitant Medications were not reported. On 13 Jan 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm (Lot number: 025L20A). She immediately felt a burning sensation in the arm, dizziness, and developed hives on her arm, face and chest. The hives on her face were itchy. She presented to the Emergency Department and was treated for anaphylaxis. Treatment included intravenous diphenhydramine and intramuscular epinephrine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, burning sensation in the arm and anaphylaxis, were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 39-year old female patient with unknown medical history and concomitant medications. The patient experienced an unexpected event of Anaphylaxis that was considered medically significant. Additionally, the patient experienced expected non-serious event of Burning sensation in the arm. The events occurred immediately after receiving their first of two planned doses of mRNA-1273 (Lot number: 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
379	COVID19 (COVID19 (MODERNA))	0 days	Unknown	1005346-1	No	Anaphylactic reaction; A spontaneous report (United States) was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history included allergy to azithromycin (hives). Concomitant medications were not reported. On 09 JAN 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 09 JAN 2021, while sitting in the waiting area, 8 to 10 minutes after the injection, the patient experienced warm feeling, tongue getting bigger and collapsed. She was given intravenous medications and health care professionals were monitoring her vitals. The patient was transported to emergency via ambulance and was given two doses of EpiPen in the ambulance and by the time she arrived hospital she was doing better and was discharged after 4 hours. Treatment provided included EpiPen and intravenous medications. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a female patient of unknown age with relevant medical history of allergy to azithromycin who received her first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection and experienced a serious medically significant unlisted event of an anaphylactic reaction within 8-10 minutes after the injection. The reaction was described as warm feeling, tongue getting bigger and collapsed. Patient was transported to ER and given two doses of EpiPen while in the ambulance. By the time she arrived at the hospital, she was doing better and was discharged after 4 hours. Treatment also included IV medications. Based on temporal association between the use of the product and the start date of the event within 8-10 minutes after the vaccine administration, a causal relationship cannot be excluded and the event of anaphylaxis reaction is possibly related.
380	COVID19 (COVID19 (MODERNA))	0 days	Unknown	1031463-1	No	Anaphylactic reaction; A spontaneous report was received from a healthcare professional concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Anaphylactic reaction. The patient's medical history included allergy to milk. No concomitant medications were reported. On 12 Jan 2021, 5 √ 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced chest tightness and tachycardia symptoms following which she was transported via gurney to the observation area. The patient looked sleepy and had trouble arousing her. The blood pressure was at 140/80 mmHg, heart rate was in the 90s to 100s heartbeats per minute. The patient's breath sound decreased bilaterally. It was also noted that her throat felt uncomfortable. The reporter stated that anaphylaxis reaction was suspected due to the rapid decline in status. Following an increasing heart rate and complaints of chest discomfort the patient was treated with a dose one of epinephrine pen. It was noted after a minute or two the patient's chest felt better. Her blood pressure was stable at 140/80's mmHg, the heart rate initially increased to 110 and then back down to 100 about 5 minutes after the first dose. At about 8 minutes from dose one of epinephrine pen, the patient's heart rate increased to 160 and developed additional symptoms of chest tightness again so a second dose of Epinephrine pen was administered. The patient was somnolent but protecting airway. Oxygen was added 2 liters after second dose of epinephrine pen. The patient's oxygen saturation dropped right around second dose of epinephrine pen to 94% but about 2-3 minutes later it was back at 98%. The paramedics arrived 5 minutes after second dose of epinephrine pen and care was transferred to them. The patient was transported in a stable condition. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the Anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a 24 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction. The event occurred 1 day (5-10 min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen (2 doses). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
381	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0902836-1	No	Patient received covid-19 vaccine. 20+ minutes later patient states she began feeling flushed and nauseous. Patient states she look at her injection site, and it was hot and red. Local reaction approx. 2 inches x 2 inches. Dr. ordered 25 mg oral Benadryl. Vitals stable at 1840 133/88, 66 for pulse and regular, SPO2 99% on room air, respirations 20. Patient continued having complaints of light headedness and nausea. 1850 119/79, 74, 99% RA. Dr. states patient may depart from clinic if able to sit up and walk out, patient given instructions go to ED in symptoms progress. 1857 120/82, 70, 99.4. Patient's face becomes flushed and hot on left side, patient states she is shaky, and does not feel well at all. 1905 patient transferred to ED on 2L O2 for further evaluation and workup. Narrative ER Medical decision making narrative: Accu-Chek was obtained noting a glucose to be at 80. She received IV fluids as well as Solu-Medrol Benadryl and IV Pepcid. She also received IV Tylenol as she developed a headache while in the emergency department. Headache resolved and she was able to ambulate without assistance. Requested to go home states she felt much improved near normal. Clinical Impression: Adverse reaction to drug Patient Education: Anaphylaxis (ED)
382	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0902837-1	No	Patient feeling very anxious before and after vaccination. Described having difficulty swallowing water shortly (~15 min) post vaccination. Patient was tearful but breathing normally. Walked under her own power from the pharmacy down to the Emergency Room for anxiety over anaphylaxis. Given dose of Vistaril in ER.
383	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0903693-1	No	Patient has hsitory of anaphylaxis to foods and medications, carries Epi-Pens. 20 minutes post delivery, patient ""feels throat swelling"" and slight shortness of breath. Patient checked by on staff physician. Patient took 25mg (self) of Benadryl (oral).""
384	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0903713-1	No	Patient reported feeling hot shortly after receiving her vaccine with an itchy arm. We provided and ice pack and laid her down on a stretcher. Patient became slightly erratic and we proceeded to wheel her down to ER. ER summary below. ED Course: Patient's pertinent past medical, social, family medical history were reviewed from both the nursing notes and the electronic medical record. This is a 27-year-old female with a past medical history as above presenting with a chief complaint of concern for urticarial rash in anaphylaxis following a COVID-19 vaccination. ß I did speak with Occupational Health who stated that this patient is well-known to the hospital, stating specifically that she becomes very anxious with vaccinations/needles and breaks out in hives on previous injections. This information was given to his after her initial presentation. Patient had already been removed provided epinephrine given concern of possible anaphylactic reaction given her area, diaphoresis, pruritus and diffuse urticaria. ß I was called into the room multiple times as patient continued to ask to be discharged. I did have multiple conversations with her in regards to need for continued monitoring given possibility of anaphylactic reaction. She feels that this was due to her anxiety and states that she is completely asymptomatic and at her baseline at this time. She once again is asking to leave. I did discuss my recommendation for continued monitoring as well as the risks of leaving without continued monitoring. The patient is able to choose, communicate and make choices clearly and understandably. The patient is able to understand risks, benefits and alternatives of therapy explained by myself. The patient can make a logical and rational decisions according to my assessment. The choice made by the patient is consistent with the patient's values and is consistent with character and decision capacity in the patient's past, according to friends and family present. There is no impending medical risk to this patient to warrant my holding the patient against their will. ß Patient will be discharged in stable condition at this time with strict return precautions and instructions for close outpatient follow-up. She was provided EpiPen given possibility of anaphylactic reaction in the future.
385	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0903925-1	No	5 minutes after shot administered, became very hot and flushed. Felt tingle in throat. Turned bright red. Sent to ER. Throat tingle subsided after about 30 min. No anaphylaxis. Given Zyrtec for slight itchiness
386	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0906056-1	No	Patient notes that she received the COVID vaccine around 1800 today. After receiving the vaccine she notes she had developed a headache. She was otherwise doing fine until around 2000-2100 when she noticed her left arm become numb with paresthesias from her left bicep to her hand with whole arm localization. She felt her hands and wrists were puffy at this time and somewhat swollen. She reports feeling ""floaty""/Dizzy at this time, and at least once had to sit down due to this. She started feeling her heart race and some associated SOB, this has since resolved. She notes that she had two loose stools around this time as well. This progressed to develop into right numbness/paresthesias from her mid right forearm down to her hands. As the evening progressed she developed itchiness of her bilateral arms and torso. She notes that she has had a waxing/waning reddish rash on her arms that has been pruritic. She has since developed intermittent nausea, and still endorses feeling some ""skipped beats."" While in the ED from Triage to repeat evaluations her lips began having progressive swelling. She had been given Benadryl 50mg, Zofran 4mg, 1L IVF. Given ongoing tachycardia and lip swelling she was given Prednisone 40mg and Epinephrine for allergic reaction and concern for anaphylaxis.""
387	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0906272-1	No	19 y/o fully immunized female with history of anxiety presents for dizziness and nausea x 2 hours. Received COVID vaccine at 14:30. At 16:30 went from sitting to standing, felt dizzy and nauseous. No syncope. No palpitations. Similar reaction to influenza vaccine. No intervention required to previous vaccination. No history of anaphylaxis. BP 125/88, pulse 88, RR 18, 02 95%, temp 37.3.
388	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0910123-1	No	21 y.o. female who arrived by from on-campus presented to the emergency department for Nausea, face/tongue/distal extremity numbness 5 minutes after receiving Covid vaccine. Patient states that the symptoms are intermittent and ""come in waves."" She states that she was simply sitting in a chair doing nothing on the symptoms started. She does not feel like her tongue is swollen, she has no difficulty with breathing, no new rashes, and her nausea is not persistent. She has no history of anaphylaxis. She has no history of food or other allergies, and has never used an EpiPen. She does not typically have symptoms after receiving injections and is a phlebotomist and does not have fear of needles. Patient's symptoms resolved within 1 hour of her stay. She felt well, had no difficulty with breathing, did not notice any development of rashes, abdominal pain, nausea. She states that her heart rate is typically 80s/90s when she checks it. ß After her fluids are complete, and she is observed for 4 hours, patient has no symptoms, and feels safe to go home.""
389	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0910216-1	No	21 y.o. female normally healthy who arrived by to the emergency department for Post COVID-19 vaccination reaction. Patient states approximate 5 minutes after the vaccine, she started to feel lightheaded and nauseated. She does notice the sensation of throat irritation, but denies any shortness of breath or difficulty breathing. Denies any tongue/lip/airway swelling, abdominal pain, new rash/pruritus, diarrhea, emesis, fever/chills, chest pain. She has no history of anaphylaxis or use of EpiPen. No significant allergic reactions in the past Initial reevaluation approximately 30 minutes after arrival, patient status unchanged. She still felt lightheaded and nauseated with a sore throat. No new rashes, shortness of breath, difficulty breathing. Her voice was normal, and did not report any new GI symptoms. Heart rate was 109 with one half fluids given thus far. ß On reevaluation 2 and 3 hours after arrival, patient's heart rate normalized into the 60s?70s, she was asymptomatic. She was slightly fatigued from the Benadryl. She felt safe to go home. Follow-up call a few days later and patient was doing fine with no symptoms.
390	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0910337-1	No	vaccine at 11:30 am on 12/18/20 and after 15 mins she felt the room started to spin, dizzy and tunnel vision. nausea and dry heaves also 2-3 mins after. persistent dizziness. pruritic rash and was taken to the ER by wheel chair. About an hour after the vaccine, she felt something in the back of her throat, speech ok, able to swallow. No sob. She was treated with benadryl, pepcid, zofran and fluid. She felt very hot and shaking. In the ER, she noticed that the rash had progressed to her back. Notes chest redness, back with erythematous, raised pruritic bumps on back and arm (smaller size of dime) Within 4 hours of treatment, she had improved. That night at 2am she had a rash -not as pruritic. She took more benadryl. No rash after. No new meds, no nsaids. She has never had any medical problems or rashes before. Her symptoms are concerning for anaphylaxis but it is reassuring that her vitals were ok and that she did not progress and improved with benadryl and pepcid - advised to not get 2nd vaccine dose - will plan on skin testing her in the future
391	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0919503-1	No	rash, hives, anaphylaxis, throat tightening, felt out of body
392	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0924070-1	No	Patient was administered the first dose of the Pfizer vaccine 0.5mg IM Rt Deltoid this AM in the Covid-19 Vaccine Clinic.Patient waited 12 min went to change her clothes and come back to the clinic with complaints of hives and feeling warm. Patient had raised red welts on right upper arm. Patient has a history of Anaphylaxis reaction with a Meal Ready to Eat (MRE) in the past, other allergies to grapefruit seed extract with reaction of edema. Pt has no c/o of SOB or Chest pain, no other swelling at this time. Dr. notified, 0.3mg Epinephrine 1mg/mL (1:1000) given IM Left Deltoid, 25mg Benadryl IM given Rt Deltoid per MD verbal order and anaphylactic protocol. Pt transferred by wheelchair to the ER for further evaluation. Report given to ER RN.
393	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0929875-1	No	Patient walked out fine after receiving the vaccine. Was able to walk up to the registration desk and carried a conversation with the staffs. He sits down in the waiting area to be monitored. We heard his phone dropped, looked up and saw him tilting over on the right side was about to fall off the chair. Staff grabbed him and held him back onto the seat, proceeded to picked up his right arm and held him in place. He looked unconscious while staff held him. He came back to his senses approximately 10 seconds later. After he regained consciousness, staff took his blood pressure which was 111/44, SpO2 was 100%, and heart rate 58. Patient looked pale but not critical. Conversed with our staff and stated that this has happened before when he receives other vaccinations. Patient's father is a physician and reported that the patient is scared of needles and did not need any medications from anaphylaxis kit or crash cart. We gave him water and he left after sitting for a while.
394	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0930881-1	No	At time of vaccination ~5 minutes after the injection of the pfizer vaccine I developed a tightness in my throat, I was still waiting in line and I did not think much of it, therefore I did not alert the medical personnel about the reaction. Approximately @15mins after the injection I left the site and developed a sense of something wrong and did not feel ""right"", my chest became tight, hoarseness in my throat and speach, lightheaded, and I remember taking a sip of my coffee thinking it was more difficult to swallow than usual. May I note I was in the passenger seat and not driving the vehicle. I alerted my mother of the reaction, both sceptical because of my hx of no known allergies. We both figured as long as I can breath and I was still conscious, with no signs of cyanosis I would be fine. At around 10:45 I took my BP: which was 106/62 I typically run low. I then took two 25mg Benadryl capsules which did help the throat tightness to an extent, however the tightness in the chest, lightheaded and dizziness still persisted. I was aware of the potential for Bi-phasic anaphylaxis so we had an Epi-pen on stand by just in case. I was stable for the rest of the day. At approximately 10pm I did notice a small erythematous non-pruritic rash across my chest. The symptoms of the reaction did subside within 24hrs. I remained in stable condition and recovered with time.""
395	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0932143-1	No	I got palpitations and tongue numbness 5-7 mins after receiving the IM injection. No rash/wheezing/hypotension/angioedema. Got treated like anaphylaxis with epinephrine, decadron, benadryl, pepcid
396	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0932286-1	No	About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.
397	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0934714-1	No	headache soon after vaccine (gone ), hard to take a deep breath(denies anaphylaxis), wheezing with activity, coughing, fatigue later the same day as vaccine
398	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0938534-1	No	Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.
399	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0940999-1	No	Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.
400	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0941021-1	No	Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER
401	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0941121-1	No	?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER
402	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0943070-1	No	Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium
403	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0943443-1	No	Systemic: Anaphylaxis-Severe
404	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0943722-1	No	Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day
405	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0949597-1	No	Anaphylaxis- throat closing, feels SOB 15 minutes after vaccine.
406	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0951174-1	No	Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.
407	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0951824-1	No	Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.
408	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0970033-1	No	Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.
409	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0974136-1	No	Patient received their first injection of Pfizer COVID-19 vaccine. About 20 minutes post-injection, patient began swelling in throat similar to anaphylaxis reaction patient has with peanuts. Took Zyrtec, better after 1-2 hours. Pt. transferred to ER for follow-up from vaccine clinic.
410	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0974153-1	No	Patient received vaccine and about 20 minutes post-injection began experiencing throat swelling similar to anaphylaxis with peanuts. Pt. took Zyrtec and felt better 1-2 hours later. Pt. was transferred to ER for follow-up.
411	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	0977251-1	No	Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-Severe, Systemic: Other- Itching-Severe
412	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1048846-1	No	Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.
413	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	18-29 years	1071167-1	No	Occipital neuralgia; anaphylaxis; feeling like passing out on and off for the next 2-3 hours; he felt lightheaded; little short of breath; fatigue; he had a lot of posterior lymph pain in the back of his head, for 2 weeks on and off; heaviness at the back of his head left sid; chest tightness; he developed a sensation like he was going to lose control of his mind; This is a spontaneous report from a contactable Other Health Professional, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 08Jan2021 at 13:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma exacerbation, GERD, childhood anemia, a retinal tear in the right eye all from unspecified dates and unknown if ongoing. The patient also reported medical history three episodes (June 2019, August 2019 and October2019) of anaphylaxis due to ""Exercise Induced Anaphylaxis."" Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899) on 21Dec2020 at 13:30 after which he experienced pain at the vaccination site which lasted twenty-four hours. The patient's past product use included adrenaline (EPIPEN), an unspecified corticosteroid and an unspecified antihistamine for past allergic reactions. The vaccine was administered in a hospital. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included ciclosportin (RESTASIS), azelastine (AZELASTINE), mometasone furoate (FLONASE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PROTONIX) all for unknown indications from unknown dates and unknown if ongoing. Within four weeks prior to the vaccination the patient had received unspecified ""allergy shots"" He received ""two shots"" (one in each deltoid) on 15Dec2021 and ""two shots"" (one in each deltoid) on 05Jan2021. The patient reported that fifteen to thirty seconds after the second dose of the COVID-19 vaccination he felt lightheaded and a little short of breath. This lasted about eight minutes and then subsided. Approximately thirty to forty minutes (about 30 minutes after he left the facility) later the symptoms returned. He felt short of breath and he thought he was going to pass out. The symptoms included fatigue, shortness of breath lightheaded and feeling like passing out on and off for the next two to three hours. He stated he has completely recovered. He continued to say that he was feeling fine for three days then he began having bilateral cervical lymph pain greater on the left than right, a lot of posterior lymph pain in the back of his head (for two weeks on and off). These symptoms also resolved on their own. He also experienced (""a couple of days later"") a sensation where he thought he was going to lose control of his muscles and lose consciousness. He also developed a sense that the was going to lose control of his mind with heaviness at the back of his head, left side. He went to the Emergency Room (date not provided) and they provided Valium. He also reports an Emergency Room visit on 13Jan2021 during which he underwent a CT scan of the head which was normal and a neuro consult suggesting occipital neuralgia and he was put on muscle relaxers. He also stated that experienced shortness of breath and chest tightness after his allergy shots on 26Jan2021 and he specified that he had never before had these reactions to his allergy shots. After that he had yet another possible allergic reaction after eating pizza on 30Jan which included throat swelling as well. He further stated that on 04Feb he had anaphylaxis vs asthma exacerbation. On the following day he developed a heaviness to his left occipital head with that same feeling of wanting to lose control of his muscles. He never had that before. He started Prilosec about one and one half weeks prior to the reporting date. In follow up the Other HCP reporter/patient answered ""Yes"" to the following questions (DCA) about symptoms experienced: Bilateral wheeze/bronchospasm, upper airway swelling, increased use of accessory respiratory muscles, dry cough, difficulty breathing (without wheeze or stridor, sensation of throat closure, tachycardia, nausea. These were reported without dates and without context with regard to the events reported initially. These were also reported as not requiring treatment and having recovered on unspecified dates. Lab data included three SARS COV 2 nasal swab tests (14Jan2021, 03Feb2021 and 11Feb2021) all of which were negative. Unspecified treatment was reported for the events anaphylactic reaction and mental impairment. The clinical outcomes of the events Anaphylaxis, loss of consciousness, dizziness, dyspnea, fatigue and lymph node pain were reported as recovered on an unspecified date in 2021. The clinical outcome of mental impairment, heaviness of head, chest tightness and occipital neuralgia were reported as unknown.""
