Pfizer

Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.  She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed "mild LV non compaction at the apex" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms.

Last night I broke out into a bunch of itchy spots that resemble hives all over my body. The hives went away in the morning. Just now, 3:57pm today, I have puffy eyes and a swollen throat.

Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fatigue, not usual self , fussy , incosebale. Patient is a non verbal child

Vaccine admin at 04:15pm on 03/17/2021. Patient began to have difficulty breathing and cold sweats at 04:20pm. Paramedics were alerted and arrived at 04:31 pm. They treated her for high CO2 level with oxygen and let her go.

Began complaining that she was short of breath at 10pm on 3/16, needed nebulizer treatment for wheezing on 3/17 at 1am, could not get wheezing under control with 2 nebulizer treatments at home, so went to ER at 2am. Was dosed 16 puffs of albuterol over about 40 minutes. Vomited and then administered IV fluids and blood was drawn/chest x-ray performed. Discharged at 6am on 3/17.

11:57am C/O difficulty breathing. Vital signs: 118/68 101 16; 12:10pm 112/68 74 16; 12:25pm 112/70 71 16; Disposition: Patient left with Mother. No signs of distress. Full ambulatory.

Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart palpitations, dizziness, tiredness,

Patient became unresponsive within 15 minutes of getting vaccine. Her eyes were wide open, lips were turning blue, and had appeared to stop breathing.

Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress and was not in any way exerting herself. She described the attack as a feeling of someone sitting on her chest and began to hyperventilate. The color drained from her face and her hands felt numb. Her asthma attacks are generally exercise-induced, so this was highly unusual. She took a dose of albuterol ( 2 puffs with a spacer) and followed her asthma action plan. She laid down and slowed her breathing. 20 minutes later her facial color returned to normal. Two hours later her hands returned to normal. She was disoriented for about 5 hours.

By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high fever of 102, body aches and extreme fatigue. She had a fever all day on 8th and experienced severe fatigue. She is still weak, having body aches and a low grade fever on Friday the 9th. Her chest pains stopped on Thursday.

Pt received her covid vaccine, pt did not wait, was walking around withfather, she felt dizzy and dad reported she fell. we did not see her fall. She was sitting on 20 when dad came toget us. Pt felt dizzy, ringing in ear, had her lay down on floor with feet elevated. BP pressure reading were 128/75 hr 70, 130/72, 75, pt now feeling better and sitting 108/76 64 108/76 64 and 118/76 76. Pt father declined ems. Pt waited until she felt normal, drank bottle of water, no longer dizzy, went home. Father instructed on emergency care. Followed up call with father at 5:08pm. Fahter reported she was tired, sometimes sob and advised to take pt to e.r. for evaluation.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium

Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax. Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation. Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.

Patient presented to the ER following her first COVID immunization. Symptoms started an hour after the vaccine was administered. Stated her heart felt like it was racing, she had increased SOB, headache, was tired, nauseous, and had nasal burning.

Shortly after administration of the vaccine, patient began feeling lightheaded and nausea. Patient was crying and had rapid breathing. Patient appeared to be having a anxiety attack. 911 was called. Blood pressure was taken 3 times over the course of ~5 minutes. Emergency response personnel arrived and continued to assess and monitor the patient. The patient eventually left with her father (AMA)

10 hours post vaccination, she felt tightness in chest and felt slightly wheezy. 16 hours post test she was wheezing, taking shallow breaths, and felt like her throat was constricted. Shallow breaths only. Symptoms slowly dissipated. She returned to normal over the next two days post reaction.

Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER. At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.

My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes after the shot. No issues. That evening at approximately 6:00pm, she had a red rash on her upper chest and throat. She stated that she was having a hard time breathing and swallowing. I gave her a Benadryl tablet and watched her for approximately 15-20 minutes. she continued to feel tightness in her throat and said it burned when she swallowed. She confirmed again that she felt her throat was swelling. I drove her to the closest ER located at. My daughter was seen and it was determined that she was having an allergic reaction. DR recommended continue Benadryl tab every 4 hours for the next 12-24- hours. We were discharged to home. I administered another does of Benadryl at approximately 10:15pm. My daughter went to sleep. I woke her up at 3:00am to check on her and she stated she did not have a rash and her throat was fine. She was running a low grade fever of 100.5. I gave her 500 mg of Tylenol for the fever. When my daughter woke later that morning at approximately 8:30am, she still did not have a rash or throat swelling. Her fever was gone.

An hour after Pfizer vaccine administration, the parents of the 16 year old patient returned to the pharmacy and reported that their daughter was complaining of trouble breathing in the parking lot. The immunizing tech asked the parents to bring the patient back to the pharmacy. The patient returned and while crying and gasping for air, she reported that it felt as if someone was constricting her throat. She also complained of stiff fingers and feeling numbness/tingling in her upper extremities. Assuming anaphylactic reaction, one dose of epinephrine was administered. The patient said she felt slightly better after the first dose but then 2 minutes later, said her breathing was getting worse, and again described feeling her throat tightening. Five minutes later, a 2nd dose of epinephrine was administered. The patient was taken to the hospital by paramedics.

Pt received her first dose of Pfizer vaccine and at 1148 started to c/o tongue and throat "beginning to swell". Pt states hx of the same with penicillan. Pt is with mother. Pt was given 25mg Benedryl PO at 1200. EMTs called to evaluate Pt and released by medics home with mom. VS per medics at 1215 BP 114/68 HR 70 RR 16 O2 sat 98% RA

Patient was vaccinated and left with her mother to sit in her car for 30 minute monitoring period. Patient's mother stated patient was experiencing extreme anxiety getting the vaccine and after 20 minutes was wheezing. She brought patient inside and a Pharmacist came to check on her and her mother stated that she has had a reaction to a medication in the past and just needed Benadryl. Benadryl was given to her and she took it orally. Her pulse and blood oxygen were measured with a finger pulse oximeter and were both normal. Shortly after she was panicking more and had a seizure. Her mother reported that she has frequent seizures when she has anxiety/panic episodes. Her seizures were persisting so 911 was called. Paramedics arrived shortly after and took patient to the hospital. A few hours later the patient's mother came back to us to inform us that she was released from the hospital and was feeling fine and back to normal.

Tightness in chest, extreme nausea, dizziness, headache, shortness of breath. After receiving the vaccine I had these symptoms for the rest of the day, as of this writing I am still feeling mostly nausea and the tightness in my chest has died down.

Patient states she feels dizzy, lightheaded, and SOB. EMS was called and was checked out by EMS personnel. Both parents were present during the incident..

Came in for second vaccine and indicated on screening possible reaction to first vaccine. Mom stated this occurred that evening while watching TV. Patient stated she had some swelling in throat, face and some difficulty breathing that was relieved with benadryl.

Arm soreness, tightness in chest, dizziness, nausea, difficulty breathing. Symptoms started pretty much right after getting the shot but the dizziness and tightness in chest stopped after I took a nap about an hour after the shot. As of the submission of the form I am still feeling soreness in my arm but it?s lessened a bit and I still feel nauseous and am having trouble breathing properly.

Patient waited 15 minutes after administration of vaccine. No adverse reactions at that time. Later in the evening, approx 6:30pm, patient's mother called on-call physician and stated she was developing hives all over. "Brief" episode of shortness of breath per mother, symptoms faded after an hour. The next morning, hives returned along with "pimple" like bumps sporadically showing up on the face where the hives where. Patient stated the bumps hurt and are itchy. Benadryl and hydrocortisone cream were recommended. No difficulty breathing or any other sx noted. Will continue to monitor reoccurrence of hives/bumps.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium

Five days following her first Pfizer COVID vaccine, she woke up from a dead sleep with sharp chest pain, shortness of breath, and feelings of her throat closing. She was given one dose of oral steroids by PCP, but continued to have the feeling that she couldn't breathe due to her throat closing throughout the day so she presented to the ED. There, she reported continued chest pain, worsening SOB, and the feeling that she could not breathe. She was tachycardic to 140 bpm, but otherwise vitals were stable. She was admitted and monitored on continuous telemetry and pulse oximetry overnight. By the following day on 4/29, her symptoms had largely resolved and she was discharged.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

Client c/o "chest hurting and hard to breathe" approx. 15 mins. after 2nd Pfizer dose. EMS was called for transport to local hospital. V/S @ 12:35: AOx3, BP 118/90, HR 72. At 12:42pm, client reported increased difficulty breathing and rated chest pain 7/10. V/S @ 12:42 BP 122/82, AOx3, HR 66, RR 22. At 12:50 medics arrived on scene and assumed care of client.

Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4, her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic reports she coached the client on her breathing to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.

16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She was accompanied by her father. Pt received vaccine IM to her left deltoid. Pt completed vaccine at 2:55pm at which she sat down for her 15 minute observation period. As soon as she sat down she called over the staff that administered the vaccine. She explained to her that she felt nausea and was breathing heavily. I then walked over to them and the attendee was very pale and breathing heavily. By that time I had RN getting attendees history from her father, She has no history of allergic reactions, not taking any medications and no current illness. She is "slightly asthmatic" but is not taking any rx. RN was helping me by putting cold pack behind attendees neck. Pt then proceeded to explain that she felt nauseas and starting dry heaving. RN then brought over trash can and attendee started to vomit. I then started to proceed and take her vitals. first set of vitals were taken at 2:58pm BP: 90/60 HR: 132 RR: 24 O2: 100%. Attendee at this point was diaphoretic, pale, breathing heavily and vomiting. We continued to monitor attendee in which she started to feel better by 3:08 pm. She was no longer pale, diaphoretic or vomitting and was breathing normally. We provided attendee with water and continued to monitor her. Now that pt was calm, I was able to ask her some questions. She stated that she had a smoothie and an avocado toast about an hour prior to vaccine. She explained to me that she does have a phobia to needles and was feeling very anxious prior to appointment. I then repeated her vitals at 3:16pm BP: 98/60 HR:89 RR: 20 O2: 99%. I had attendee stand up off chair and walk at 3:22pm. She felt fine and did not feel dizzy at all. No signs of distress noted. She was then discharged and walked out with her dad at 3:25pm.

it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated and sweat and almost faint. she said that she has hard time breathing. WE gave her 0.3mg epinephrine then she is ok and better. we called EMS over. and she is all fine after that. SHE did not need to go to hospital.

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital. Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA

My 16-year-old daughter, very healthy without any health conditions, got her first dose of the Pfizer vaccine on Saturday evening, April 10th, at around 5pm. On Wednesday, she started complaining of shortness of breath, chest pains, which she described as a feeling of someone stubbing her heart. By Thursday, she began blacking out repeatedly throughout the day, each blackout lasting about a minute. These progressed and whenever she blacked out, she would not remember what happened. At first, she and I brushed it off as maybe lack of calcium since she rarely drinks milk. But as they intensified, I began to become more concerned. I told her I cannot leave her by herself in the house as I prepared to go pick up her young siblings from school then schedule an appointment with her doctor. On our way back home, she blacked out again, however, it was for more than a minute. Straight away, I drove to the ER close by. The doctor came back to inform me that her heartbeat was irregular and concerning based on her age. In that same moment, she began complaining of excessive pain like someone punching her heart out, and then she passed out again. Still with my two other children, the whole ordeal began to frighten them and illicit some heavy tears. Being that this ER was general admission, the doctors insisted they call in the paramedics to transport her to another ER for children. However, after being transported to the other ER, her condition began to intensify rather quickly and the pediatric doctor at the second ER informed us we would have to be transferred to Childrens intensive care unit where the cardiologists could check her heart, find the ultimate cause, and monitor her closely. In that moment, as a mother, I was speechless and extremely terrified. Seeing my daughter being transferred from ER to ER, made it even tougher on me so much that I could no longer hold myself together. Here she was in terrible pain and being moved around with no clear diagnosis and treatment. From there on, we spent a couple days in the Cardiac ICU waiting and praying with friends for answers and the best treatment she could get to ease the pain. By about the third day of being in the ICU, the cardiologists informed me, she had Acute Myocarditis. This was so shocking in a sense that both sides of the family have no history of heart issues. Secondly, she is a very healthy child.

Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as well as cough, news throat the head and troubles breathing was noted to have normal oxygen saturation and was given an albuterol inhaler and told that she had a virus. She followed up in the PCP office on 4/21/2021 with worsening troubles breathing and was given Decadron in the office, 4days of prednisone, CXR and labwork. CXR showed possible reactive airway disease and was to do steroid and continue out albuterol every 4 hours. Had negative/normal lab work and positive Covid antibodies. History of Covid 10/2020. Felt almost completely back to normal by Sunday, her last day of steroids. On Monday had worsening of her breathing throughout the day, increased troubles breathing again after softball that night. Albuterol did seem to help up. Called the office as she woke up Tuesday morning with worsening and would started on Flovent. With no improvement return to PCP office on 4/29/2020 with marked inspiratory stridor. Was admitted to the hospital for work-up of return of stridor. Had a normal chest x-ray and neck/soft tissue x-ray. With continued troubles breathing and chest pains with decreased heart rate was elected to go to Hospital where she could have further work-up. When the ARNP came helicopter, was concerned about her airway and she intubated to fly to hospital. Was dx there with Sudden Acute Onset of Vocal Cord Dysfunction and is continuing with therapies.

Dizzy and sensation that she was being choked with shortness of breath approximately 15 minutes after receiving vaccine.

One day after the vaccine, feeling fatigued, feverish (99.5), headache Two days after the vaccine, feeling some SOB w exertion, chest heaviness Mild chest heaviness 3 days after, resolved by end of day.

16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement who presented to the hospital on 5/6 with fever, increased stool output, and perianal skin breakdown. Her course was complicated by respiratory failure (requiring ICU admission for CPAP), pancytopenia, diarrhea with buttock skin breakdown requiring rectal tube for wound and stool management, and extensive workup which was unrevealing for an infectious cause. She clinically improved with respect to pancytopenia with discontinuation of felbamate, and completed a treatment course with Zosyn for suspected buttock SSTI.

anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation. Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years). The patient's concomitant medications were not reported. Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.

is a 16-year-old female patient admitted with tachycardia. Starting 1-1/2 weeks ago, mom notes that she has had episodes where she feels her heart racing. It began 1-1/2 weeks ago with her crying and her watch that her heart rate was 208. They went to the ED, where she was given some fluids and her heart rate improved so she was sent home. She had had prior episodes of mild tachycardia up to the 140s in the past but which has always improved with fluids. Mom states that she used to have a lot of trouble maintaining her hydration and would not drink a lot of water. Since the last 1-1/2 weeks, she has been having these episodes 1-2 times a day that last about 1 to 2 minutes with a max of 5 minutes. When it comes on, she feels dizzy and lightheaded, and after the episode she feels a big rush of blood to her head. She also has some associated shortness of breath. She denies having any episodes of chest pain at all. She has never passed out, she has never felt like she was going to pass out, she has never felt like she was out of balance. She denies any nausea or vomiting during episodes. She denies any headaches during the episodes. She does have history of migraines, but has not had one in the last couple weeks. Her prior resting heart rate was in the 80s per her watch, and lately it has been in the 110s to 120s while awake in 80s while asleep. Along with the episodes, she also feels some pulsating sensation in her abdomen. She does not have any abdominal pain. Today, her heart rate was again in the 200s, but it was worse than before because it lasted about 30 minutes total. Lately they have been using an app that continuously monitors her heart rate. Since these episodes started, she has cut down on her caffeine intake and she has increased her water intake. Does not feel that this helped. She has never had syncope in the past and has never had seizures in the past. Patient was started on carvedilol which has helped control heart rate and was encouraged to drink fluids. Per primary care team, her current episode of tachycardia was not due to the vaccine.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild

48hrs post-vaccine began with polyarthralgia, progressed to myalgias, arthritis, weight loss, abdominal pain/diarrhea, mucosal ulceration, and dyspnea, now admitted for evaluation which is suggestive of systemic lupus erythematosus.

Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "weird". She began to itch and cough, apparently trying to throw up, felt her throat was itching and swollen. She stated she couldn't swallow and was having a hard time breathing (although she was breathing). We administered an Epi Pen 0.3mg (only one) and called 911. Patient was transported to the hospital by ambulance.

I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 hours post vaccination began feeling of throat closing- able to breath ok/safely but short of breath (O2 says 99% HR 60?s - WNL), feeling floaty and light- as if not on ground, body feels tingling and numb, difficulty sleeping, right pupil dilated greater than left but both pupils reacted to light appropriately with check. Pupil over dilation one side resolved by next morning. Other symptoms still continue. Other SE?s are common: HA, low grade fever 100.9, body aches. Currently 33.5 hours post vaccination at submission. Pfizer #1 on 4/30/21 Lot# EW0173 Pfizer #2 of 5/21/21. Lot# EW0187

Patient reported throat tightness and dizziness exactly 19 minutes after the vaccine was given. Patient could still speak. She was advised for sip of water to see how she does and reported difficulty of swallowing. She verbalized experiencing the same thing when she received her flu vaccine about 10 years ago. Immediately sent to ER via wheelchair. Patient continued to be verbal until the arrival to ER.

Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.

5 days after vaccination- loss of smell and taste, shortness of breath, sneezing, coughing, ear infections, fatigue, and headache.

Presented to ED on 5/13/21 with trouble breathing, chest pain, back pain and numbness. Had been exposed to boyfriend with flu like symptoms 3 weeks prior and had had some symptoms around that time but had been improved. SARS-CoV-2 PCR negative in ED. patient afebrile but workup in ED revealed troponin of 0.71, no EKG changes. Symptoms resolved in ED but given troponin was admitted to the hospital for further evaluation. Echo performed and normal. Troponin trended in hospital and patient discharged without events.

Shortly after receiving vaccine (about 5 minutes), pt complained about difficulty breathing. I went to check on her and she appeared pale and seemed very drowsy and unresponsive to questions. She continued to complain about dizziness and nausea. Her parents grabbed some water for her and still there was no improvement. I called 911 to report the symptoms and was advised to administer EpiPen. When asked if her breathing improved, she nodded yes, but she did not appear to have improved. She continued to be unresponsive to questions and appeared extremely drowsy. Within 15 minutes, the ambulance arrived.

Patient had fever and nausea with some vomiting roughly 5-10 minutes after receiving vaccine. Patient also had some trouble breathing but it resolved within a five minutes. Gave patient cold compress over her neck and monitored her breathing and nausea. All symptoms resolved and she was able to leave facility.

The patient was previously well then shortly after the first COVID vaccine she began experiencing fatigue slowing to her swim times ( she is an high level swimmer) and felt "Off". She presented to my office on May 6, 2021 three days after her second COVID vaccine I examined her and heard a slight hint of a wheeze and in addition to labs did a CXR which was Abnormal with evidence of a LLL consolidation and a pleural effusion. We then did a CT scan with contrast and started her on antibiotics and I called Pulmonology to get her in quickly since swimming trials were approaching and we had to do our best to get her in shape to compete. We also did a rapid COVID test which was negative at my office on May 7, 2021-- The pediatric pulmonologist repeated the CXR 5 days later and there was more fluid and she was now having more sx of cough and feeling worse so she was Admitted to the Hospital on May 11th and had a Chest tube placed and drained 950 cc of serous fluid . Pulmonology, oncology and rheumatology consulted to rule out various other causes of the pleural fluid in an otherwise healthy girl. Surgery did the procedure and followed up outpt. She was in the hospital for approximately 4 days. Proximity of sx onset to doses and other sources being essentially ruled out lead to concern for vaccine complication.

Patient reports immediately after receiving the vaccine she developed chest tightness and pain that has continued to wax and wane the past two weeks. Has some intermittent difficulty breathing and fast heart rate that each last about 20- 30 minutes. Also accompanied by dizziness or lightheadedness. Reports her whole right leg feels tingly and her joints hurt, but denies weakness, redness or swelling of the joints or right foot. Also has a continuous headache that started within an hour of receiving the vaccine and worsened over the next few days. This too has waxed and waned.

Client received 1st dose in seriers of Pfizer on 5/18/2021. Client started with itching and hives on 5/25/2021 and treated by parent with OTC ibuprofen and benadryl. No improvement noted and symtoms progressed on 5/26 and 5/27. On 5/27 symptoms worsed with swelling of lips and tongue and finally difficulty breathing. Parent took client to Hospital ER on 5/27 where she was treated with IV benadryl and steriods. Symptoms have not re-occurred. Client given EpiPen and has not used. Parent denies any other ideas of what could have triggered this allergic response.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.

Myocarditis (with chest pain, shortness of breath, dizziness) starting after first dose, worsening after second

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Nausea-Mild, Additional Details: Took BP and pulse shortly after, 109/72 HR 83 (within normal limits). Monitored her for almost an hour, counseled on what to do if symptoms worsen (go to hospital). She left with her nurse guardian. I called her 1.25 hours later, she was doing much better and nurse guardian was still monitoring her. BP and pulse still normal (per nurse/guardian).

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: Patient appeared weak, pale, sweaty, shaky about 5 minutes after the first dose was given to her. She complained of visual disturbances and progressive shortness of breath. Stated her throat felt a little tight but was not experiencing and swelling of of any parts of her face. She then complained of an intense headache that was getting worse. Patient was admitted to the hospital to make sure she was ok.

Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3. She experienced mild myalgias in the day following the vaccine. However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea. Pain radiated to her throat. Given severity of pain, she presented to the emergency department. In the ED she was afebrile, tachycardic, and initially hypertensive. Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315. ESR 25, CRP 7.61. Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation. SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%). Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring. Following admission, she was started on ibuprofen. She notes that her substernal chest pain has improved somewhat since admission. Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.