414	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0902674-1	No	Patient has a prior anaphylaxis reaction to Doxycycline. 10minutes after immunization, she developed sweaty palms and lightheadedness. No throat swelling or difficulty breathing. Placed supine, BP 160/100, HR 60-70, O2 97% RA. After a period of monitoring the symptoms improved. No intervention given.
415	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0904210-1	No	Anaphylaxis within 15 minutes of administration
416	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0904398-1	No	Anaphylaxis type reaction, stridor, treated with 02, epi pen, moved to hospitals ED
417	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0904418-1	No	Initially started as numbness of the lips, then progressed to angioedema (swelling of the lips) with face itchiness. Then progressed to throat tightening and swelling feeling, consistent with anaphylaxis.
418	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0904485-1	No	Sensation of tightening in throat and sensation of difficulty swallowing. No rash. No dyspnea. No stridor/wheezing. Vital signs unremarkable. Suspect globus sensation. Plan observation until resolution or progression to anaphylaxis.
419	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0905300-1	No	39-year-old female with history of ADHD, anxiety, melanoma presents with palpitations. Patient received a Covid vaccine today and started having palpitations, lightheadedness, shortness of breath and feeling flushed a few minutes afterwards. Rapid response called and patient taken to ED for assessment. Patient denies facial or oral swelling, rash. patient denies any recent fever, nausea, vomiting, cough, diarrhea. Denies chest pain, abdominal pain. Last menstrual period end of November. Has allergies to Bactrim and clarithromycin. Presentation concerning for possible vaccine reaction, no anaphylaxis. EKG and labs within normal limits. Patient was rehydrated in the ED. Patient was discharged home on same day (12/20/2020). Pt alert and oriented x 4. Pt ambulated out of ED with a steady gait in no apparent distress.
420	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0905302-1	No	39-year-old female with history of ADHD, anxiety, melanoma presents with palpitations. Patient received a Covid vaccine today and started having palpitations, lightheadedness, shortness of breath and feeling flushed a few minutes afterwards. Rapid response called and patient taken to ED for assessment. Patient denies facial or oral swelling, rash. patient denies any recent fever, nausea, vomiting, cough, diarrhea. Denies chest pain, abdominal pain. Last menstrual period end of November. Has allergies to Bactrim and clarithromycin. Presentation concerning for possible vaccine reaction, no anaphylaxis. EKG and labs within normal limits. Patient was rehydrated in the ED. Patient was discharged home on same day (12/20/2020). Pt alert and oriented x 4. Pt ambulated out of ED with a steady gait in no apparent distress.
421	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0906373-1	No	Pfizer-BioNTech COVID-19 Vaccine EUA On 12/21/2020 13:17 the patient received the first dose of COVID-19 vaccine. During monitoring, the patient experience itching skin. Hives and welts were not located. The injection site was read and hot. No wheezing occurred, no tachycardia observed. The patient report a history of anaphylactic reactions to food (Sesame), but has never had an anaphylactic reaction to vaccines in the past. Patient also reports anaphylaxis to lidocaine. The patient was treated with ice pack on injection site, 50 mg diphenhydramine, 10 mg cetirizine, and 20 mg famotidine. Patient was observed for a full hour. Advised to pre-medicate at 2nd dose and to alert vaccinator of this reaction.
422	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0906684-1	No	sensation in throat/a menthol cough drop stuck in the throat; flushed; diaphoretic; burning into my chest; some random hives; This is a spontaneous report from a contactable consumer (patient herself). A 38-year-old female patient received first dose of bnt162b2 (lot number: EL0140), via an unspecified route of administration at site of left arm at 11:30 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included Oral Allergy Syndrome, ADHD (attention deficit hyperactivity disorder), multiple food allergies, and allergies: PCN, Ceclor and Lovenox multiple. Concomitant medication included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Within minutes after vaccination, the patient became flushed and diaphoretic followed by a sensation in her throat, it felt that she had a menthol cough drop stuck in the throat and the burning into her chest. Once the medics administered IV Benadryl, the sensation in her throat went away. She was in the emergency room for about 3 hours and had some random hives throughout the rest of the evening. She had anaphylaxis previously to avocado and to an allergy shot. This was definitely nothing close to anaphylaxis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Dec2020.
423	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0907256-1	No	*Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) S: 35 yo F who received Pfizer vaccine at 16:47 w/acute onset of left sided facial swelling and difficulty swallowing. Within five minutes of being administered vaccination, pt reported pain at the injection site radiating up to her jaw followed by left sided facial swelling. She started reported palpitations and subsequently reported a ball in her throat O: Pulse was in the 60's, BP of 128/72, pulse of 88-97 satting at 99% on RA. General: young female, anxious. HEENT: NC, AT, mild left sided cheek swelling, OP clear, MMM. Neck: Supple, left sided tender cervical LN. Lungs: CTAB. CV: tachycardic rate, regular rhythm. Extremities: Hands are clenched and cold. Neuro: Alert & oriented. A/P: Anaphylaxis -Given left facial swelling, 25 mg Benadryl PO administered. pt tolerated well. -17:22-Throat swelling reported. EPI #1 administered right thigh. -17:32-EPI #2 administered. Throat felt better at 17:35. 17:36-FD EMS arrived. BP 194/126. -17:38-EPI #3 administered right thigh. HR 135, BP 154/105. -17:43-EPI #4 administered left thigh. -17:46 pt transported to ER via EMS.
424	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0907354-1	No	Patient was vaccinated and within just a few minutes of vaccine administration began to feel throat tightening, difficulty getting air, tachycardia, and dry mouth. Admitted to a past history of anaphylaxis with shell fish and endorses similar symptoms. Employee was treated with an epi pen and taken to the emergency room for additional monitoring and treatment as needed Treatment dugs:
425	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0909209-1	No	Mild anaphylaxis with angioedema of the tongue within minutes of injection.
426	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0910907-1	No	Anaphylaxis symptoms starting about 45 minutes after injection. Initial symptoms were severe light headedness and tachycardia. Epi-pen self administered 5 minutes after onset of symptoms. Symptoms resolved within 30 minutes of Epi-pen administration.
427	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0911420-1	No	itching skin; injection site immediately red and hot; injection site immediately red and hot; could not locate hives or welts; This is a spontaneous report from a contactable pharmacist. A 36-year-old female patient (pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 21Dec2020 13:15 at single dose on left arm for COVID-19 immunization. Medical history included anaphylactic reaction to food, Anaphylaxis to sesame and lidocaine, had never had anaphylactic reaction to vaccines in past. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 13:15 (01:15 PM), the patient experienced itching skin, could not locate hives or welts, injection site immediately red and hot, no wheezing observed, no tachycardia observed. Treatment included observed for an hour, ice pack on injection site x2, 50mg diphenhydramine hydrochloride (BENADRYL), 1 10mg cetirizine hydrochloride (ZYRTEC), 20mg famotidine (PEPCID). Advised to pre-medication prior to booster dose and alert vaccinator of this reaction to be prepared. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.
428	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0912619-1	No	Right side tongue numbness, tingling and burning in/around lips, elevated heart rate 136+, Blood pressure spike 165/105. Shortness of breath believed to be r/t elevated heartrate. Within 10 mins of shot. Face flushed, redness worsened with some swelling to ears and tongue skin felt like a sun burn rawness. Throat tugging noted. Dispatched an ambulance, had my husband take me around corner to ER where I was treated for anaphylaxis with 1 dose of Epi IM, IV solumedrol, and two rounds of benadryl IV. I was monitored and sent home on steroids, benadryl, and cimetidine for several days. I was issued an Epi Pen at that time. The rash and redness with feeling of burning has come and gone since as well as the tongue numbness on right side.
429	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0913214-1	No	39 yo female scheduled for COVID vaccine. Reports only incident of anaphylaxis d/t pineapple allergy 4 years ago; medication allergies limited to migraine s/s, not anaphylaxis. Denies possibility of pregnancy. Tolerated injection well. Upon standing ~5 min after injection, pt began experiencing lightheadedness and warmth/diaphoresis. Pt's monitoring and care transferred to clinic. Pt given Benadryl 25mg, famotidine 20mg, 1000ml NaCl IV, Solumedrol 125mg IV. Pt symptoms resolved and sent home with Epipen 2-Pak, Loratadine 10mg, prednisone 20mg, Benadryl 25mg/
430	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0913714-1	No	Anaphylaxis- generalized hives
431	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0915024-1	No	Vaccine administered at about 13:00 on 12/29/20. Within 5 minutes, patient developed became flushed and developed tachycardia as high as 160, and a feeling of being ""overstimulated"". The patient self-administered 10 mg Claritin. Within 20 minutes of injection, the patient developed profuse diarrhea and erythematous modeling around the injection side. In the evening, she had fatigue body aches, and nausea. The following morning, it was clear that the patient had an injection site reaction with firmness, redness, and warmth. The erythematous modeling had spread to the wrist of the left arm as well as to the chest and down to the elbow on the right arm. No rash on rash or any other sign of allergy or anaphylaxis.""
432	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0915235-1	No	anaphylaxis (generalized urticaria approx. 9 hours post-injection)
433	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0915371-1	No	vaccine at 5:56pm, at 6:08 pt reported itchy throat and took 25 mg Benadryl; at 6:13 pt was red and itchy all over and took another benedryl; pt reported having an epi pen but did not want to use any epi (even ours) because she would have to go to ED; at 6:29 she used her inhaler because she had some tightness; at 6:56 pt was less sloptchy and red; O2 sats remained above 93 the entire event and boyfriend drover her home; contacted her at 7:30 and she was much better. This lady is a nurse practitioner and was acutely aware of her symptoms as she has experienced anaphylaxis multiple times.
434	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0915897-1	No	35 y.o. year-old female RN that presented to the clinic today for a Pfizer-BioNTech COVID-19 vaccine. Pfizer-BioNTech COVID-19 vaccine was administered at: Time: 0852 Date: 12/31/2020 Patient presented with symptoms at time 0905 while being observed following vaccine. Patient's symptoms include the following: Skin and Mucosal symptoms: No Respiratory Symptoms: Yes: Sensation of throat closing. If described on scale of 1-10 with throat closure being a 10, stated ""throat closure could feel like a 2-3 on 1-10 scale. Symptoms also described as ""scratchy throat"". She hadn't had any breakfast today. She reported history of reaction after pneumococcal ppsv 23 vaccine which consisted of very red, sore, swollen arm with fever following vaccine. Reported to healthcare provider who let her know she ""suffered an allergic reaction to one or more components of the pneumococcal vaccine and not just side effects"". She was treated with ibuprofen, ice, and advised to take zyrtec, allegra, or benadryl. She reports she took benadryl and never required any epinephrine. She denied any shortness of breath, difficulty breathing, or swelling of the face, mouth, or throat with that reaction. She does report a possible reaction to bees/wasps for which she felt previous tingling in the lips, but when reviewed with her PCP, they opted to not order epi pen for her use at the time. She denies ever needing epinephrine or epi pen use in the past that she is aware of. Gastrointestinal Symptoms: No Cardiovascular: Yes: Dizziness The following actions were performed: Patient was brought to exam room to lie down Feet were elevated Given some water Given some juice Vital signs: @0915 BP 130/85, Pulse 84, Oxygen on room air 100%, Temp 98.8 F, @0923 BP 126/85, Pulse 75, Oxygen on room air 100% Airway, Breathing, Circulation, and level of consciousness assessed and normal Bendaryl 50mg administered as a single dose Patient reported dizziness was resolved quickly after lying down. She stated her ""throat closure"" symptoms were also improved. She drank water, apple juice, and had 2 saltine crackers without incident. Airway, Breathing, Circulation normal throughout assessment period. Vital signs again checked at 0945: BP 135/85, Pulse 80, Oxygen 100%, Temp. 98.9 F. Discussed normal adverse events following this vaccine with patient. Also discussed more severe adverse events which can include difficulty breathing, swelling of face/throat, fast heartbeat, bad rash all over body, and dizziness or weakness. Discussed she could take another dose of benadryl if she was concerned about any continued, mild swelling of throat in 4-6 hours. If she has severe swelling of face/throat that is worsening or not resolved with benadryl, she should call 9-1-1 immediately. She voiced understanding. We discussed that she would need to weigh the benefits/risks of a 2nd dose, and if she does choose to get a 2nd dose based on a minor reaction not causing severe anaphylaxis, she would need to make sure staff are prepared with benadryl and epinephrine to be used if needed. She voiced understanding. Her husband was notified and he came and picked her up after she was observed for an additional 30 minutes in the observation area outside the clinic. She left the observation area at 1016.""
435	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0919680-1	No	Anaphylaxis reaction
436	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0920128-1	No	tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
437	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0922464-1	No	A couple minutes after injection I felt flush over my chest area. It lasted about 30 seconds then my heart started racing. My iwatch heartrate notified me that my heart rate was 162. This lasted for about 7 minutes. My throat felt a little scratchy but not to where I had anaphylaxis reaction to seafood.
438	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0923555-1	No	Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to feel throat tightening, difficultly getting air, tachycardia, and dry mouth. Admitted to a past history of anaphylaxis with shell fish and endorses similar symptoms. Employee was treated with an epi pen and taken to the emergency room for additional monitoring and treatment as needed
439	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0924234-1	No	anaphylaxis
440	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0924380-1	No	Anaphylaxis requiring epinephrine and ER visit, no hospitalization required
441	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0925780-1	No	Within 5 minutes of vaccination patient began to experience tachycardia and throat tightening. She was given 25 mg cap Benadryl PO and assistance was called when her heart rate reached 150 BPM about a minute later and further climbed to 188 BPM. She was transported to the Emergency Department where she was administered epinephrine, lorazepam, methylprednisolone, racepinephrine, and lactated ringers. She spent several hours in the Emergency Department and was discharged home but returned later that night at 06:00 PM for return of symptoms (tachycardia: 185 BPM, anxiety) and was administered Benadryl, solumedrol, Pepcid, Ativan, and Lactated Ringers. She was diagnosed with acute allergic reaction, nascent anaphylaxis, and panic attack. She went home again after this second ED visit. On Monday, 1/4/21, the patient reported to Employee Health with resumption of symptoms. Calming techniques were discussed and she went to a quiet area for 15 minutes to compose herself. Employee Health Nurse referred patient to Employee Assistance Program for anxiety care.
442	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0928759-1	No	Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/97 Heart Rate 78 Respiratory Rate 16 Temp 36.9 ªC (98.4 ªF) Temp src Oral SpO2 97 % 34 y.o. female who arrived by From on-campus presented to the emergency department for an allergic reaction to the Pfizer COVID-19 vaccine. Pt received the first round of injections at 1707 tonight and experienced adverse reactions. Pt endorses dizziness which is accompanied by central abdominal pain and itching of her left thigh. Pt states that her throat is dry, but adds that it could be from not drinking much fluids today. Pt has a hx of anaphylaxis from shellfish and angioedema. She says these current symptoms are not similar to the ones she experienced from anaphylaxis or angioedema. Pt has not started or changed any medications, but had an IUD inserted about a week and a half ago. Pt denies any fevers, chills, coughs, cold symptoms, chest pain, palpitations, shortness of breath, headaches, nausea, vomiting, bowel or bladder problems, or urinary complaints. Clinical exam shows central abdominal pain just above the umbilicus with itching of the posterior aspect of the left lateral thigh. Will administer PO Prednisone and PO Diphenhydramine in the ED and observe the pt. No epinephrine injection was deemed necessary at this time. DDx: allergic reaction 1910 hours: Discussed further treatment and vaccine advice with the pt. Will discharge pt to home. Provided follow up instructions to her PCP, for reevaluation. Discussed return precautions. Vital signs are stable at time of discharge.
443	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0929338-1	No	Anaphylaxis - started with metallic taste in mouth followed by tongue swelling and chest heaviness
444	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0930315-1	No	With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.
445	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0930456-1	No	- Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along with feelings of mild illness (like a cold) and arm pain which is consistent with other vaccination response. - Waited at clinic for 30 minutes as directe
446	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0930653-1	No	Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait time because of prior history of anaphylaxis (non-vaccine). Within a few minutes she developed light-headedness and dizziness, these symptoms continued to worsen so she notified our nurse who was observing post-vaccine patients. She was promptly wheeled to our anaphylaxis room at 8:50 and placed in semi-Trendelenburg position. In addition to light-headedness and dizziness. she reported mild neck tightness and throat fullness. She had facial flushing and conjunctival injection with some tearing. She was monitored for Vital Signs and Oxygen Saturation. Within 20 minutes her symptoms progressed to chest heaviness, increased effort to take a breath and shortness of breath. She was mildly tachycardic with HR 96, though did not become hypotensive, B/P was 140/92. She had no gastrointestinal symptoms. She was anxious and ""did not feel right"", but did not report ""impending doom"". At 9:05 Epinephrine 1:1000, 0.3mL was administered IM, upper-outer thigh. Symptoms began improving within 8 to 10 minutes and were mostly gone by 9:20. At 9:17 she was given Diphenhydramine Solution 25mg, Famotidine 20mg, Prednisone 20mg. Her vital signs and Oxygen Saturation remained stable. (see flow sheet) Patient was monitored by an RN for 2 hours in our anaphylaxis room, on monitors, full crash cart present.""
447	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0931271-1	No	? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to HD since we were so busy. ? Around 4pm in the afternoon after we closed HD, I went back to the ER. She was recovering and doing fine. Her ER nurse and patient did have a question about receiving the 2nd dose, and I provided the same answer that Dr provided to Dr about taking an Allegra 30 minutes before the second dose. ED Note: Patient presents with symptoms concerning for angioedema or anaphylaxis after immunization with Covid vaccine. Patient described a sensation of warmth and also later tingling in her throat which was treated aggressively with medication for this problem so as to prevent airway closure or further worsening symptoms. Patient was treated with IV fluid hydration along with H1 and H2 blockers, IV steroids and also subcutaneous epinephrine. On my reevaluation, her symptoms completely resolved with treatment. She was without other concerning findings on examination or by history and was without further angioedema or anaphylaxis after period of observation. She was discharged with prescription medication in good condition and asked to return should she have any further problems. Immpression: Angioedema, allergic reaction to vaccine, throat tingling, throat warmth MEDS in ED: Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses diphenhydrAMINE (Benadryl) 25 mg = 0.5 mL once IV push methylPREDNISolone (SOLUMedrol) 125 mg = 2 mL once IV push famotidine (Pepcid) 20 mg = 2 mL once IV push EPINEPHrine 0.3 mg = 0.3 mL once intraMUSCULAR
448	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0935576-1	No	Patient reported prior to vaccination hx of anaphylaxis to shellfish and macrobid. She was a 30 minute post-vaccine nurse monitoring. ~15 minutes after receiving vaccination, patient reported to the nurse dizziness, nausea. Nurse placed patient on stretching and called for provider assistance. SBP in 160s, DBP >100, HR 130s or higher, oxygen saturation on room air ~98%. Epinephrine 0.3mg IM administered. Nurse placed Nasal cannula oxygen with oxygen saturation 100%. Patient BP improved, HR improved to low 100s occasionally in 110s if patient talking to someone new such as Fire response. Patient reported continued dizziness. BP prior to EMS arrival 146/91 left arm automatic cuff, Temp 98.3F, P 106, oxygen on nasal cannula 100%. Upon EMS arrival, patient transferred to ER.
449	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0935903-1	No	rash on left arm, rash on right arm, rash on left leg. Given diphenhydramine 25mg PO and observed for 1 hour, no increase in reported symptoms. No difficulty breathing / SOB/ wheeze / anaphylaxis noted.
450	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0940548-1	No	Systemic: Anaphylaxis-Severe.
451	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0941848-1	No	"PMH htn who c/o n/v/d and flu like symptoms. Patient received first dose of pfizer vaccine 12/23/20 at 3pm. A few hours later started having epigastric pain to his back with numerous episodes of n/v nbnb. +chills and myalgias. Denies having any prior adverse reactions to vaccines. Denies any nsaid or etoh use. Denies any abd surgeries. Took 12mg zofran, about 4mg which were IV w/o relief. Denies any itching or rash or hx pancreatitis or anaphylaxis. +mild sob. """"
452	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0941886-1	No	@0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and arms bilaterally. NAD, no SOB, v/s 154/110 (normal for her is 102/80s). 98% RA, hr 95, 96.9 temp and no pain. Did report dizziness. patient has a history of
453	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0942081-1	No	Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat. She has also noted episodic throat tightness and SOB in the 10 days since the vaccine. She has a history of anaphylaxis w/ morphine. She has an autoimmune condition currently being evaluated by rheumatology. Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose.
454	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0942114-1	No	Received the 1st dose of COVID vaccine, felt well when she left, but developed a lot of fatigue and was in bed by 7 pm, very unusual for her. She woke up next day and had some swelling on her forehead and generalized itching. She took an Allegra and facial swelling resolved. No perioral swelling or lesions. No erythema. Then had 3 episodes of vomiting. Still feels nauseated. She contacted her PCP, who advised being seen. Pt uses Singulair at night, Allegra or Zyrtec in morning if she is itchy. Pt denies cough, shortness of breath, abdominal pain, diarrhea, skin irritation. For Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type- ondansetron ODT (ZOFRAN ODT) 4 mg oral tablet,disintegrating; Dissolve 1 tablet on tongue and swallow every eight hours as needed for nausea/vomiting. Dispense: 15 tablet; Refill: 0. Pt appears well. No facial swelling. History consistent with allergic reaction to COVID vaccine. No evidence of anaphylaxis.Pt to self-report to Occ Health and agency. I also left message at Occ Health. Zofran ordered prn nausea. Pt has an Epipen. She lives with her husband, who can also monitor her. To ED if she develops fwelling, shortness of breath, cough, wheezing, persistent vomiting, or otherwise worsens.
455	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0943073-1	No	Systemic: Anaphylaxis-Severe, Systemic: Vomiting; symptoms lasted 2 days
456	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0944923-1	No	Systemic: Anaphylaxis-Medium; symptoms lasted 1 day
457	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0945182-1	No	Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Rapid Response called and she was brought to ED. At ED, evaluation done, pt stable, felt to be likely anxiety/panic attack as cause of symptoms, and low likelihood of anaphylaxis. Pt was given rx for Epi pen to keep on hand just in case.
458	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0945615-1	No	The patient had received her first dose of the Pfizer COVID-19 vaccine (lot number EL 1283, exp 4/30/2021) and about an hour later, she began to experience chest tightness and throat tightness. She took her albuterol inhaler, but did not feel better, and proceeded to go to the ER. She has a history of asthma, but regards it as mild and only takes albuterol as needed. She denies having any cutaneous, gastrointestinal, or cardiovascular symptoms. At the ER, she was administered diphenhydramine and corticosteroids--she began to subjectively feel better. She denied a history of allergic reactions to medications or vaccines, and denied a history of anaphylaxis. She was not taking any medications on the day of her reaction, and was at her baseline health. She had no vaccines within the past 14 days.
459	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0947496-1	No	Itching/redness at injection site; Itching/redness at injection site; Itching/redness up neck; Itching/redness up neck; This is spontaneous report from a contactable pharmacist. A 39-year-old female patient (unknown if pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the Left arm on 06Jan2021 at 08:15 PM (at the age of 39-years-old) as a single dose for COVID-19 immunization, lot number: EL0142. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included anxiety and depression, coronary artery spasm, hyperlipidemia. Known allergies included latex allergy (anaphylaxis). Concomitant medications in two weeks prior to the vaccination included atorvastatin 20mg, isosorbide mononitrate 60mg extended release (ER), multivitamin, omperazole 20mg, sertraline 50mg and tizanidine 2mg for muscle spasm. On 06Jan2021 h 08:15 PM patient experienced Itching/redness at injection site and up neck. Oral (PO) diphenhydramine hydrochloride (BENADRYL) 50mg was given to treat the events. Rapid Response called and observed for 30 min. Discharged to husband's care. It was unknown if, since the vaccination, patient has been tested for COVID-19. Outcome of the events was unknown.
460	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0947796-1	No	At 0803 employee complained of his throat tightening and he was placed on an AED and EMS was called and a non-rebreather and Anaphylaxis kit were brought 0805 HR 118 RR 22 employee breathing was not labored AED ""no shock advised"" employee now reporting centralized tight feeling chest pain 0807 HR 122 RR 20 employee breathing was not labored. AED ""no shock advised"" 0809 HR 118 RR 22 AED ""no shock advised"" 0811 HR 102 RR 18 employee breathing was not labored. AED ""no shock advised"" Employee reported Chest pain ""less tight"" still with dry mouth ,difficulty swallowing and now burning sensation in throat 0811 HR 104 RR 18 AED ""no shock advised"" employee breathing was not labored 0813 EMS arrived and care of employee handed over. 02 and pharmacy monitoring applied. They assessed and took patient to ED Received Solu-Medrol, Pepcid, and Benadryl in ED""
461	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0948001-1	No	chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.
462	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0949845-1	No	34-year-old male presenting with lightheadedness and transient episode of hypertension following vaccine administration. Appears most consistent with vasovagal episode and patient does report similar episodes in the past. ECG performed without any acute ischemic change. Symptoms have resolved by the time of my evaluation. Blood pressure within normal limits. No clinical features concerning for anaphylaxis
463	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0949903-1	No	That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I have taken amlodipine now I have felt lightheaded and less cognitively sharp than normal basically the entire day. I received the above Pfizer COVID-19 vaccine around 12:45 PM, within about 3-5 minutes of receiving the vaccine and standing in line to check out I suddenly felt I was going to loss consciousness/collapse so started lowering myself to the ground and then became unconscious and fell. Healthcare staff informed me I was unconscious for about 20-30 seconds. I woke up and initially felt confused, but quickly realized what had happened. Then I felt nauseated, had some stomach cramps and thought I was going to have diarrhea. They considered giving me Epi for possible anaphylaxis, but I requested they observe further for any skin reaction/hives, airway symptoms, etc given I was skeptical the syncope may have been fully or partially related to the amlodipine I took that morning. Symptoms slowly improved over 20-30 minutes, but the lightheaded feeling and nauseated lasted hours. No Epipen, medications, or interventions were needed.
464	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0950162-1	No	The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I asked her if she had any history of anaphylaxis. She said she did to morphine. Her bp was 119/74 with a pulse of 94. She said her nose was starting to get itchy, her ears and scalp were itchy, and her eyes were blurry. She had red blotches all over her neck and chest. She said her throat was tight. She was able to swallow the water she requested. I gave her 50mg of benadryl. She had no visible signs of being unable to breathe. I explained to her we could call 911. She reported she had no insurance. She said she was on her lunch break at the hospital and wanted to get back. She did walk back across the street unassisted. Clinical observer, followed her over just to verify she made it in the building. She ended up checking herself into the ER instead of returning to her shift.
465	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0952009-1	No	Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
466	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0952049-1	No	Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous report from a non-contactable nurse. This patient reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first dose the patient only had a sore arm and maybe fatigue. No treatment received for the adverse event. She was also breast feeding. Events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
467	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0958221-1	No	Systemic: Anaphylaxis-Severe
468	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0958626-1	No	Systemic: Anaphylaxis-Severe
469	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0973553-1	No	Minor itching of arms (not at injection site) and around lips.; Minor itching of arms (not at injection site) and around lips.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date not reported), via an unspecified route of administration at the right arm on 12Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included Latex allergy, chronic migraine, seasonal allergies, and had previous anaphylaxis due to insect stings. Concomitant medication included sumatriptan. The patient previously took Tylenol and experienced allergy. It was reported that the patient experienced minor itching of arms (not at injection site) and around lip. It was reported that the event started shortly after the thirty minute (15:15) wait after injection and ended around an hour after injection (15:45). Patient further reported that she has previous history of anaphylaxis due to insect stings. It was not bad enough to seek treatment and it took a bit to realize that it wasn't just a result of her worrying, but it was noticeable. No hives, no redness. Patient did not feel the need to seek treatment, but she did monitor symptoms until they eased. Vaccine was from a vial with no latex, due to existing minor allergy. No treatment was given to the patient in response to the event. There was no COVID prior to vaccination and no COVID test post vaccination. The patient recovered from the event on 12Jan2021 at 13:45.
470	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0977240-1	No	Systemic: Anaphylaxis-Severe, Systemic: Other- Angioedema, complained of systemic burning sensation most severe on face-Severe
471	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0977568-1	No	Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving her first Pfizer vaccination. Denies hx of known allergies or hx of anaphylaxis reactions. Pt reported palpitations and metallic taste in mouth 15 minutes after receiving the vaccination as well as a slight tightness sensation in her throat like there was something stuck in her throat. Metallic taste resolved after a few minutes. Pt denied SOB, swelling of face/tongue/throat, difficulty swallowing, nausea, rash, itchiness, dizziness. No visible swelling. BP: 127/66 HR: 80 O2: 100% Paged Allergy. Pt advised to stay for 30 more minutes and reassess. After 30 minutes pt reported palpitations had resolved. Throat symptoms improved but not completely resolved. Paged Allergy again to check in. Advised to give Zyrtec 10 mg and observe to see if there is any improvement
472	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0986180-1	No	Patient reported feeling abrupt onset at about 5 minutes after injection of a sensation of 1/2 of her head feeling hot like she was in a hot shower and a flushed feeling. No other sx that would suggest anaphylaxis. 40 minutes in while still experiencing above affected side ear was flushed. Given 50mg of benadryl at that time and all symptoms resolved by 65minutes
473	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0986681-1	No	facial and eye swelling. No anaphylaxis noted.
474	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	0994105-1	No	Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.
475	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1004369-1	No	hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
476	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1015650-1	No	1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. 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.
477	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1046858-1	No	Patient was being held for monitoring after receiving the COVID-19 vaccine. Within 1-2 minutes, patient developed facial redness and itching. She then started to feel as if her throat was itchy and started coughing uncontrollably. Denied lip or tongue swelling. Was feeling normal prior to receiving the vaccine. Was not recently seen/assessed for other medical care. No similar symptoms previously. Patient was taken to the Emergency Department. Ptaient did have a few red splotches on her chest, but these did not appear consistent with urticaria per the ED physician's report. ED physician felt patient's symptoms may be secondary to anxiety. However, given history of anaphylaxis and feeling of throat itching it was felt necessary to treat for possible allergic reaction. Patient was given epinephrine, Benadryl, famotidine, and Solu-Medrol. She was then monitored in the ED for 4 hours. During this time, she developed no new symptoms. She continued to breathe easily with normal and stable vital signs. She was discharged with instructions to buy OTC Benadryl 25mg PO to take every 8 hours for 48 hours. Prednisone 20mg, 3 tablets orally daily for 5 days weas prescribed. An EpiPen was also prescribed. Patient advised not to receive second dose of the vaccine and to follow up with her primary care provider.
478	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	30-39 years	1062022-1	No	tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events ""tongue and lip tingling and subjective swelling"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.""
479	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0903957-1	No	Immediately after vaccination, pt had arm, neck and facial pain, which improved, but did not go away. Rash developed on her abdomen this evening. Recommended benadryl and close observation for anaphylaxis and medical attention if it continues to spead.
480	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0904881-1	No	Staff member stated that she had an allergic reaction ""after the vaccine""...unsure of time frame and was still at work. She has a rash, hives and swelling around eyes....no immediate anaphylaxis. She verbally described her incident. Was treating with Benadryl (even though there was a stated allergy from 2013), then followed up with her family doctor, for steriod therapy on 12/18. She has not communicated with me further or have any absences from work at this time.""
481	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0905726-1	No	hives on my neck and above my ear/few sparse hives; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received bnt162b2 (BNT162B2) lot number and expiration date were not reported, via an unspecified route of administration on 16Dec2020 at 07:15, 0.3 ml single dose for immunization. Medical history included seasonal allergy and seasonal asthma. The patient's concomitant medications were not reported. The patient stated that she received the product this morning (16Dec2020) at 0715. She mentioned that she took a shower this evening, 13 hours later, and observed hives on her neck and above her ear. She confirmed that she was not having an anaphylaxis and there are no other symptoms. She also denied any soreness at the injection site or pain. She stated that she has no other symptoms and no pain, no soreness. She added that she received vaccine on 16Dec2020 and wondered if there was a side effect of some hives, she meant that she was not having an allergic reaction and she got the vaccine at 7:15 this morning and she have been fine, but she just have like a few sparse hives at 20:30. When asked about causality, the nurse stated ""Yes I do. I have never had hives before."" She did not think that she needed treatment but she was wondering if it was common or she wasnot having any anaphylactic reaction and they were sparse. She doesn't have it on her trunk, she just have some on her neck and there was like one above her ear. She put BENADRYL cream on them, they are fine, and they don't itch. She was just like preemptively treating them because of her high risk for work. Therapeutic measures were taken as a result of hives on my neck and above my ear (urticaria). The outcome of the event was unknown. Information on the lot/batch number has been requested.""
482	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0905896-1	No	Patient observed for over an hour due to symptom development including complaints of pressure in head, diaphoretic, swelling and increase muscle tone/rigidity in her left arm, tongue feeling thick. Brought to ED for care after an hour of observation. In the ED, left arm rigidity/spasm worsened. Here is the physician note: Patient's headache is improved. She has no neurological deficits or subjective complaints or objective exam consistent with a recurrent CVA. She has no evidence of significant anaphylaxis related to the immunization. May be a recurrence of her underlying medical problems that she has been seen by neurology for something similar. Possible unmasking of this is related to the Covid vaccine is difficult to determine. We will have her work individually with our pharmacy, infectious disease team to determine whether she is a candidate for a second vaccination. She would like to return home right now her CT labs are otherwise unremarkable I think this is reasonable. Return precautions for more significant etiologies were discussed at length. Received lorazepam 0.5 mg IV x1, diphenhydramine 25 mg IV x1, and methylprednisolone 60 mg IV x1.
483	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0905993-1	No	The patient was in her normal state of good health prior to the vaccination. Almost immediately after receiving the vaccination, she began having a headache, then got an urticarial rash. She then felt a ""lump in [her] throat."" She was coughing uncontrollably. She was brought immediately to the Emergency Department where I assessed her with my resident. She had signs of a Type I Hypersensitivity Reaction including a hoarse voice, globus feeling and diffuse urticaria. She was treated at the vaccination site in the hospital with Benadryl 50 mg PO prior to ED evaluation and she self-administered Ibuprofen 400 mg. She did not have stridor or airway swelling. She was able to speak in full sentences. She was NOT treated with epinephrine, as she was in stable respiratory condition and improved with Benadryl (as previously administered at the vaccination clinic, Pepcid IV and Solumedrol IV. My concern over this reaction is that the patient has NO PRIOR HISTORY OF ANY ALLERGIES AT ALL. I have read and seen in the media reports of anaphylaxis with a history of allergies, however, this is the first case I have heard of regarding an anaphylactoid reaction in a patient with no prior history.""
484	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0906775-1	No	Chills at 5-10 min after vaccination, with voice change and SOB 15-20 min after vaccination concerning for anaphylaxis. Epi given im x1. given immediately at voice change and immediately taken to ED.and currently receiving care
485	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0907187-1	No	Possible allergic reaction - paresthesias of L tongue and throat; Possible allergic reaction - paresthesias of L tongue and throat; Possible allergic reaction - paresthesias of L tongue and throat; Sensation of tongue and throat swelling; Sensation of tongue and throat swelling; This is a spontaneous report from a contactable Health Care Professional. A 48 years old non-pregnant female patient received BNT162B2 (Pfizer-Biontech covid-19 vaccine) on 17Dec2020 at 15:15, at single dose, for COVID-19 immunisation. The vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included food and drug allergy. The patient received concomitant medications (unspecified, received within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 17Dec2020 at 15:15, the patient experienced possible allergic reaction - paresthesias of L tongue and throat, with sensation of tongue and throat swelling. No anaphylaxis. No abnormal physical exam findings. Emergency Room Visit required and the patient received the following treatment: diphenhydramine hydrochloride (BENADRYL), prednisone, and loratadine (CLARITIN). Clinical outcome of the adverse events was unknown at time of this report. The case was assessed as non-serious. Information on the lot/batch number has been requested.
486	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0908464-1	No	Patient received the COVID-19 vaccine. Patient described feeling dizzy and light headed. Patient placed on floor. Syncopal event / vaso-vagal. No signs of anaphylaxis or allergy, but epipen 0.3mg was administered. anticubital IV line placed for access if needed. Patient taken to ED for observation. Returned to duties within 1 hour of the event.
487	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0910221-1	No	Patient experienced dizziness, sweating, and nausea in the 15 minutes following vaccination. Patient was taken to the emergency department, all vital signs were normal, no symptoms of anaphylaxis. Patient stayed in emergency department for further monitoring
488	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0911998-1	No	Anaphylaxis requiring epinephrine
489	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0912018-1	No	Anaphylaxis requiring epinephrine
490	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0912867-1	No	Patient is a 40 y.o. female with no known past medical history brought to ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Pt is a nurse and experienced decreased level of consciousness following her COVID vaccinationn. Pt reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. BGL within normal limits. Pt denies any other complaints or symptoms at this time.
491	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0912996-1	No	Wheezing, throat tingling and anaphylaxis, dizzy, mostly the breathing. I was coughing nonstop
492	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0913054-1	No	At 1430, she received the COVID-19 vaccine and started feeling flushed, right-sided neck tightness, and throat constriction shortly afterwards. At 1435, she was given a dose of epinephrine and brought to the Emergency Department for further evaluation. Upon arrival to the Emergency Department, the patient reports feeling better. Her last menstrual period was 2 weeks ago. No rash or itching. No history of anaphylaxis to vaccines. No history of COVID-19 diagnosis. Denies pregnancy.