Pain in her chest, lungs, and ribs; Costochondritis; Myalgia; This is a spontaneous report from a contactable physician (patient's father). This is one of the 2 reports from same patient. A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Mar2021 as single dose for covid-19 immunization. Patient received first dose of bnt162b2 on unknown date in 2021, 3 weeks before the second dose for covid-19 immunization. Medical history included asthma (Diagnosed when she was 5 years old), allergies (Pollen, dust, walnuts, coconut, diagnosed when she was 3 years old) and migraine from Sep2019. Concomitant medications included Amitriptyline 25 mg for migraine, Macrogol 3350 (MIRALAX) daily for constipation and salbutamol sulfate (VENTOLIN HFA) asthma pump taken as needed for asthma which patient had not used this for a while before the vaccine. The patient received the second dose and then 5 days later she had to be taken to the emergency room. The patient was only 16 years old but was able to be vaccinated because she had asthma, so she is high risk. In Mar2021, 5 days after the second dose, the patient had horrible pain in her chest, lungs, and ribs. On 26Mar2021 or 27Mar2021 the patient woke up with this pain, then that night it hurt when the patient breathed or talked. The patient was taken to the emergency room at that time and was diagnosed with costochondritis, the patient was not ever admitted to the hospital. The patient was given ibuprofen 600 mg prescribed but it didn't help. Unknown lot, NDC, and expiration date for the Ibuprofen. The pain was still there so the patient was given naproxen and she has been taking that for almost 2 months now. Sometimes the pain gets better but sometimes it gets worse. Unknown lot, NDC, and expiration date for the Naproxen. The first 4 weeks the patient had to lay down because she couldn't sit or stand for more than 15 minutes because of the pain. The patient was fine and then 5 days after the second dose she got the pain, and it doesn't go away. The pain is under the breast like 4 fingers under it and in the middle near the sternum. The pain hurts more when the patient moves and changes positions. It was reported that "Two days ago, the pain was a 2 out of 10, but randomly it goes to 5,6, or 7. Today the pain is a 4 out of 10". The caller said this event was ongoing and persisting. When the patient went to the emergency room on 26Mar2021 or 27Mar2021 they checked her for inflammation and rheumatoid arthritis, but it was negative. The patient's blood work was normal, the chest x-rays were normal too. The patient also went to the emergency room on 05May2021 and was not admitted. The care team checked the patient again and they said it was myalgia or something. The patient was not resolved from the events. The causality assessment with suspect vaccine reported as Related to the events pain in her chest, lungs, and ribs. Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Pulmonary pain, Costochondritis and Myalgia. 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.

chest pain; body aches; dizziness; SOB; near syncopal event; an EKG showed non-specific ST abnormalities with labs showing elevated troponin,; mildly elevated CRP; Upon readmission, her troponin was elevated (2.06 on 5/10); myocarditis; This is a spontaneous report from a contactable nurse. A 16-year-old female patient (pregnant: No) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 16-year-old, via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine, unknown if any other medications the patient received within 2 weeks of vaccination. Known Allergies: NSAIDs. On 19Apr2021, the patient experienced myocarditis, chest pain, body aches, dizziness, SOB, near syncopal event, an EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, with outcome of recovering. Upon readmission, her troponin was elevated (2.06 on 5/10) on 19Apr2021 with outcome of recovering. Seriousness criteria-Caused/prolonged hospitalization. The patient was hospitalized for myocarditis from 19Apr2021 to 23Apr2021. The patient was hospitalized for other events for 6 days. The adverse event result in Doctor or other healthcare professional office/clinic visit. Emergency room/department or urgent care. Clinical course as follows: patient is a 16 yo girl, s/p admission (19Apr-23Apr2021) with myocarditis, s/p IVIG (19April) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (15April). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. An EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Upon readmission, her troponin was elevated (2.06 on 10May). It was unknown prior to vaccination the patient diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. covid test type post vaccination: Blood test. covid test name post vaccination: SARS COV2 ANTIBODIES QUALITATIVE on 19Apr2021, covid test result: Positive. covid test type post vaccination: Nasal Swab, covid test name post vaccination: Respiratory Virus Panel by PCR on 19Apr2021, covid test result: Negative. Information on the Lot/batch number has been requested.; Sender's Comments: The reported myocarditis with chest pain, body aches, dizziness, SOB, near syncopal event and the abnormal lab data were possibly related to the bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), considering temporal relationship and the inflammation features. 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.

Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days. (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)

Fatigue - rapid heart rate when standing up, exceeds 120bpm when walking or standing and then goes down when lying, chest pain, severe headache, shortness of breath. All tests to rule out other causes negative

pt felt slight tightening of chest and throat- injected epinephrine- pt felt better after about 15 minutes and was released to her mother. After phone discussion on 6/13/21, mother said symptoms returned later in the day and she went to ER and received a steroid injection. Per mother on 6/13/21. pt was feeling fine

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: bp was 105/78 and hr was 85

shortness of breath; Chest pain; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 06May2021 at 11:00 (Lot Number: Ew0153) at 16-year-old as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 15Apr2021 at 11:00 (Lot Number: Er8731) at 16-year-old as single dose for COVID-19 immunization. On 09May2021 at 06:00, the patient experienced chest pain, increased heart rate, shortness of breath. The events result in emergency room visit. The test and medication were received as treatment. The outcome of events was recovered in 2021. No follow-up attempts are possible; no further information is expected.

16 y/o F with hx of autoimmune disorder and Tourette's syndrome BIB mom for dizziness s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses muscle pain, nausea, sinus pain, throat pain, and HA. Pt with fever (Tmax 100.2F) onset this AM. Denies chest pain and difficulty breathing. Pt reports she feels a little out of breath. Mom has a heart rate monitor at home and states pt's HR has been in the 140s. No medications taken. NKDA. Differential Diagnosis: vaccine reactions, myocarditis, pericarditis. After physical assessment and management, pt is well appearing, explained to mom on reassessment symptoms have improved, no longer dizzy or having trouble breathing. Pt still feels a little myalgia. Explained symptoms likely from vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and persistent fever.

Sharp chest pain and left shoulder blade/back pain with difficulty taking deep breaths. Did not report initially because it went away after a few days, but after reading the studies wondering if she had the myocarditis/pericarditis side effects.

Patient reports having felt chest pain and shortness of breath the night she was vaccinated. She was taken to the hospital and had lab work done. Patient was discharged and had follow up visit the next day (6/4/21) with primary care physician, who ordered additional labs and EKG. D-dimer, troponin and EKG also came back unremarkable.

Patient became lethargic within 5 minutes. Within 10 minutes she developed tightness in the chest, difficulty breathing, and numbness in both hands. We administered an Epi-pen and symptoms began to improve in 10-15 seconds. She then was evaluated by emergency medical personnel and taken to a local hospital for follow up.

takes my breath away; Sharp pains in chest that come and go; This is a spontaneous report from a contactable consumer (patient). This 16-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 01May2021 at 17:00 (at the age of 16-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included asthma, migraines, lactose intolerant, and eczema. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included stool softener and nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine (VITAMIN B-COMPLEX) from unknown dates for unknown indications. The patient did not have any known allergies. On 03May2021 the patient experienced sharp pains in chest that came and went. "Took her breath away." The patient did not receive any treatment for the events. The outcomes of sharp chest pains and took her breath away were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. The patient received dose 2 of BNT162B2 (lot number EW0180) on 22May2021 at 17:00 as a single dose in the right arm for COVID-19 immunization. No follow-up attempts are needed. No further information is expected.

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Approximately 5 minutes after administration, patient fainted while seated in chair. After awakening, patient reported feeling faint and tingling in her extremities. Patient was breathing heavily. After breathing normalized, patient reported severe menstral cramps. Patient was given Midol, water, and pretzles. Shortly after, patient stated that she was still light headed so she laid on the ground. Patient eventually recovered and left pharamcy.

Started early afternoon on June 27, 2021. Patient had hiccups. Parent treated with the hiccups with water, holding breath, brown paper bag breathing. The patient had continuous hiccups Sunday, went to sleep, woke up Monday and didn't have the hiccups. Monday afternoon the hiccups started back up and were more frequent. Tuesday neck twitching started in addition to hiccups. Wednesday neck twitching, blinking of eyes, and hiccups/gasping for air continuous. Only when in deep sleep does she stop.

Patient went to urgent care 1 day after vaccine for feeling tremors and pains in her lower extremities. She also began to feel shaking in her entire body and had lightheadness, shortness or breath, and nausea. She vomited one time. EKG showed Sinus Ventricular Tachycardia/Sinus Tachycardia and was sent to ER by EMS. In ER fluids were given and all further testing normal. Discharged and told symptoms due to dehydration.

sore muscles all over entire arm in pain when used Extreme chills fever mood swings extreme fatigue muscle pains headache dizziness hyperventilating

Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, and dizziness with change of position. Pt's mom was advised to take pt to ED or urgent care for evaluation.

Received 1st dose at 3pm on 7/7/21. Observed by facility staff for 30 minutes. Felt fatigued, but otherwise no symptoms. On 7/8/21 at 7:45am went for a run outside. Mid-run felt generalized, severe itching and swelling in throat and facial swelling. Returned home within minutes, reported symptoms to me (mom). Called 911. Epi-Pen 0.3mg injection given in right thigh with no effect. Three minutes later, another Epi-Pen 0.3mg injection given in left thigh given. Benadryl 25mg PO given. Attempted 2nd Benadryl dose...unable to swallow. EMS arrived. Taken to ER. Symptoms slowly improved. Solumedrol IV given in ER. Monitored for 2.5hrs then discharged home with Prednisone PO for 5 days.

day after the first Pfizer vaccination (18 hours) Pt is a 16 year old female with history of anaphylaxis and asthma who presents today with allergic reaction after receiving her Pfizer vaccine. Patient states she had her first dose yesterday, but did not have any immediate reaction. This morning when she was running at school she began to notice itching to her face and scalp as well as swelling to her nose and difficulty breathing. Mother gave her EpiPen and Benadryl with significant improvement in her symptoms. No report of nausea or vomiting. No report of abdominal pain. She denies any new foods or shampoos or perfumes. Mom does report concerned that she has a history of rebound anaphylaxis generally 6 hours after the initial insult.

Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaking) Racing heart, 6 days after 2nd dose. Shortness of breath, 6 days after 2nd dose. Acetaminophen and ibuprofen.

Beginning the day following the 2nd does of the Pfizer vaccine, my daughter has been experiencing shortness of breath with minimal activity that she had not experienced before the vaccine. Today, July 14, 2021, is day 6 and her symptoms have continued. Her pediatrician ordered a chest x-ray and EKG to rule out any serious issues, and both tests (conducted on July 13, 2021) were normal. He prescribed an Albuterol inhaler to be used twice daily for one week. She started the Albuterol today, on July 14, 2021.

Received her 2nd shot at 16:00 yesterday (7/10/2021) *first shot was June 18, 2021 She started experiencing chest pain last night, also complained of shortness of breath when going up stairs She took 1/2 apap tab (strength not specified) for injection site pain (After first shot, she had anxious at the time of the shot; her BP was checked and was within normal limits. Only issue beyond that was redness of her arm). Follow Up call to parent on July 11, 2021: Spoke with mom. She took daughter to the emergency room last night. EKG and chest x ray were both normal, She was given a muscle relaxer in ER with improvement of pain. Child is sleeping but when mom checked on her she said her pain was minimal this morning.

Patient was given her second covid19 vaccine at approximately 1045. She stood up and walked to a chair in the waiting room. At 1048 she passed out and had a small seizure. Mom said she normally passes out after a shot for a short period of time but this was the first time she had a seizure. She was moved to the floor. She was sweating, eyes glossed over, said she felt like she couldn't breathe and couldn't feel her extremities. She stayed on the floor until EMS arrived approximately 10 minutes later. She was moved to a chair and once she tried to stand up she was moved back to the floor. She left in a wheelchair and was taken to her moms car.

shortness of breath for 1 week starting on 4/26/21 that presented at 5 minutes at a time, intermittently, no medications used, resolved spontaneously. No history of asthma or lung conditions previously

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hyperventilation-Medium, Additional Details: Patient complained of sleepiness, lightheadedness and we contacted rescue at the parents request

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE ADMINISTRATION, PT FAINTED FOR A FEW SECONDS, STARTED JERKY MOVEMENT. WHEN CAME BACK SHE DID NOT REMEMBER ANYTHING. THEN AGAIN SHE FAINTED TURNED EXTREMELY PAIL WITH EXCESSIVE SWEATING AND FEELING HOT, SHE SEEMED STUNNED GAZING TO ONE POINT NOT ABLE TO TALK OR MOVE. RPH ASKED TO CALL 911 IMM. PT TURNED BLUE WITH VERY LOW PULSE AND SHALLOW BREATHING. RPH ADMINISTERED EPIPEN TO THE UPPER OUTER RIGHT THIGH TO HELP RAISE BP AND PULSE. PUT PT IN SUPINE POS W/ ELEVATED FEET

Fainted, flushed colored skin, breathing limited, tachycardic. EMS called and recommended a doctor visit for the day of. Was not transported to the hospital by EMS personnel.

difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; exhaustion; This is a spontaneous report from a contactable health care professional (patient's mother). A 16-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via intramuscular in the right arm on 14Jun2021 03:45 PM (at the age of 16-years-old) at single dose for covid-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced approximately 24 hours of difficulty breathing and strong internal chest pain that gradually subsided, along with chills fever, body pain, and exhaustion on 15Jun2021 06:00 AM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021. The report was reported as non-serious. Information on the lot/batch number has been requested.

patient experienced what appeared to be an anaphylactic reaction immediately after receiving the vaccine. Patient's chest became extremely red and splotchy. Patient's blood pressure was slightly elevated. Patient reported no difficulty breathing and no wheezing was witnessed. The doctor remained in the room with this patient and monitored her until emergency services arrived. Patient refused hospital transfer. Patient was alert and vocal during entire incident. Patients mother was shown how to enroll herself and her daughter in V-safe. Patient will remain in clinic for monitoring and will be followed-up with later this evening and tomorrow morning.

Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's mother got up and walked to counter to make 2nd dose appt. Patient started leaning over in chair and fell to the floor (witness reports patient bumped head). Per witness, mother ran to patient's side. This writer heard someone call for help. This writer was in the back assisting with immunization clinic. Patient was observed lying on the floor w/ mother at her side. Patient appeared confused and was actively trying to sit upright. This writer and patient's mother explained that she had experienced a vasovagal reaction after her COVID-19 vaccine. Patient was instructed to stay in lying position while vital signs were obtained. Patient was able to verbalize name, DOB, and place. Vital signs at 1040 (BP 98/55, HR 61, O2 98% on room air). Patient was diaphoretic and pale. Patient reported eating breakfast this morning. Patient was observed crying stating "I feel like I can't breathe." This writer continued to monitor vital signs (BP 120/72, HR 77, O2 99% on room air). Staff placed several ice packs on patient. She complained of headache and told staff that her head hurt. Mother of patient requested EMS to be called. Staff called EMS. Vital signs at 1050 (BP 101/64, HR 92, O2 98% on room air). Patient reported feeling better and was able to move to sitting upright position on the floor. Patient appeared less diaphoretic and color was returning to normal. Patient was moved to wheelchair w/ assistance from staff. Patient was provided with water and crackers. EMS arrived to the facility at 1050. EMS evaluated patient, but patient declined to be transported. V/S stable. Patient reports history of passing out unrelated to vaccine administration. Staff explained that mother/patient need to inform staff w/ the 2nd dose of vasovagal hx, so patient can receive vaccine lying down. Staff provided mother w/ concussion education and explained what S/S would indicate a need to go to the ER. Patient was also encouraged to f/u with pediatrician. Patient was taken out to car via wheelchair by staff at 1100.

Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.

Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium

The patient began to experience dyspnea, then shortly thereafter began to develop flushing of the face.

Dad says 5-10 min after vaccine pt started having sx. Pt says it feels like she can't breath, like her throat is closing off. Pt walk with Dr. to ambulance about 50 feet away and was taken to ED.

Dad says 5-10 minutes after vaccine patient started having symptoms. Patient said it felt like she couldn't breathe, like her throat was closing off. Patient walked with staff member to EMS ambulance ~50 feet away.

Written by the patient and guardian: " 8-10 minutes after shot, complaints of light head an throat closing up. Removed mask for fresh air, no relief. Went to get up for water, immediately for light headed, pale face, checked-out look in eyes. Body went limp, set 17yo in chair, still was light headed and lethargic. Laid 17yo down on floor, administered water. Vision came back dizziness went away. remained seated for another 15minutes. Continued hydrating w/ water, other symptoms diminished." From Dr.: "Witnessed patient pass out in chair, within 10-20s was helping caregiver lower patient to the floor and patient had come to. Increasingly alert. Endorses above narrative, as well as not having eaten or drinking much today, "maybe an apple". She does not have a history of vasovagal syncope. Patient Pulse at 65, normal breathing, no distress, no signs of injury. Overall episode appears to be vasovagal syncope. Patient asked to drink water and remain at the vaccine center an additional 15-20 minutes for observation. After 15 min patient feeling back at baseline. No further medical intervention.

Pt is complaining of shortness of breath and dizziness. As well as typical post-covid vaccination symptoms (i.e. aches, fever/chills). All symptoms started roughly noon - vaccination was around 4PM the previous evening.

patient felt faint and that her throat was closing up after 2 minutes.. called 911 and administered 1 epipen in left lateral thigh. patient responded quickly with proper color and felt much better according to patient. I observed patient for 30 minutes and after her mother and her confirmed her as feeling just fine, the patient and mother left the pharmacy.

17 YEAR OLD PATIENT: AFTER RECEIVING VACCINE PATIENT SAT IN OVERVATION AREA, UPON SITTING DOWN EXPERIENCED DIZZINESS, SHORTNESS OF BREATH, FATIGUE. PATIENT DEMONSTRTING RAPID EYE MOVEMENTS, RESPONSIVE TO DIRECET QUESTIONS AND TO PAINFUL STIMULI THOUGH UNABLE TO SPEAK IN FULL SENTENCES. DENIED CHEST PAIN, COUGH NAUSEA, VOMITING. MOTHER STATES SIMILIAR BEHAVIOR WHEN SHE DEVELOPED BLOOD CLOT IN THE PAST. PATIENT THEN STATED FELT LIKE THROAT WAS SCRATCHY.

After 2nd vaccination, client felt throat itchiness and swelling, and tongue swelling 15 minutes after. Client and guardian verbalized same adverse effects after 1st dose, and risks explained prior to 2nd dose vaccination. Client had difficultly swallowing and guardian gave client oral Benadryl which decreased some symptoms. No s/sx of resp distress, no SOB. client and guardian verbalized they did not need to be transferred to ER for further evaluation. Client and guardian left clinic @ 2:45 PM

Eyes started itching about 12 minutes after injection. Started getting very dry mouth and throat 15 minutes after shot. Felt lump in throat and throat tight about 17 minutes afterwards

Pt began to complain of dizziness and then shortly thereafter said she could not see. I dialed 911 and while on the phone with 911, the patient said she was experiencing shortness of breath. I administered an EpiPen and waited for EMS to arrive. Pt was transported to hospital and later released

5-10 minutes post vaccinating while waiting 30 minutes pt began hyperventilating with fluctuating LOC. Family member reported hx of allergies so she was waiting 30 minutes, EMS onsite, pt began drooling so EMS took her to local hospital. Nurse reports v/s remained stable. I have not heard back from pt or family as I attempted follow up calls and emails.

About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. While waiting at Urgent Care for 30 minutes, her face, tongue, and throat became swollen, hives developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home.

Itchy Body, itchy mouth, trouble breathing started about 10:00 am, 10 minutes after getting the shot. Went to Hospital Er and was intravenously given: diphenhydramine 50 mg, ND (0.9 % sodium chloride) bolts 1,000 ml, and methylprednisolone sodium succinate 60mg at 11:19 am. I was also injected with EPINEPHrine 0.3 mg at 11:20 am, and an albuterol nebulizer solution 5mg at 11:18 am. Stayed at the ER until 2:30 pm, got sent home and feel much better now.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild

Per ER HPI on 3/19/2021: 03/19 21:19 This 17 yrs old - Female presents to ER via Private Vehicle with complaints of Allergic Reaction. 21:19 Patient is a 17-year-old female she presents to the clinic with mom, the concern is that the patient wonders if she is having an allergic reaction, she says she received a Covid vaccine on Wednesday and then today earlier received an HPV vaccine and another vaccine that she cannot remember the name of. She feels like there is a tight sensation in her throat. She denies any chest pain or shortness of breath. Patient denies any abdominal pain. Denies any swelling of her lips, tongue or cheek. Patient denies any other associated signs and symptoms.

I started to feel a slight pressure on the right side of my throat around 1:30 hours after the vaccine was administered. The pressure was drastic, but it slightly relieved after about two minutes. I took 2 benadryl and kept feeling pressure, although it was lessened. After about 2 more hours I took 6 medrol pack 4mg tablets to see if the symptoms alleviated. Around 30 minutes after I took the medrol pack, I felt the same pressure, but on the left side of my neck, and it lessened after 1 minute. I still feel some pressure on the left side of my neck 10 hours after the vaccine was administered. I all took 1,000 mg of Acetaminophen 1 hour after the vaccine was administered to relieve some pain that I was feeling in the vaccination site.

Patient had anxiety prior to receiving vaccine and after. She said she felt very nauseas and wanted to puke. Was having trouble breathing. Patient did end up puking a few times. She was sweating and overheating, her tongue was starting to go numb, but she said her throat was not closing up. Her lips started to become white and she said she was having trouble seeing. her vision came and went at different times. EMS arrived and did diagnose her with an allergic reaction, gave her benadryl, and an ice pack. And sent her home.

Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: symptoms started after they had waited the 15 min in store and were well on their way home. they included: speaking overly slow or oddly, left arm tingling, chest pain/SOB, developed into shooting pain down right leg. pt laid down for nap and awoke with swollen eyelids. pt still experiencing shortness of breath and having to limit activities

Patient is a 17-year-old, female. Alert, oriented X3, clear speech, able to answer to the questions. No known underlying medical conditions. No history of allergies. Denied having allergies to food, other vaccines, or components of COVID-19 vaccine. At 1:52 pm, the patient received her first dose of Pfizer (lot number EW0162, expires on 07/2021) on left deltoid, given by RN. Patient continued to be A&Ox3, walked herself over to the EMT waiting area with a steady, balanced, and sat down. At 2:10 pm, while waiting in observation area, patient reported feeling "light-headed" and ?tightness? in throat to her father. The patient?s father alerted EMTs of his daughter?s symptoms. EMT responded by offering the client a water bottle, assisting her to anti-gravity chair, and taking the patient's vitals. At 2:15 pm, BP 128/78, HR 66, Resp 14. Patient states the last time she ate was at 11:00 am, when she had a bagel and a cup of coffee. EMT alerted Lead RN of patient?s symptoms. Vial signs were taken every 5 minutes. At 2:20 pm, BP 126/80, Sp02 at 99% room air, HR 69bpm, Resp 16/min. At 2:25 pm, BP 126/80, HR 75 bpm, 17 resp/minute, unlabored. Patient still reporting lightheaded-ness and states ?it feels like I swallowed something when I breathe in?. At 2:30 pm, BP 117/78, HR 53, RR 14 res/min, unlabored, SpO2 99%. Patient reports tightness in throat ?feels better?. Patient and father were provided with education related to the use of Diphenhydramine for symptoms of allergic reaction. RN advised patient and father that if the tightness in throat worsens, to take Benadryl and notify health care provider. Patient and father were provided with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. At 2:40 pm, BP 120/74, SpO2 98%, HR 74 bpm, RR 15 res/min, unlabored. Patient ingested 16 oz of water, denied any discomfort. Patient denies lightheadedness. At 10:45 pm, BP 123/80, HR 69, RR 16 res/min, unlabored, SpO2 99%. Patient left facility at 2:50 pm, accompanied by father to car. Patient denies dizziness and lightheadedness Patient was able to walk without assistance, gait was steady and balanced. Patient's father stated he would be driving her home.

wheezing, chest tightness. Hx of asthma. Epi-pen, albuterol inhalers. Pt sent to Urgent Care, then ER

Pt complained of Shortness of breath and chest tightness that started just a few minutes after vaccine administration. Pt has history of asthma. Exam done within normal limits. Pt given 2 puffs of albuterol. Symptoms remain mild after 45 min of observation. Pt discharged home with precautions.