493	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0913081-1	No	Patient received her Pfizer COVID vaccine at approximately 11:40 a.m.. She stated immediately after she received her shot she had headache and felt shaky She waited afterwards felt ok and so drove back to work (about 45 min drive). Approximately 1 hour after shot she developed generalized itching especially around the head neck and arms. She developed a red fine rash of her bilateral upper arms and blotchy rash on her chest and neck, similar to her prior reaction to Sulfa drugs in past. She called employee health and was directed to be seen in clinic. Pt walked down and notified me and she was immediately placed in room and was evaluated. She did take PO Benadryl 50mg about 145pm. Patient feels a little nauseous. A little jittery. No fever no chills no chest pain or shortness of breath no lip swelling or tongue swelling no difficulty breathing. She had some loose stool yesterday. Headache is improved no vision changes. No prior history of anaphylaxis. No other new exposures (lotions, foods, pets, meds etc) other than COVID 19 vaccine today. She appeared uncomfortable. Solumedrol 125mg IM was given in office. patient was observed > 1 hour. no change in symptoms. vitals stable. discharged home with prednisone taper.
494	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0914274-1	No	mild anaphylaxis. Began with flushing about 5-10 minutes after vaccine. Proceeded to stomach cramping with diarrhea and itching in throat and of tongue. I took 2 diphenhydramine 25mg capsules and famotidine 20mg. Proceeded to the ED with the administering RN, Received 1 dose epipnephrine IM, SoluMedrol and famotidine IV. Coughing, itching and cramping subsided in about 10 minutes. Discharged on 60mg prednisone QD for 5 days after ED monitoring until vitals were stable.
495	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0914574-1	No	started as tachycardia, then started have anaphylaxis reaction
496	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0915762-1	No	Vaccine administered at 0945. At 0955 patient developed symptoms including: tightness in chest, lump in throat, voice changes, BP 130/88, Pulse 66, Cap refill <3. No past anaphylaxis, but severe past reaction to codeine.
497	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0916260-1	No	mild anaphylaxis
498	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0916653-1	No	Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and famotidine. Was given prescriptions for epipen and oral steroids (60mg x 5 days).
499	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0916756-1	No	Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
500	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0917557-1	No	itching sensation. No rash. No shortness of breath. No anaphylaxis.
501	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0919966-1	No	lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
502	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0921116-1	No	Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction. Within the 30 minute waiting period, she felt like her lips and tongue were tingling and her throat was scratchy. She denied shortness of breath, chest pain, difficulty swallowing or difficulty breathing. Vital signs were stable. Due to her history of anaphylaxis reaction with various medications and shellfish, she was taken to the ER. In the ER she received IV Solu-Medrol, Benadryl and Pepcid and her symptoms resolved. She was observed for 6 hours and then released to home.
503	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0923043-1	No	Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly."" Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.""
504	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0923572-1	No	anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable Pharmacist (patient). a 40-year-old female patient (no pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140) via intramuscular at Left arm on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included known allergies to egg, seafood, azithromycin, orange and seasonal allergies. The concomitant was reported as cetirizine hydrochloride (ALLERTEC) and PRN 1371. The patient with no known past medical history brought in by CODE Team to RUH ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Patient was a nurse and experienced decreased level of consciousness following her COVID vaccination. Patient reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. Blood glucose (BGL) within normal limits. Patient denies any other complaints or symptoms at this time. Adverse event start date: 23Dec2020. Treatment was unknown for decreased level of consciousness. The outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis /decreased level of consciousness cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. 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.
505	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0925062-1	No	Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
506	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0925190-1	No	Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
507	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0926344-1	No	I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination and felt fine. When I got home two hours later from work and got in the shower, I noticed that I had a red, slightly raised, pinpoint and very defined red rash. The rash was all over my abdomen, my back and my neck. The areas felt warm but I did I not have itching, pain or any other anaphylaxis symptoms. The rash faded entirely in the next 48 hours.
508	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0928455-1	No	Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
509	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0930174-1	No	Following administration of COVID19 vaccine (Pfizer), patient experienced a ""scratchy feeling"" in her throat and feeling that her throat might be closing up. She denied any other symptom. Patient had no history of anaphylaxis. Patient was monitored until symptoms resolved. No treatment was required. Note: Patient received second dose of vaccine (from same lot# EH9899) on 1/6/21 and no adverse reactions were observed after 30 minutes monitoring. Patient reports that she felt much less anxious when receiving the second dose of vaccine.""
510	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0930328-1	No	anaphylaxis with immediate whole body swelling. Epinephrine 0.3mg IM administered
511	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0930548-1	No	While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vaccination. Approximately five minutes after receiving C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs) I regained alertness and felt severe nausea and general weakness and was assisted into in ER bed. Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn. ED staff continued to monitor me for the next 2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned. A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)
512	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0931742-1	No	Recipient came in c/o feeling ""flushed"". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels ""better"". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.""
513	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0940575-1	No	Systemic: Anaphylaxis-Severe
514	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0940775-1	No	This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of allergic reaction s/p 1st COVID vaccine at 1330 this afternoon. Patient states he became very flushed to his face/chest 2-3 minutes after receiving the vaccine. EMS was on scene and evaluated the patient. He was found to be a little confused/disoriented upon questioning which quickly resolved. Patient was also having mild difficulty swallowing, however states he was not gasping for air. He had an IV placed for precautions, however no medications were given. Patient was transferred here for evaluation. He currently feels asymptomatic aside from a dry throat. Patient denies having any hives, shortness of breath, or syncopal episodes. He also denies having prior episodes of anaphylaxis requiring epinephrine.
515	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0943258-1	No	Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
516	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0945213-1	No	I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and ""I feel like I am in a cloud."" She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.""
517	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0945363-1	No	PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING CLEARANCE FROM HER PCP. DUE TO HISTORY OF ANAPHYLAXIS PATIENT MONITORED BY PROVIDER AFTER ADMINSITRATION OF VACCINE. WITHIN 20-30 MINS OF ADMINISTERING VACCINE PATIENT DEVELOPED COUGH AND COLOR CHANGE IN EXTREMETIES. PATIENT TRANSPORTED DOWN TO ED FOR FURTHER EVALUATION.
518	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0946901-1	No	1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
519	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0948297-1	No	Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
520	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0949931-1	No	Patient complained of feeling light-headed and a little dizzy at 10 minutes post-administration. Pulse-oximetry applied revealed normal spO2, but tachycardia to 140bpm (this patient's resting HR is approximately 55-65). Apple Watch data confirmed rapid increase in HR at that moment. BP increased from normal baseline to about 150-160 SBP. No chest pain reported. No signs/symptoms of anaphylaxis (rash, wheezing, etc.). HR gradually recovered to normal levels within 30 minutes and patient was released after 60 min observation. Patient reported generalized fatigue in weeks following injection. Nineteen (19) days after injection, patient developed unprovoked resting tachycardia to approximately 180bpm (following some moderate weigh-lifting exercise). Symptoms did no resolve sufficiently and patient was transported by EMS to ER for evaluation
521	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0950619-1	No	About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
522	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0951312-1	No	Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
523	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0958331-1	No	Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
524	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0958576-1	No	Systemic: Anaphylaxis, Systemic: Seizure-Severe
525	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0959465-1	No	Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
526	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0959901-1	No	Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nausea and chills within 30 min of receiving the 1st dose of the COVID-19 vaccine 4 hours ago Denies rash, shortness of breath, vomiting, diarrhea, trouble swallowing or breathing, swelling of throat, tongue, lips or eyes. No fever. Patient states her BP was taken when she was having the symptoms and it was 170s systolic. Patient is presenting today with report of nausea, chills and elevated BP s/p COVID-19 vaccine. Patient has no evidence of anaphylaxis or severe allergic reaction. . Patient has normal vitals and in no respiratory distress. Will discharge home with close outpatient follow-up.
527	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0973216-1	No	? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
528	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0973831-1	No	Felt a little ""weird"" right after vaccine, after an hour she felt like she was suffocating. Went to ED for SOB, felt like throat was closing. Given prednisone, benadryl. Questionable if she was given epinephrine in ED. Will follow up with allergist before second dose. HX of allergy to cats and grass. No hx of anaphylaxis.""
529	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0976797-1	No	hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
530	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0977208-1	No	Systemic: Anaphylaxis-Severe
531	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0979350-1	No	Systemic: Anaphylaxis-Severe
532	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	0993521-1	No	a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
533	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1045871-1	No	Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. ß At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though ""somebody was breaking my bones"" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. ß She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. ß Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. ß She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. ß No known history of allergy to polyethylene glycol. ß No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. ß She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. ß She denies any recent medication changes or new over-the-counter medications. ß She has not previously been diagnosed with COVID-19.""
534	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1051526-1	No	Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath. His blood pressure and heart rate increased during the event. He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS. In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms. During the course of his stay he was treated with Benadryl, dexamethasone and albuterol. He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
535	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1051574-1	No	Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
536	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1051587-1	No	Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
537	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	40-49 years	1067988-1	No	heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
538	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0903016-1	No	Approximately 11 minutes after receiving the vaccine, the patient complained of shortness of breath, tingling in arms and hands, numbness and tingling in legs and feet, and was observably shaking, with no complaints of swelling in throat or other signs of anaphylaxis. Patient was brought to ER in same facility via stretcher and was examined by staff there. ER report states the patient presented with shortness of breath and what appeared to be a panic attack, with fast breathing, slight flushing, and shaking. Per ER report, the patient was treated for an acute anaphylactic reaction, with clear lungs and given an EpiPen shot in the right thigh. IV was initiated and given a fluid bolus, solu medrol, famotidine, and lorazepam. Labs and a chest x-ray done and reviewed. After treatment, patient found to be stable and was discharged home at 4:42 pm with orders for famotidine, albuterol inhaler, and epinephrine pen.
539	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0903690-1	No	About an hour after vaccine, felt itchy inside, watery eyes and congestion - treated with 25 mg Benadryl. No anaphylaxis
540	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0904886-1	No	I was ok for first 15-20 mins post vaccine and was sitting in chair and calling family and friends When I stood up I felt 'funny""- kind of hard to describe I walked around and mostly felt ok but not hundred % but didn't feel dizzy but didn't feel 100% myself either I checked my radial pulse and it felt normal and there was no BP machine there to have a check done I left hoping to feel 100% soon I walked to my car in the parking lot and started driving home Around 200 yards from the hospital I felt weird warm rush like feeling through my whole body Knowing that anaphylaxis can occur at this stage I panicked and turned car around and went directly to ER to be checked out My BP was not low and I was observed for short duration and discharged home then- vitals were taken almost half an hour post vaccine Further records can be sought from ER as they should have reported this as well I also had arm pain/malaise and low grade temp of 100.5 at home for 24 hrs that resolved subsequently The initial symptoms within first half an hour made me file this report""
541	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0906495-1	No	11 minutes into the vaccination, patient noted to have tongue and mouth tingling and heart racing. No noted tongue/lip/throat swelling, dyspnea, n/v, abdominal pain, rash, near-syncope. Started to improve after 30 seconds.. H/o tachycardia secondary to salmon, no prior anaphylaxis or use of epinephrine in the past. Sent to ED for evaulation
542	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0906887-1	No	Pfizer-BioNTech COVID-19 Vaccine EUA: Systemic: Anaphylaxis, Fainting
543	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0906928-1	No	Patient with a reported history of anaphylaxis to several things and carries her own EpiPen. She was brought to monitoring room at 1835 With complaints of cough and at that time had taken two puffs of albuterol inhaler. Patient also reports some medicating with 50 mg of Benadryl two hours prior to vaccine. O2 sats were 99% heart rate 69 and lungs CTA. At 1845 patient self dosed another 2puffs ofalbuterol. At 1845 HR 130 and sats 98%. At 1850, BP 173/139 HR 127. Patient continued to develop a progressive cough and SOB. Consulted Dr. by phone. We dosed with Zyrtec 10 mg po and assisted pt with administration of her own epi-pen. Followed up with ED next day. Pt had been escorted there from vaccine clinic after epi-pen administration and progressive SOB. ED reported pt remained hemodynamically stable and A&O x 4. Treatment consisted of Benadryl 50 mg IV, Pepcid 20mg,IV, solumedrol 125 mg IV, fluids 1L, and racemic epi. Discharged home after 3 hours.
544	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0907160-1	No	(I'm a physician who received the vaccine at my medical clinic). 5 minutes after receiving the vaccine, I felt very dizzy and faint. We checked my BP (which is usually 120/70; I do not have hypertension), and it was 190/120, HR 120-130 bpm. We rechecked it several times and it stayed there. After 5 minutes, I suddenly felt better and my BP had dropped to 140/70, HR 70. I felt exhausted. No other problems. They watched me for 30 minutes and I felt fine. I had my husband drive me home. As we were driving home (now one hour after the vaccine), I realized that my throat was closing up. I was breathing fine but I realized I was having an anaphylactic reaction from the vaccine. I have never had any allergic reactions before to vaccines, etc. He drove me back to the emergency room of my hospital, where they diagnosed me with an allergic reaction/anaphylaxis to the vaccine. They gave me emergently IV solumedrol (steroids), pepcid, and benadryl, which fortunately worked immediately. They observed me for several hours and I was fine. They sent me home. The next morning, I felt exhausted and my throat was hoarse and sore, but that went away several hours later. It was a terrifying, terrible experience. I thought I was going to die. I had to pay $1000 out of pocket for the ER deductible.
545	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0907173-1	No	Anaphylaxis reaction with hives, stridor/airway edema, wheezing
546	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0910595-1	No	broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; throat pain, coughing; throat pain, coughing; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 57-year-old female patient received fist dose of bnt162b2 (BNT162B2, Brand Pfizer), via unknown route of administration in Left arm on 21Dec2020 12:00 PM at single dose for covid-19 immunisation. Medical history included Known allergies to medications, food, or other products: Azithromycin Flushing, Spinach-anaphylaxis, mild allergic reactions to the Ocrevus, azure and Seasonal allergies, Multiple Sclerosis, Irritable bowel syndrome (IBS-C), post herpactic neuralgia. Concomitant medications included other medications the patient received within 2 weeks of vaccination baclophen, clozapine (KLOPIN), ocrelizumab (OCREVUS), sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), mo. She is not pregnant at the time of vaccination. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced within 15 to twenty minutes of vaccine, broke out in hives on face and hoarseness, tightness in throat then sent to ED where hives continued to form on back the arms, throat pain, coughing, hoarseness increased from 21Dec2020 12:15 AM. AE resulted in: [Emergency room/department or urgent care]. Outcome of the events was unknown. Treatment received included Epinephrine, solumedrol, Benadryl IV. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination: covid test type post vaccination was Other, covid test name post vaccination was Nasopharyngeal Sofia2 SARS Antigen on 21Dec2020 with result of Negative. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. Test Name was Nasopharyngeal Sofia2 SARS Antigen. Vaccine Facility information available. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be completely excluded. Medical history of known allergies may have predisposed patient to react this way. 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.
547	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0912166-1	No	Upon registration, pt informed staff she normally gets hives and itching with flu vaccine. Pt received COVID vaccine at 1205. Pt sat down in monitor area at 1209. At 1221, pt stated she started to feel slight itching. At 1230, pt stated itching had increased. RN also noted redness to neck. Pt denied any SOB, difficulty breathing, tingling in mouth, or any other anaphylactic symptoms. At 1234, RN gave 25mg Benadryl orally. Pt requested to receive smaller dose instead of the entire 50mg. Pt stayed to be monitored until 1255. No other symptoms noted. Pt educated to monitor for further signs of anaphylaxis.
548	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0913023-1	No	physician/patient with history of anaphylaxis to shellfish - symptoms of tingling tongue & syncope. no longer carries epi pen sue to ability to avoid food. 10 minutes post vaccination pt/physician experienced tongue tingling similar to prior anaphylactic events. administered 25 mg. Benadryl po. no further issue, vital signs stable throughout & later in evening.
549	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0913233-1	No	10:30 AM After receiving the COVID-19 vaccine, the patient experienced an anaphylaxis reaction that included, throat closing and tongue swelling sensation, itchiness, and hives on her bilateral arms and legs. Patient received 65 mg of Benadryl IV, 125 mg SoluMedrol IV, two doses of 0.3 epinephrine IM, 1 mg of Ativan, and 4 mg of Zofran, then taken to the ED for further monitoring. Patient was on 2L NC for comfort, sats in mid 90s off oxygen, and monitored the patient for a few hours. Patient discharged to home with stable vital signs off oxygen and a steady gait.
550	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0914318-1	No	Progress Notes (Physician Assistant) ? ? General Surgery/Trauma Cosigned by: MD at 12/29/2020 12:36 PM Expand All Collapse All ß COVID VACCINE CLINIC 12/22/2020 ß Date: 12/22/2020 ß Subjective Patient is a 55 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. ß She denied any history of previous adverse reactions to vaccines. ß She was given the Pfizer vaccination in the left deltoid muscle. ß During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety. She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling. ß This provider was notified of patient reaction and she was then assessed in the emergency bay area. ß Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain. ß Problem list, past medical/surgical hx, medication list reviewed and discussed with pt. She has no hx of previous hypersensitivity reactions to immunizations. ß ß ß Review of Systems Negative, except for above. ß Objective ß Vitals Vitals: ß 12/22/20 1123 12/22/20 1130 BP: 131/65 114/56 BP Location: Right arm ß Pulse: 78 70 SpO2: 99% 99% ß ß Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Murmur present. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: Palpations: Abdomen is soft. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. ß ß ß Assessment/Plan ß Assessment: Transient anxiety associated with covid vaccine administration ß Plan: Treatment included observation, serial examination, monitoring of vital signs. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. ß Patient was monitored for approximately 45 minutes post injection with multiple physical exams and serial vitals signs with no observance of local or systemic hypersensitivity response. At the time of discharge she had no complaints and was able to ambulate easily without assistance. ß Signs and symptoms of anaphylaxis were reviewed and discussed, and she was instructed to call 911 or report to the ED immediately if those signs/symptoms develop. She verbalized understanding. ß ß PA-C Electronically Signed 12/22/2020 11:53 AM ß ß
551	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0914998-1	No	The patient is a nurse who was well until COVID vaccination. She was observed for 15 after vaccination and did well. She then returned to her medical unit. About 30 minutes after vaccination, she became extremely cold, dizzy, had a transient headache, and was found to be hypertensive. Her nurse colleagues placed her in a Bair hugger and she was still cold. On arrival to the ED, she was hypertensive (max 170/107), subdued and initially reporting dizziness, headache now resolved, otherwise well-appearing on exam, with no signs or symptoms to suggest classic allergic reaction or anaphylaxis. A tryptase level sent to further assess for the possibility of atypical allergic reaction, and she was initially just observed. When she didn't improve and continued to report dizziness especially with standing, and reported that she hadn't had much to eat or drink all day, she was given a fluid bolus and a snack. ß After 2.5 hours of observation, during which time the blood pressure fluctuated, the patient felt much improved. She was less hypertensive (150/89 at discharge) with no intervening symptoms. She was discharged and did not return to the ED. I am not aware of follow-up. ß
552	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0916090-1	No	EE has a history of anaphylaxis reaction to Latex. EE states she was intubated in Mexico over this in the past. Pfizer-BioNTech vaccine given, 20 minutes later EE c/o dizziness. EE places on cot and starting wheezing and being short of breath. Lungs sound tight and wheezy throughout. ß 1052- Epi 0.3mg IM given in Right Deltoid 1053- Benadryl 50mg IM given in Left Deltoid ß 1054- EE getting restless and starts feeling chest tightness. Epi 0.3mg IM given in Right Deltoid ß Code Green Team arrived at 1054. ß BP 197/126, HR 88, RR 44, blood sugar 109 ß 1058- EE getting wheezing and short of breath again. Epi 0.3mg IM given in Right Deltoid and Benadryl 50mg IM given in Left Deltoid. ß 1059- EE transferred to ED on stretcher, escorted by ICU RN and ICU MD. In ED- patient given solumedrol, epi, benadryl, phemodidine, ativan, zofran x 2 and ee sent home with medications as well.
553	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0916553-1	No	Approximately 20 minutes after vaccine administration patient noted that she had some lightheadedness and chest pain after the vaccine, but that it had already completely resolved. She stated that she got lightheaded shortly after administration, and noted that it lasted approximately 10 minutes before resolving. She stated that she had an episode of mild chest pain that lasted approximately 2 minutes before completely resolving. She expressed anxiety related to vaccine administration noting history of anaphylaxis after influenza vaccine and PPD testing. Patient monitored for another 15-20 minutes without incident. Patient noted that she was feeling well and had no concerns upon leaving. She verbalized understanding to call EMS or go to ER if symptoms change or worsen. ß Follow up call placed to patient 12/31 @ 1720. She states that she is feeling fine and had no other symptoms after leaving. She denies any concerns at this time.
554	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0917854-1	No	Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
555	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0917955-1	No	25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itching and airway constriction. I had already left the drive-thru vaccination clinic and was driving to the hospital emergency room where I work. I informed my colleagues of my symptoms and was treated for anaphylaxis with IV diphenhydramine and famotidine over several hours. I was given a prescription for a prednisone taper for the next 6 days.
556	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0919916-1	No	The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe headache; chills; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at left arm on 18Dec2020 at 14:00 at single dose for covid-19 immunization at workplace clinic. Medical history included hypolipidaemia, allergic to sulfa drugs (hives), allergy to adhesive (severe skin blistering). There was non other vaccine in four weeks and no other medications in two weeks. The patient previously took naproxen (NAPROSYN) and amoxicillin clavulanic acid (AUGMENTIN ) and was allergic to both drugs, and experienced anaphylaxis for naproxen. The patient experienced severe headache, chills and flu like symptoms the night after the shot on 18Dec2020. The next day on 19Dec2020 at 10: 00 AM a rash appeared on her forearms and was on her ankles, calves and scalp at time of the report. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
557	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0919971-1	No	heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
558	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0923556-1	No	Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting
559	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0924255-1	No	5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded. Patient has a history of anaphylaxis and had Epi Pens with her. 1600 Vitals: BP: 184/72 P: 117 SaO2: 100% Epi Pen self-administered. 1605 Vitals: BP: 125/74 P:103 SaO2: 100% Nurse transferred patient to ER in wheelchair for further treatment and evaluation.
560	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0925060-1	No	Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
561	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0929310-1	No	Anaphylaxis with a hives, itching, and airway involvement
562	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0931348-1	No	Patient felt tongue swell, and then her throat started to close. -Anaphylaxis
563	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0931881-1	No	Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
564	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0938693-1	No	"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg. Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. """"
565	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0941389-1	No	Systemic: Anaphylaxis-Severe
566	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0941861-1	No	@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient has a history of allergies - anaphylaxis. Vitals taken: b/p 197/116, hr 70, temp 97.5, 02 sat 99% on r/a. States she has HTN and takes meds. She did take he
567	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0941948-1	No	Hives diffusely involving arm back eye and chin. No anaphylaxis.
568	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0943775-1	No	Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium
569	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0945499-1	No	This staff member, with a known history of severe allergies and history of anaphylaxis, experienced tightness in chest and cough starting about 15 minutes after receiving the covid vaccine. Tightness in chest continued to worsen and she was administered her own Epi pen at 10:42AM. EMS was called and she was transported to the emergency department for further observation.
570	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0945956-1	No	difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation. Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection; 9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition included Idiopathic Angioedema. 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.
571	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0950797-1	No	Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry ""tickly"" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.""
572	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0964910-1	No	Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Vomiting-Mild
573	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0964931-1	No	Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
574	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0970834-1	No	Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
575	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0974343-1	No	about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.
576	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	0979441-1	No	Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had chest pain, shortness of breath, nausea, back pain, and sweating. On evaluation a mild systolic murmur and irregular heartbeat were noted. Patient was transferred to the emergency department where initial vitals were within normal ranges except for blood pressure 145/104 mmHg. No wheezing, vomiting, respiratory distress, or anaphylaxis noted. Patient administered aspirin, morphine, acetaminophen, diphenhydramine, ibuprofen, and ondansetron and symptoms resolved. Repeat vitals were within normal ranges and patient discharged to home stable.
577	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1015641-1	No	yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
578	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	50-59 years	1046203-1	No	Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started ""twitching everywhere"" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.""
579	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0903327-1	No	Patient reported that she started to feel unwell immediately after the vaccine with some nausea. She presented to the Emergency Department where she was treated by myself approximately 17 hours vaccine administration. She was having vomiting, diarrhea, diffuse rash, and throat discomfort. She was successfully treated for anaphylaxis and was able to discharge to home.
580	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0913746-1	No	hx of ""anaphylaxis at 3yo due to pcn so patient was observed post covid vaccine for 30 min. At about 40 min post vaccine she reported some itching in scalp only. No chest pain, SOB, lightheadedness, No oral/facial swelling; ; hx of asthma on meds but no wheezing now. evaluated in emp health - BP 122/70; P80; NAD; Lungs clear; Skin clear Given 50 mg Benadryl po ( has taken this ""many times before"") Mild scalp itching at 10 am ; back to work and rechecked at 11:50 am - ""only very mild scalp itch"" Advised ED if worse.""
581	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0917490-1	No	Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.
582	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0922700-1	No	Ee stated upon observation entrance, that she would be observed until 10:15am r/t ""anaphylaxis"" to Morphine. Informed us that she became ""itchy"" for ""3"" days prior to the 1st dose on 12-16-20. Ee c/o ""itching"" to this nurse @ 1005. Benadryl 25mg given @ 1005. Remains to c/o ""itching"" @ 1015. Ice pack applied to chest to relive itching @ 1015. Around 1025 Ee stated she felt ""relief of itching"". This nurse also gave Ee (1) Benadryl 25mg to take w. Her. Ee stated she was feeling better @ 1034. Left observation @ 1035.""
583	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0933957-1	No	As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple years ago. PCP discussed benefit to prevent complications of COVID vaccine outweighs risk to get COVID vaccine. Discussed this as well with patient. She agrees to get the vaccine. ß I stayed with the RN and patient for 30 minutes post vaccination and she had no symptoms other than BP and Pulse elevated further to 150s/90s. P upper 80s. She was transitioned to anther office with plan to continue observation for another 15 mins and recheck her BP. ß About 45-50 mins post vaccine, she reported her lower arms and right side of her neck felt swollen but had no SOB or mouth swelling or itching. She was talking in normal sentences. Her face became more flushed as well as the posterior aspect of her forearms and she said the neck felt more swollen. Epi Pen was administered at 8:40 am and EMS was contacted. Her BP was 160/100, pulse ox 96%, RR 26, Pulse 88. ß Transferred to ED.
584	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0936194-1	No	Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported. The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
585	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0943364-1	No	Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ
586	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	0976758-1	No	like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was ""like an anaphylactic reaction but not in her throat."" itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. 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.""
587	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	1045619-1	No	The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
588	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	60-64 years	1051783-1	No	Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was ""irritated"" with ""everyone talking"", that she ""can't hear everyone all at the same time"", that this is just ""too much"" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.""
589	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0907911-1	No	Patient with past medical history significant for thyroid cancer was given Pfizer COVID-19 vaccine at approximately 1430 at our facility. After receiving vaccine patient felt flushed, face hot, felt something squeezing neck (similar to tight collar). 25 mg PO diphenhydramine given X 1. Patient having shivering on and off. Felt swelling progress up into back of throat. Had to clear throat and swallow harder. At 1511 patient was checked into the emergency department at our hospital. At 1527 famotidine 20 mg IV once given. BP was found to be 232/100. Amlodipine 5 mg IV once given at 1909. Labetalol 10 mg IV once given at 1812, labetalol 20 mg IV once given at 2034, clonidine 0.1 mg PO once given at 2127. Patient sent home at approximately midnight. Diagnosed with possible anaphylaxis and hypertensive urgency (no history of HTN).
590	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0923557-1	No	Anaphylaxis throat itchiness, throat tightness, sinus swelling, ear fullness Narrative: Patient reported throat itchiness, throat tightness, sinus swelling, ear fullness. Transported via EMS to nearest ER
591	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0931868-1	No	Had COVID vaccine and was being monitored. At 10:10am, she became nauseous and started vomiting. She felt short of breath and difficulty breathing. Felt dizzy/lightheaded. History of anaphylaxis and allergies. History of COPD/asthma. Due to vomiting, short of breath and dizziness, given epipen at 10:15am and called 911. Continued to monitor and developed worsening shortness of breath. Second epipen given at 10:25am.
592	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0943825-1	No	Systemic: Anaphylaxis-Mild, Systemic: trouble breathing, wheezing; symptoms lasted 1 day
593	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0943938-1	No	Systemic: Anaphylaxis-Severe; symptoms lasted 0 days
594	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0946951-1	No	Systemic: Anaphylaxis-Severe
595	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0948366-1	No	Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
596	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0956348-1	No	Systemic: Anaphylaxis-Severe
597	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0958278-1	No	Systemic: Anaphylaxis
598	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0958964-1	No	Patient received first dose of COVID-19 vaccine and within 15 minutes felt tongue swelling and lip swelling and felt heart was racing like she has been exercising. Feels lightheaded and dizzy. No trouble breathing. Patient was immediately assessed. Benadryl 50 mg given in clinic. Minimal improvement in lip and tongue swelling. Patient feeling more lightheaded. Vitals: BP 120/70, Pulse 69-72 O2 saturation 98-99%. PE: CV: normal rate: Respiratory: CTAB. HEENT: swollen upper and lower lip and tongue swelling (angioedema) Skin: mild redness in left hand, no hives noted Patient has had hx of anaphylaxis in the past to compazine and phenergan. Recommend ER Evaluation and monitoring.
599	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0984793-1	No	7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins that she should take me to ED for Zofran. Upon getting to ED I was wheezing badly and trying to find inhaler in purse; wheezing and unable to catch a breath I was placed in a room, by then my body was turning red and wheezing worse. I was given epinephrine and prednisone immediately for anaphylaxis. They reacted immediately upon my arrival. Time I unsure. I just say thank God for them. Meds Given- Tylenol Duoneb, Decadron, Benadryl, Epinephrine, Pepcid, Nss
600	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	0990421-1	No	I had anaphylaxis yesterday; Throat is still swollen; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Concomitant medication included metformin (unknown manufacturer), levothyroxine sodium (LEVOXYL), fluoxetine (unknown manufacturer), empagliflozin (JARDIANCE), rosuvastatin (unknown manufacturer). The patient experienced anaphylaxis and throat was still swollen on 15Jan2021 about 30 minutes after when she received the shot, with outcome of recovering. The patient was transferred to emergency and was treated for the event.
601	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1022076-1	No	unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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.
602	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1023483-1	No	BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
603	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1046164-1	No	Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfizer) administration. Patient has documented history of anaphylaxis with IV contrast. EMS on-site provided cardiac monitoring. Observed elevated BP.
604	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1046833-1	No	On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar ""episodes"" with low BG. EMS checked BG (POC = 144).""
605	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1047425-1	No	anaphylaxis, Rx w/epi X2
606	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1047436-1	No	Onset of vaccine: 17:19 Onset of symptoms at 17:25 with tongue tingling to entire tongue Onset of other sx at 17:27: red hands Patient opted to stay in waiting room until hand concern She ambulated without assistance to medical center She was given Benadryl 25 mg po with water, tolerated well at 17:47 VS taken and stable 128/74 RR: 14 Pulse 82 At 18:00, sx of tongue tingling improved, but tinnitus BL worsened - this is common for patient She was discharged to home at 18:07 with her partner Instructed to call PCP in AM, and watch for other developing sx of allergy/anaphylaxis overnight
607	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1049960-1	No	2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to assessment area, HR 100, labored resp, O2 6L NRmask initiated. (ct reports similar reaction as previous anaphylaxis). 15:22pm-911 called, HR 120, Epi 0.5ml admin. 15:37pm transfer via ambulance to hospital. 02/18/2021 evening, f/u call to client by PHN, throat still feels 'weird', ct reports had 2nd Epi in ambulance, 3rd Epi in ER, plus Benedryl gel, Ct then recalled had anaphylaxis reaction in past to bee sting had ER visit, tx w/ steroids at that time. PHN recommended ct talk with PCP re epi pen order.
608	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1051446-1	No	grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. 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 RAs, Ethics Committees, and Investigators, as appropriate.
609	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1061990-1	No	Started with itching on left neck; swelling below left eye; hands were swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for covid-19 immunization. The vaccine was administered at the pharmacy. Patient was not pregnant at the time of vaccination. Medical history included sarcoidosis and hypertension both from an unknown date, and one unknown anaphylaxis a year ago (2020). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine besylate. On 27Jan2021 16:30, it was started with itching on left neck, then swelling below left eye and hands were swelling. The patient was concerned enough she took a Benadryl. The events result in doctor or other healthcare professional office/clinic visit. Treatment received for the events was Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
610	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1068030-1	No	rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events ""headache, fever, chills, body ache, and 3 days with out sleeping"" was unknown. No follow-up attempts are possible. No further information is expected.""
611	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	65+ years	1076830-1	No	She is experiencing an Allergic reaction, rash; little coughing spell; Itching eyes/My eyes started itching; Multiple hives all around her right eye; Wheezing; didn't feel comfortable; her upper lip became puffy/bottom lip began to swell; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201), intramuscular at upper left arm on 21Feb2021 at 08:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included seasonal asthma, allergy to class A antihistamines that started in her 20s, facial & peripheral edema, blood pressure abnormal, and celiac disease. The patient had known allergy to Benadryl and when she takes it she gets peripheral and facial edema, lip swelling, top and bottom, hives around her whole right eye. The patient also has an allergy to Class A antihistamines that started in her 20s. She said the allergy started with Seldane & Claritin. She said she had giant hives with Claritin. She said she was told there were 2 classes of antihistamines & she couldn't use the Class A antihistamines. She said she previously reported her Seldane, Claritin & Benadryl allergies, saying she has facial & peripheral edema. She said she only uses the Class B antihistamine Cimetidine now. Concomitant medications included metoprolol, omeprazole, and pravastatin. On an unspecified date, the patient was experiencing an allergic reaction, rash. On 21Feb2021, the patient experienced ""her upper lip became puffy/bottom lip began to swell,"" multiple hives all around her right eye, wheezing, and didn't feel comfortable. On 21Feb2021 at 14:00 (reported as about 2PM), the patient experienced ""Itching eyes/My eyes started itching."" On 21Feb2021 at 21:00 (reported as 9PM), the patient experienced little coughing spell. The reporter considered the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing as serious medically significant. The patient further reported that she felt fine after the shot, her arm was not sore, nothing. She said her arm was fine, and she had no problems, whatsoever, after receiving the COVID-19 Vaccine. She said she has had some weird allergic reactions in the past, but no anaphylaxis. About 12:00 to 12:30 PM (also reported as around midday), the patient's lip felt puffy. She said she had ate an apple and thought maybe something was on the skin of the apple. She said then her bottom lip began to swell, so she took 3 Cimetidine (NDC Number: 49035-820-72, lot number: 9AE2576A, expiry date: Dec2020). The patient stated that she was allergic to what she believe are class A antihistamines as they gave her facial and peripheral edema including Benadryl and everything on the list. About 2PM, the patient's eyes felt itchy, she took allergy eye drops (eye drops seasonal relief with tetrahydrozoline HCL 0.05% and zinc sulfate 0.25%. She said the product packaging reads it soothes eyes, and she said the eye drops worked. Lot number: AC8K275, expiration date: Sep2021). She said when she looked in the mirror, she saw a large hive on her eye (clarified as multiple hives all around her right eye). And about 4PM, she realized that her lips felt puffy, so she repeated the Cimetidine, it kept them from getting worse. At 7PM, her eye felt worse. She had this real hive that surrounded her right eye, she took a picture so she could report it to the doctor. The patient have an appointment on Wednesday. At 7:30PM, the patient's lips were puffy, she repeated the Cimetidine again and took of the 200 mg, she takes 3 at a time, she mentioned she could take 4, but she takes 3. She said she took more Cimetidine at 8:30PM, and talked to a pharmacist, who told her to call Pfizer to report her reaction. She said she attempted to call Pfizer last night, but it was too late, clarifying Pfizer Medical Information was already closed for the day. The patient also reported that she had a little coughing spell at about 9PM, so she stayed up with her husband till 10PM because she didn't feel comfortable. The patient told her husband to wake her up every once in a while. The patient felt a little wheezy, she used both of her inhalers, she could hear the wheezing, she used the serevent diskus (Serevent Diskus 50 mcg Inhaler. She said she has been using the Serevent Diskus Inhaler for seasonal allergies for years and the inhaler works. She said she occasionally uses the Serevent Diskus for colds during the winter. She said she realized she was wheezing last night and thought she should use the Serevent Diskus. NDC Number: 0173-0521-00, Lot Number: VV3E, Expiration Date: Sep2021) and Flovent (Flovent HFA 110mcg Inhaler, NDC Number: 0170719-20, Lot Number: C47A, Expiration Date: Jul2021). That seemed to be okay, she went to bed, and had a good night no problems. She said she woke up this morning and felt better. She said she sounds a little gunky this morning, clarifying that was somewhat typical for her. The patient further reported that she got up at 6:30AM, she took a shower, she was having a rebound reaction, and wheezing, so she took 3 more Cimetidine and repeated the inhalers. She clarified while her symptoms worsened after the hot shower this morning, her symptoms are much less than yesterday (21Feb2021), saying she was aware of her symptoms today, and paying attention to them. She said her lips became puffy, and she was wheezy after the hot shower. She said she took Cimetidine and her inhalers again this morning to treat the rebound reaction. She decided to repeat again at about quarter to 10AM, she repeated again trying to keep it under control. In the meantime, she spoke to her doctors office, and they just said keep doing what she's doing, and if she get real bad, call 911 or go to emergency room (ER). The patient have an appointment, the patient's big concern was that she probably shouldn't get the second COVID shot. She read on (website), that there was a very rare, mild anaphylactic reactions. What caught her eye was that this takes place about 4 hours after the dose. This was when her symptoms began, lucky her. Her whole life has been allergy related. The patient don't know if celiac disease has anything with this. The patient wanted to know whether or not there was some way to take the shot without killing herself. She said she was not having breathing difficulty, she was just wheezy. She said she repeated the Cimetidine about a half hour before she called Pfizer today. She said she called her doctor's office this morning, and her doctor said for her to keep treating her symptoms as she had been doing. She said her doctor told her to call an ambulance or go to the emergency room if her symptoms happen to get worse. She said she read online that skin anaphylaxis (hives, itching, and swelling of the eyes, face, lips and throat) can occur with the COVID-19 Vaccine. She clarified she read the information about the COVID-19 Vaccine at (Website name). She said she read skin anaphylaxis was extremely rare and less than 1% of the population has the allergy, and those individuals should not get the COVID-19 Vaccine. She said she was upset because what she read probably means she can't get the second COVID-19 Vaccine shot. She said she read the skin anaphylaxis appears within 4 hours after getting vaccinated with the COVID-19 Vaccine. She said her symptoms occurred in almost the same amount of time as to what she read about a skin anaphylaxis reaction to the COVID-19 Vaccine. She said she has a regular check-up on Wednesday (24Feb2021) with her doctor, and will speak further to her doctor about getting the second COVID-19 Vaccine. The reporter considered the events lip felt puffy, eyes started itching, hives, and wheezing as serious medically significant. The patient had no emergency visit. The patient had no relevant tests done. Therapeutic measures were taken as a result of the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing. The patient had not yet recovered from the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing while outcome of the events rash, little coughing spell, and didn't feel comfortable was unknown. The reporter considered the events swelling lips, itching eyes, hives, and wheezing as related to bnt162b2.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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.""