One hour after returning home.Heaviness in limbs, unable to walk, shortness of breath, nausea, heaviness in chest. PCP provided oxygen, steroid shot, shot for nausea in office. Observed until symptoms subsided. Released with Rx for steroids and anti nausea medications

Pt complained of feeling dizzy, pt then complained of feeling her throat was closing. Epi and IM Benadryl were administered to pt

Patient not seen in office. History obtained via phone from father of patient and patient herself. Very early on 4/19/2021, 8hrs after receiving her 2nd Pfizer COVID-19 vaccination, patient began developing nausea, chills, sweating, fever and malaise. Highest fever was 102.3', with symptoms treated with Advil 600mg. Had x1 episode of vomiting that day, none since. The next day 4/20, patient woke up with new-onset lip swelling, progressing to periorbital swelling and swelling of her facial cheeks & rash. She then began having a cough with some throat tightness with some mild discomfort with breathing in her throat, but no chest tightness or wheezing. Tongue not swollen per patient. Benadryl 25mg PO given multiple times and patient used her Albuterol MDI a few times as well, which helped. She continued to have fevers to 101' throughout the day, treated with Advil again. At night, patient then developed semi-itchy red "hives" on her legs. Per patient, she didn't feel she needed to go to ER for her symptoms or throat tightness/breathing issue. She was still drinking & urinating well and had been consuming light solids foods. The same day 4/20 in the afternoon, patient was prescribed over the phone Prednisone 60mg PO x1 which she first took after 5pm, with tapering dose over the next 4 days, in addition to increasing Benadryl to 50mg PO and starting Qvar 80 MDI BID, while using Albuterol prn. Via phone call to father this morning 4/21, patient reportedly slept well last night and woke up this morning with significantly less symptoms. No longer having throat tightness/breathing issues, with much less periorbital/facial swelling. Still fatigued but no longer having fevers, either.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild

At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.

difficult swallowing post vaccine - tightness of throat. ; Gave Epi 0.5ml at 14;18; Ambulance at 1430

ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEAKNESS, FATIGUE, FEVER, CHILLS, VOMITING, DIARRHEA. I TOOK HER TO THE HOSPITAL WHERE WE WERE TOLD THAT IT WAS DUE TO VACCINE AND SHE WAS SENT HOME WITHOUT MEDS. SHE BECAME WORSE AND WORSE AND DEVELOPED HEART ATTACK SYMPTOMS: CHEST PAIN, WHEEZING, TIGHTNESS AND HEAVINESS IN CHEST, INTENSE BACK PAIN. WE RETURNED TO THE ER AND SHE WAS DIAGNOSED WITH PERICARDITIS. WE WERE ALSO TOLD THAT HER HEART WAS SLIGHTLY ENLARGED.

Recipient is a 17yo who presented for second dose of COVID-19 vaccine. She reported some anxiety related to receiving dose #2, and had some nausea after dose #1. She was alone as a driver of her own POV. Consent was obtained from the recipient and her custodial grandparent by phone, witnessed by doctor. She initially did well after the vaccine, but after approximately 5 minutes began to complain of feeling nauseated, lightheaded, and tingling extremities (hands and feet). She was noted to be hyperventilating, and was placed in a supine position but continued to feel some lightheadedness and difficulty breathing. Breath sounds were clear without wheezing noted, HR 70s with RRR. She was noted to have ongoing anxiety, nausea and symptoms progressed and although she remained normotensive to hypertensive (initial BP 128/74), she had repeated episodes of syncope. She was transferred to the ambulance and further vitals and EKG were obtained. She had some confusion after episodes of syncope and some seizure-like activity with syncope, with very brief episodes of LOC, with noted tachycardia with HR up to the 140s during episodes of syncope. BP ranged 129/86 to 140/84. IV access obtained and she was given NS and started on oxygen at 2 liters, but saturations remained in the 98-99% range. She was ultimately transferred to the local ER for further evaluation and management given ongoing symptoms, evaluated at hospital.

After a few minutes of receiving vaccine, patient reported dizziness, light headedness, and blurry/dots in vision. She then became more upset leading to hyperventilation and crying. She then said she had tingling in her fingers, which progressed to difficulty moving her fingers/stiff fingers, and coldness and redness in tips of fingers. She then reported she was loosing sensations in her feet and legs. 911 was called. We tried to have the patient take slow deep breaths. We offered an ice pack and water up front and a heat pack for her fingers. Paramedics arrived. Her blood pressure, heart rate, oxygen saturation, glucose were within normal limits. She was given oxygen and the paramedic was able to help her slow her breathing. Her fingers went back to normal and she felt fine before leaving. She did not feel the need to go with the paramedics.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Mild

? Cough sx x 3 days ? Shortness of Breath ? Headache ? Nasal Congestion -consider use of OTC medications such as DayQuil/NyQuil, Robitussin or Delsym for cough - OTC nasal spray and decongestants may provide temporary relief. If you have hypertension, diabetes, thyroid disease, or are pregnant you should avoid using these products. - A mix of 1/2 honey and 1/2 lemon juice can be used to soothe the throat and help loosen thick mucus in the throat or use warm salt water gargles. Use of hard candy, or throat lozenges for sore throat or cough (sugar free if Diabetic) -Steam inhalation by standing in a hot shower or sitting in the bathroom when hot shower is running helps with nasal discomfort. Vaporizers and humidifiers are not recommended due to the risk of burns, bacterial growth in improperly cleaned equipment, and mold formation in the home -Saline nose drops help loosen secretions. Commercial or homemade may be used (1/4 tsp. salt dissolved in 8 ounces warm water distilled or boiled water, discard solution after 48-72 hours) -Consume extra fluids, maintain a nutritious diet, get adequate rest -Take Tylenol as needed for pain and/or fever.

Pt has had a rash on neck and face X 3 days. She reports its slightly itchy, swollen and red. Not painful. It started on neck and spread to face. No fever, no trouble breathing. Very slight tight feeling in her throat yesterday with mild difficult in swallowing, but otherwise no issues swallowing/breathing today. Had first dose of covid pfizer vaccine 10 days ago. Has tried benadryl and hydrocortisone (one dose/application each) with no significant improvement.

03May21-daughter C/O obstruction in throat. upon view, left tonsil is enlarged, red, 'puffy', striated with white patches. Uncomfortable to swallow. slight runny nose, congested voice, puffy eyelids (slight). Went to urgent care, was tested for Mononucleosis and results positive.

Patient reported throat "tightness" that progressively was getting worse. She denied breathing nor swallowing difficulty. 0.3cc Epi given IM in left deltoid, per facility protocol. Patient was then transported to the ER via wheelchair and admitted to Pediatrics unit for observation. Her mother was with her the entire time.

Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.

Pt started having nausea and then had difficulty breathing and hyperventilating. Pt was transported by EMS.

Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy raised red rash on her Right forearm while at school. Benadryl helped a little. A worsening headache, cough and wheeze started evening 4/27/21. She took Tylenol and used her Albuterol inhaler. She slept poorly due to itch, headache, bad cough & wheezing. On 4/29/21, 4 hrs after taking Benadryl, she developed an urticarial rash on her Left forearm (right arm improved by then). A pruritic, extensive petechial Left-sided facial rash began that evening which worsened the next am and spread to right side of face. Headache comes and goes. Rash spread to upper arms 5/3/21 despite daily Claritin. Facial rash is fading

Patient received second dose of Pfizer COVID-19 vaccine and experienced symptoms of difficulty swallowing while waiting in-store for 15 minutes afterwards. Patient initially reported feeling warm and a slight tingling sensation in her arm, after an additional 5 minutes (20 minutes total post-injection), reported feeling a throat tightening sensation and difficulty swallowing. Patient was not short of breath, was able to speak without difficulty, and reported to be able to breathe normally. No epinephrine was administered and EMS was called for evaluation. EMS assessed that the patient was stable, had no signs of swelling in or around the throat area, and did not suspect an allergic reaction. Patient was released home with parent shortly after assessment.

Throwing up, headaches, abdomen pain, soar throat, chills, fever, sleepy, coughing violently, sneezing constantly, mucus coming up well coughing, wheezing, painful coughs, 05/06/2021

Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.

immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.

hives along both arms and chest one hour after receiving injection. Sensation of throat swelling and very slight difficulty breathing. Did not seek medical attention. Took benadryl and symptoms resolved within 40 minutes of taking benadryl

Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started crying. RN asked if she was okay, stated she was scared and that her arms felt weird and her chest was tight. RN asked some questions about her health history, she then offered a granola bar and water. Client drank some water, declined snack. Clients hand began to shake, RN offered to lay client on a cot but client declined. Her dad came to check on her, she broke down saying that her arms were numb and chest was tight. The 15 vaccine minute timer went off, client stood but legs were week. She sat down and then slid herself onto the floor. She at first went into a fetal position then laid out flat on the floor. Client began acting more panicked and frantic with short quick breaths and her hands appeared to be contracting some. Clinic team made the decision to call 911 and administer 0.50 mg epinephrine. Ambulance arrived quickly and client was taken to the Medical Center via ambulance.

THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SHORTNESS OF BREATH, SWEATING. SHE WAS CONSCIOUS AT THE TIME THE EMS ARRIVED.

Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient waited 15 minutes after receiveing vaccine and felt fine, on the drive home the patient says she had some difficulty swallowing water that caused pain in her chest, then passed out momentarily, patient returned to the pharmacy where we checked her BP which was 107-67, patient mom was on the phone with her physician, monitored the patient for additional 10 minutes and patient said she felt well enough to return home. Gave patient chocolate bar since she had not eaten anything.

About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious. She was sitting in a chair slumped forward, we pushed her back in the chair. The patient was tensed up, sweaty, with labored breathing. She was assessed to not to be in respiratory distress and held so she wouldn't slide out of the chair she was sitting in. She began to return to consciousness and pulse seemed relatively normal with breathing returning to normal after 3 minutes. Local EMS was activated. The patient was given cold water to hold on her neck and was alert. Local EMS assessed she was ok and the patient's mother refused transport to the ED. The patient left on her own.

Patient's sister came over to get RN and said patients throat was closing up. RN Grabbed doctor on site to assess. MD and RN auscultated with stethoscope; good air movement and color. Alert, oriented, speaking full sentences. The patient had a potential reaction to COVID-19 vaccine. Many co-morbidities and previous reaction noted. Rn and MD evaluated. Despite good air flow, patient reports throat closing up. Patient self-dosed Benadryl (50mg) with no improvement. 911 called. Mom Called. RN gave report to EMS, EMS took over care and consulted mom who denied transport and with patient. Patient's blood glucose also read "high" on meter x2 times.

Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as well as inflammation in joints. Was in the hospital for 7 days and was on IV, morphine and then switched to hydro-morph for severe pain. Was given ketorlax via Iv for inflammation as well and steroids. Has been put on steroids for 1 month, Colchicine for 3 months, naproxen for inflammation.

Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylaxis reaction). Treated by school nurse with epipen then ambulance paramedics arrived and administered nebulizer treatment, IM benedryl, dexamethasone and transported to ER for follow up stabilization. ER administered additional antihistamine. Patient was discharged from ER stable and in much improved condition.

Patient feeling her throat is swollen with a lump vs sat 98% HR 81 bp 131/70 patient felt better immediately after IM Benadryl was OBS for 45 mins and requesting discharge home was with mother

My 17 year old daughter had her second Pfizer shot on Sunday, May 16 at 10AM. On Wednesday, May 19the she woke up and said that she had a terrible time in the middle of the night with a tight chest and she couldn't catch her breath. She wouldn't go to Urgent Care with me so I told her that we had to call the 24 hour nurse line (on the back of the insurance card). I called and she spoke with a nurse, then spoke with a doctor on the phone who told her to go the doctor if her symptoms got any worse.

Two days after receiving the vaccine, the patient fainted at the home. Has had intermittent shortness of breath, and dizziness

Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes after receiving pfizer. Given water, vital signs obtained. HR low into the 50s, O2 sat 93-94%. Placed on a stretcher. After vitals obtained pt color returned and she stated she started feeling better. HR improved to 70s, O2 sat 97% on RA. BP stable throughout.

High fever 1 day after vaccine of 102, SOB since vaccination (unresolved), chest 4 days after vaccination (resolved)

Patient felt like she was having trouble breathing, stated it felt like someone was sitting on her chest. didn't feel like throat was closing, but felt anxious. asked patient if she would like benadryl, she stated yes. sat for 20 minutes after receiving benadryl and felt okay, felt like her trouble breathing went away.

Patient was asymptomatic 4 hours after vaccination given at 10a, then in the evening started to develop chest pain, shortness of breath, nausea, and abdominal pain. Patient came to ED for evaluation. She received epinephrine IM 0.3 mg, Benadryl 25 mg, Pepcid 20 mg, 1 L NS bolus, Toradol and PO Tylenol for pain management. Patient is now feeling better.

Chest Pains Shortness of Breath Costochondritis - Per the Doctor These conditions were present after the first vaccine shot on April 6th and then again after the second shot on April 27th. Doctor initially thought it could be a simple case of Acid Reflux and gave her Nexium. Once that didn't work, she had her Chest X Ray done that came back all clear. She then had her blood tests done and that too came all clear except for Vitamin D3 that came in at 15 so doctor gave her a 50,000 unit Vitamin D3 dose. That also didn't do much to relieve the chest pains and shortness of breath so he had her EKG and Echo done and those were all clear as well. Finally, he gave her a day steroid course of Prednisone at 40 mg/day which is where she is currently. It is helping her a bit but she is still complaining of original two issues - chest pain and shortness of breath. She is also doing cold and warm compressions throughout the day that helps her temporarily.

Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to hyperventilate and ended up throwing up. After letting them sit and relax for 5 minutes, the patient then had to throw up again and told their mother they felt like they were going to faint. Mother and myself stood by, while patient did end up fainting. We slowly lowered them to the ground, and on the way down their body got stiff and patient had uncontrollable movements and was hardly responsive. Mother and myself finally got her safely to the floor as they came to and was responding to verbal ques and stimulation from mother. Mother went to get water and i stayed with the patient to ensure no other things happen. Patient ended up doing alright after relaxing for a few and then i walked them and mother to their car and ensured they were feeling good enough to go home. I then advised the mother to seek medical attention.

Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling slightly lightheaded. She proceeded to lose consciousness. Mother honk the horn and alerted staff to come to help. Patient was in the car on the passenger side, patient was fully sitting up. I reclined her all the way down in her passenger seat, she was slightly gasping for air, Ambulance was called for evaluation. She had loss of consciousness for approximately 30 seconds. She regained consciousness and said she was feeling confused as to what it happened. Denies any feelings of needing to vomit, Or post ictal symptoms. EMS and fire we?re on scene by then, report given to paramedics on site. Patient declined further medical treatment and Ian made with the ambulance. after this stating she was a little tired. She continue to wait for 30 minutes, she had 1 episode of emesis and felt better. At the site with no issues.

Follow up report - The symptoms - severe headaches; shortness of breath; difficulty breathing; chest pain and throat pain with activities - even if he walked across the room he had this pain along with the shortness of breath; body aches and fatigue. He is an athlete and not able to do any of the sports - he starts breathing heavily when he walks across the room. He couldn't attend school for over a month. Has been to several physicians - a pulmonologist several times; cardiologist; gastroenterologist; his pediatrician. He got a steroid shot - 24th, given to him for the headaches. Last Monday, the 24th of May (the pulmonologist gave this to him). It (the headaches pain) was really bad on Tuesday, Wed, Thursday and he started feeling better with the headaches on Friday. He has been given an inhaler and Pepcid for acid reflux (gastroenterologist). These have given him a little relief - but he don't know if it's the steroid shot or the inhaler that is helping. Yesterday he tried to go to his Sports class and he couldn't do it - there was a problem with breathing; a lot of shortness of breath. The headaches and the breathing issues are still what are debilitating him the most.

8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours post vaccination, developed acute chest pain, shortness of breath, difficulty breathing when laying flat. Required ibuprofen. 6/3: felt better, required ibuprofen. Presented to ED on 6/4 with continued symptoms (chest pain, shortness of breath), noted to have elevated troponins. Transferred to Hospital on 6/4 to ICU for monitoring. To the floor on 6/5. Clinically doing well just on NSAIDs with slowly decreasing troponins. Dx: probable acute myocarditis per cardiology based on clinical symptoms and troponin leak

Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.

5 mins after administering vaccine pt had difficulty breathing, chills, sweats, blurry vision, nausea, temp was 95, numbness in hands, and ringing ears. Possibly a seizure her mom said her arms were shaking a little I didn?t see anything

Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Following 2nd covid-19 vaccination, patient became very lightheaded and fainted while seated in chair. After coming to again, she was very pale, having a hard time controlling her breathing and stated she couldnt see. 911 was called and upon the paramedics arriving, blood pressures both sitting and standing were taken, as well as a blood glucose reading. The patients blood pressure was low but stable, and her blood glucose reading was normal. Patient walked out of store with paramedics and Mom.

Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L arm. Shortness of breath. pain worse with inspiration, no positional changes. Similar to previous myocarditis episode in 2019 (thought to be 2/2 virus as had fevers, fully resolved). No recent URI, last sick 1 year ago, no covid per knowledge. Had COVID vaccine week prior without side effects. Presented to hospital. Initial troponin 0.819> 4.43. CK-MB 42.8, CK 471. BMP, CBC, CRP within normal limits. ECG non ischemic however mild j-point elevation in anterior leads consistent with myocarditis. POCT echo normal. Patient admitted for IVIG, steroids, viral panel and monitoring.

Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:34pm. At 1:34pm, client reports to vaccinator that she feels dizzy. Vaccinator offer client water and client starts drinking it. PHN 1 & PHN 2 arrive client reports she "feels weird" PHN asks client to explain and client is unable to describe. Client is alert and oriented X 4 and is already seated in zero gravity chair due to reporting history of syncope. Vaccinator offered client water and client starts drinking it. Client reports no headache, no shortness of breath, no blurred vision, no chest pain, just dizziness. At 1:34PM vitals heart rate taken manually by PHN :72 and blood pressure: 128/74, unable to get oxygenation due to long acrylic nails. PHN gets report from mother that client reports with the first dose something similar happened that she experienced dizziness after vaccine. Client was kept in observation and symptoms resolved prior to client going home. Clients mother reports no medical history, no medications and no history of allergies. At 1:36PM PHN gets called away for another adverse reaction and PHN stays with client. At 1:39pm client reports dizziness is resolving but still "feels weird", PHN asks client to clarify what weird means and she says "it feels like my heart is slower." At 1:40pm client reports she is feeling sleepy, PHN attempts to call 911 and gets disconnected. At 1:41pm vitals: blood pressure: 130/82 and pulse:134. At 1:42pm PHN calls 911 again to reconnect and observes clients lips look purple, closed eyes but able to answer questions and speak in complete sentences. Ask RN to get AED as instructed by 911 dispatcher. At 1:45pm, client reports having trouble breathing and RN placed zero gravity chair to laying position and assist client with coaching her to take slow deep breaths. Fire department paramedics arrived at 1:47pm and assumed care. Client was wheeled out on a gurney at 1:50pm.

Seen in office 06/09/2021 by Dr Extensive urticaria rash, tight throat beginning 36-48 hours after second dose of Pfizer COVID vaccine. Claritin 10mg 2 po qday for 7 days, continue Nexium, Benadryl prn.

Patient was seen in COVID vaccine clinic for first dose of Pfizer vaccine. Patient has a history of penicillin allergy where she developed hives and also a contraindication to the flu vaccine when she was 6 months old. The contraindication listed in the chart was "crying for 3 days." Patient received COVID vaccine and 20 minutes later reported her throat felt as if it was swollen and her tongue was tingling. 50 mg Benadryl given to patient. Vital signs all stable, pule ox on RA 100%. Mother called PCP who recommended being seen in the Emergency Dept d/t complaint of swollen throat. RRT called to help facilitate transfer to ED.

PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.

At around 9:25 am on Thursday, June 17th, 2021, a seventeen-year-old Foreign-speaking patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:30 am. The Pfizer vaccine was administered at 9:37 am. Observation nurse reported that around 10:04 am the patient complained about having a severe headache. The observation nurse notified charge nurse that she needs assistance. The charge nurse immediately obtained a pulse oximetry reading of 99% and a pulse of 88. The charge nurse assessed if the patient is experiencing any symptoms of hives or redness, shortness of breath, or any difficulty breathing or swallowing. The patient stated to the observation nurse that she was having difficulty breathing. At 10:06 am the charge nurse called 911. While the charge nurse was standing and speaking with the 911 operator, the patient started to faint and laid her head on charge nurse's stomach while she was sitting. The patient looked like she was sleeping and making some whimpering sounds for about 2 minutes. At the same time, these events were taking place, observation nurse reported that another 17-year-old minor started complaining of a severe headache and ?seeing stars?. First responder paramedics came on the scene at around 10:09 am and took over care of the patient. At that point charge nurse attended to another patient, 17-year-old minor. Patient was also exhibiting a reaction to the Pfizer Covid-19 vaccine. First responder paramedics left with patient at around 10:15 am and she was taken to hospital for further observation.

At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:35 am. The Pfizer vaccine was administered at 9:39 am. Observation nurse reported that around 10:06 am the patient complained about having a severe headache, ?seeing stars?, feeling very dizzy, and not feeling well. Nurse assisted patient to lay down on the mat in case the patient may faint. Charge nurse obtained a pulse oximetry reading of 95% and a pulse of 96. Charge nurse checked if the patient experienced any symptoms of hives/redness, shortness of breath, or any difficulty breathing or swallowing. The patient complained to observation nurse that she was having a hard time breathing, severe headache, and chest pain. Observation nurse instructed patient to be calm and to relax. Charge nurse instructed the patient to take deep slow breaths to help increase O2 levels but the patient complained to the observation nurse that she cannot breathe through her nose. At 10:15 am charge nurse continuously monitored the patient?s B/P, pulse, and O2 level readings. The BP reading was 117/64 with a pulse of 78 and an O2 level of 100%. At approximately 10:16 am, patient started showing signs of change in LOC and lost consciousness for a few seconds. First responder paramedics from the first minor incident were still at the scene waiting for the 2nd ambulance to arrive. The first responder paramedic did a sternum rub using his knuckles with a closed fist to the center of the patient?s chest and immediately after the patient gasped for air and regained consciousness. The patient remained in a sitting position on the floor to be able to breathe easier. At approximately, 10:18 am charge nurse took another BP reading of 121/76, a pulse of 96, and O2 level of 99%. At approximately 10:20 am, patient started exhibiting a change in LOC and was very disoriented again. Observation nurse kept calling the patient?s name but did not get a response. This lasted for around 30 seconds while the patient gasped for air before becoming responsive again. At this time observation nurse observed that patient could not recall her name and did not know how she got there. At approximately 10:22 am, charge nurse took another BP reading of 165/133, a pulse of 122, and an O2 level of 96%. At around 10:24 am, the charge nurse took another BP reading of 112/78 and pulse of 112 with an O2 level of 96%. The second ambulance arrived at approximately 10:26 am and took over. The second ambulance?s first responder paramedics left with patient at approx. 10:29 am and took her to hospital for further observation.

Pt. with some SOB, headache, stomachache, nausea , decrease appetite 5 hrs after receiving 2nd Covid-19 Vaccine (Pfizer). Epi (111000)She improved after giving 0.3 mg and giving Prednisone . She was sent home on tab Prednisone 20 mg bid x 3 days

Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt began to display symptoms related to anxiety that progressed to hyperventilation/nausea/full on body aches/ pt states she was then unable to move her arms/legs/hands due to body aches. Pt reported that her body was aching and that she was feeling nauseated. Pt's fingers were turning blue due to intense clenching. Paramedics/Ambulance called for so pt can be further evaluated.

Vaccine received at 0914, reaction occurred at 1008. Difficulty breathing, swelling to upper and lower lips, throat tightening, audible wheezing, rash to neck and chest. Two doses of Epinephrine and Benadryl given, oxygen administered, EMS called and taking to hospital via EMS at 1027.

Patient received her first COVID Vaccine on 6/4/2021 and on 6/5/2021, 6/6/2021, 6/7/2021, and 6/8/2021, she experienced chest pain and shortness of breath. She experienced shortness of breath even when ascending the staircase in our home. She felt chest pain and tightness in her chest for 4 days after receiving her vaccine.

Patient's maternal aunt reports that about 2 weeks after her second covid vaccine she began having shortness of breath and chest pain. Patient went to local ED and was seen to have a left sided pleural effusion (same side she has a ventriculoplueral shunt). Patient continues to struggle with shortness of breath and chest pain and left sided pleural effusion since and has visited multiple emergency rooms. Most recently patient was admitted to hospital on 6/23 and was seen to have a worsened pleural effusion and lab work that were positive for Lupus.

extreme hives on body; first night hard woke up with a hard time breathing; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 17-years-old) as single dose for covid-19 immunisation at workplace clinic. Medical history included anxiety. Patient had known allergies as she got a rash from Sulfa drugs. Concomitant medication included (other medication in two weeks) fluoxetine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Solution for injection) on an unknown date (at the age of 17-years-old) for COVID-19 immunisation. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient did not have COVID-19 and the patient not been tested for COVID-19 post vaccination. On 16Feb2021, patient experienced first night hard woke up with a hard time breathing and extreme hives on body on 20Feb2021. Therapeutic measures were taken as a result of the events included Benadryl. The outcome of events was recovered on an unknown date in 2021. Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.

She had the vaccine on 5/16 around 10:00am. The symptoms started at 5:00pm on 5/16 exp extreme sharp chest pains with difficulty breathing. We did give her Tylenol for pain for sharp pain around 7 pm started to come back. She was taken to ER to make sure it was not related to the vaccine. At the ER she had Chest X-rays, EKG, Bloodwork and her D-Dimer test was elevated she had a CT scan done showed swollen lymph nodes on (left arm)no problems with her heart.We was told to follow up with pcp told to continue to watch her for myocarditis. She has a follow up Sonogram scheduled on 7/16 to ensure the swelling of the lymph nodes has went down.

3 days after receiving Pfizer vaccine. pt developed chest pain and shortness of breath. Seen at ER diagnosed as Pericarditis/Chest Wall Pain. Sent home on ibuprofen . Still having chest pain and shortness of breath. It has been 5 weeks per mom.

Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane

Patient reports about 35 minutes after vaccine was given her throat felt like it was swelling up and she was having trouble breathing. She drank some water and it improved. The sensation of swelling or her throat and trouble breathing occurred over 2-3 hours and then went away. she did not seek medical attention and only notified us when she came back for her second dose.

Pt.initially had acute onset left arm pain with left sided chest pain worsened with deep breathing with nausea and vomiting. She gave herself her stress dose hydrocortisone, but when she did not improve she presented to the ED on 4/25/2021. EKG was performed and was normal. She was discharged with ad vice to rotate tylenol and ibuprofen and to stress dose her hydrocortisone. She, however, continued to be very symptomatic and developed tachycardia and symptoms of orthostasis. Large workup was done to assess the status of her endocrine diseases and to assess for onset of new autoimmune endocrine conditions. Laboratory evaluation was normal. troponin testing was not sent. She was referred to her primary pediatrician for further evaluation. Her pediatrician did a full evaluation and could find no cause for her symptoms. Arm pain gradually resolved but palpitations, mild sinus arrhythmia with tachycardia and symptoms of orthostasis continued. She tolerated wean of her hydrocortisone poorly and required large doses and slow weaning. Symptoms were still present and bothersome on 5/17/21 but had slightly improved, although she remained unable to attend full days of school (she is an excellent student). Case was discussed with infectious disease, who recommended delaying the second COVID vaccination, so this was done. Eventual working diagnosis was marked vasomotor instability of unclear origin, likely post inflammatory, concern for triggered by COVID vaccination. cardiology referral was placed. She was seen by cardiology 7/6/2021. EKG showed sinus arrhythmia and borderline right axis deviation, unchanged from ED presentation 4/25/2021. echocardiogram revealed only previous PDA closure. Cardiology placed event monitor and noted low suspicion for myocarditis, but consideration of cardiac MRI in future if no improvement.

Approximately 3 minutes after injection, pt. reported that her vision had gone black, her ears were ringing, and she felt faint. I notified the nurse immediately. Within another minute her breathing became rapid and faint. She was given water and coached to breath slowly and deeply. The nurse checked her blood pressure with a result of 67/22. A second BP check resulted in 70/27. The nurses transferred her to the ER. In the ER, a third BP check 20 minutes after injection resulted in a normal reading of approximately 110/70. She continued to take oral fluids for approximately one hour before being released. The medical staff reported to us that this is a completely normal reaction for many people to all vaccinations, and suggested that she should get the second dose of Pfizer vaccine in 3-4 weeks. However, when we check the CDC website we find that these are anaphylactic symptoms and should not get the 2nd dose of Pfizer, so we are greatly concerned and decided to report the event.

Notes COVID VACCINE CLINIC Subjective Patient is a 18 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines and denies reaction to her first dose. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. She denied difficulty breathing, difficulty swallowing, wheezing, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and tongue swelling.   ALLERGY REVIEW OF SYSTEMS: Patient denies facial swelling, chest tightness, shortness of breath, rash and dizziness + throat tightness:     Previous Reactions: Denies previous reactions to vaccinations.   Objective   Vitals Vitals:   01/08/21 1143 01/08/21 1204 01/08/21 1227 BP: (!) 144/89 131/81 104/76 Pulse: (!) 125 (!) 109 99 Temp: 98 °F (36.7 °C)     SpO2: 99% 99% 98%   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling of lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal.   Assessment/Plan Treatment included: benadryl 25mg po and solumedrol 125mg IM. Follow up response to treatment: good. Patient had improvement in throat tightness. Does mention being lightheaded after. Patient discharge: Stable to go home and follow up with PCP. Patient called a friend for a safe drive home. She was instructed to go home and rest for the remainder of the day. Denies having any symptoms on discharge. Discharged at 1229.   If she experiences any adverse symptoms in the future, advised to F/U in ER.

throat tightness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on Jan2021 at a single dose in the left deltoid muscle for COVID 19 vaccination. Medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines and denied reaction to her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID 19 vaccination on an unspecified date. The patient was seen at a COVID vaccine clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness on Jan2021. Treatment included: Benadryl 25mg po (orally) and Solumedrol 125mg IM. The event did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch has been obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of throat tightness cannot be excluded, considering the plausible temporal relationship. Sever 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.

100.1 fever at 630pm , swelling of face, chest pain , trouble with breathing , redness of face , and body pain at 8pm ,

Patient felt dizzy and short of breath. Complained of feeling like her heart was racing and chest pain. Was seen in the ED and received antihistamines and was monitored. Continued to complain of symptoms 7 days after receiving the vaccine and called in to work that day as well.

4 February 2021@0300-patint says she had body aches, Threw up, fever HA and SOB @ this time 1000-4 February 2021-she feels poopy/crappy I reminded her to go to the ER if she gets worse Motrin doesn't really help her feel better-she can sip some Gatorade to assist with the HA, BA & fever

Patient received second dose of Pfizer vaccine on 2/5. Patient was anxious during administration of vaccine. Discussed how patient felt after first dose vaccine and SE experienced (sore arm only - tolerated well). After she calmed down, then administered vaccine when pt felt ready. ~10/15 min later patient reported flushing, trouble catching breath, pulsing headache & shaky. Gave 2 Benadryl, monitored BP/HR (normal), injection site (normal), no angioedema/blocking of oral cavity/throat. Patient advised to lay down and reported feeling better ~ 1 hour later.

After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.

Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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.

Throat tightening. Patient states it's how she feels when she has an allergic reaction. Pt. has used her Epi Pen for this before in the past. Patient airway is able to breath, drink and have a conversation.

After getting my second shot, I felt extremely dizzy and disoriented. My vision became blurry and I had trouble breathing. I also threw up several times. I felt lightheaded for a few more minutes and then I was able to stand again.

My throat partially closed up for several hours. I did not get treatment as I could still breath. Caused me to loose my voice with has not yet come back (today?s date 03/20/2021)

migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.

PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF HER CHAIR. I WAS ABLED TO CATCH HER IN TIME AND LAY HER DOWN ON THE GROUND. PT LOST CONSCIOUSNESS AND STOPPED BREATHING. WAS ABOUT TO PERFORM CPR BUT PT WOKE UP BY HERSELF AND ACTED NORMAL AGAIN.

Immunization was given at 4:20PM and at 4:30PM in the store they sat and said they were feeling hot and had trouble breathing. She was conscious but had trouble speaking to EMTs when they arrived. She was taken to an emergency room and was able to walk out of the store with support.

Within 5 mins of receiving the vaccine, patient collapsed, skin turned red, had difficulty breathing and "strange feeling in throat" on her way to the 15 minute observation room. 911 was called and 2 Pharmacists rushed to her and one administered an epinephrine pen. Patient could breathe more deeply after the epi pen administered. One pharmacist stayed with her in case another dose of epinephrine needed to be administered, once the paramedics arrived the pharmacist left the room so they could care for the patient.

Took Benadryl before getting the shot at 2:30pm Allergic reaction resulting in facial and throat swelling, red welts at the back of the throat, wheezing, going unconscious and shaking all within 2 hours of receiving the vaccine Took second Benadryl to try and calm down the reaction (no effect) Epipen was given at the advice of my physician at 6:30pm Was directed to the ER Given medication in the ER Released after 4 hours

Intense soreness, tiredness immediately after for 3 days Starting on 4/11 loss of taste and smell Starting on 4/12 loss of taste and smell plus sore throat, runny nose and difficulty breathing

The day after the vaccine was received, the patient noticed arm and face swelling. She also experienced shooting pains and tingling in the same arm she received the vaccination. At work, it hurts when she carries things and has dropped items, which is unusual. Pain is mainly in the shoulder, but sometimes in the forearm. She has tried Tylenol, ice and naproxen with no relief. She received methylprednisolone on 4/12, and now feels that she is having an allergic reaction. Complaints of increased wheezing, shortness of breath and swelling of her skin, she has used her albuterol inhaler at home which has provided no relief. On 4/13 she received albuterol by nebulizer and an IV dose of methylprednisolone at the emergency department. She is going to start albuterol nebulizer at home, continue OTC antihistamine, discontinue the methyprednisolone and start prednisone tomorrow.

Patient was given vaccine in left deltoid. Approximately 10-15 minutes later, father came to the window to report patient's throat feels tight and closing and patient is getting flushed. I verified with patient if she can breathe, and she stated she could only breathe through her nose, and her throat is tight and closing. I went out of the pharmacy and administered the EpiPen dose on outer left thigh as the other pharmacist was calling 911. The mother arrived at the pharmacy and stated to us she is an ER nurse and told us to cancel the 911 response as she would take the patient to ER immediately. Patient was given the vaccination card and mother took patient away to go to ER, as patient could still walk. The patient appeared stable.

Pt reports day 1 post vaccination fever, throat tightness; diffiuclty swallowing; difficulty breathing "a little"; dizziness; lightheadedness. Pt sent to ER

Shortness of breath, chest pain, rapid heart beat. Called triage nurse, was advised to go to ER her symptoms weren?t normal for the vaccine side effects. At ER they gave her Tylenol to lower her her heart beat.

Patient had anaphylaxis reaction. Tongue swelling, SOB, rash, Given benadryl. Taken to ED for observation. Epi pen, benadryl, pepcid, and solumedrol administered.

Pt and father moved into the waiting area with vehicle. According to dad, pt began seizing in the car one minute after the vaccine administration. Dad called out to waiting area Monitor. Monitor called for help. LT and SPC appeared on scene. 1257 Pt was visibly having tonic clonic seizure. SPC administered EpiPen in Right Leg. 911 was called. Pt stopped seizing and was awake and confused. She then became AOx4. Pt visibly distressed and hyperventilating. 1259 Pt had tonic clonic movements and seizure again. Seizure last less than 15 seconds. Pt then became AOx4 again, distressed, and became nauseous. HR 56 SpO2 98% 1300 Pt vomited while sitting up. Still distressed and hyperventilating. RR 30. Post vomiting HR 116, SpO2 97%. Pt moved to stretcher and moved to shade. 1306 Firefighters arrived. HR 114 BP 141/46 SpO2 97% RR 24 AOx4 1312 Ambulance arrived. 1320 Pt left for medical center.

Patient: Female, Per RN notes: "1610 vaccinated L deltoid, Reaction time: 1611 Fainted, Chin lift and head support, Patient recovered BP 82/55, HR 73 at 1614. Slight nausea. After vaccine administered, patient stated she "didn't feel good". Encouraged patient to deep breathe and wiggle toes. Noted pale in color and she lost consciousness. Noted breathing, still rapid response called. Patient awake, alert, transferred patient to gurney. Patient agreed to go/be transferred to the ER with security and ER nurse. "

Fast heartbeat, shortness of breath, dizziness. Started 1-2 hours after shot administered. Intensity increased around 5PM. Had to seek emergency medical help. Admitted to ER at Medical Center at 6PM, discharged about 9PM.

Shortly after receiving vaccine the patient developed lip swelling, throat swelling. EMS evaluated patient and found tonsils were swollen. Vital signs BP 152/100 RR 20 HR 104 Oxygen sat-98% on room air. Patient received IV benadryl and was transported to local hospital ED for further evaluation and treatment.

Headache, Fever, Chills, Muscle pain and hard time breathing. Fatigue. Currently treating with Tylenol and Ibuprofen and rest.

After about 6-8 hours I began to have flu-like symptoms such as feeling feverish, feeling achy, & having a headache. I also felt like it was hard to breathe. But, today May 3rd, 2021, 2 days after the vaccine I developed a rash on my left side (vaccine side) from my armpit down to the top of my ribs. It?s red & looks & feels like sunburn.

After the Covid-19 vaccine, Patient said that she had back, ears and neck pain. She also felt dizziness and shortness of breath. A few minutes later, these symptoms was improved. After about 10 minutes, the patient was back to normal.

Fever or Chills Cough Shortness of Breath Difficulty breathing Fatigue Muscle or body aches Headache Sore throat Congestion or running nose Nausea or vomiting Diarrhea

Patient notes feeling of dyspnea that started a few minutes after getting second vaccination. No chest pain, palpitations or sensation of throat closure. VSS. Physical exam reassuring. She was observed for 30 minutes and during this time she notes symptoms have completely resolved.

At 10 minutes post-vaccination, patient had noted a dry, scratchy feeling in her throat and asked if I (mom) had brought a water bottle with us (I had not). At 20 minutes post-vaccination, patient began feeling her throat tightening, tongue swelling, and stated that her lips/mouth/tongue had a tingling sensation. At this point she was taken to the nurse/paramedic to be monitored with EKG, pulse oximetry, and given a bottle of water to drink. After 30 minutes of monitoring, the nurse/paramedic asked patient if her symptoms were improving and if she felt well enough to go home. She said that her symptoms were not gone, but improving, so she was told to sign a waiver/refusal of care form and released. However, at 11 hours post vaccination (1:30 AM), the symptoms returned (tongue swelling, throat tightening, tingling sensation in and around her mouth). I administered Benadryl (2 tablets), monitored for 30 minutes, and symptoms improved. No further symptoms after that point.

vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%. At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) contributed to the occurrence of the serious event Generalised tonic-clonic seizure. 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.

Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Feeling of passing out, in and out of consciousness, general weakness, sweats, weakness in breathing-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe

Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not able to reach patient for follow up.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

This is a 18 Years old Female presenting with chest pain for [a couple hours last night]. Pain started [gradually]. It is described as [dull and aching], radiating into [nowhere]. Pain is described as [moderate] upon onset and is currently [mild]. [No] history of the same. Pain [is not] worse with exercise. Patient [has no] decrease in exercise tolerance recently. Patient states that she received her second dose of her Pfizer vaccination 3 days ago, and last night she started to experience chest pain, headache, palpitations, and shortness of breath, and feeling dehydrated.

Patient received the vaccine at 4:15 pm. 4:27 staff notified of symptom onset. 4:30 BP 110/88 P 92 Patient reports feeling lightheaded and throat feels swollen 4:35 Lightheadedness comes in waves. Last ate around 12 noon. Feels like "lump in throat" slight pain with swallowing. Denes SOB, itching or N/V 4:57 No progression of symptoms, no new onset of symptoms. educated patient and Dad on signs and symptoms of severe reaction. Left with Dad at 4:57

Patient's mother called us on 5/28 to inform us that her daughter received the Pfizer vaccine on 5/16 and started having symptoms on 5/22: Swelling of lymph nodes, breasts, and what felt like her throat, a fever of 102F and felt like her heart was pounding. Patient's mother states that her heart is no longer pounding but is still having swelling and fever.

Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.

Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains in my heart making it hard to breathe as well as having erratic heart beats and blurry vision. The symptoms worsened approximately 24 hours after to where it has and continues to be sharp shooting and constant pain in my heart that travels into my left arm. Simple things like walking and breathing make it extremely painful.

Tachycardia; Lost 14 pounds; Ulcerative colitis flare up; Throat and glands swollen; Throat and glands swollen; vomiting a lot and couldnt hold food and water down; Diarrhea; This is a spontaneous report received from a contactable consumer (reporting on herself). A 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 07Apr2021 13:30, as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171; Expiration Date: was not reported ) via an unspecified route of administration in Arm Left on 28Apr2021 12:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included colitis ulcerative from 2015 and ongoing. Additional Information for Other Conditions: states was in remission for 6 years prior to her second dose of the vaccine. The patient's concomitant medications were not reported. It was reported that she had a pretty severe reaction to her second dose of BNT162B2. States she has been in the hospital for 5 days last week and has now been in the hospital for 4 days this week because of side effects from vaccine that she received on 28Apr2021 which was her second dose. She thought the side effects would go away after the first hospitalization but was readmitted. First admitted to the hospital on 01May2021 for severe reaction to the shot for 5 days then was sent home because they thought the side effects would go away but the side effects have still been heavy. She was admitted again on Friday (14May2021) to the hospital from the side effects that are continuing. States she had lost 14 pounds from the time she was home from her first visit to the hospital. Patient vomiting a lot and couldnt hold food and water down: States that right after she got the second shot a couple of hours later she vomited a lot and couldn't hold food or water down which started 28Apr2021 and that she hasn't thrown up since Friday 14May2021, but has improved. She was starting to recover from it, it was just starting to get better. The really bad diarrhea started on the 28Apr2021 and was ongoing. The doctor thinks the second dose of the vaccine caused an ulcerative colitis flare up. She noticed the tachycardia on 29Apr2021. States her resting heart rate before the vaccine was 55 on average and now her resting rate was 105-115, and when she gets up to walk around it was 140-160. States that this was what was preventing her to be able to leave the hospital now. Tachycardia was the reason for admission for the first hospitalization. she was at urgent care she was tachycardic and her throat and glands were all swollen and they thought she needed to be admitted to the hospital. Swollen glands recovered last week, either 12 or 13May2021 and was completely recovered from that. Clarifies throat and swollen glands recovered 13May2021. Her dates of admission were 01May2021- 04May2021 for tachycardia. States she was currently at hospital and was admitted 14May2021 and was still there today for tachycardia and weight loss. States the tachycardia warranted both hospital admissions but the weight loss also contributed to the second admission as well. States her current weight was 116 after losing 14 pounds. She was weighed on the 4th when discharged from her first hospital admission and she weighed 130 pounds or 59 kilograms then had a follow up appointment with her cardiologist on the 14th for tachycardia and was weighed then and was 116 pounds at that time. They then sent her to the emergency room right after that follow up appointment to be admitted. States she hasn't been weighed again during this hospital admission so she thinks her weight was the same. She coughed and said sorry something got stuck in her throat, then continued her conversation. Ulcerative Colitis flare up- states she was unsure of when it transitioned from diarrhea to this flare up of ulcerative colitis. States she has just starting getting steroids and they increased her normal medications for her condition and was starting to improve. States she has a picture of her vaccine card and the events started after her 2nd dose. They did a procedure to confirm it was flare up at around 15:00 on 17May2021, performed a sigmoidoscopy and just found her left colon and rectum were inflamed as results which was similar to the ulcerative colitis flare up. The patient underwent lab tests and procedures which included heart rate: 55, heart rate: 105-115, heart rate: 140-160 on an unspecified date, sigmoidoscopy: found her left colon and rectum were inflamed as r on 17May2021. The outcome of the ulcerative colitis flare up was recovering, for event tachycardia, diarrhea and on 29Apr2021 with outcome of not recovered , lost 14 pounds was not recovered, and for vomiting a lot and couldnt hold food and water down was unknown and for events throat and glands swollen was recovered on 13May2021.

Approximately 10 minutes after the shot, patient reports not feeling well, rapid heart beat, shakiness, and has difficulty breathing (feels like her throating is closing up). Gave one dose of 0.3 mg Epi-Pen 15 minutes after the vaccine. Called paramedics and arrived at 5:35 pm when patient was taken to the hospital. Patient was alert when she was picked up by the paramedics.

Chest pain/heart palpitations with onset approximately 10 hours after second COVID-19 shot. Heaviness in chest, harder to breath, tightness in throat. Blood pressure normal, but heart rate increased. No fever or other symptomology. Symptoms worse reclining and trying to rest rather than upright.

Symptoms included tightness of the throat and trouble breathing. They took my blood pressure and it was also very low. I took benadryl and they gave me some water and a shot of epinefrin. I got to the hospital probably around 6:45. They gave me more benadryl, and started giving me prednisone and another steroid. It took a few hours for it to improve, and there wasn't any immediate relief. I was released at around noon and took 2 more days of steroids before feeling better.

The evening after receiving the vaccine, pt began having headache, lightheadedness, shortness of breath, nausea, loss of appetite. Th next day (6/10) she notedmyalgias in lower back and hips with shooting pains in her knees and vomiting. She also noted mild fever and chills, nasal congestion and discharge with mild sore throat, and substernal chest discomfort. She described it as tightness with radiation to her throat and jaw, and right arm, witout radiation to her back, not associated with nausea, but is associated with shortness of breath and diaphoresis. Chest discomfort worse with lying down. Rapid COVID test negative. Upon arrival to ED on 6/11, her troponin was mildly elevated (0.039ug/L), D-dimer elevated at 348ng/mL, CRP also elevated at 5.96 mg/dL. ED physician diagnoses acute myopericarditis and patient was admitted to Critical Care Unit. On 6/13/2021 patient was discharged stable (limited bedside echo showed small pericardial effusion). Pt denies pleuritic chest pain on day of discharge.

Patient received the 2nd COVID vaccine Pfizer Lot #ER8736 exp. 07/31/2021 on 06/10/21 at 3:15 PM. Client returned to facility the following day, 06/11/21 with her boyfriend who was receiving a vaccine. The client alerted EMT at approximately 4:11 of a "rash on my left leg." RN and another RN responded. The client reported development of rash on her left leg approximately 2 hours following receiving her 2nd COVID vaccine. The client stated the rash was "itchy" and has been getting worse since it first appeared. RN noted hives along her left leg. The client also stated that she developed "shortness of breath" this morning around 10AM. She states this resolved after she "took a nap." The client also reported experiencing chills, body aches, and pain today. The client states she took Tylenol today. The client states she developed a similar rash about 1-2 hours following receiving the 1st COVID Pfizer vaccine on 05/20/21 at 2:51PM. She said the rash following her 1st vaccine was "not as itchy" as the current rash. Vital signs at 16:13 were as follows BP: 132/92, HR 106, Respirations 24. RN explained that our current protocol did not allow for administration of any medications. RN's provided education regarding signs and symptoms of anaphylaxis, when to seek EMS, to follow up with PCP as soon as possible, and V-safe. The client was provided a list of community clinics in the area. RN reiterated if the client experiences shortness of breath to seek EMS. The client voiced understanding of this. Vital signs repeated at 16:18 were as follows: BP 122/86, HR 82, Respirations 20. Client left the premises unassisted with a steady gait. The client was visualized getting into personal vehicle by EMT at 16:32.