612	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0911280-1	No	anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the first of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Dec2020. The clinical outcome of anaphylaxis was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505821 different patient/same drug/event;US-PFIZER INC-2020505822 different patient/same drug/event;US-PFIZER INC-2020505823 different patient/same drug/event;US-PFIZER INC-2020505824 different patient/same drug/event;US-PFIZER INC-2020505825 different patient/same drug/event
613	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0911281-1	No	anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the second of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Dec2020. The clinical outcome of anaphylaxis was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
614	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0911282-1	No	anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the third of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Dec2020. The clinical outcome of anaphylaxis was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
615	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0911283-1	No	anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the fourth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Dec2020. The clinical outcome of anaphylaxis was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
616	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0911284-1	No	anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the fifth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Dec2020. Therapeutic measures were taken as a result of the event and included administration of epinephrine (MANUFACTURER UNKNOWN). The clinical outcome of anaphylaxis was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
617	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0911285-1	No	anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the sixth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Dec2020. Therapeutic measures were taken as a result of the event and included administration of epinephrine (MANUFACTURER UNKNOWN). The clinical outcome of anaphylaxis was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
618	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0925758-1	No	experienced eye puffiness; light headed ness; scratchy throat; This is a spontaneous report from a non-contactable consumer via Pfizer Sales Representative. A male patient (Health care worker) of an unspecified age and gender received BNT162B2(Pfizer BioNTech COVID-19 vaccine) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced eye puffiness, light headed ness and scratchy throat 10 minutes after vaccination in Dec2020. Reaction was not considered anaphylaxis. Patient received epinephrine, Pepcid and Benadryl in the ED, felt completely back to normal within an hour and was released. Event took place after use of product. The outcome of events was recovered in Dec2020. No follow-up attempts are possible; information about batch number cannot be obtained.
619	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0939490-1	No	1st dose of the vaccine last 29Dec2020/she is already scheduled to take it next Friday; she felt kind of itchy; saw pink all over her body; broke out in a rash; This is a spontaneous report received from a contactable nurse (who is also the patient). A female patient of an unspecified age received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date not reported), via an unspecified route of administration, on 29Dec2020, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the 1st dose of the vaccine last 29Dec2020. After a few hours, she felt kind of itchy and saw pink all over her body and broke out in a rash for a few days. She mentioned that it was not anaphylaxis and is looking for recommendations if she can receive the 2nd dose of the vaccine as she is already scheduled to take it next Friday (15Jan2021, pending clarification). The outcome of the events was unknown. Information about batch/lot number has been requested.
620	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	0962204-1	No	shortness of breath (SOB) with hyperventilation; shortness of breath (SOB) with hyperventilation; Lightheaded; red blotching on face and neck; appeared shaky; This is a spontaneous report from a contactable pharmacist. An adult female patient (pregnant unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 for first dose at single dose (lot number: EL1283) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded, shortness of breath (SOB) with hyperventilation on 08Jan2021. She was laying on the floor and appeared shaky with red blotching on face and neck on 08Jan2021. Medical response called. Anaphylaxis medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to emergency room (ER). Patient also received Diphenhydramine and Famotidine. The events resulted in emergency room/department or urgent care. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162b2 to the events 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.
621	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	1019142-1	No	Anaphylactic reaction; I felt as if my throat was closing off; I have cramping feelings in my throat; felt as if my throat was closing off; I was very sick for 3 days; This is a spontaneous report from a contactable nurse. A nurse of unknown age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The nurse reported that she had her COVID 19 shot the past week and she reported her symptoms and wondered should not take the second dose because she was very sick for 3 days but that did not bother her. The thing that bother her was that she felt as if her throat was closing off, she had cramping feelings in throat. She was afraid that it was beginning to be 'anaphylaxis' but it was not. She reported that it did not go any further than that but she was fearful that her throat was going to close completely off. At the time of reporting the outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The suspected anaphylaxis with throat tightness and throat spasm were probably causally related to the use of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. 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.
622	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	1023485-1	No	anaphylaxis; she didn't feel well; she felt weak; felt like throat was closing; Her heartrate was 113; low grade headache; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was not sure if patient made her symptoms worse with her attitude, but in the first 5 minutes (27Jan2021), patient reported she didn't feel well, she felt weak, and felt like throat was closing. She was referred to the ED (emergency department) for anaphylaxis and given 1 dose of epinephrine. The ED said they do not know if it was an anaphylactic reaction. Her heart rate was 113 (27Jan2021). After that, she rested for the rest of the day and now has a low grade headache and some of the typical side effects (unspecified). Reporter asked for the recommendation for the second dose. The events were not serious as per reporter. Therapeutic measures taken as a result of the event anaphylaxis. The outcome of the event anaphylaxis, didn't feel well, felt weak, felt like throat was closing, heart rate was 113, and low grade headache was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug.. 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 RAs, Ethics Committees, and Investigators, as appropriate.
623	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	1023486-1	No	low grade head ache; GI c/o; anaphylaxis; Difficulty breathing; Lightheaded; throat felt like swollen/Throat getting narrower; did not feel well; hr 112; nausea; Didn't feel right; This is a spontaneous report from a contactable Physician who reported for a patient (staff member). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and during 15 min observation window did not feel well. It was later reported by the same reporter that within 3-5 minutes after injection the patient didn't feel right. Felt lightheaded, wasn't there. Having difficulty breathing and felt throat was getting narrower. Stated throat felt like swollen and heart rate was 112. Went up to people at vaccine center, was given Benadryl and sent to the Emergency Room (ER). Told she was having anaphylaxis. ER was not convinced of anaphylaxis, but was given epinephrine. Ultimately was given epinephrine although they stated that unclear if anaphylaxis or not. Was given 50mg of Benadryl. Was given Zofran for nausea. 'Today' (28Jan2021) had low grade head ache and GI c/o (gastrointestinal complaints of). Had no previous issues with vaccine or drug reaction. Has comorbidities. The reporter was seeking recommendations for the second COVID-19 Vaccine. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
624	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	1068254-1	No	anaphylaxis; head was feeling funny; sweating profusely; This is a spontaneous report from a contactable consumer (patient). This 79 (unit unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 10Feb2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose on 10Feb2021 at 12:00. On the same day (10Feb2021), at 20:00, the patient's head was feeling funny, sweating profusely, and felt like ""anaphylaxis"". Patient also asked about potential receipt of second dose. Patient stated she will reach out to healthcare professional (HCP). Outcome of the events was unknown. Information on the batch/lot number has been requested.""
625	COVID19 (COVID19 (PFIZER-BIONTECH))	0 days	Unknown	1091427-1	No	felt like she was having a ""heart attack""; extremely nauseous and dizzy; extremely nauseous and dizzy; reported stiffness in both legs and could not walk; reported stiffness in both legs and could not walk; This is a spontaneous report from a contactable pharmacist. An elderly (65+ Years) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 23Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Public Health Clinic/Administration facility. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 intramuscular on unknown date at SINGLE DOSE for covid-19 immunisation. After 2nd dose on 23Feb2021, the patient felt extremely nauseous and dizzy, felt like she was having a ""heart attack"" though no reported difficulty breathing or anaphylaxis. The patient also reported stiffness in both legs and could not walk and do could not reach phone to call anyone. No treatment received. The outcome was unknown. No covid prior vaccination. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal relationship, the causal association between BNT162B2 and the reported ""felt like having a heart attack"" cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.""
626	COVID19 (COVID19 (UNKNOWN))	0 days	30-39 years	0950054-1	No	anaphylaxis
627	COVID19 (COVID19 (UNKNOWN))	0 days	30-39 years	1147830-1	No	At approximately 1238 patient was noted to be on floor, experienced fall from chair. 911 called. came to patient. Pt placed in recumbent position. noted to be having seizure regained consciousness. Airway not obstructed no s/s if respiratory destress noted. Regain consciousness after 2 seconds. Vs bp130/82, O298% on RA, HR 72, RR 28. Denies pain or discomfort. Pt alert and oriented able to state his name date location. Mae x34 l neurologically intact. did not give Epi . No s/s of anaphylaxis noted. please patient and become a position. Ambulance and fire department on site at this time.
628	COVID19 (COVID19 (JANSSEN))	1 day	18-29 years	1180552-1	No	Flulike symptoms -- fever, body aches, chills, abdominal pain, fatigue, headache; onset 6 hours after receiving vaccine, resolved 24 hours after receiving vaccine. HIVES without anaphylaxis -- developed 12 hours after receiving vaccine, still progressing 40 hours after receiving vaccine
629	COVID19 (COVID19 (JANSSEN))	1 day	30-39 years	1130405-1	No	I have a history of anaphylaxis, and disclosed that to the medics so they watched me more carefully, which was good, as while I did not experience anything that severe, I did immediately get itchy, turn red and feel quite nauseated. However, after they monitored me awhile, I told them I felt okay to go home. The next day I had the expected mild flu-like symptoms, which I anticipated. However, what?s been atypical is they returned tenfold three days later. This time with a much higher fever (103), severe chills, fatigue, a seemingly never-ending headache, muscle spasms, chest palpitations and suddenly I am experiencing asthma (which is typically seasonal) and am coughing, too. I?m now a week past when I was vaccinated and each day was feel worse, not better. I have had to cancel my clients and hire a sitter to care for my kids as I am too weak and ill to do it. I looked up common reactions and nothing states chest pain and/or asthma, nor that it should last this long. That said, as I am high-risk, I work from home and homeschool both of my young kids. Thus, I have been nowhere aside from the vaccine site. Moreover, my partner, our kids and sitter get routinely tested for me, and everyone is negative. Thus, it appears I am having prolonged, heightened side-effects much more intense than the ?mild? flu-like symptoms otherwise reported, which is concerning. I took no medication prior to receiving the vaccine, either.
630	COVID19 (COVID19 (JANSSEN))	1 day	30-39 years	1138002-1	No	Patient received the J&J COVID vaccine around 10:00 a.m. In the evening began experiencing subjective fevers, chills, nausea, headache. He took ibuprofen around 4:45 a.m. in the morning and went to work. Symptoms do not improve and patient presented to ED for evaluation. Patient denies chest pain, shortness of breath, vomiting, diarrhea, dysuria. No Hx anaphylaxis. Denies sensation of upper airway stridor or other respiratory symptoms. Past medical history is unremarkable. He is not on home medications. Denies smoking or illicit drug use. Patient was given 1 gm Tylenol, 10 mg metoclopramide, and 1 L NS. Patient improved, and was discharged
631	COVID19 (COVID19 (JANSSEN))	1 day	40-49 years	1182619-1	No	Anaphylaxis with throat swelling and hives.
632	COVID19 (COVID19 (MODERNA))	1 day	18-29 years	0909309-1	No	Full body hives beginning about 36 hours after vaccination. Angioedema in the hands, feet, and lips beginning about 48 hours after vaccination. Hives did not improve with Benadryl so doctor prescribed prednisone. No severe reaction such as anaphylaxis, but reaction was moderate enough to make daily life difficult.
633	COVID19 (COVID19 (MODERNA))	1 day	18-29 years	0947314-1	No	Chest pressure/tightness starting approximately 24h after the vaccine. No allergic reaction or sign of anaphylaxis. No shortness of breath or trouble breathing, just general chest tightness. Got a little better the next day, but still a bit of chest tightness. Almost feels like the type of chest pressure you get when you have a bad cold with postnasal drip.
634	COVID19 (COVID19 (MODERNA))	1 day	18-29 years	0957544-1	No	Pt reported to clinic for 1x left axillary lymph node enlargement secondary to COVID-19 vaccination, pain 7/10 and swelling the size of a ping pong ball. No anaphylaxis. Pt reported to clinic on 20 Jan 2021, 5 days after swelling presented.
635	COVID19 (COVID19 (MODERNA))	1 day	30-39 years	0935904-1	No	I have a history of prior anaphylaxis in 2009 when I received (separate arms, same date and time) the 2009 seasonal flu vaccine and the 2009 H1N1 vaccine. Both were from multi-dose vials and providers I established care with following the reaction believed I likely had a reaction to a preservative. I?ve received single-dose flu vaccines with no issues since then. When I received the Moderna covid vaccine on 1/8/21 I had some right-sided throat swelling about 15 minutes after injection. It did not worsen and I was monitored for 1 hour after shot time. I went home and the feeling in my throat resolved after about 4-5 hours with no medication or intervention needed. I did not have any other symptoms until 3pm on 1/9/21. Started with mild abdominal pain, an hour and a half later I had chills, headache, fatigue and fever around 100.8F. No medication taken. The fever resolved within about 6-7 hours. On Sunday 1/10/21 the abdominal pain worsened and was a constant pain around umbilical region that felt as if it radiated outward, LLQ slightly worse. It was severe, directly affected normal daily functions. I could not walk, move, eat or drink room-temp water without pain increasing. Walking 20ft at one point even caused me to crumble to the floor and cry, had to stay there for 5 minutes before even attempting to get back to the couch. No diarrhea, no vomiting, no fever, no nausea. I did have loss of appetite. The pain continued through the night and was constant. I could not find a comfortable position to lay in and tossed and turned most of the night. At 0430 on 1/11/21 I got up out of bed to pee, abdominal pain was so bad it kept me awake for about an hour after. Pain finally started to improve and I was able to sleep from 0530-0930. When I woke up on 1/11/21 around 0930 my abdominal pain was very mild and continued to improve as the day went on. Currently (1600 on 1/11/21) my abdomen feels about 90% better, I have no other symptoms. The symptoms, specifically the fever and abdominal pain, caused me to miss 2 days of work (Sunday 1/10/21 and Monday 1/11/21).
636	COVID19 (COVID19 (MODERNA))	1 day	30-39 years	0974547-1	No	HISTORY OF PRESENT ILLNESS: SHORTNESS OF BREATH (CHEST PAIN, sob , BACK PAIN STARTING TODAY AT 0900, STATES ADVIL AT 1000, SSENCOND COVID VACCINE YESTERDAY AT 1500) 32-year-old female with past medical history of anxiety, asthma, Hashimoto's thyroiditis, psoriasis who presents the emergency department with chief complaint of body aches and shortness of breath. Patient is a nurse. She received her 2nd dose of the Moderna vaccine for COVID-19 the day prior to arriving in the emergency department. This morning she did feel some mild body aches but otherwise was feeling fine. Starting later today after her shift at work she developed severe body aches bilateral upper shoulders and down her spine, she also reports some shortness of breath, dizziness. She felt unsafe to drive home feeling like this. She had taken some Advil earlier in the day around 10:00. She denies any fever, nausea or vomiting. No history of severe vaccine reaction or anaphylaxis. She has had anaphylactic reaction to Enbrel prior. She denies any throat swelling, muffled voice, difficulty swallowing, abdominal pain. patient is mildly tachycardic and hypertensive. Likely due to pain. Patient is experiencing adverse reaction to the 2nd dose of the Moderna COVID-19 vaccine. I discussed with her she is having an immune response to the vaccine. She does have a history of rheumatoid arthritis which could contribute to the elevated immune response as well. The patient is given 30 mg of IM Toradol for body aches here in the emergency department. She is instructed to call PCP for close follow-up, rest, drink plenty of fluids. She has no signs or symptoms consistent with anaphylaxis at this point.
637	COVID19 (COVID19 (MODERNA))	1 day	30-39 years	0986584-1	No	Excess sneezing that started approximately 18 hours after the vaccination and lasted for 12 hours. The patient sneezed a total of 30 - 40 times. There were no other symptoms, such as rhinorrhea, rhinitis, or anaphylaxis, therefore this may have been a mild allergic reaction to the vaccine. The sneezing resolved without intervention.
638	COVID19 (COVID19 (MODERNA))	1 day	40-49 years	0938244-1	No	Moderna COVID- 19 Vaccine Moderna Lot #012L20A January 2021 left deltoid CC: Itching reaction, remote to the site of Moderna vaccination, 26 hrs post-injection 47 year old presents with rash rt. thigh on 1-7-21 at the Health Services, Employee Health Received Moderna Covid 19 mRNA vaccination #1 yesterday 1-7-21 at 8:50 am, left deltoid. Noted itchy area on rt. thigh ~ 26 hrs post-vaccine. No trouble breathing, no throat or facial swelling, no h/o problems with vaccination, no h/o anaphylaxis. No new topical exposures. No new supplements, no recent antibiotics. Denies fever. She apparently rubbed/scratched through pant leg, when felt itching, and then saw a bruised/red area after this. Exam: Skin: 5 xc 10 cm nonblanching petechial and ecchymotic area rt. ant. thigh, no papules or pustules, no warmth to touch. Pt. encouraged to register with V-safe. Rec. oral anthistamines as directed/needed. I spoke with patient on 1-11-21, no new itchy areas, still using Benadryl for the localized itchy area that she reports is resolving. Was harm caused: employee is fine. Difficult to say if this is vaccine reaction vs. coincidental occurrence.
639	COVID19 (COVID19 (MODERNA))	1 day	50-59 years	0918182-1	No	shortness of breath, hypotension, presumed anaphylaxis
640	COVID19 (COVID19 (MODERNA))	1 day	50-59 years	0932236-1	No	Has reported history of anaphylaxis to aspirin. Symptoms have started to resolve at this time with use of acetaminophen
641	COVID19 (COVID19 (MODERNA))	1 day	60-64 years	0923549-1	No	Headache, Myalgia, Anaphylaxis, Fever, HYPERtension, oral thrush Narrative:
642	COVID19 (COVID19 (MODERNA))	1 day	65+ years	0985370-1	No	Mild anaphylaxis 14 hours later!! Upper palate and tongue slight swelling and very itchy all over extremities
643	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	18-29 years	0910338-1	No	Arm pain and Migraine .. Took Migraine medication and that's when I had a anaphylaxis reaction . I have an appointment to see a specialist to verify if the reaction was caused by the COVID vaccine or the medication I took that day
644	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	18-29 years	0918568-1	No	36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the areas where I have HA fillers - lips and tear troughs. Both Restylane products. Ended up going to the ER at 2 AM and receiving angioedema/anaphylaxis protocol. IV benedryl, famotidine, and solumedrol. Was put on prednisone and hydroxyzine for at home care for the next 3 days after event. Swelling went down by the next afternoon.
645	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	18-29 years	1100309-1	No	Swelling and pain of left supraclavicular lymph node approximately 18 hours after second dose/left axillary node temporarily swollen; Swelling and pain of left supraclavicular lymph node approximately 18 hours after second dose; Left supraclavicular node is no longer painful, but still swollen and palpable (moveable); This is a spontaneous report from a contactable other hcp (patient). A 28-year-old non-pregnant female patient received 2nd dose of bnt162b2 (lot number: EK4176), via an unspecified route of administration in the left arm on 09Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included allergies: shellfish- severe GI response (not anaphylaxis) from an unknown date and unknown if ongoing. Concomitant medication included desogestrel, ethinylestradiol (APRI), colecalciferol (D3), paracetamol (TYLENOL) and unspecified multi vitamin. The patient did not receive other vaccine in four weeks. The patient previously received 1st dose of bnt162b2 (lot number: EH9899) on 19Dec2020 11:30 AM in the left arm for COVID-19 immunization. On 10Jan2021 06:00, patient experienced swelling and pain of left supraclavicular lymph node approximately 18 hours after second dose. Also left axillary node temporarily swollen. Left supraclavicular node is no longer painful, but still swollen and palpable (moveable). Outcome of events was recovering. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Jan2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given for events. The patient was not diagnosed of covid prior vaccination.
646	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	30-39 years	0913774-1	No	Patient is a 38 y.o. female presenting with nausea with middle taste sensation after immunization. Presentation most consistent with vasovagal reaction versus allergic reaction. No signs of severe allergic reaction or anaphylaxis, no signs of cardiopulmonary compromise.
647	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	30-39 years	0926690-1	No	Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continued to day 3 post vaccine). No signs of anaphylaxis.
648	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	30-39 years	0942710-1	No	Swollen lymph nodes upon palpation to left armpit; visible swelling to left armpit; pain to left armpit; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of BNT162B2 (also reported as Pfizer brand, lot no: EK5730), intramuscular on 06Jan2021 at 06:30 at a single dose on the left arm (as reported, also reported as left deltoid) for COVID-19 immunization. Medical history included anaphylaxis to ""unknown chemical substance"" while jogging in Oct2014 that resulted in a 4 hr hospitalization in an emergency department. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 16Dec2020 at 8:00 PM intramuscular on the left arm for COVID-19 immunization. The patient reported swollen lymph nodes upon palpation to left armpit with noted visible swelling to left armpit as well as pain to left armpit on 07Jan2021 at 6:30 AM. The symptoms were present 24 hours post vaccination intramuscular to the left deltoid (as reported). The patient did not receive any treatment for the reported adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.""
649	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	40-49 years	0952432-1	No	49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented +3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
650	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	40-49 years	0976830-1	No	a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140, expiry date: 31Mar2021) intramuscular on left arm (left deltoid) single dose for COVID-19 immunization on 21Dec2020, 10:20 am, at 43-year-old. No medical history, drug allergies and family history. Concomitant medication included: multivitamins (unspecified) daily whenever she remembered to take them. The patient had no issues with that vaccination, maybe a little tiredness and achiness the next day (22Dec2020), but no reactions, no asthma, anaphylaxis or anything. Had a CBC, CMP, and 2 chest x-rays and they were all normal. The patient was not deceased. Relevant tests included: CBC, CMP and twice Chest X-ray; all with normal results. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
651	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	40-49 years	0993626-1	No	Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. 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.
652	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	50-59 years	0937256-1	No	Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That night woke up with muscle spasms all over her body and took her temp which was 101. The muscle spasms stopped at 0300 on 12/31. After that she developed a migraine. Headache last 22 hours and then just went away. She was tired the following day 1/1. All symptoms resolved on 1/2. She received the first vaccine in the ED and is scheduled to receive the second one in the ED as well. She has h/o anaphylaxis to food and bugs.
653	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	60-64 years	0912201-1	No	redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line; right eyebrow was swollen and neck had a thin red line; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in the left deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included hypertension (diagnosed at 47 years old ), hypothyroidism, Hashimoto's disease from 2000 to an unknown date (diagnosed 20 years ago), anxious person and weight loss. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN), taken for blood pressure from 2000 to an unspecified date, levothyroxine sodium (SYNTHROID), taken for hypothyroidism and Hashimoto's disease from 2015 to an unspecified date, rosuvastatin calcium (CRESTOR), taken prophylactically from 2010 to an unspecified date and semaglutide (OZEMPIC) taken for weight loss from May2020 to an unspecified date. Family history included; the patients mother had an allergy to Sulfa and allergy to penicillin and the patients father had unspecified allergies and hay fever. There were no prior vaccinations within 4 weeks. On 19Dec2020, the patient experienced redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line and right eyebrow was swollen. The reporter considered the events to be non-serious. The patient was worried about anaphylaxis, so they went to the emergency room (ER) for the reported events but was not admitted. The patient was treated in the ER for the events with diphenhydramine hydrochloride (BENADRYL), prednisone (MANUFACTURER UNKNOWN) and famotidine (PEPCID). Relevant tests were none. The outcome of the events was recovering. The reporter stated that there was a reasonable possibility that the events were related to the suspect product.
654	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	60-64 years	0921320-1	No	significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
655	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	60-64 years	0938085-1	No	High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
656	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	65+ years	0996739-1	No	Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar.; This is a spontaneous report from a contactable Physician. A 75-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 18Jan2021 19:30 at single dose on left arm for COVID-19 immunization. Medical history included Stroke, diabetes, hypertension, anaphylaxis to bee stings. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sitagliptin phosphate (JANUVIA), hydrochlorothiazide, telmisartan, rivaroxaban (XARELTO), gabapentin and baclofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to Morphine and experienced Hives. Approximately 22 hours after vaccination the patient had a seizure on 19Jan2021 17:15. She felt fine up until the seizure occurred. She never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar. No treatment was received for the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolved. Information on the lot/Batch number has been requested.; Sender's Comments: Based on the time association and previously allergic reactions to bee stings and other drugs, the possible contribution of suspect BNT162B2 to the event seizure cannot be excluded in this elderly patient with multiple medical histories including stroke, diabetes and hypertension. 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.
657	COVID19 (COVID19 (PFIZER-BIONTECH))	1 day	Unknown	0910604-1	No	Developed vomiting, four to five times; Diarrhea; Abdominal pain; Slightly flushed face and minimum facial flowing; Numb ears/Numb body; Bleeding; Anaphylaxis; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis on 20Dec2020. Clinical course: the patient received the COVID vaccine on 19Dec2020, and since then she had developed onset of vomiting after 3 o' clock this morning on 20Dec2020, four to five times, numb ears, numb body. She also had diarrhea and bleeding. She had some abdominal pain and she also complained of having slightly flushed face and the minimum facial flowing. The outcome of events was unknown. Information for Lot/Batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event anaphylaxis was related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event bleeding with BNT162b2 can not be completely 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.
658	COVID19 (COVID19 (MODERNA))	10-14 days	40-49 years	0965822-1	No	. On Friday 1/8/21, Pt was vaccinated with Moderna first dose in the left deltoid muscle. No immediate issues/complications. Beginning Tuesday 1/19/21 (eleven days post-vaccine), she reports noticing itching in the injection site; no rash or other symptoms (e.g. temperature elevation, shortness of breath, wheezing, swelling, hives). Today 1/20/21 her arm has a noticeable ?rash? type reaction. She reports continued itching but no particular pain or tenderness. No visible pustules but the area is reddened and very slightly warm but not ?hot-to-touch?. At about 4:15 pm, the affected area measured approximately 2 + inches (5.5 cm) wide by 2 + inches (6.5 cm) long. 1/21/20, Pt reported taking oral diphenhydramine overnight /1/20/21) with reduced itching/swelling but again today notes return of redness, swelling and warm to touch. Pt reports about 3 years ago having a ""tetanus"" booster ? had a reaction of the entire upper arm with swelling, redness and hot-to touch. No reported anaphylaxis. Based on consultation with the regional medical director, and the Infectious Disease Specialist, they will defer providing the second dose of Moderna. Pt has been referred to her private health care provider with a recommendation to consider referral to an infectious disease practitioner for any future COVID-19 vaccine administration.""
659	COVID19 (COVID19 (MODERNA))	10-14 days	50-59 years	0922858-1	No	Presented in ED with a reddened and swollen area of her left deltoid region.. The patient states that she received the Madrona vaccine on 21 December in the left deltoid. She states that she had no problem with the vaccine initially. She states that she even hiked this last weekend and felt fine. She states that she developed a reddened area of the skin 3 days ago that has been increasing in size. It is now tender and somewhat warm to the touch. She states that she also felt some itchiness of her upper chest. She is not sure if she has any true hives in this area. She denies facial, tongue, or lip swelling. She denies difficulty breathing. She denies chest pain. She denies abdominal pain, nausea, vomiting. ASSESMENT and PLAN ß Erythematous, hive-like region of the left deltoid that began 12 days after the Moderna vaccine. This is likely a localized delayed type IV hypersensitivity reaction. Bedside ultrasound performed by myself. I do not note any pocket of fluid to indicate an abscess. However, there is a small possibility that this could be cellulitis. A cellulitis would be much more concerning. From an allergic perspective, she has no evidence of anaphylaxis based on the timeframe and her current symptoms. As a result, she will continue on Benadryl for now at 50 mg every 6 hours and will be placed on doxycycline 100 mg twice a day for 10 days. May use prednisone taper but she should wait for 48 hours. If she has improvement with doxycycline and Benadryl, she should continue with this. The Benadryl is truly as needed and if it is improving, she does not need to continue on it. She will.
660	COVID19 (COVID19 (MODERNA))	10-14 days	65+ years	0977427-1	No	The injection site on my right upper arm is swollen, red, itchy, and warm to the touch. Measures 4? long and 3? wide and is oval shaped. I noticed an itch on 1/24/21 @ night and again the next morning and upon close inspection found the reddened oval shape that was warm and swollen. It continues today on 1/27/21. I am not exhibiting any signs of anaphylaxis. My concern is whether is is safe form me to receive the second Moderna vaccine on February 9th.
661	COVID19 (COVID19 (PFIZER-BIONTECH))	10-14 days	40-49 years	0965554-1	No	Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed ""full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up"". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.""
662	COVID19 (COVID19 (JANSSEN))	2 days	18-29 years	1116847-1	No	Patient called pharmacy complaining of tight throat, hives, and itching. All occurred about 36 hours after vaccination. Advised patient to take 50mg of Benadryl 4 hours apart then 25mg every 4 to 6 hours. Patient described a close form of anaphylaxis. Advised patient to proceed to ER if difficulty breathing or symptoms progress. Also advised patient to follow up with PCP if symptoms continue for another 24-48 hours.
663	COVID19 (COVID19 (JANSSEN))	2 days	30-39 years	1103262-1	No	allergic reaction. Rash, itchy to BLE and BUEs x 2 days with swelling; pt reports mainly in joint areas, getting worse today and spreading; received J&J vaccine on 10MAR21. Rash with redness and itchiness to BUEs/BLEs; no pain; patent airway. MDM: Pt does not have anaphylaxis. The temporal relationship to COVID vaccine is suspicious. Will treat as allergic reaction. F/u and return precautions discussed.
664	COVID19 (COVID19 (MODERNA))	2 days	18-29 years	0965724-1	No	Anaphylaxis treated at Tufts Medical Center -Full body hives on 1/21- treated w Benadryl, Claritin, Famotidine -1/22 woke up with lip swelling, throat itching, lip tingling- came to ER on this date for evaluation, given epinephrine IM, Benadryl IV, fluids IV, prednisone PO
665	COVID19 (COVID19 (MODERNA))	2 days	40-49 years	0936941-1	No	- Pain and swelling of left armpit x 5 days (received the Moderna COVID-19 vaccination on 1/5/2021). No airway or ocular involvement; No acute anaphylaxis; No acute infection or lymphangitic streaking appreciated. Supportive measures were advised. May t
666	COVID19 (COVID19 (MODERNA))	2 days	40-49 years	0986426-1	No	Took vaccine on 1/21/21. Symptoms on 1/23/21 included widespread rash, lips swelling, hives, dizziness, trouble breathing. Received epinephrine, steroids, benadryl. Diagnosed with acute anaphylaxis due to possible allergy to Polyethylene Glycol
667	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	30-39 years	0932322-1	No	Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..
668	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	40-49 years	0905133-1	No	anaphylaxis
669	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	40-49 years	0914192-1	No	Moderate to severe pain at injection site; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids.; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; This is a spontaneous report from a non-contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Asthma and Ehlers Danlos, and Known allergies: Hives with amoxicillin and anaphylaxis with shellfish. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), ethinylestradiol/levonorgestrel (QUARTETTE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Moderate to severe pain at injection site, and 2 days after vaccination I had swelling, redness, hives and itching on both eye lids on 25Dec2020. Treatment received for the adverse events included Benadryl 50mg once. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
670	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	40-49 years	0925494-1	No	Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
671	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	40-49 years	0939738-1	No	Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
672	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	50-59 years	0961886-1	No	swollen uvula, throat lymph edema, arm soreness. has history of anaphylaxis
673	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	60-64 years	0909000-1	No	Subsequent idiopathic anaphylaxis event 1 1/2 days later
674	COVID19 (COVID19 (PFIZER-BIONTECH))	2 days	60-64 years	0942459-1	No	1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
675	COVID19 (COVID19 (JANSSEN))	3 days	50-59 years	1130098-1	No	I started developing hives first down my right leg, then on my stomach and on my tailbone starting 4 days after receiving the vaccine. So far, I continue to develop them slowly. No anaphylaxis, but a strange systemic reaction.
676	COVID19 (COVID19 (MODERNA))	3 days	30-39 years	1050206-1	No	I had hives despite having taken my daily dose of Claritin that seemed to get worse as the day continued. I reached out to my Healthcare clinic and they were unsure if there was a simple treatment and almost required me to go the emergency room for this. I conducted a telehealth consultation with a doc who was not my primary care physician and was unfamiliar with my preexisting exercise urticaria condition that occasionally results in light hives but never anaphylaxis for me without Claritin. I declined going to the emergency room since this did not seem that serious and instead took another Claritin to try to get the somewhat worsening hives with no apparent cause to stop without an unnecessarily escalated situation. My throat was slightly itchy but I never became anaphylactic likely due to taking an additional Claritin and not doing anything requiring physical effort for the day beyond telecons from home because I left the office to telework mid morning after I started getting continually slightly worse hives. By evening I was ok and the next day just had a slightly sore throat but was able to work and just started the day with 2 Claritin without any further instance of hives appearing. The day after that I returned to my standard 1 Claritin dose with no ill effects. From this event, it seems clear that a 72 hour downing period from dose 1 is insufficient and should be upped to 96 hours. Prior to this more severe event, I had, on days 2 and 3, a sore left arm at injection site that prevented me from even reasonably lifting my arm to a height sufficient to grab my cell phone off it's charger while lying in bed without serious discomfort. That level of arm discomfort prevented me from working out or would have prevented me from anything other than light office work involving my vaccine arm. My level of tiredness for the couple days following this dose also required that I take an hour long nap days 1 and 2, and no nap at all is usually the norm for me.
677	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	18-29 years	0946542-1	No	Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.
678	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	30-39 years	0936837-1	No	The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue. Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
679	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	30-39 years	1016608-1	No	sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report from a contactable Other HCP. This other HCP reported different events for the same patient during diffferient vaccination dose. This case is referred to the second vaccine dose A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247 intramuscular on 13Jan2021 12:30 second dose at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Hospital . Vaccine location: right arm Medical history included asthma, eczema, hypersensitivity, anxiety and depression. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan (RIZATRIPTAN), salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levocetirizine dihydrochloride (XYZAL), betamethasone (BETAMETHASONE). The patient previously took aspirin and experienced rash. The patient experienced flushing, palpitations and hyperhidrosis after the first dose of bnt162b2 vaccine. The patient experienced sudden onset lower lip angioedema- only on the right side of my lip on 16Jan2021 20:30 with outcome of recovered. The action taken was not applicable. Therapeutic measures were taken: benadryl inhaler self treated, consultation w/allergist and allergy testing. The reporter stated ""developed sudden onset lower lip angioedema only on the right side of my lip. I took 50mg benadryl and my inhaler and monitored- I never developed itching, additional swelling, difficulty breathing or other symptoms of anaphylaxis. Swelling had resolved by morning. I had no other new exposures that have yet been identified, although I am going through a work up with an allergist.""; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021073355 Same patient/ drug, different dose/AE.""
680	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	40-49 years	0912903-1	No	12/29/20- Spoke to CG. Received Pfizer COVID-19 vaccine, dose #1 on 12/23/20 @ 4pm. Stayed in Observation area for 15 minutes without any problem. Suddenly, on 12/26/20 (3 days after receiving the COVIID vaccine), CG felt ""itching to throat, gum, mouth and body; itching head to toe"", also noticed ""lip, mouth swelling"" as well as ""wheezing"". Stated she has history of ""asthma"". CG then self-medicated with ""Claritin and Albuterol inhaler"" without much improvement on 12/26/20. Then the next day, on 12/27/20, itching to throat and mouth is resolving but still had shortness of breath and itching body. On 12/28/20, CG came to work but still experienced itching body and ""hard to breath"" when wearing surgical mask (required at work). CG was sent home and saw primary care physician (PCP) via virtual visit. Per PCP's evaluation, CG has had ""delayed allergic reaction"" to COVID-19 vaccine. PCP recommended CG to continue with Benadryl and Albuterol inhaler until recheck on January 4 for re-evaluation and discussion on preparation of 2nd dose with steroid and EpiPen. CG would like to complete the vaccination series to receive 2nd dose. As of today, 12/29/20- CG stated she still has shortness of breath and itching and will be off work until re-evaluation by PMD on Jan 4, 2021. Reviewed CG?s consent form of COVID-19 Vaccine- Date received 12/23/20 @3:37pm. Answer of NO to question ?Do you have a history of severe allergic reaction (e.g. anaphylaxis) to another vaccine or injectable medication??""
681	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	40-49 years	0936388-1	No	if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine; delayed hyper sensitive reaction; Angioedema; Urticarial rash; This is a spontaneous report from a contactable other hcp. A 47-years-old male patient received first dose of bnt162b2 (BNT162B2), unknown on 18Dec2020 (lot number: EK5730) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a Physician Assistant. Caller states that she is calling about the Covid Vaccine. She had a patient received his first dose of the vaccine on Friday 18Dec2020, 3 days later on 21Dec2020 he had an urticarial rash that persisted, The urticarial rash was treated with prednisone and resolved by 27Dec2020, it has not reoccurred. The allergist said it was a delayed hyper sensitive reaction that was Prompted by the immune simulation from the vaccine. The Patient was treated for the urticaria. Caller would like to know if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine? Caller is very upset and frustrated and stating she wants to speak to someone that is a clinician with the clinical trial team who can give her recommendations for a specific patient. Caller asks if they should do Prophylaxis with antihistamines for the second dose. He did not have anaphylaxis but he had angioedema. Caller states that she did a Vaers report on 22Dec2020, but no one contacted her. He started taking Zyrtec and Vistaril. The Allergist said it was fine and he will still need the 2nd Booster Dose. The Angioedema started on 22Dec2020, it was also treated with prednisone, in addition to being administered Benadryl IM, and Vistaril. The outcome of the event urticarial rash was recovered on 27Dec2020 and Angioedema was recovered on 22Dec2020. No follow-up attempts are needed; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase level and complement panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. 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.