AFTER VACCINATION, PATIENT SAT AT THE WAITING ROOM. WITHIN A FEW MINUTES HE BECAME PALE WITH COLD CLAMMY SKIN, THROAT SWELLING, SLOW THREADY PULSE, SEIZURE LIKE SYMPTOM, BARELY RESPONDING WHEN WE TRIED TALK TO HIM. 911 WAS CALLED IMMEDIATELY AND EPIPEN WAS GIVEN WITH DADS PERMISSION. AFTER A FEW SECONDS, PT BECAME ALERT AND CAN RESPOND WITH US. I MONITORED HIS RESPIRATION AND PULSE RATE WHILE WAITING FOR EMS. EMS TOOK OVER APPROX. WITHIN 10 MINUTES AND TOOK THE PATIENT TO THE EMERGENCY ROOM.

Myocarditis The right side of my chest began feeling sore with sharp burning pain 2-3 hours after getting home and resting at my kitchen table. I was out of breath and would feel excruciating pain whenever I would move around. I thought I was dying or going to die because of the pain I felt and spent the next 3 days resting in bed.

12 days after vaccine experienced closing of throat; difficulty breathing; vocal chord dysfunction; excessive congestions; sore throat; cough; bloody noses; fatigue. Went to urgent care and confirmed negative Covid-19 and negative strep test. Saw campus clinician on May-24 and determined "just allergies." Saw primary physician on May-17 . Also confirmed allergies but severity of symptoms not typical for patient who has been on immunotherapy for years for seasonal allergies.. Initiated aggressive allergy treatment with medications and when symptoms got worse instead of better wad finally put on oral steroids. And then also required a course of antibiotics. Illness lasted almost 3 weeks.

About 5-10 minutes after patient received first dose of COVID-19 Pfizer vaccine she lost consciousness for a few seconds. When pharmacist got back out to patient she had already come back to (eyes opening and trying to talk), but was clearly having labored breathing and became pale, began sweating, and her pulse was very faint. Father did not mention any history of fainting at the time, but turns out patient had a similar reaction when getting blood drawn not long ago. Patient appeared to be wheezing and stated she could not breath so 911 was called. EMS took over from there. After speaking with them, patient was okay after her blood pressure returned to normal (had decreased significantly according to EMS) and was able to lie flat for some time.

Went to go get the vaccine a little after 10am, later that night after 10PM the adverse event began. She started wheezing and coughing sounding very congested, she did take her inhaler that evening. On the following Sunday she was still congested and the coughing wasn't getting better which lead to taking cough syrup. That Monday she went to work however she was coughing later that night and mucus was coming up. On Tuesday she went to the doctor and was told she was okay and that everything will be fine. Two days later she had a fever running into that Saturday which lead to going to the hospital following speaking to her pediatrician. She was giving antibiotics and Prednisone at the hospital visit.

I was having trouble breathing.; I felt like I was going to faint/I was dizzy.; I was dizzy and hot; I broke out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 26Jun2021 at 13:15 (at the age of 18-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no medical history and past drug history. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Jun2021 at 13:30, the patient experienced patient was having trouble breathing, felt like patient was going to faint, patient was dizzy and hot, patient broke out in a sweat. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Events resulted in Doctor or other healthcare professional office/clinic visit/physician Office Visit. No treatment was received for events. Patient had no prolonged hospitalization. On 27Jun2021, the outcome of events was resolved. No follow-up attempts are possible. No further information is expected.

Patient experienced a hive under her right eye and said her throat felt a little tight but had no difficulty with breathing. two doses of 25mg liquid diphenhydramine was administered at 11:40 am and 11:50 am

Following SARS-CoV-2 vaccination on 7/8 the patient then developed a subjective fever and chills, after which she took Advil. On 7/9 she then developed waxing/waning shortness of breath and tachycardia with palpitations. On 7/10 the patient then developed chest pain which lead to ED presentation and admission.

Patient reported chest pain and shortness of breath 2-3 days following her vaccination. She did not present until one month later.

15 minutes post vaccination patient complained of shortness of breath and numbness of left side of body

Chest tightening; Chills; Heat all over the injected arm; Sweating; Hand shaking (on injected arm); Difficultly breathing; Nauseous; Lingering chest pain; Heat all over the injected arm, chest and head area; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 9655) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple allergies and pollen allergy. Concomitant medications included mometasone furoate (FLONASE) and cetirizine hydrochloride (ZYRTEC); both taken for allergies. Prior to the 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 four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 21:00, the patient experienced chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

2 hours later after vaccination, patient started feeling uncomfortable. She felt better the next day, but started having persistent symptoms on 06/30/21 with difficulty to take deep breath and felt uncomfortable in the throat as well. Patient also felt dizziness on 07/01/21 - not anymore on 07/03/21. Provider scheduled a F/U visit on 07/05/21. On 07/05/21 televisit, patient chest discomfort persistent but stable; prev episodes of shortness of breath, throat discomfort, and dizziness still recurring intermittently. Provider recommended immediate evaluation; patient declined. Provider scheduled a F/U visit on 07/06/21. On 07/12/21 televisit, chest discomfort persistent but stable. Patient was no show on 07/06/21 and self reported to ER. Patient stated that easily fatigued and needing to take deep breaths; denied palpitations, LOC, MS change, or other neuro/cardio/pulmonary symptoms. Provider referred patient to F/U with cardiologist.

Chest pain; Breathing difficulty; Part of my body is like burning now; side of my body, my back is burning; This is a spontaneous report from a contactable consumer. A 18-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0183) as DOSE:1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced chest pain , breathing difficulty, part of my body is like burning now; side of my body, my back is burning. Consumer stated, I am having some side effects from my vaccine, chest pain and difficulty breathing and then a part of my body is like burning now. Do you know if it's an allergy? I don't know what it is? Consumer stated, Yeah, really bad chest pain like the first day I took it which goes away but today I am experiencing the back of my body really some it should I don't know, something wrong in my body. Consumer stated, the breathing that has gotten better but reactions today, side of my body, my back is burning. Consumer stated, I have just received the first shot. The date that was I believe that was 24MAY at, I believe that 2:05. Expiration Date of first dose of COVID Vaccine: Consumer stated, No, I don't see it expiration date, I only see the date I took the Vaccine. Consumer stated, I would say the first day I experience like chest pain and little difficulty to breathe and then that went away. That was the first day yes and the second day no symptoms and then the third day I have been just happen initially today just like the back of my body is like burning. Consumer stated, I believe on the right side, I got the shot on my right arm I believe. Consumer stated, all medical condition I have just allergies that is it. (Further not clarified. Hence, not captured in tab). Consumer stated, I have not taken any treatment. Consumer was informed about the for the concern and was provided with the number as ## and requested to dial the option 3 and informed about timings as 8AM to 8PM Monday to Friday and 9AM to 3PM Saturday and Sunday as per EST. The outcome for the events was unknown. Follow-up attempts completed. No further information expected.

chest and heart pain; Short of breath; chest and heart pain; sore arm; tremendous pain; The chest pain is pinching and tightening like a poking of a needle or tightening of the chest; This is a spontaneous report from a contactable consumer. This consumer reported for an 18-year-old female patient (reporter's daughter). An 18-year-old female patient received BNT162b2 (BNT162B2), first dose, intramuscularly, administered in arm left on 11Jul2021 15:30 at the age of 18 years old, at 0.3 ml single dose for covid-19 immunisation. Medical history was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's Mother in law has a heart problem, the patient's brother was born with a hole in his heart. There were no concomitant medications. There was no other vaccine in four weeks. The patient experienced chest and heart pain on 12Jul2021, short of breath on 12Jul2021, sore arm on 11Jul2021, tremendous pain in Jul2021, the chest pain is pinching and tightening like a poking of a needle or tightening of the chest in Jul2021. The reporter was calling on behalf of his daughter. The vaccine didn't sit right with the patient. The patient had chest and heart pain and was short of breath. The patient went to her primary care provider and they checked her out and gave them a cardiologist's name to go see tomorrow. The doctor prescribed some ointment to rub on the chest. The doctor recommend that the patient not get her second shot because there was a heart condition that runs in the reporter 's wife's side of the family. The cardiologist was going to do an ultrasound on the patient. The patient was going through tremendous pain and colleges are requiring the vaccine, which was why she got it. The chest pain started Monday (12Jul2021) night at midnight. First came the chest pain and then the shortness of breath. The patient had arm pain and they recommended that she take Tylenol. Tuesday (13Jul2021) the patient had chest pain and took Tylenol and recommended that she see a cardiologist. The patient took Tylenol for her sore arm. The chest pain was pinching and tightening like a poking of a needle or tightening of the chest. The patient is going to be getting an MRI and sonogram tomorrow at the Cardiologist. The doctor is not advising the patient to take the second shot because the symptoms are worse with the second shot. The outcome of the events chest and heart pain, short of breath was not recovered, of the event sore arm was recovering, of the other events was unknown. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.

Patient reported no adverse event or allergies at pre-screening so received vaccine around 1:55pm and around 3.25pm patient reported of headache, SOB, faster heart rate, having to stop in middle of sentence, chest hurting breathing in . Emergency services was called and patient was assessed while waiting for emergency services to arrive. At 3.39pm BP 125/80 mmHg, 84 bpm and oxygen stat. 97%, again at 3.42pm oxygen stat. 98% and pulse 81bpm

30 minutes after injection, had sore arm, "hurting" while breathing, increased heart rate, increased blood pressure; after arriving at ER, more than 1 hour after injection, had vomiting x 3, hives/welts on chest and arms, fever and chills

I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pain (perhaps 7/10 on a pain scale) and fatigue. I was able to work out (exercise bike 30 mins) and shower despite the pain. Then, around noon today (nearly 24 hrs post injection) I began feeling increasingly dizzy and warm. I stood to go to my bed and lost consciousness and collapsed. I was only unconscious for perhaps 15 seconds. I woke up feeling very shaky and cold and breathing rapidly. I was able to slow my respirations. My skin on my face and hands was very pale (lips were whitish blue). My housemate had called 911 for me: FD showed up and took a couple sets of orthostatic vitals. My BP when seated on the floor was around 110/80, pulse 80, and my BP when standing was around 90/70, pulse 100. I was able to walk to the bed without help so I decided to stay home and just hydrate, sleep, and keep a close eye on things. Now (1620, around 4 hrs after passing out). I still feel lots of soreness, but only very minor dizziness.

19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, difficulty breathing, dizzy, lump in throat, headache, nausea, cough. 1 dose of Benadryl 25 mg given at 1430. Patient states she is medical fragile and has a HX of epilepsy. EMS called at 1500 evaluation mild allergic rxn will transport to hospital for further evaluation.

A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm I got chills and muscle soreness throughout my whole body. I then started to develop pain in my chest while breathing and I was having to gasp for air(this was around 5:30pm). My skin (mostly on my back) felt like it was burning and itchy. That lasted the entire night. 24 hours after the injection and I am still feeling tightness in my chest when I breathe, sore throat, and sore muscles.

19 y.o. female who arrived to the emergency department for 19-year-old female with history of COVID infection several months ago was receiving her COVID vaccine this morning when she developed nausea and tightness in her throat about 15 minutes after the injection. Epinephrine was administered prior to transfer to the ED. She denies any rash. She does feel slight shortness of breath. She denies headache earache sore throat or rhinorrhea cough vomiting diarrhea fever chills or abdominal pain. She has had hives and tightness in her throat from several medications in the past including Prevacid Prilosec Zantac and iodinated contrast media. No new medications. Anaphylactic type reaction and patient advised to not receive the 2nd vaccine. PMH: Diabetes mellitus Initial Vital Signs Blood Pressure 01/25/21 0902 132/85 Heart Rate 01/25/21 0902 92 Respiratory Rate 01/25/21 0902 16 Temp 01/25/21 0925 36.6 °C (97.9 °F) Temp Source 01/25/21 0925 Oral SpO2 01/25/21 0902 99 %

About 5 minutes after receiving vaccine, patient reported flushing, severe shortness of breath, and chills. Onset and worsening of symptoms was very quick and decision to administer 0.3mg epinephrine and call 911 was made. Patient airway was monitored until EMT arrived and patient taken to hospital for monitoring. Patient underwent further monitoring but was released after a few hours arriving at hospital.

Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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.

off breathing patterns; Headache; Chills/shivering; body aches; extreme thirst; weak; high temperature; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ez3249), intramuscular at the left arm on 25Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Type 1 diabetes and hypothyroidism. Concomitant medication included insulin. The patient previously took the first dose of BNT162B2 on 04Jan2021 intramuscular on the left arm for COVID-19 immunization. The patient experienced off breathing patterns, headache, chills/shivering, body aches, extreme thirst, weak, and high temperature on 26Jan2021 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.

Awoke the next morning with severe headache, fatigue, muscle pain (?felt Like being hit by a truck?). Slept 1.5 days, out of breath walking to bathroom from bed. Treated with sleep and sips of water, soup. However, her mild daily migraine became more severe 2 weeks after the 2nd dose, her vision has worsened, and her eyes spontaneously dilated with pounding headache a few days ago along with nausea. It appears this 2nd dose has made her daily (mild) migraines much more severe.

1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands. Patient stated she did have a Depo-Provera Injection after 1st vaccine approximately 3 weeks ago. Pt did state she pre-medicated herself with Benadryl 50mg orally at approximately 1300hrs today. Mom was present with patient while covering physicians and EMS on duty assessed patient. VS:112/82-B/P, 123-HR, 18-RR, SaO2 98% on RA. Allergies: Steroids, fish FMHx: Sports induced asthma and gallstones. 1550: Patient had notable facial swelling eye redness and flushing. 0.15 Epinephrine IM via home Epi-Pen self delivered by patient's mother for increase SOB, and tightness in chest. EMS transport called to transport patient to location. VS:118/86-B/P, 100-HR, 18-RR, Sa02 96% on RA. 1600:Transfer of care to EMS staff assisting in transfer of the patient.

One hour after vaccination, she experienced itchy throat, facial flushing, tongue swelling, respiratory distress, and abdominal pain and cramping. Patient self-administered epinephrine injection 0.3 mg in the car on the way home. Administered a second dose at home 45 minutes later. Then went to Hospital ER. she was given injections of benadryl and phenergan. observed and released.

Patient began experiencing difficulty breathing a few hours after getting her covid 19 vaccine. She took benadryl and zyrtec to relieve the symptoms. About 3 days later the symptoms started back and again she took the benadryl and zytrec. She is currently symptom free.

12/17/2020 patient vaccinated with Pfizer COVID 19 vaccine. A few minutes after receiving vaccination patient reported feeling very dizzy,weak,lip swelling, "pressure" and "tingling and swelling" in her throat. A rapid response was called. EpiPen 0.3 mg/0.3mL administered IM into the right thigh. In ED patient was treated with Decadron 10 mg IV x1, Benadryl 50mg IV x1, and sodium chloride 0.9% 1 liter x1. Patient was discharged home after 4 hours of observation and no further complaints. Patient was instructed to follow up in the family medicine clinic and take all medications as prescribed. No follow-up in clinic related to allergic reaction noted in records.

Patient received vaccine on 03/16/21 at 440pm, woke up on 03/17/21 with bumps on her left arm where the vaccine was given. She then woke up on 03/18/21 having chest tightness and shortness of breath.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: difficulty hearing-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: We called 911. EMT came in. All the vital signs were normal. After 30 minutes, the patient recovered.

5 minutes after, I started getting hives - on chest and stomach and back and was spreading onto my legs. One of the nurses at the site, gave me several doses of Benadryl and a Zyrtec. I was there 45 minutes - I kept getting more and more hives and my throat was getting itchy and my breathing was off a little bit. After taking the Benadryl, it started slowing down eventually and I was able to leave in 45 to fifty minutes. My primary care physician told me to take Benadryl before and after getting the second round of the vaccine. I had hives and a small rash on my chest for three days and I had to take Benadryl for those days. I t was extremely itchy. Symptoms resolved by end of day three. There was also a slight tingling in my fingers while I was experiencing the rash.

Patient was receiving her first dose of the Pfizer COVID-19 vaccination and several minutes afterwards she developed dyspnea, intractable cough, nausea, sensation of her throat closing, difficulty breathing and sensation of facial swelling. In the ED, the patient was administered epinephrine 0.3 mg IM and was given albuterol inhaler, Zofran 4 mg IV, Solu-Medrol 125 mg IV, 1 L fluid bolus and milligram Pepcid IV and 50 mg of Benadryl IV. Pt received discharge instructions and stated understanding concerning medications, follow up care and when to seek emergent care. Pt PIV removed. Pt verbally acknowledged discharge instead of signing paperwork. Pt was ambulatory to discharge with all belongings and was escorted to the front of the bldg by staff.

Difficulty breathing, wheezing , shortness of breath, legs were cold. Treatment 1 dose of Epi-Pen 0.3mg. , elevated legs. EMS called.

Pt walking to Observation: RN reports "deer in headlights look" pt reports feeling dizzy, SOB, fatigue & weakness. Pt brought to Triage in . transferred to gurney, EMTs and MD at beside. pt very tired. BF gives hx of pt responding like this before. (nothing to do with vaccine. No adverse effect with dose 1.) Pt states she was born without inferior vena cava and has CA Stents. States she "does this and then gets transferred to or my Cardiologists office." Can't recall last episode. 14:30 EKG NSR, Pt weak BUE & BLE, cant move legs. Pt states she has not eaten today but had 3 shots of Expresso. 14:31 IV started in R-hand, 200ml NS bolus. BS 107 mg/dL. 14:58: Decision to transfer patient to ER as not improving on weakness. Transferred to Hospital via AMB @ 15:01.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: Temp 98.6 and BP normal

When I first got the vaccine, i got dizzy and sick to my stomach with a headache. I decided to leave after sitting for 20 minutes and go back to work because it got a little better. on tuesday. A few hours later, my chest started to ache and my throat started to hurt. thinking I had asthma due to the heat, i ignored it and used my inhaler. By the next day, I was coughing and it hurt worse. I was still dizzy but worse, felt neasious and had a headache. I used my inhaler twice with no help. My arm started to hurt to move, and my injection spot became a red lump. By Thursday, I could barely take a normal breath. It hurt to walk, talk, yawn, sneeze or anything that lifted my need to breathe above bare minimum. It hurt greatly and I couldn't take a full breath. I felt like my lungs were swollen and my throat hurt to swallow. I was very dizzy and had horrible nausea.

Experienced the following after 7 minutes of the vaccine: shortness of breath, lightheadedness, dizziness, chills, and fast heart beat. Symptoms began to subside after 5 minutes and nausea and chest pain began After another five minutes, another episode of shortness of breath, lightheadedness, dizziness, chills, and fast heart beat Symptoms slightly bettered and was taken to emergency room Fast heart rate still continues, along with lightheadedness, shortness of breath, and occasional dizziness

Worsening over 6 days: arm injection swelling and sharp pain (severe, 1st day on: ice pack), headache (severe: advil, tylenol, thera flu), muslce aches all over the body (medium: 2nd day on); tiredness (medium-severe: 1st day on), sore throat (severe: 3rd - 5th day: cough drops); congestion/nasal and chest with cough and yellow mucous and sneezing (severe: 4th day on: nyquil); difficulty breathing (medium: 5th day on); runny nose (medium: 4th day on); temperature (5th day on, highest of 102: tylenol); nausea/vomitting/diarrhea (5th day only: bland food, BRAT diet), swollen lymph nodes (medium: 4th day on). Possible loss of smell and taste but could be due to congestion. Doctor prescribed (and was carried out): antibiotic (Cefdinir, just in case) and steroid shot.

Patient reported light headedness, shortness of breath, and itchy throat about 15 min after vaccine. Patient took 50 mg diphenhydramine PO, remained on site for about an hour, reported improvement in symptoms at that time and left.

I Received the shot at 10:45am on April the 15th, no side effects except arm soreness afterward. Then at around 7:40pm that same night, I began getting terrible itchy on my face, back, arms, and neck. It worsened and I started having trouble breathing (it felt like my throat had tightened)/a hoarse voice, and my pulse was faster than usual and I felt woozy and tired.. I called a nurse hotline and she recommended for me to be seen at an ER, and I went home to tell my parents and they called a doctor friend, and I was told to take Benadryl and if anything got worse to go to the ER. The next day when I woke up I felt mainly tired and had a slight cough and was scheduled a telehealth appointment, and I am taking Zyrtec 10mg and Pepsin 20mg daily x one week with Benadryl as a back up in case the symptoms flare up, and am advised to go to the ER if the breathing issues return. In terms of symptoms now, I am just a little itchy.

Patient presented to our primary care office 10 days after her Pfizer COVID booster shot was administered. She started with hives over her torso, arms and legs the day prior which was 9 days after her booster vaccine. Patient was placed on benadryl and pepcid for urticaira. Her symptoms progressed over that day with difficulty breathing, vomiting and syncope. She was taken to the emergency department. She was observed and placed on 5 days of oral prednisone. SHE DID NOT REQUIRE ANY EPINEPHRINE and was observed in the emergency department for hours prior to discharge. Symptoms resolved fully.

This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (not pregnant at event onset and time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 11Feb2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included Ewing Sarcoma which was not ongoing (Diagnosed at 5 years old, treated with chemotherapy for 1 year, cancer free for 13 years). There were no known allergies. Concomitant medications included low dose ethinylestradiol, norgestimate (TRI-SPRINTEC) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 20Jan2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. Starting 15Feb2021 at 12:00, the patient began to have shortness of breath that got progressively worse throughout the week. On 22Feb2021, she woke up with severe shortness of breath and her O2 saturation was 82%. She went to the hospital emergency department and was given a chest CT, and diagnosed with large bilateral pulmonary embolisms. She also had severe right ventricular strain due to the PEs. She was rushed into an EKOS procedure and a IVC filter was also put in. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), and Life threatening illness (immediate risk of death from the event). COVID test (test type: Nasal Swab, test name: Novel Coronavirus PCR) post vaccination was Negative on 22Feb2021, and Negative on 29Mar2021. Therapeutic measures were taken as a result of the events and included Heparin drip, EKOS and IVC filter procedure. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Patient slumped into chair in the observation area. I rushed to her. She was hyperventilating, but not wheezing or making any high pitched sound while breathing. Patient was conscious, and could answer my questions coherently. Patient was told to take off her mask so she can breath more easily. Patient kept saying "I'm sorry" and was told there's nothing to feel sorry for, and we wanted to make sure she was fine. Pulse was slightly elevated. Hands were warm and sweaty. Patient asked for a bottle of water. After drinking some water she felt better. It was likely a panic attack episode. I checked on her five minutes later. She just finished talking on the phone with a family or friend. She was a lot better at this point. She agreed that that was likely a panic attack. I advised her she should be able to receive the 2nd dose later, but should consult her PCP.

The patient is a 19-year-old female who presents for an allergic reaction s/p receiving her 1st COVID vaccination at 1640 today. About 15 minutes later, the patient developed a tingling sensation in her tongue, tight scratchy throat, and swelling in her upper lip. She denies any rash or shortness of breath. She denies having any drug allergies, but does note an allergy to macadamia nut in the past. She denies taking any anti-histamines or epinephrine prior to arrival. She reports a history of ADHD and took 30 mg of Vyvanse, which typically causes her heart rate to elevate in the low 100s. LNMP: 3-4 weeks ago. She denies any chance of pregnancy.

9 days ago, got Pfizer vaccine #1. Immediately after vaccine, felt nausea, lightheaded. She was sitting in a chair and felt unable to sit in chair, needed support. "It was too much work to talk, knew answers, hard to speak." No LOC. BIBA to ED. Athol ED notes reviewed, found to be anemic (drew off IV), subsequently not confirmed. She has ongoing nausea (without vomiting), poor appetite (eating toast with avocado, pizza pockets), fatigue (slept 11 hours and felt tired on awakening, napping), shaky (whole body), weak (unable to break apart frozen bread loaf, but no focal weakness), high HR on ambulation (on apple watch, 170-180, even 200), vertigo (when turns head, feels tilting or rarely spinning, lasting a few seconds or minutes), gets cold very easily, throat felt and appeared to be jumping, maybe a little hard to swallow. Per mother (by text) she is "shell of her former self." Works front desk has missed work except yesterday when she was able to get through a 3 hour shift. Cognition is mostly intact. She and mom do not know what to attribute this to. She if feeling better than after she left the hospital, better for a while, some worse now but not as bad as immediately after. No CP, no cough, fever. She has felt a little SOB last week, maybe after standing or taking a few steps.

Patient transferred from medical group practice for b/l PE. Patient reports chest pain and SOB x 4 days ago. Patient has also been having hemoptysis for the past couple days as well. Physical exam is remarkable for tachycardic heart rate and rhythm is regular. Patient given heparin bolus and infusion and admitted to hospital for acute large main vessel pulmonary embolism. 2D echocardiogram showing no signs of right heart strain. Patient was transitioned to oral Eliquis and given a 1 month supply on discharge. Patient told to stop birth control and avoid NSAIDS. Patient instructed to F/U with PCP and hematology.

On 04/24/2021, 2 minutes after the Pfizer immunization given to patient, complained of not feeling well. As soon as the pharmacist ran to help her, she looks seriously pale, nauseous, sweaty, and then lost all her faculty. She said she could not see anything and started to feel difficult of breathing. The pharmacist immediately gave her EpiPen, and called 911. While waiting for EMS, she started to feel a bit better, could see things. EMS came, measured her blood pressure, and told that she got syncope. They transported her to the hospital.

Patient was taken into Med Obvs for throat tightness. Patient describes that she experienced tightness and dryness in the throat after receiving the second dose vaccination. VS were checked at 14:36, HR: 90, RR: 19, BP: 122/83, SPO2: 99. Patient was encouraged to relax and have sips of water. Next VS were taken at 14:53, HR: 73, RR: 19, BP: 119/81, SPO2: 100. She was made comfortable on the stretcher with head of bed elevated to allow expansion of her lungs and reduce the risk of aspiration while sipping on water. Last VS were at 1508, HR: 65, RR: 20, BP: 121/83, SPO2: 100. Patient was released at 1511 by herself after symptoms lessened.

Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer. A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation. Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00, the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination. COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.

Roughly an hour after vaccination, experienced light-headedness and dizziness. During the night, a mild fever and nausea. The next day, four episodes of vomiting, fever, dizziness, headache, and body aches. During the second night, fever rose to 101. The second full day, worse headaches, sensitive to light, chest tightness (hurt to breathe deeply, cough, and laugh) and body aches. Third full day, mild chest tightness. Only medication taken to treat adverse affects was ibuprofen.

At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night and went to bed around 2am that night. The next day, I woke up around 10:30am and was sore until about 12pm when I began to feel completely awful. I was tired and no pain reliever helped with the muscle aches in my shoulders and back. I felt like my chest was being weighed down and it felt like a horrible chore to even breathe. About 24 hours after the shot, under my jaws began to hurt terribly and ice didn't do much to help it. I finally fell asleep on 04/28 around 2am and woke up on 04/29 without any pain.

After receiving my first vaccine on 4/13/21, I had a small asthma attack after about 20 minutes that went away quickly. After my second dose, I started feeling out of control of my muscles almost immediately. I also noticed the injection site was bleeding more than the first shot. 30 minutes later, the shaking became extensive and uncontrollable. I returned to clinic and the paramedics told me I was having an anxiety attack. The shaking continued on and at about 4:00pm I felt that my throat was puffing up. I went to the hospital and they put me on a variety of medications (Benadryl, Pepcid, and methylprednisolone). I felt better soon after. The next morning I have a sore throat, feel feverish and have a headache.

Patient received the [1st] COVID vaccine (Pfizer Lot # ER8732). RN 1 reported to RN 2 that client had a reaction within the 4 hours following administration of first dose. RN 2 responded. Client report experiencing fatigue, dizziness and that the "floor looked funny" approximately 5 minutes after vaccination. Client reports she was offered EMS and client denies. Today she admits to some shortness of breath that lasted about 1 minute and that she does not fully recall what the EMTs and Nurses were telling her. RN 2 consulted with medical team who determined that this client is not eligible for Pfizer as 2nd dose. Medical team determined client can be offered Janssen as 2nd Dose. RN 2 reported to client that her name and phone number would be sent to our scheduling team for her second dose Janssen. Client verbalized understanding. Client denied additional concerns.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium

Patient states she received the first dose of the Pfizer COVID vaccine on 5-5. Patient states she has the feeling of her throat closing on 5-5, but then resolved into a sore throat which has affected her eating. Patient woke yesterday with urticaria allover causing itching and a burning sensation. Patient has been taking Benadryl and using hydrocortisone cream with little relief of itching, but no relief of the urticaria. Patient denies changes in lotions, soaps or detergents. Patient has not eaten anything new. Patient states the only thing different recently was being put on Bactrim and Keflex for an abscess on 4-30. Patient stopped taking the antibiotics yesterday when she saw the rash. Patient received the vaccine at pharmacy.

Shortness of breath & dizziness/vertigo. Onset: 05/09/2021 7:00 AM. Still ongoing as of 05/11/2021 12:30 PM.

Patient experienced shortness of breath shortly after dose One day post dose - patient experienced vertigo

1:15 Patient left the building after 15 minute wait ,went to eat. Felt chest and throat tightness and burning. Came back to COVID vaccine clinic. Also reported a headache. PSO2 100 %Pulse 72 b/p 128/82, crying ,face red. Skin pink warm and dry. Respirations even and unlabored. Informed her that her vital signs are stable , she can be taken to ER. Wanted to wait and be monitored here. 1:25 PSO2 99% pulse70 calming down called mother to talk. 1:37 PSO2 97% pulse 78 reports chest and throat tightness 1:42 Still reports throat and chest tightness. B/P 132/84 Pulse 76 PSO2 98 does not want to go the ER wants to go home. Informed to go to ER for any shortness of breath or further problems.

Reported itching and hives at 11:45 am. Gave 25 mg diphenhydramine. Breathing became more distressed and gave 0.3 mg epinephrine in upper left thigh at 12:00 pm. Breathing and itching improved. Paramedics arrived at 12:05 pm and took over.

I started having vaginal bleeding on April 14th. The first day, it was the same amount as a regular period. In the days following, the bleeding became very heavy, having me go through a super-sized tampon with a pad every 1 and a half to two hours along with several large blood clots each time changing. On the 15th, I called the on-call nurse for my gynocologist and she said that it might have been from the vaccine and taking birth control, since many patients of hers had called with the same problem. The bleeding continued at this rate all the way until my second dose on April 29th. I saw my primary doctor that day and she tested my hemoglobin, which came up at 10.7, which was slightly anemic. She prescribed an Iron supplement and told me to skip my "period" days and go straight to my next pack of birth control when the one I was using was finished. The next day, I experienced severe nausea, diarrhea, chills, fever-like symptoms, difficulty breathing, and extreme fatigue. I went to the Emergency Room, and they gave me about an IV and a half. They said I had extreme dehydration, and was slightly more anemic than when tested the day before. Following that day, the bleeding was significantly lighter and then stopped for a few days on the following Thursday when I started my new pack of birth control. I had little to no blood for.a couple days, followed by bloody discharge up until Tuesday night, the 11th of May, when the bleeding started again, being about the same amount as a regular period. I am still currently bleeding at this rate.

Diarrhea; Throat constriction; Worsened breathing; Fatigue; Vertigo/Head spinning; This is a spontaneous report from a contactable consumer. A 19-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 16Mar2021 at 14:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was sometimes allergic for some types of fruit (edema of mouth, pustules in mouth). The patient did not receive any other vaccine in four weeks. The patient's medical history included phenylketonuria, thyroid gland disease, Crohn's disease. The patient's concomitant medication included zirtec, magnesium, acylpirin. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On the same day of COVID vaccination with in one minute, the patient felt throat constriction, worsened breathing, feeling of vertigo. The patient administered double dose of antiallergic drug Zyrtec and the symptoms re-solved. Only fatigue and mild vertigo were persisted. The next day after vaccination, the patient experienced diarrhea, and persisted till the day of reporting, and only mild form. The patient felt head spinning was still present. The patient received home treatment and patient was ready for possible adverse events, therefore the medication was available immediately. The outcome of the event diarrhea was not recovered and rest all other events was recovering. Follow-up attempts are completed. No further information is expected.

had the Pfizer vaccine LOT WE0169 clinic she had in less 48 h generalized hives + swollen joints and fingers as well SOB + chest tightness she was prescribed Benadryl but still after 10 days she is still w same symptoms and hives getting more uncontrolled

Pt brought to ED w/concerns for allergic rxn immediately following COVID-19 vaccine at PCP office (5/19) where w/in 15 mins, experienced significant lightheadedness, dizziness & throat swelling & itch w/wheezing. In ED, developed brief episodes of syncope and was administered EpiPen, IV fluids, solu-medrol and famotidine w/improvement. After multi doses of epi IM for recurrent symptoms throughout observation, was started on epi drip. Ultimately discharged, however, returned same night with recurrent anaphylactic rxn and was again started on an epinephrine drip and claritin. Of note, pt had previously had COVID on 1/22/2021. Pt discharged w/plans to f/u w/ allergy and immunology at Hospital.

8:30 am - Sudden chest pains, pressure and shortness of breath. Came on suddenly and worsened as time went on. Shortly after 9am placed call to family Dr and was directed to go to ER. Arrived at ER around or shortly after 10am. ER immediately did a EKG then followed by all of the tests listed below. Blood work showed elevated heart enzyme which signaled there was an issue. As day progressed the heart enzyme continued to elevate. 2pm-2:30pm we had a diagnosis and were told she would need to stay overnight for observation while they started her on drugs to get her heart stabilized. She was hooked to a heart monitor throughout the night. Discharged with treatment plan the next day 5/22.

Pain in arm; Swollen; Itching; Headache; Nausea; My left nose clogged up; The left side of my throat burns, hurts to swallow and is swollen.; The left side of my throat burns, hurts to swallow and is swollen.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021 16:30 (at age of 19-year-old during vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had received birth control pills within 2 weeks of vaccination. The Patient had not received any other vaccines within 4 weeks prior to the Covid vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 25May2021 12:00 AM, the patient experienced pain in arm, swollen, itching, headache, and nausea for the first few days in the night of. On 29May2021 (Saturday, four days later), her left nose clogged up and the left side of throat burns, hurts to swallow and was swollen. Since the vaccination the patient had not diagnosed with COVID-19. The outcome of the events were unknown. Information about lot/batch number has been requested.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild

Patient has had a 2 day history of left sided chest pain, chest tightness, shortness of breath, dizziness, nausea and tightness in the left shoulder.

hypokalemia (2.9 mmol/L); hypocalcemia (6.4 mg/dL); puffy eyes; respiratory symptoms; possibly stridor; This is a spontaneous report from a contactable physician. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included food allergy, anaphylactic reaction. The patient's concomitant medications were not reported. The patient woke up the next morning on 20May2021 with puffy eyes and respiratory symptoms (possibly stridor) and self-administered epinephrine, then was taken to the nearest ED where she received additional epi and albuterol. Those symptoms eventually subsided, but what triggered the study stop was her lab findings consisting of hypokalemia (2.9 mmol/L) and hypocalcemia (6.4 mg/dL). In the AE grading scale that the study is using (the FDA's scale used in vaccination studies), these values are considered Grade 4 As such, we met the study stopping rule of a single Grade 4 event and since they were detected one day after vaccination, the site PI indicated that they could be "possibly related" to the vaccine. These abnormalities were promptly corrected and the participant is doing OK, based on the most recent update. There is no report that the reporter could identify that these electrolyte abnormalities are vaccine related and I am contacting you to confirm that this is, indeed, the case. We believe other explanations should be considered (e.g. epinephrine plus beta agonist administration can lead to both hypokalemia and hypocalcemia through beta2 effects; alternatively, or in addition, hyperventilation could result in respiratory alkalosis that has similar effects). The patient underwent lab tests and procedures which included blood calcium: 6.4 mg/dl on an unspecified date Hypocalcemia , blood potassium: 2.9 mmol/l on an unspecified date Hypokalemia. Therapeutic measures were taken as a result of puffy eyes, respiratory symptoms, possibly stridor. The outcome of the events was unknown. Information regarding lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported puffy eyes and respiratory symptoms (possibly stridor) and the use of bnt162b2 is possible. Considering that these events likely occurred under the context of an allergic reaction based on the temporal association and the positive response to epinephrine and albuterol. The patient also has a history of food allergy, anaphylactic reaction which place the patient at risk. As for the events , hypokalemia and hypocalcemia, agree with the reporter that the use of the beta 2 agonist , as well as the respiratory alkalosis explain the occurrence of these events. 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.

Pfizer COVID vaccine administered 04/27/21. Reports that she started feeling unwell almost immediately after injection. Immediate Reaction (onset <5 min) associated with the following symptoms: ? Visible swelling and pain at the injection site ? Increased nasal secretions and eye tearing ? Chills Around 30 minutes after, she had also developed: ? Swelling of the tongue (felt "heavy") ? Flushing, diaphoresis, and nausea, followed later by vomiting ? Dizziness/lightheadedness/weakness ? Dyspnea, wheezing, and cough ? Hives on arms and chest No throat tightening or tachypnea. She did not attempt speech. No one in the clinic took her blood pressure or pulse ox The patient brought her epi pen with her but elected not to use it. Left after 30 minute observation period. Thinks that the people at the vaccine clinic did not recognize that she had hives because of her dark complexion. The people administering vaccines were not medically trained Patient's mom recognized that she was not feeling well when she picked her up. She took benadryl which helped with allergy symptoms. She then developed fever up to 102.3, chills, headache, nausea, and myalgias x 5 days

When I got the shot I immediately got extremely tired witch us normal I belive but a few hours later at 4:30 ish I was swimming bc I felt okay and my heart started pounding more then normal when I'm swimming so we leave and go home my heart was still pounding 2 hours later and now my chest is tight and I'll randomly gasp for air its been I belive 2 days after the vaccine and my heart is still pounding and the gasping for air has not stopped the gasping is a random thing so uts not a continuous cooking feeling just every now and then the heart pounding though has been continuous qnd the night after the shot I had gotten worked up on top of the heart pounding qnd thought I was about to have a heart attack I calmed down and have yet to go to a hospital bc its only really bad when I'm walking or getting worked up if it does not pass by Thursday I will be seeing a doctor

Patient is a 19-year-old female with no significant past medical history BIBself with report of midsternal chest pain (described as soreness) that started around 8:20 AM when she woke up with associated jaw pain and L>R upper extremity pain. She reports pain is worse with deep breaths and has improved significantly since it started (currently rated 2/10). She took three ibuprofen tabs (presumably a total of 600 mg) prior to presentation but took no other pain medications. Denies abdominal pain, nausea, vomiting, fever, chills, leg pain or swelling. Denies cigarette, alcohol, or drug use. Patient received her 2nd Pfizer COVID vaccine 4 days ago, with initial side effects of chills, body aches, and intermittent headaches resolving yesterday. Emergency Department to Inpatient.

fell on the floor and she lose all the conscious; she got a kind of choke; fell on the floor and she lose all the conscious; lose all the energy; cannot breathe; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received bnt162b2 (Pfizer product, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Last Friday (unspecified May2021) she was vaccinated with the Pfizer and she got a lot of symptoms of the vaccine, after 20 seconds she fell on the floor and she lose all the conscious and took that it was minute and half to come up and she got a kind of choke, cannot breathe and lose all the energy, it took almost 2 days to become normal again. The patient's mother did not want her to get another shot. The outcome of events was recovered. Information about lot/batch number has been requested.

Patient reported anaphylactic type symptoms with swelling of her throat, shortness of breath, wheezing within 15-20 minutes after vaccination. Patient was taken to ER for further evaluation.

Pt reported that they developed a rash, throat swelling/closure after the first dose. Pt was presenting for second dose on 6/22. Unknown time course for development/resolution of reaction. Pt also has an allergy to Peanut butter flavor (SOB) and Egg (rash)

Patient experienced shortness of breath and chest pain resulting in a visit to the ER (02/07/2021) where doctors found multiple blood clots in lungs as well as decreased heart function due to stress on cardiac system. Patient was hospitalized for 3 days and had to have an INR procedure to remove the blood clots (Patient is now on blood thinner and diagnosed with Antiphospholipid Syndrome after event.)

After 4 hours from when the shot was administered, I had an extreme itch starting with my head, wrists, and armpits. I began to see rashes and welting. I took Benadryl which calmed it down for an hour. However, that night my vision became very blurry and I was extremely dizzy. The following day, I woke up with hives all over my legs, arms, chest, and back. I took more Benadryl, however these rashes and hives remained a problem all day long. That night, my lips trippled in size and were very swollen. My hands and feet began to burn and rash. I contacted a doctor and was told to to go to the ER if my breathing was compromised. My throat was a little swollen, however it went down and was not as swollen as my lips. By the fourth day, I was feeling better with little to no rashing.

Inflamed heart and chest wall pain. Went to dr. when breathing and drinking became painful, ekg and chest x-ray were normal. given steroids to reduce inflammation and sent home

Patient received her second COVID 19 shot on April 26, 2021. She began to feel general fatigue toward middle/end of May. Also at end of May she began to experience chest pain when working out. On June 14th she felt chest pain just walking and developed a cough. I took her to ER on June 15th around 1am. Her chest X-ray showed some abnormality. Around 3am she had significant difficulty breathing. She was admitted and a cardiologist and pulmonary physicians determined she was in heart failure with an ejection fraction of 10%. She was life flighted to another hospital where she spent 3 weeks on Echmo and Impella, received a heart transplant on week 4 and is still in ICU recovering. We are not sure if the vaccine is related to her illness. We just know that patient was a healthy 19 year old, former high school athlete, current straight A student having completed her freshman year of college, and no health issues prior to this event.

Patient called on 7/7 and let us know that she had been treated in the ER for HR >100, on and off fever, dizziness, shortness of breath when lying down, fatigue, and neck pain since receiving her second dose of the vaccine. She is following up with a cardiologist and will let us know of the outcome of this appointment.

I was diagnosed with Postural orthostatic tachycardia syndrome. I was given medication. Currently on treatment. I passed out and had tachycardia. That would cause shortness of breath and dizziness. I was diagnosed in March and I am currently on medication treatment.

Pt.'s mother states after receiving the 2nd dose of Phizer 07/08/2021, starting experiencing shortness of breath the following day 07/09/2021. Urgent Care visit 07/10/2021 gave steroid shot, follow-up with Cardiologist. Worsened 07/11/2021 ER visit, Colchicine prescribed 2 weeks with follow-up with Cardiologist. Still experiencing shortness of breath.

Pronounced weight loss began within two weeks of the first dose. Patient lost 30 pounds in 3 months. She was diagnosed as a Type 1 diabetic July 12, 2021. Her symptoms during those three months included weight loss, dizziness, fatigue, sensitivity to heat, racing heart, easily out of breath, nausea and vomiting.

Pt is a 19 y/o F who suddenly endorsed feeling dizzy, hot, short of breathe, and peri-oral itchiness ~ 10min after receiving first dose of Pfizer vaccine (done at 1357). PMHx pertinent for hx of anaphylaxis to bee stings, currently being treated with allergy shots, last injections given 12JUL21. Pt was immediately evaluated, with initial VS done at 1415 with BP 110/70, SPO2 99%, HR of 94, RR >20. Endorse chest tightness. Lungs CTA B/L, pt noted to be diaphoretic. Patient had a near syncopal episode and was placed in supine position and given an epi-pen 0.3mg at 1418. EMS was called. Repeat VS at 1420 found BP of 115/60, SpO2 100%, HR 100, RR >20. Lungs still CTA b/l. Patient endorsed improved SOB and less peri-oral itching. Chest tightness improved, Pt was AOX3. EMS arrived at 1435, pt stable. Transferred pt to EMS.

PT USUALLY HAS A SWOLLEN ARM AT THE INJECTION SITE WHEN SHE DOES GET INJECTIONS. AND HER MOM SAID SHE GETS ANXIETY KINDA FEELING WHEN SHE GETS INJECTIONS BC OF THAT. WAS TOLD AFTER THE SHOT THAT INFO. PT INITIALLY EXPERIENCED , WHILE CRYING VERY LITTLE SHORTNESS OF BREATH. BUT WHEN SHE PUT HER MASKED DOWN, SHE FELT A LOT BETTER. SHE THEN FELT A LITTLE DIZZY THEN AFTER PUTTING HER AGAINST THE WALL AND RAISING HER LEGS , FELT BETTER AND DIZZINESS WAS GOING AWAY. AFTER 5 MINUTES, SHE FELT SLIGHT CHEST TIGHTNESS. KEPT MONITORING HER. CALLED THE AMBULANCE.. THEY CAME AFTER 1O MINUTES..

Hives, Redness, itchiness Patient feels trouble breathing for 2-3 seconds. After removing her mask she feels better. Pulse 90, 02 98%. Patient transferred to gurney vitals checked. Given oral Benadryl 25mg, Pt provided water and had a few sips. Advised to consult PCP about adverse reaction. Patient stated that she history of fainting and feels nervous about the vaccine. Patient stayed extra 30 mins in the observation area. Patient feels better and left for home with mother.

Client reported development of shortness of breath, chills, fever, and nasal congestion 2 days after the 1st COVID vaccine Pfizer. The client stated the symptoms lasted one week. The has a history of asthma and is prescribed Albuterol. The client stated she used her Albuterol inhaler, which helped with the shortness of breath. The client presented to the emergency department for evaluation in order to return to work. The client states she was prescribed Tylenol in the emergency department. The client also received a negative COVID test while in the emergency department. The client has a history of allergies to cats which is controlled with Loratadine.

CLIENT STATED SHE WAITED THE 15 MINUTES AND THEN STARTED TO HAVE DIFFICULTY BREATHING AND DROVE AROUND TO ENTRANCE OF CLINIC. CLIENT PRESENTED WITH RAPID, SHALLOW BREATHING, SHAKING. NURSE RAN TO GET EPINEPHRINE WHILE ANOTHER STAFF MEMBER STAYED WITH CLIENT. EMT SUMMONED. EMT GAVE OXYGEN, BENADRYL & CONTINUED TO SPEAK WITH CLIENT'S MOM VIA SPEAKER PHONE AND TO REASSURE CLIENT. FAMILY MEMBER CAME TO PICK UP CLIENT FROM CLIENT.