682	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	40-49 years	0947110-1	No	Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She tried applying ice on the most red part on the arm but the swelling continued to grow. Then she started applying heat in addition to applying HPR+ cream that she uses for urticaria. The only thing that the patient stated that helped a little was the ice pack. The patient ended up going to the emergency department on 1/14/2020 for the rash / welt that developed beyond her arm and to the neck and eyelid area which she described as itchy. The patient was prescribed a 4 day prednisone 50mg daily course along with Benadryl as needed and Pepcid 40mg daily which she states have helped alleviate the itchiness but has not completely resolved yet as of today 1/15/2020. Per ED note, patient presented with mild erythema around the injection site and non-specific rash to the neck. Patient has clear speech and no oral swelling and no signs of anaphylaxis. Patient discharged home in stable condition and advised to follow up with primary care doctor in 2-3 days.
683	COVID19 (COVID19 (PFIZER-BIONTECH))	3 days	60-64 years	0911414-1	No	Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint; Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), via an unspecified route of administration on left arm on 17Dec2020 at single dose for COVID-19 immunization. Medical history included wasp venom with anaphylaxis. There were no concomitant medications (No other-vaccine-in-four weeks, no other-medications-in-two weeks). The patient previously Stage 4 breast cancer in remission on Xeloda. The patient experienced joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint on 20Dec2020. All events were reported as non-serious. The patient did not receive treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
684	COVID19 (COVID19 (MODERNA))	4 days	40-49 years	0948185-1	No	48 year old female presenting for evaluation of left arm and armpit pain. Patient reports she received the Moderna COVID-19 vaccine on 1/6/2021. Reports within the first 24 hours she developed pain to the injection site, nausea and some abdominal discomfort that resolved by the evening of 1/7/2021. Patient reports yesterday she still noticed some soreness to the left arm (this was the arm the vaccine was injected in). Reports she also had pain to the left armpit with some tenderness and pain extending to the breast at times. Reports that she was wearing a sports bra at work and she had to take it off due to pain in the armpit. Denies any fevers/chills, body aches, fatigue. Denies any nasal congestion, sore throat, cough, loss of taste or smell, chest pain or shortness of breath. Denies any abdominal pain, vomiting or diarrhea. Denies any history of anaphylaxis. Denies any history of severe reactions to vaccines. Patient was advised this is possible side effect from vaccine but patient very concerned and wanted to be evaluated.
685	COVID19 (COVID19 (PFIZER-BIONTECH))	4 days	40-49 years	0909607-1	No	Received Pfizer COVID-19 vaccine without untoward effects on 12/18. Given her usual allergy shot by her allergist on 12/22 (she has been receiving these for several years; I was told this is a protein antigen in a glycerine suspension). Within 15 minutes, patient developed anaphylaxis: generalized erythema, swelling, pruritus and hypotension requiring epinephrine, and diphenhydramine. Patient recovered over several hours.
686	COVID19 (COVID19 (MODERNA))	5 days	30-39 years	0937320-1	No	Rash Narrative: Pt called w/questions about taking OTC benadryl for a rash that is on her arms and legs and some on her trunk that she reports began last night, five days after receiving dose #1 of the covid vaccine on 12/30/20. Denies any other symptoms at present and is primarily concerned about reporting her rash. No history of anaphylaxis in her medical history or other allergies to food or medications are known to her. Rash appeared scattered to trunk and extremities x4, red, raised, dry bumps that do not itch at present. Agreed that 25-50mg oral benadryl would be a good choice to start, which she states she will do. She in an APRN and states she feels comfortable recognizing new or additional symptoms for which she should seek medical attention, such as difficulty breathing, rapid heart rate, worsening of rash, swelling off her face, throat or lips, or dizziness/weakness. She has family at her home as well and is not alone.
687	COVID19 (COVID19 (MODERNA))	5 days	40-49 years	0923543-1	No	Tachypnea throat tightness, short of breath, concern for anaphylaxis Narrative: Present to ED five days after vaccine w/c/o tightness in throat and shortness of breath; treated in the ED w/epinephrine, benadryl, famotidine and methylprednisolone and observed for two hours; prescribed Epi-pen for take-home. Discharged home.
688	COVID19 (COVID19 (MODERNA))	6 days	18-29 years	0914013-1	No	ARM WAS SORE FROM TIME OF SHOT UNTIL 12/25/20 AM. ON 12/29/20 AT 11 PM EMPLOYEE NOTED ITCHING TO INJECTION SITE. ARM WAS ALSO SWOLLEN AND RED. THIS HAS PROGRESSED TO MUSCCLE PAIN TO ENTIRE RIGHT ARM. EMPLOYEE CALLED PCP WHO OFFEREN NO ADVICE. EMPLOYEE THEN CALL INFECTION PREVENTION NURSE AT HER EIMPLOYMENT (MEDICAL CENTER). IP CONSULTED WITH PHARMACIST WHO ADVISED EMPLOYEE TAKE BENADRYL. IP REVIEW SIGNS TO WATCH FOR-ANAPHYLAXIS AND INFECTION. WAS ADVISED TO COME TO THE ED IF SYMPTOMS WORSEN.
689	COVID19 (COVID19 (MODERNA))	6 days	50-59 years	0941315-1	No	Anaphylaxis requiring administration of Epi
690	COVID19 (COVID19 (PFIZER-BIONTECH))	6 days	40-49 years	0920624-1	No	41-year-old female HCW who received Pfizer BioNTech vaccine (Lot # EK5730) on 21 Dec 2020 in her left upper arm. No other vaccines were received that day. She reports a sensation of warmth and tenderness locally right after vaccination. On the evening of vaccination, she noted a small area of redness and swelling at the vaccination site. She denied anything out of the ordinary with regard to vaccine administration, except the vaccine might have been given ""a little lower"" than usual. She did not experience any respiratory, CV, dermatologic, or gastrointestinal signs/symptoms during observation post-vaccination or during the next several days. Post-vaccination day (PVD) one, patient noted some tenderness, warmth, redness, and some bruising surrounding the vaccination site. (SEE PVD 1 Photo); local reaction gradually resolved (SEE PVD 7 Photo) and currently, all that remains is a big bruise. On the evening of 26 Dec, patient reported having some ""congestion"" and took some Nyquil. She reports a good night's sleep, but upon awakening, she noted mild shortness of breath and she ""couldn't open"" her eyes due to swelling. She also noted her bottom lip and tongue were swollen and she experienced a tight feeling in her throat and chest. She also reports mild swelling of her hands. She denies hives/urticaria, wheezing, stridor, dysphagia, loss of consciousness, or gastrointestinal-related symptoms. Patient self-treated with oral Benadryl, Pepcid, and Zyrtec, as well as using her Albuterol inhaler. After 2 hours, her symptoms had not improved, so her spouse took her to the Emergency Room. In the ER, she was placed on a cardiac monitor, and shortly after arrival, she received IM Epinephrine (x2), followed by IV Solumedrol. She was observed for 8-10 hours and discharged home with a 5-day course of oral steroids. She was diagnosed with ""anaphylaxis"" and instructed to follow-up with her Primary Care Provider. Since discharge, she has continued to note some facial swelling, and on 29 Dec, she was having problems breathing for which she used her inhalers, and symptoms resolved. On the day of vaccine receipt, patient reports feeling well prior to vaccination. She denies previous vaccine reactions. She denies any exposures that might have been potential triggers to her reaction on 27 Dec √ ""the only thing different was the vaccine""""
691	COVID19 (COVID19 (PFIZER-BIONTECH))	6 days	40-49 years	0938815-1	No	5-6 days after my shot I had a allergic reaction. Anaphylaxis.
692	COVID19 (COVID19 (MODERNA))	7 days	18-29 years	0925262-1	No	Rash started on 1/6 around the injection site. Developed into L axillary lymphadenopathy, fatigue, myalgias, and headache. Erythema does recede with benadryl but does not resolve. was a little wheezy on 1/6. She has h/o anaphylaxis due to latex and has an epi pen
693	COVID19 (COVID19 (MODERNA))	7 days	30-39 years	0973849-1	No	Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Anaphylaxis-Mild; symptoms lasted 8 days
694	COVID19 (COVID19 (PFIZER-BIONTECH))	7 days	30-39 years	0914042-1	No	Woke up with at 3:30am with extremely sore throat, swollen uvula, could not swallow, multiple scattered petechiae on soft and hard palate. Afraid of angioedema or delayed acute anaphylaxis. Paramedics called. Treated at Facility with IV dexamethasone, diphenhydramine, Pepcid. Swelling resolved in 2 hours. Petechiae still present.
695	COVID19 (COVID19 (MODERNA))	8 days	30-39 years	0990670-1	No	Pt received first dose of COVID-19 vaccination on 7 Jan 2021. She reports 8 days after receiving the vaccine she woke up with her left arm (vaccine arm) feeling like ""deadweight"". The vaccine sight was warm to the touch, swollen, and an erythematous, raised, pruritic rash was present. The rash stayed localized, did not spread. Interventions include ice, Tylenol, and Motrin with no relief. Pt reported resolution of above symptoms 72 hours after they presented. She reports some lingering fatigue and a swollen lymph node in axillary chain n the arm pit of the arm she recieved the vaccine. She denies drainage/discharge from site, pain in area, or overlying pore/punctum. She denies angioedema or anaphylaxis reaction to the vaccine.""
696	COVID19 (COVID19 (PFIZER-BIONTECH))	9 days	40-49 years	0920962-1	No	I had soreness; started with itching, redness and swelling at site of immunization.; started with itching, redness and swelling at site of immunization./5.0 cm area of redness and induration; 5.0 cm area of redness and induration at site; started with itching, redness and swelling at site of immunization.; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730, expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included food allergy, oral allergy, no anaphylaxis. Concomitant medications were not reported. On 26Dec2020 18:00, the patient started with itching, redness and swelling at site of immunization. Patient also had a 5.0 cm area of redness and induration at site. Patient also had soreness on an unspecified date but no other reaction. No therapeutic measure was taken as a result of the events. Clinical outcome of pain was unknown while for the other events was not recovered. Follow-up attempts are not possible. No further information is expected.
697	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	18-29 years	1073645-1	No	Within 1-2 minutes I experienced full body tingling; facial numbness; vision became distorted/blurry; vision became distorted/blurry; whole body was sweating; abdominal pain; lower extremity aching; nausea; experienced moderate to severe lower back spasms; sciatica; This is a spontaneous report from a contactable other health professional (patient). This 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# ELO739), via intramuscular on 04Feb2021 03:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history included medullary kidney disease, and allergies to iodized contrast and bees (both resulting in anaphylaxis). The patient did not received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 1-2 minutes (03:15) patient experienced full body tingling and facial numbness. A minute later his vision became distorted/blurry and he began getting warn. A minute later his whole body was sweating, he was experiencing abdominal pain, lower extremity aching, and nausea. These symptoms other than the sweating persisted for another 5 days. After the 5th day, patient experienced moderate to severe lower back spasms and sciatica that resulted in an urgent care visit and a prescription for muscle relaxers and a mild pain reliever. The muscle spasms have been present for a week now and is slowly getting better. Patient was seen by an orthopedic urgent care where they recommended physical therapy and limited walking/sitting for extended periods of time. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included diphenhydramine hydrochloride (BENADRYL) (day of vaccination) and muscle relaxers. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of whole body was sweating and sciatica was not recovered, outcome of moderate to severe lower back spasms was recovering, outcome of other events was recovered on an unspecified date in Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.
698	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	30-39 years	0911334-1	No	Hives; felt itching to her scalp; This is a spontaneous report from a contactable other hcp (patient). This 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), intramuscularly on 21Dec2020 06:40 at single dose on left deltoid for COVID Prevention. Medical history included Polycystic ovarian syndrome, was diagnosed with this in her early 20's and ongoing, Hypothyroidism from 2015 and ongoing, Corneal abrasion from 2020 and ongoing (Patient got a corneal abrasion to her right eye, about a week ago and is currently using eye drops for prophylaxis against infection), and anaphylaxis. Concomitant medication included metformin tablet oral at 750mg, once daily for Polycystic ovarian syndrome, she has been taking the product on and off since being diagnosed with PCOS and ongoing, thyroid (ARMOUR THYROID) oral at 60 (unsure if the product is MG or MCG) once daily for Hypothyroidism, started product four or five years ago and ongoing, moxifloxacin hydrochloride (VIGAMOX) at 1 drop to right eye, three times daily for Infection prophylaxis from Dec2020 and ongoing, patient got a right corneal abrasion last week and is using the product as infection prophylaxis. The patient was a Physician Assistant, who works in the ER, who just received the COVID vaccine at work. The patient stated that she got hives after her injection. The patient received the vaccine today at about 6:40AM. She stated that she was instructed to wait 30 minutes after receiving the vaccine because she does have a history of anaphylaxis, but not to vaccines. So it was about 5 to 10 minutes before her 30 minute wait time was up, that she started getting the hives on 21Dec2020. She stated that the hives she got started on her left wrist, and then they worked to bilateral upper arms, and then she also felt itching to her scalp but states she did not feel a rash on her scalp. She took 50mg of Benadryl orally for treatment. It was stated that the hives have resolved at this time, but patient was unsure as far as outcome goes, because she took Benadryl and the hives are gone now, but she does not know if they will return or not. She stated that she only had to take Benadryl and she declined checking in to the ER, so she considers this, not serious. The outcome of hives was recovered, of felt itching to her scalp was unknown.
699	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	40-49 years	1023494-1	No	anaphylaxis; This is a spontaneous report from a non-contactable healthcare professional (patient himself). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Jan2021. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
700	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	50-59 years	0923406-1	No	anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020. The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events. Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. 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.
701	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	50-59 years	0931300-1	No	Pt reported onset of ""quivering"" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted & interviewed (Dr.) patient. Ambulance called. Vitals re checked Benadryl 25 mg PO given. Paramedic & Ambulance arrive 4:35 59 y/o who states she had anaphylaxis before her symptoms started the same as today. C/o quivering lips & H/A No rash or respiratory comp (EMT's exam - normal except ? movement. Assessment - Possible allergic RXN Plan - Ambulance transport to ED""
702	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	50-59 years	0943624-1	No	Anaphylaxis tongue swelling and throat soreness Narrative: developed throat pains and tongue swelling 1/6/21 whereas mRNA vaccine Covid 19 Pfizer was given at Hospital. Advised not to taken 2nd dose until etiology of tongue swelling and throat pains identified. His 1/6/2021 covid 19 test (biofire- which include Covid 19 infection and all possible viral etiology was negative.
703	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	60-64 years	1023356-1	No	Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. 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 RAs, Ethics Committees, and Investigators, as appropriate.
704	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	65+ years	1056646-1	No	My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections ""decided 0.2ml instead of 0.3ml"", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, ""1st half of flu shot, I get sick, then the 2nd half nothing"". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.""
705	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	65+ years	1062061-1	No	Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.
706	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	65+ years	1062223-1	No	not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision was off; foggy; confused; coughing; felt severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped; severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher you know more towards my throat; rapid heart rate, 100bpm and 102bpm and lasted for couple of days.; my head was more clear but still had some pressure and woozy; Trouble concentrating; ALT High; Test: Cholesterol; Result: Little High/Cholesterol 207 was high; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9269), via an unspecified route of administration on 07Feb2021 (at the age of 67-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Medical history included ongoing asthma, type 2 diabetes mellitus, seasonal allergy (told to take Zyrtec for seasonal allergies prophylactically). Facility in which the vaccine was received was a clinic at a high school through the local hospital. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), glipizide (GLIPIZIDE). On 07Feb2021, the patient received the first dose and while walking to the observation area (about two minute after receiving the vaccine) the patient experienced very very intense headache, felt an ungodly pressure in my head, vision was off, and trouble concentrating. When she sat down got real foggy, confused and was not thinking straight, was coughing and experienced severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped. Patient began taking deep breath. It went back over to left side of my chest and the tightness (stayed in my left chest for probably 3 days but not to the same degree). The fogginess and the intense pressure in my head, it was bad to the point she thought she would not be able to drive home, waiting for 30 minutes, and because she was not thinking clearly she didn't even ask anybody for help. When she got to the car she waited 15 minutes more before driving home. Patient stayed like this for 2 days. When she reached home, she experienced a rapid heart rate, 100bpm and 102bpm and lasted for couple of days. Each day got gradually better, her head was clearer but still had some pressure and woozy. The patient did visit the physician, he did an EKG and other test. The doctor did not think what I had was an anaphylaxis reaction. Physician recommended she make sure to take her inhalers, for asthma and told me to take Zyrtec (for seasonal allergies) ahead of time. Consumer inquired if she should receive the second dose. The patient underwent lab tests and procedures which included blood cholesterol: little high 207 on Feb2021, blood thyroid stimulating hormone: normal on Feb2021, electrocardiogram: normal on Feb2021, full blood count: normal on Feb2021, hemoglobin: 6.9 on Feb2021, heart rate: 100 bpm on Feb2021, heart rate: 102 bpm on Feb2021, metabolic function test: Alt high on Feb2021. No treatment was given for the events. The clinical outcome of the events not thinking straight, pressure in my head, foggy, confused, coughing, tightness in the left side of my chest , it then moved to the center of my chest then moved up towards throat, rapid heart rate, Woozy, intense headache, vision was off and trouble concentrating was recovering while ALT High, and Cholesterol; Result: Little High was unknown.
707	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Unknown	1010718-1	No	Arm at the site a little bit above the elbow where biceps are, were sore,; slight headache; exhausted; bad cold/cold type symptoms; upper respiratory infection with a sinus infection; upper respiratory infection with a sinus infection; mild respiratory infection; not feeling well; like a viral cold; nausea; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm) on 09Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included paracetamol (TYLENOL). It was reported that patient wanted to know if she should get the second vaccine in the series. Patient mentioned that she had the first Pfizer Covid vaccine 09Jan2021. Approximately three weeks later, she developed a mild respiratory infection. It was mentioned that patient has psoriatic arthritis (one Dr told her she would experience more symptoms getting the second dose- another Dr told her she could die) and her physician wants her to start methotrexate, however, she is not currently taking this product. Patient is currently only taking paracetamol. Patient also mentioned that she had three friends who had the Pfizer Covid vaccine and they felt awful like they had the flu for 48 hours post vaccination. Patient asked if there was no allergic reaction to the first vaccine, will there be no allergic reaction to the second vaccine. Patient also asked if it is okay to start on methotrexate after having the vaccine and if this will decrease effectiveness. On an unknown date in Jan2021, patient stated she is not feeling well last night, something like a viral cold. Patient also stated ""It was not bad at all. Arm at the site a little bit above the elbow where biceps are, were sore, slight headache the day after the 1st dose, after 3-4 hours I was exhausted, 2 days exhausted, maybe slightly nausea"". Patient also mentioned Thursday night that she had a very bad cold from the beginning and has upper respiratory infection with a sinus infection. It was also reported that patient was not on immunosuppressants and has never had anaphylaxis. It was also reported that patient had swelling in her hand from the arthritis. On 21Jan2021, it was reported that patient went to urgent care with upper respiratory symptoms and a COVID test was performed which was negative. Patient stated that she is to have #2 covax this coming Saturday and is still dealing with some cold type symptoms and asks if she should get the second covax. Patient is not running a fever. Outcome of the event 'bad cold/cold type symptoms' was not recovered, outcome of the remaining events was unknown. Information on lot number/batch number has been requested; Sender's Comments: Based on the temporal relationship, the association between the event upper respiratory tract infection with BNT162b2 can not be completely 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.""

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