I woke up with sever stomach pain and nausea. I could not lay down or else it would hurt worse. By the afternoon this turned into chest pain, shortness of breath, headache, sweating, back and muscle pain, and a fever of 101.4.

Stayed fir Observation for 15 minutes then left. 25 minutes after injection, developed rash and swelling on arm, chest, face with rapid heart rate and shallow/rapid breathing. Called number on vaccine sheet and was sent to ER but was turned away due to over crowding (COVID) and told to go to PCP, which was two hours away. Went to urgent care instead and was immediately treated with steroids and antihistamine.

10/30-tested + for COVID; recovered @ home suffers from chronic anxiety after 10 mins after vac, patient thought throat was Scratchy & closing. leading to crying/hysteria/panic attack. Once attended to, all calm. 20% of who presents with throat itchy & swelling that occurred shortly after her vaccination. Pt thinks it could be a panic attack. PE - unremarkable. Plan - home with monitoring.

EE reports, started to be nauseous overnight, 1/12 into 1/13. 1/13 10 am, chest heaviness, SOB, anxiety, unable to function at work 1/13/2021, to Urgent Care, prescribed zofran for nausea. Was asked to contact her PCP regarding her HR 130, EE was on buprion and abruptly stopped taking it for 2 weeks without PCP recommendation, "I thought I didn't need it anymore". EE reported to OHN on 1/13, she restarted the med and took her first dose on 1/12 and her second one on 1/13. Covid results negative

Weakness and lightheadedness about 15 minutes after vaccination. Pt had some slight difficulty breathing but self resolved. EMS on site provided first aid at paramedic level. Pt was observed for 30 minutes before symptoms resolved. Pt advised seeking further treatment but felt okay to complete refusal of transport. Medical Control familiar with vaccination clinic called and advised on situation and agreed on treatment plan.

PATIENT REPORTED "SHAKY BREATHING," "PAIN ALL OVER BODY," AND FEELING NAUSEATED. SYMPTOMS WERE NOT RESOLVING UPON USING CONTROLLED BREATHING TECHNIQUES, AND RELAXATION. PATIENT WAS BECOMING DISTRESSED ALTHOUGH WAS NOT EXPERIENCING RESTRICTED AIRWAY.

0925 AMThroat light swelling, feels something back of throat, dysphagia, dyspnea. Recent sinus infection, 0928 Benadryl po Last meal 1200am,Vital signs stable 0939am Feels better, still feels a lump in throat. 0955 Vital signs stable D/C

Body aches; chills; SOB; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on 22Jan2021 17:00 (reported as 05:00 PM) at SINGLE DOSE for COVID-19 immunisation. The patient was administered COVID-19 vaccine at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included endometriosis, interstitial cystitis, depression, anxiety, post-traumatic stress disorder (PTSD), pelvic pain, migraines, and diagnosis of COVID-19 prior to vaccination. Concomitant medications included etonogestrel (NEXPLANON), duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR), pantoprazole, and others (unspecified). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported) on 31Dec2020 at 11:45 AM at the right arm for COVID-19 immunization and patient was 20-year-old at the time of the vaccination. On 22Jan2021 at 20:30 (reported as 08:30 PM), the patient experienced body aches, chills, shortness of breath (SOB), and fatigue. The reporter considered the events as non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events body aches, chills, SOB, and fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

15 min after vaccine, pt started complaining of chest pain and shortness of breath. EMS called and transferred to local hospital

After two minutes post vaccination patient reported feeling extremely anxious, hyperventilating. Advised to lay in recliner, given fluids and monitored for an extended period. Vitals 110/82, 76 HR. After 60 minutes observation patients symptoms resolved and cleared to leave.

This patient was given the COVD vaccine and then had an adverse reaction. She experienced a racing heartbeat, couldn't feel her tongue, and she had difficulty breathing. One of the pharmacists who was monitoring the patient administered an epi-pen and after 20 minutes or so the patients symptoms subsided.

Rash is on my chest and on my upper back; Can barely breath; I can't really eat or swallow because my throat is swollen; I can't really eat or swallow because my throat is swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Feb2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma, diabetes, autism and attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 03Feb2021, the patient had rash on the chest and upper back; can barely breathe; and could not really eat or swallow because the throat was swollen. The patient did not receive any treatment for the reported events. The outcome of the events, 'rash on the chest and upper back', 'can barely breathe', 'could not really eat or swallow because the throat was swollen', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.

- Hot and burning internally immediately - Face redness and swelling and all below within the first 30-60 minutes - Rash on both arms, chest, legs - Lips bright red - Itchy - Sweating - Flush - Throat pain and mild swelling

Patient reported symptoms of: tachycardia, shakiness, vision changes, tongue numbness and shortness of breath following the first dose of the COVID19 Pfizer-BioNTech Vaccine on 2/5/2021. Patient said that historically has experienced tachycardia and shakiness after getting a flu shot or booster a few years ago. Symptoms reported by patient were enough to suspect potential anaphylaxis, and patient consented pharmacist to administer epinephrine. Patient was then advised by the pharmacist to follow-up with her primary care doctor as soon as possible to report the incident and to discuss the risk versus benefit of the vaccine, whether recieving the second dose would be appropriate for her. Patient returned to assisted living facility for her second dose of the COVID19 Pfizer-BioNTech vaccine on 2/26/2021. Patient said that she discussed the incident with her doctor, was told it would be appropriate to get the second dose despite her reaction and was advised to take "cautious measures". Pharmacist reviewed the patient information and screening questions, discussed the potential side effects and reiterated her risk of experiencing the same reaction with the second dose. Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Pharmacist asked patient if she had any questions/concerns or additional information to add prior to getting her vaccine, and patient denied having any at that time. After administering her second dose, pharmacist instructed patient to stay in the observation area for at least 30 minutes and to ask the staff for water given her experience with the first dose. Patient asked pharmacist how common it was for someone to get a reaction from the vaccine, and then mentioned that her family memeber had to drive her to the emergency room after her first dose becuase her throat was "burning", and was told that her throat was "a little swollen" and recieved a second dose of epinephrine at the emergency room. Patient included this information after the fact her second dose was already administered. Approximately 5 minutes after receving her vaccine, the patient reported similar symptoms that she experienced on 2/5/2021: tachycardia, vision changes, shortness of breath and chest tightness. After monitoring patient with no resolvement of her symptoms, patient was then given a dose of epinephrine by the pharmacist, and the paramedics were called in to assess patient and take her to the emergency room.

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.

48 horus after second vaccine Right eye periorbital swelling and mild drainge Throat swelling described as feeling like it was hard to swallow - no acute distress Question of increased respiratory rate - normal respirations noted in clinic 2.5 x 2.5 cm nodule, well demarcated and moveable with sudden appearance to forehead Onset of floaters in B/L eyes occurred 4 hours later, after administration of oral benadryl and prednisone Tx: Patient was given Benadryl 50mg orally and Prednisone 60mg orally. Withing one hour throat tightness resolved, respiratory rate reamined normal, left eye swelling was improving and nodule to forehead was decreasing in size. Floaters were persistent. 24 hours later pt reports no recurrence of throat tightness, normal respiratory rate, resolution of left eye swelling, some decrease in size of forehead nodule. Floaters have been persistent and unchanged. *24 hours after second vaccine pt has onset of palpable lymph nodes to anterior cervical chain, single node to left supraclavicular chain and left axillary swelling. This was not considered an allergic reaction and attributed to immune response to vaccine.

After receiving first mRNA Covid vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.

Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed throat closing, angioedema, and perioral cyanosis. They were treated by EMS on site with epinephrine, diphenhydramine, methylprednisolone, ondansetron, and normal saline fluids. They were transported to emergency department. During reexamination, the patient?s symptoms improved and they were discharged to home.

20 yo female with recent hospitalization for myocarditis. Pt initially Dx with Covid 19 on 31 Dec 2020 and received Pfizer COVID Vaccines on 19 and 09 Feb. Pt reports on 21 Feb developing fevers of 107 and stomach upset, by 25 Feb she developed chest pain, SOB, weakness, continued fevers and diarrhea. She was seen at ER on 25 Feb where she was tachycardic, hypotensive, and hyponatremic with an elevate lactate. She was transferred to another hospital and found to have a Troponin of 0.629. she was admitted from 25 Feb to 04 March. During that time she had an ECHO with an EF of 35-45% with global hypokinesis and peak BNP of 1389. Pt is currently felling well with no chest pain or shortness of breath.

chest heavy, throat swelling. Evaluated by EMS- Transported to Emergency room/department or urgent care.

Patient reports to clinic with vaccine related illness. Patient received the 2nd Pfizer COVID Vaccine on 3/14/21. She reports having developed symptoms on 3/15/21 including fever, chills, headache, myalgia, chest tightness, runny nose, and productive cough. She reports coughing up purulent sputum. She reports having congestion and ear pain for 2 weeks prior to receiving vaccination, related to seasonal allergies. She denies sick contacts and has not been taking any OTC medications at this point. Vaccine Reaction Patient presents with: body aches, fever and fatigue Presenting symptoms: cough, fatigue, fever, headaches, myalgias, rhinorrhea, shortness of breath and sore throat Severity: Moderate Onset quality: Gradual Duration of current symptoms: 2 days Timing: Gradually worsening Chronicity: New Treatments tried: Rest Worsened by: Activity Response to treatment: Mild improvement Associated symptoms: arthralgias, chills and nasal congestion Associated symptoms: no abdominal pain, no chest pain, no decreased appetite, no dizziness, no ear pain, no neck stiffness and no lethargy Zika exposure risk: None Covid-19 Vaccine #1 Date: 1/21/2021 Covid-19 Vaccine #2 Date: 3/14/2021 Vaccine Manufacturer: Moderna Covid-19 Administration Site: Left Arm Patient prescribed: Bromfed, Ventolin, Flonase,Doxyxyline, and encouraged to take Tylenol and rest. She was educated on when to go to the ER if worse.

Part one: Within one minute of injection, I was extremely dizzy and had to force myself to breathe. My hearing became muffled and I couldn't hear. I was hot and cold, pouring sweat. My tongue was numb and my mouth became dry. Part two: As the dizziness began to subside, the second phase of the reaction started. I had nausea. I felt EXTREME abdominal/uterine cramping, which was the worst part. The cramps came in waves (Ex: cramp for a minute, subside for 10 sec, repeat). I thought I was going have an uncontrollable bowel movement as a result, but thankfully did not. The cramps lasted about thirty minutes. The dizziness became mild during this phase but was still there. I was in excruciating pain and debated calling an ambulance. This pain felt worse than when I broke two bones. During the entire reaction I felt extreme anxiety and impending doom (I did not feel this way prior to receiving the vaccine). For the rest of the day I felt tired and extremely anxious (impending doom).

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Medium

Patient felt her throat was closing. She experienced nausea and itchiness. EMS responded and administered diphenhydramine 25mg injection. Patient was taken to hospital via ambulance.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: WAS CLOSE TO FAINTING BUT DID NOT.-Mild, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: COMPLAINED OF DIZZINESS, VISION DISTURBANCES. STORE CALLED EMS BUT BY THE TIME THEY GOT TO STORE THE PATIENT WAS ALERT AND RESPONSIVE. PATIENT ALSO COMPLAINED OF THURST AND WE GAVE HER WATER TO DRINK. THEY DID A FULL WORKUP ON HER BUT DID NOT TRANSPORT HER TO HOSPITAL. SHE LEFT WITH HER MOTHER , EVENT LASTED ABOUT 45 MINUTES .

Patient c/o "feels some dizziness in head" while sitting in Covid Monitoring area; post 1 st dose Pfizer vaccine, administered est. time of 10 minutes prior. Assisted to monitoring cot into semi reclined position. Is alert, talking with no visible distress. 1317 Vitals 124/76, O2 sat 99%, P 71. Pt. mother at side. Notes allergy to PCN with no other health issues; does have speech impediment. 1318 notes continued feeling of dizziness and SOB with mask on; mask lower below nares: encouraged to deep breathe slow. 1318 EMS called. 1230 Vitals O2 sat 100%, P - 68. No noted skin rash / redness, denies itching and no tongue / lip edema. Remains alert and responsive to staff questions. 1322 Vitals - B/P 117/70, P 70, O2 sat 99%. 1325 EMS arrived. Pt notes decrease dizziness / SOB with P - 67 & O2 Sat 99%. 1328 EMS assessment in progress; O2 sat 99%, P 71. 1332 Pt transported from site via stretcher with EMS and mother at side. Patient left without being seen in the Emergency Department

Fast heart rate/feeling like I was going to pass out; dizzy/heart palpitating/skin sensitivity (my skin would easy become flushed) I received the shot on Wednesday morning, was tired for the rest of the day (normal) and mentally I was healthy/happy. Thursday morning, I started to feel extremely sluggish and I struggled to catch my breath. 1-10 (10 being severe) I would rank this at a 5. Friday morning is when I really felt like an 8 and my listed symptoms weighed me down. I would define these symptoms as episodes. Each episode would last a couple of minutes and I would return to my normal state. I felt an 8 till the following Sunday/ Monday. Tuesday, felt a little better.

Pt. states she received her vaccination on 04/06/2021. She states she was experience soreness at the vaccination site and fatigue for 2 days. Today she is experiencing chest pain on inspiration and was unsure if this could be related to the vaccine. Advised patient to go to urgent care/ED or contact primary care physician

Patient reported throat tingling similar to a fruit allergy she has. She was given 50mg benadryl 30 minutes post-vaccination. Patient developed wheeze/voice change 1 hour post-vaccination. EMS was called. 90 minutes post-vaccination, patient condition was worsening and she was transported to ED via EMS

received her first dose of Pfizer vaccine of the series. On her way to the observation area she began feeling weak, lightheaded, nauseas and dizzy. This was about 5 minutes post vaccination. She made it to an observation chair and an RN was notified She was given an ice pack and water. VItals were initially read at BP 69/42, SPO2 99%, and HR between 90 and 100. BP was then taken manually and was 98/62. Despite SPO2 level steady of >95% , patient state she was having trouble breathing and speaking. She also stated that her throat felt sore. She also felt "shaky" and was visibly shaking. She continued to appear and feel worse. Her mother was with her and agreed with the move to call an ambulance and she was transported to the ER.

After about 30 minutes post-injection, throat started to get tight and scratchy. After about an hour and a half, tongue went numb and throat did not get better, and was still tight and closing. Gave me prednisone and Benadryl and took albuterol inhaler that opened throat and that helped open throat and Benadryl helped with the scratchiness.

Major dizziness, tightness of the chest, diarrhea, difficulty breathing, rapid heart beat, the symptoms began to show after the vaccination in 4 hours. At first, it was only pain in the arm where the injection occurred. Now, there is also swelling of the arm when the injection occurred.

After I was administered the vaccine at the University, after spending a few minutes I began to feel a sensation in my throat as if it were swelling, scratching and when I swallowed I did not feel it. Every time the minutes passed I felt it more. After the 15 minutes passed, I notified him and a paramedic gave me all the vital signs which had an elevated blood pressure and an elevated pulse. They took me to the ambulance where I was under supervision. I continued with the sensation of throat and dizziness. I took the medicine that the doctor had prescribed: benadryl and prednisone in case of having an allergic reaction. I continued with the symptoms and my mother was watching me in case of having difficulty breathing and when I got home I got a little nauseous. Present tiredness and pain in the area that disappeared on Sunday. From Sunday until today I have presented insomnia since it is difficult for me to sleep and I manage to sleep a few hours.

Within the first 20 minutes her arm was heavy. By 9:30 pm extreme arm soreness, chills, swollen and burning throat. That night intense fatigue but couldn?t sleep because of nausea and vomiting. By morning a cough developed, sneezing and clogged and mucus dripping from nose. By 1:00 pm 4/17/2021 fever of 99.9. By 3:20 pm it is 101 degrees with a headache, body aches and straining eyes.

Starting one day after my vaccine, i began to feel a clogging and muffled sensation in my right ear. Slowly throughout the day i lost my hearing in that ear. I also have difficulty breathing through my nose, especially my right nostril.

Rash - both arms, redness to cheeks, history a anaphylaxis. Complaint of difficulty breathing. Hydrocortisone cream applied bilateral arms. Patient took Benadryl 50mg tablet. Onset of symptoms was observed within 60 minutes of vaccine injection. Symptoms improved within 45 minutes.

A mild?severe allergic reaction that caused massive swelling (face, tongue, and neck), severe pain, a rash/hives, shortness of breath, and minor asphyxiation.

patient c/o shortness of breath and dizziness. Started at 2:05PM, Dr. was notified and evaluated patient Vitals: 100/72mm hg Pulse: 82 SPo2: 98% DX: Vasovagal syncope Monitored patient symptoms for 30 minutes patient was stable and was release home

headache in my eyes so bad i couldn?t open them. terrible nausea that resulted in vomiting at 6:30 A.M. the next morning. Internal bleeding in kidneys that resulted in blood and foam in urine - blood cleared in 4 days; foam cleared in 4 days. Back pain where kidneys are located. Shortness of breath when lying down for 3 nights; had to sleep propped up.

Patient had vasovagal episode manifested with shaking and numbness of the upper and lower extremities, skin is warm to touch and flush. Nursing Intervention: Elevate legs on dashboard, apply cold compress on nape, give cold water to drink, V/S taken O2 Sat is 98%, Pulse is 105. Informed patient on what is happening and keep her calm. Continue monitoring. After 30 minutes patient complain of increase shaking and numbness, she said no sensation in all upper and lower digitalis and did stand up to feel her legs and feet. After a while she said she feel dizzy so I sat her inside the car and elevate her legs on dashboard then she complain of SOB. Take her V/S O2 Sat is 89 Pulse is 109. After 5 minutes take her O2 Sat again and its 85 Pulse is 110. Report to my site lead about the V/S and we Administer 8L/min of oxygen. I massage her hand and arms, stay with her. After 5 minutes her O2 Sat went up to 99%, pulse is 93.give her drink and snack. Observe her for another 10minutes, V/S is stable but her shaking and numbness still there. As they leave I advised them to go to the ER if symptoms did not stop or worsen.

On 04-21-2021, my muscles started to feel fatigued and I had chills. I woke up on 04/22/2021 at 5 am throwing up. I was throwing up all morning, having diarrhea, blurred vision, extreme fatigue, dizziness, shortness of breath, and tachycardia (160.)

Patient with PMH significant for asthma, allergies to shellfish and peanuts, presents to ED for evaluation of difficulty breathing. Mother reports the patient had been wheezing for the past week, and gradually worsened. Per mother, prior to arrival patient could not breath and having increased respiratory distress. Just prior to arrival the patient became unresponsive. The patient was tachycardic, tachypneic, hypertensive and hypoxic. The patient was emergently intubated and placed on mechanical ventilation. Per the patient's mother. The patient received her first dose of COVID vaccine the day before arrival to the ED. Diagnosis: Acute Respiratory Failure; Acute Asthma Exacerbation verses Allergic Reaction.

pt. had a little tightness in her throat which got better a couple of minutes later. She was able to swallow water with no issues. pt. is allergic to peanut, and had Epipen with her. Symptoms resolved 8 minutes later, and mom drove her home. V/S 113/73, 79, R-18, O2Sat 98%

Left arm rash within minutes of receiving vaccine. Then resolved. Headache, dizziness, difficulty concentrating, difficulty focusing vision, right ear pain-intermittent. Shortness of breath-improved with albuterol inhaler. History of asthma.

had two blood clots on her lungs; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 20-years-old via an unspecified route of administration, administered in arm left on 28Mar2021 12:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included birth control from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for birth control from Dec2020 to 12Apr2021. The patient experienced had two blood clots on her lungs on 12Apr2021 18:00. The patient was hospitalized due to the event from 12Apr2021 to 14Apr2021. The patient was recovering from the event.

20 yr old female here to receive her 2nd dose of COVID vaccine. She stated no reactions after 1st dose. After receiving dose she went to sit in chair as instructed before leaving. Two minutes later RN was notified by pharmacy staff, pt not feeling well. On approaching, pt was very pale and resting her head on friends chest. RN asked if she was having trouble breathing, she stated "A little." 911 was called and an Epi pen was brought to scene. RN asked if pt wanted to lay down and assisted her to the floor, lifting her legs up on a chair. She was very weak and had urinated on herself. She stated she had not eaten anything today and only had a little water. She was given water but only had a small sip. RN stayed by her side while waiting for paramedics to arrive. Paramedics stated BP was low and took her to Medical Center.

Passed out at around 9:58 AM, woke up feeling extreme weakness, shortness of breath, fever, and covered in sweat.

Patient had a clinical illness consistent with MIS-C after the vaccine but also had confirmed COVID infection. Hospitalized in ICU with high fever, rash, cardiomyopathy (myocarditis), renal failure requiring steroids and IVIG.

Approx 12:25pm, patient received Pfizer Covid vaccine, assessed by RN at 12:26pm, 12:30pm patient complained of throat tightness, 12:31 patient complained of voice being raspy. Radial HR 120, pupils equal and reactive. Denies nausea. No hives/rash noted. At that time, patient admitted to previously being diagnosed with Paradoxal Reactions to Medications, Anxiety and Depression. Patient takes Zoloft and Elavil, and admits to being anxious. 12:40-12:43pm patient states that she is feeling SOA, throat tightness, dizziness. Respiration unlabored, however patient admits to becoming more anxious. Patient red faced, HR 130's. 12:44pm Epinephrine 0.1mg/0.15mg/0.3mg auto injector given IM to right outer thigh. Patient tolerated well. EMS called at 12:45pm. EMS arrived to assess patient at 12:53pm. Patient walked into ambulance. Patient did not require O2. No hives noted. Denies nausea. Patient transported to ER per protocol for evaluation.

Pt received 2nd dose vax and was in observation area w/ her sister. Pt denied any reaction after first dose, did report hx of asthma.Ten min post-vax, pt called observation nurse (RN) w/ complaint of "lung pain," some SOB and abd pain. Pt had also developed hives on her chest and neck, visible to observation nurse. Pt was transferred to EMT area for assessment and observation. Pt was alert and oriented to place & time and answering qx w/o WOB or apparent distress. However, during assessment of VS, pt developed add'l hives on face, w/ eye swelling. EMTs and charge nurse recommended transfer to ED d/t multiple early sx of possible severe reaction. Pt and parent agreed. Pt transferred to Hospital via ambulance d/t risk for emergent allergic reaction.

She got her first dose of the Covid 19 vaccine on 14Apr2021/She was tested for the Covid 19 virus by the nurse at her school on 19Apr2021.; she had a headache, cough, and shortness of breath; she had a headache, cough, and shortness of breath; she had a headache, cough, and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot# EW0162), via unspecified route of administration in right arm on 14Apr2021 09:00 at single dose for COVID-19 immunization. The patient was not administered with prior vaccine within four weeks. The Patient medical history and concomitant medications were not reported. There was no AE prior vaccination and no history of previous immunization with the Pfizer vaccine considered as suspect. She got her first dose of the Covid 19 vaccine on 14Apr2021 then she got the Covid 19 virus. She did her quarantine and all her symptoms have been gone for a while and she is all better now. Her second Covid 19 vaccine is scheduled for 05May2021. She enquired if she should get her second vaccine on 05May2021 or if she needs to reschedule it. She was tested for the Covid 19 virus by the nurse at her school on 19Apr2021. Her results came back positive for the Covid 19 virus on either the 21Apr2021 or 22Apr2021. She got tested for the Covid 19 virus because after she received the Covid 19 vaccine she had a headache, cough, and shortness of breath. Her symptoms started on the 15Apr2021. She started feeling better around the 18Apr2021. The patient did not require any Emergency Room/ Emergency Room due to adverse events. The patient was recovering from the event. NO PQC involved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

During post-vaccination observation period patient reported sensation of throat feeling "thick". No other complaints. diphenhydramine 25mg oral suspension administered with resolution of symptoms by time of discharge from facility.

I felt like I was wheezing. There wasn?t an audible sound of breathing difficulty, but it felt like I had mucus in my lungs when taking a deep breath in.

Patient called having severe muscle pain describing it as feeling like all muscles in body spasming. Said due to spasms it felt difficult to breathe. Patient was advised to get checked out at hospital.

Patient developed chills, shaking and shivering about 15 minutes after her shot. No fever. No allergic symptoms such as throat tightness, SOB, itching, rash or hives. No wheezing. Symptoms resolved slowly and progressively over about 50 minutes of observation. She has similar symptoms at home about 24 hours after her first shot. VSS stable throughout. Initial BP 111/72, pulse 102, O2 sat 99%. No orthostasis at dismissal. Nothing to suggest vasovagal or allergic reaction. Likely anxiety reaction

I have to use inhaler because I can't breath; my cough is very just wheezy sounding; my cough is very just wheezy sounding; Little stuffy nose and everything; I have like all of the symptoms of like COVID and its like progressively getting worse; Little stuffy nose and everything; I have like all of the symptoms of like COVID and its like progressively getting worse; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On 03May2021, the patient had a little stuffy nose and everything but she have like all of the symptoms of like COVID and its like progressively getting worse and patient reported that everybody was telling me that these symptoms were normal to get like this. She thought she was on her day 3 now or something, which it should probably be gone because she kept reading everywhere that they only have symptoms for like 1-3 days but it's been getting worse. On 04May2021, the patient had to use an inhaler because she can't breath and her cough was very just wheezy sounding. She was not sure if she should go get the COVID test or was that normal to have these symptoms. Treatment for the events included over the counter medicine like Advil and inhaler. Outcome of events was unknown. Information about batch/lot number has been requested.

Nauseous and vomiting from start of reaction. My left arm and hand are numb this morning. So far I'm having minimal breathing difficulty but this did not settle in till about 3 a.m. I have not been seen at a hospital for this yet, but If symptoms do get worse I plan to go to an emergency clinic.

Patient said she feels very dizzy and she felt really cold and had tremor little later. Her condition of shaking got worse over period of time and she complained about shortness of breath and she was gasping for air . I asked her if she had or experienced the allergic reaction in the past and she got the prescription EPIPEN from md but didn't have it with her. I injected EpiPen 0.3mg IM. After5-10 minutes later, she complained about numbness on her extremities and tingling sensation on her finger and she still experiencing tremors. We had to call the ambulance and they arrived within 5-7 minutes.

[Chest Pain ] This is a 20 year old female who received the 1st Pfizer dose on 5/17/21. On 5/21/21 at 1723, the patient reported to our urgent care facility with a chief complaint of chest tightness (hurts when laying down), difficulty breathing, and nausea since the evening of 5/20/21. Given a recent Nexplanon insertion the day prior (5/20/21), the provider had a concern for possible PE so the patient was referred to the Emergency Department. The patient arrived at the ED and was seen by the provider on 5/22/21 at 0416. The patient continued to report chest discomfort as a heaviness, squeezing, ache. The pain was constant and worse upon taking a deep breath. Following a review of labs, EKG, Troponin, physical exam, the ED provider diagnoses 'chest wall pain' and the patient was discharged home with instructions to f/u as an outpatient for any ongoing symptoms. No additional chart documentation as of this report date (5/25/21).

Extreme sharp pain on right side of back when breathing - on 4/14/21 Went to primary care physician on 4/15/21 He had blood work and x-rays done - d-dimer came back 4 Admitted to ER In ER CT done - found pulmonary emboli (severe on the side where the pain was) Admitted to ICU that night (4/15/21) Stayed in ICU for 3 days Moved to floor Discharged from hospital on 4/19/21 Still dealing with extreme fatigue (unknown cause) still on blood thinners - 5/25/21

stomach hurting; started not feeling good; nauseated; headache; coughing; sneezing; cold-like symptoms/cold; nose got itchy/eyes got itchy; difficulty breathing/having trouble breathing; feels weak/has no energy; She experienced chills about three hours after the vaccine.; abdominal pain; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191; Expiration Date: Sep2021), via an unspecified route of administration, in Left arm on 22May2021 at 11:30 (at the age of 20-years) as single dose for covid-19 immunization. Medical history included ongoing acid reflux in the stomach; was diagnosed about one or two years ago. The patient did not receive any vaccinations within 4 weeks prior to the administration of suspect vaccine. The patient's concomitant medications included ongoing Tri-lo-sprintec (started taking it to regulate her cycle as she had an irregular period; she started this birth control 2 or 3 years ago). On 22May2021, the patient waited 15 minutes after the shot and felt fine, but later on that day (a couple of hours after) she got chills (about three hours after the vaccine). She stated she had normal side effects and did not think anything of it. On Sunday (23May2021), she had difficulty breathing (trouble breathing) and felt weak (feeling very weak and has no energy). She voiced it's hard for her to wear a mask. When she had to put a mask on it really felt like she could not breathe, and the air feels stuffy especially if she wears a mask; every couple of seconds she had to wear the mask under her nose because she could not breathe. Caller stated that she did not have this problem before receiving the COVID vaccine. On Monday (24May2021), she felt like she was coming down with a cold. Caller stated that she thought that might be her trouble breathing was from her cold-like symptoms, but she does not think it was, because she was not experiencing any cold-like symptoms on Sunday and was only having trouble breathing. She experienced coughing, sneezing, itching eyes/nose, chills, and headache. On Wednesday (26May2021), she started feeling nauseated (got very nauseous), not feeling good, she was getting a headache and had caught a cold. Caller stated she did not know if it was from vaccine shot but her eyes got itchy, her nose got itchy, and she kept sneezing and coughing. Yesterday (26May2021), the chills went away, she has not had any chills today, but she does not know if she will have any from this point on. She believed that she has recovered with lasting effects. Caller stated that not feeling well was ongoing and persisting, but then stated that she feels it was worsening. Yesterday, she just felt nauseous, today she woke up with her stomach hurting very badly and abdominal pain; her weakness has continued. Yesterday she took pantoprazole for the abdominal pain and Tylenol for the pain and headache. She stated that she had a slight headache that is now coming and going, clarifies that it is persisting. Caller thought the reason that her stomach is hurting was because of her stomach acid problem. She deals with a strict diet that she must follow for things she was not supposed to have. Since she had the COVID shot, she believes it was affecting the acid problems in her stomach. Caller clarified that she was calling to see what she should do, if she should go see a doctor or if this is normal. The outcome of events Dyspnoea, Asthenia, Sneezing, Headache, stomach hurting, Itchy was not resolved. The outcome of events of Nausea, started not feeling good, Cold like symptoms was resolving. The outcome of events chills was resolved with sequel on 26May2021, and Cough resolved with sequel on 25May2021. The outcome of Abdominal pain was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Patient was given the vaccination and she moved from the immunizing chair to the waiting area. While in the waiting area, the patient passed out briefly (less than 15 seconds), revived and was complaining of blurred vision and that her brain felt "funky." She then broke out in full body hives and was administered 2x25mg benadryl tablets orally. 911 was called. Patient then began complaining that her face and body felt numb and tingly all over. Paramedics arrived and took patient to the hospital.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: respiratory symptoms-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Error: Wrong Dose of Vaccine - Too High

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Error: Booster Given Too Early, Additional Details: GIVEN 3RD DOSE IN ERROR. INITIAL SX: FATIGUE, HA, CHILLS, THROAT DISCOMFORT. DELAYED RESPIRATORY SYMPTOMS DEVELOPED OVER WEEKEND

I was vaccinated on Tuesday, felt normal reaction. Woke up Saturday morning with excruciating pain from my right armpit to the bottom of my rib cage. Pain was worse every time I inhaled. My breast on the right side swelled up and became red splotchy and hot. Had fever symptoms for 2 to 3 days afterwards. The excruciating pain in my chest and rib cage subsided within 6 to 8 hours. However the swelling in my right breast and redness did not subside for about three days.

Fever Chills Body aches Shortness of breath Headache Fatigue Nausea Vomiting Dizzyness Loss of appetite Body pain

While patient was waiting in the waiting area after the vaccine, patient started to experience breathing issue, along with neck congestion and tingling in the mouth. Called 911. After 15 min of evaluation still didn't get better, so started IV diphenhydramine and Epi-pen and then take her to ER for further observation.

Myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. A 20-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient had not known allergies. Medical history included, abdominal pain ongoing, the patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, On 23May2021, The patient experienced myocarditis, chest pain , shortness of breath with outcome of recovering. The patient was hospitalized for myocarditis for 5 days. The patient was hospitalized for chest pain for 5 days. The patient was hospitalized for shortness of breath for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23May2021. Therapeutic measures were taken as a result of myocarditis (myocarditis), chest pain (chest pain), shortness of breath. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of myocarditis,chest pain,dyspnoea. The case will be reassessed once new 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

Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores - saw PMD received muscle relaxer, and antibiotic cream... in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) - woke AM 6/11/2021 with severe shortness of breath and was taken to ER - diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest. She died as a result.

Sudden onset of shortness of breath for an hour or so, then cramping and pain in left upper and lower extremities, followed by numbness in left upper and lower extremities. With pain in back of left knee. Also menstrual spotting for severa days? numbness progressed on 4th day after vaccine

Immediate fatigue and malaise. Nausea and vomiting by the next day, which persistent for 2 weeks. Now has higher pitched voice and dyspnea, presumably from laryngeal irritation.

I administered Covid 19 immunization and pt was waiting the 15 minutes for observation. About 5 minutes later, companion said pt said she felt like she was going to faint. We gave her a cold pack for neck and I was monitering breathing and consciousness. Pt said she sill felt faint, was having difficulty breathing, difficulty seeing and hearing. Lips turned faintly blue so technician called 911 and I administered 1 dose of Epipen in left thigh. A few minutes later I gave 10ml of Dihphenhydramine liquid. EMTs responded quickly, checked pt but symptoms resolved and she was not transported. After event patient did say she had not eaten that morning.

Fever, swollen eyes, swollen throat, fatigue, body aches , still present almost 2 weeks after vaccine. Allergic reaction (swollen eyes abs throat) occurred 5 days after vaccine

4/21/21- developed cough. 5/12/21 developed shortness of breath and exertional dyspnea. 5/15/21 developed substernal chest discomfort, blurred vision. Went to local ED- no significant findings. 5/19/21 transthoracic echo showed LVEF 52%. 6/7/21 -symptoms resolved except for mild congestion. 6/27/21 cardiac MRI: demonstrated normal biventricular function (LVEF 63%), mild epicardial scar (mid inferolateral and lateral walls), mild patch mesomyocardial scar (mid septum), mildly elevated T1, T2 in the septum.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium

Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control Cause may be a salad Breathing still doesn?t feel normal

became shirt of breath about 5minutes after getting the shot; This is spontaneous report from contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration, in left arm on 17Mar2021 at 11:00, (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient have no allergies to medications, food, or other products. Patient did not receive any concomitant medications. 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, the patient was not tested positive for COVID-19. On 17Mar2021 at 11:15, the patient experienced short of breath about 5 minutes after getting the shot. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of shortness of breath was resolving. No follow-up attempts are possible. No further information is expected.

Started having throat tightness and chest tightness, having difficulty breathing. Lasting about 15-20 minutes

Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of breath, dizzy/confused, anxious. Went to the emergency room and was given an ECG which was abnormal, tested positive in blood test for blood clot but was negative on a CAT scan. Doctor stated it was minor myocarditis, was perscribed ibuprofen and percocet and sent home

presents with chest pain and SOB after getting the Pfizer COVID vaccine this morning. She reports that she often gets chest pain and SOB when anxious. She reports that the SOB has resolved and the chest pain is getting better. She denies any wheezing or difficulty breathing. She denies any symptoms prior to the vaccine. She says she was not anxious about getting the vaccine but was not looking forward to getting it this morning.

On Sunday, December 27, I had the injection. I was fine. Monday the 28th, I was in pain in my arm. December 29 to currently ( January 4 2021) I am sick. I believe I got it from the vaccine. I have been out of work for two weeks. I will not go get the other vaccine. I thought I was protecting myself but find out I am not. I am currently laying in bed sick as a dog. I have shortness of breath, cough, sneezing,sore throat, and bodyaches. I am in severe pain

tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.

After receiving vaccine about 30 minutes, she felt dizzy. 45-50 minutes after receiving vaccine she felt itchy throat, cough, and swollen throat *Treatment: 50 mg of benadryl, 1 pen of Epipen 0.3 mg. Called EMS

lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021. Events result in doctor or other healthcare professional office/clinic visit. All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.

dizzy; itchy throat; coughing; swollen throat; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, NDC number: 59267-1000-1; Expiry Date: Mar2021), via an unspecified route of administration on 07Jan2021 11:20 at 0.3 mL, single at left arm for vaccination. Medical history included Cushing's disease (recovering), bipolar disorder from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) for bipolar disorder. On 07Jan2021, looked like after receiving the vaccine about 30 minutes later patient was standing and felt like dizzy. About 15 or 20 more minutes, or 45-50 minutes after received injection, she felt like itchy throat, then itchy throat triggered coughing, then she felt like swollen throat. For the treatment on scene patient was administered 50mg of diphenhydramine hydrochloride (BENADRYL) and when she complained of swollen throat was administered epinephrine (EPI-PEN) 0.3mg injection to right thigh. Then they called EMS who transported her to the hospital where she was admitted to the hospital. Outcome of events was unknown. This report was considered as serious per caused/prolonged hospitalization. Causality: Cannot jump to that conclusion.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events dizziness, throat irritation, cough and pharyngeal swelling 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.

1/13/21: received second dose of COVID-19 vaccine. One hour later experienced sensation of arm numbness, resolved within hours. Later in evening experienced a sensation of burning in entire right arm. 1/14/21: woke at 2 a.m. with sensations of shortness of breath. At 5:30am developed muscle spasms in form of twitches in right arm and diffuse muscle discomfort. Additionally describes chest pain in substernal location with radiation to right rib cage. Chest pain reproduced and accentuated by direct pressure. Developed fever of 99.9 degrees and was turned away when going to work. Returned home and recorded temperature slightly above 100 degrees. 1/14/21: experienced continued muscle discomfort and right arm twitches. Remains short of breath but seems to be improving. 1/15/21: continued complaints of chest pain radiating from middle of chest to right side, continued shortness of breath, and whole body pain.

Next day after the 2nd dose of the COVID vaccine patient began feeling fatigued and nauseous. Then at urgent care, patient experienced difficulty breathing, tachycardia, and chest tightness. Patient also had a seizure and brief LOC. Patient went to urgent care, rapid response called and then transported to EMS to nearby hospital.

anxious, c/o a tightness of throat, and itching. She took oral loratadine followed by oral Benadryl. She verbalized improvement in symptoms but requested assistance to go the Emergency department.

Fever greater than 100°F, extreme chills, cold extremities, muscle aches, hard breathing, and difficulty sleeping. I took 2 tablets of Acetaminophen 650mg when started to fever around 10pm, drank lots of warm uncaffeinated tea, and slept on a heated bed. Slight fever of about 99°F and muscle ache the day after, took another 2 tablets of 650mg acetaminophen at 10am.

DEVELOPED ELEVATED BLOOD PRESSURE (181/106) AND TACHYCARDIA (125), SOB, FAINTNESS, NAUSEA, RED EYES. GAVE BENADRYL 25MG PO AT 0940. BP DECREASED TO 143/88 AND PULSE 99.

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.

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.

headache, sweating and shaking 15 minutes after vaccine During the night woke up with chest tightness and shortness of breath and went to the ED-xray,ekg, IV fluids and Zofran

Experienced vomiting morning after shot along with fever of 101 and dizziness with standing, sweating and chills (1/28). Experienced Severe swelling of axillary lymph nodes (1/28-1/30). Severe swelling of supraclavicular lymph nodes ( 1/29-2/01) . Mild swelling of cervical lymph nodes (1/30-02/02). Mild swelling of submandibular lymph nodes (02/02) Lymph node swelling seemed to spread superiorly each day. Limited ability to raise arm/ sleep and pain with coughing breathing and swallowing.

exacerbation of mast cell disorder manifested sinus stuffiness, slightly SOB, facial erythema VS: B/P 122/82, P 84, Pulse ox 98%.

Immediately after receiving vaccine, R arm twitched, pupils dilated, weak, in and out of responding. BP 98/60; HR 78; normally runs low BP. Arm numb; throat tight. No welts; extreme fatigued. Rapid response; epinephrine given via epi pen; transported to ED.

Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. 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.

My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and nausea the night of receiving the vaccine. My second dose of the vaccine was 2/8/2021. I felt tired the night of receiving the vaccine and went to bed a 8pm. I woke up at 6:10am on the 9th with a severe migraine, severe nausea and dizziness. I ate a small amount and laid back down. I got out of bed at 9am and noticed both of my eyes and face were swollen and my throat was swollen. At this point I called my doctor and spoke to a nurse on the phone, she was short saying I needed to go to ER. Personally, I did not feel it was necessary at the time so I took a Benadryl and Ibuprofen. Throughout the day I continually got worse experiencing the same symptoms as the morning including sharp chest pain, restricted breathing, a low grade fever of 100.4, severe lower back pain and leg numbness. I took more ibuprofen and placed heat on my back. I took ibuprofen PM and woke up the morning of the 10th feeling better. Still have headache, lower back pain and swelling but is better than yesterday. I will notify my doctor today of the event that occurred yesterday (2/9/2021).

sudden tight feeling in throat followed by feeling like I couldn't breathe, then a red face. This happened for like 5-10 minutes, almost went to hospital. Also was shaking, coughing, felt nauseous, had diarrhea, bad body aches, a headache, and felt weak. All of this lasted for about 2 hours.

PATIENT COMPLAINS OF TIGHTNESS IN CHEST AND SLIGHT SHORTNESS OF BREATHE. PATIENTS 02 SAT WAS 97% ON ROOM AIR, HEART RATE IS 100 AND BLOOD PRESSURE IS 106/67. OFFERED TO MONITOR ADDITIONAL 15 MINS AND PATIENT REFUSED. PATIENT STATES FELLS BETTER AFTER SPEAKING WITH R.N.

21 yo female return from 2nd dose , c/o SOB , Flushed, foggy brain. 1608 BP- 128/88, SPO2- 98, P-87, R-18 Administered 50 mg Benadryl, pt began to feel increased dizziness, lowered patient to the floor and administered 6L of O2. doctor assessed patient, patient Alert and Oriented X3 lowered O2 level to 2L, Sat patient up in chair @1623 BP-146/98, SpO2-98, P-83, R-20. Pt sated she felt better and was released to aunt @ 1627.

Symptoms started after first shot after sleeping. Sore arm then a headache. After 12 hours symptoms got worse. Fatigue, slight SOB, overall body weakness/soreness. After 24 hrs of those symptoms they were mostly gone and 24 hrs after that I was symptoms free. No symptoms after second dose. I work in a out and inpatient hospital doing ultrasounds. I have done covid patients since March. I have never tested or tested positive for Covid but have been around it.

Severe breathing difficulty. Lasted 9 days which required use of albuterol inhaler every ~4-6 hours for the first 7 of the 9 days. Breathing difficulty slowly went away over many days after the first 7-9 days. Resting heart rate was also elevated (near 130-140) as well as lightheaded feeling for a few days when breathing difficulties were most severe. Now breathing is back to normal.

Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Date: 02/24/2021 Subjective Patient is a 21 y.o. adult who was seen at COVID Vaccine Clinic today for patients first dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient's 30 minute waiting period after the injection, the patient began to experience throat tightness and itching. Patient denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: includes peanut allergy, carries epi-pen. She takes 75 mg of benadryl nightly to help with insomnia and seasonal allergies. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: she was brought back to bay intially for observation as she reported to pass out when she gets shots. Shortly after injection, she developed symptoms above. No vagal issues arose. Objective Vitals Vitals: 02/24/21 1048 02/24/21 1100 02/24/21 1136 BP: (!) 153/85 106/76 124/72 Pulse: (!) 101 86 81 Resp: (!) 22 16 SpO2: 99% 100% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: Patient is not in acute distress. Appearance: Normal appearance. Patient is well-developed. Patient is obese. Patient is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Comments: Injection site without rash, erythema or swelling Neurological: General: No focal deficit present. Mental Status: Patient is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Close monitoring. Pt improving. Doing well with medication intervention. Pt has ride. Pt wheeled out to the front. Pt ambulates without difficulty. No dizziness. Instructions given on when she can take her next benadryl dose. APRN Electronically Signed 2/24/2021 11:25 AM

While in observation area, patient complained of racing heart and blood pressure elevation and some shortness of breath. Evaluated by EMS. BP 210/115 (average), P98-126. Able to communicate clearly entire time, some dyspnea but no respiratory distress. Due to elevated blood pressure and heart rate, she was transported to Hospital for evaluation/treatment.

5 mins post 1st dose vaccination patient began feeling nauseous, throat felt tight with mild pain when swallowing, tingling sensation from the chest down to her toes, facial flushing, and dizziness. She states these symptoms are common due to her history of EDS but today they are slightly worse since she got the vaccine. She was brought to the medical evaluation area via wheelchair and evaluated by us and EMS. Patient was administered Benardyl 50mg and provided orange juice and water. Vitals taken throughout and were slightly high in the beginning and then stabilized. Patient states her throat felt better and the tingling localized to her hands after 5 mins. Patient was monitored for over 45 mins. She was instructed to contact her PCP and her allergist to be cleared for her second vaccine dose. She was informed her 2nd dose should be administered at a facility where she can be observed closely. She declined transport to the hospital but agreed to follow up to the ER with any worsening signs of anaphylaxis. The nausea resolved and she felt less groggy upon leaving with her boyfriend.

Shortness of breath. Happening 2 days after the shot. Been occurring for over an hour now. Can't even speak a sentence without getting out of breath

Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who was seen at SVH COVID Vaccine Clinic today for patient's second dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. Patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient on was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, itching of skin and headaches CONT negative Eyes negative Respiratory negative GI negative Musculo negative Previous Reactions: Itching with first Covid shot Objective Vitals Vitals: 03/17/21 1501 03/17/21 1508 03/17/21 1523 BP: (!) 157/100 (!) 154/66 (!) 170/65 Pulse: 90 84 90 SpO2: 99% Physical Exam Constitutional: Appearance: Normal appearance. Patient is well-developed. HENT: Head: Normocephalic. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Uvula midline. Eyes: General: Vision grossly intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Neurological: Mental Status: patient is alert. Psychiatric: Behavior: Behavior is cooperative. Pt had taken benadryl before her visit. She was given Zytec and still had some rash and hives, but the throat tightness had went away. She was given water and crackers while in the bay. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Left at 3:42 Electronically Signed 3/17/2021 3:40 PM

pt. reports feeling like her throat is swollen on the R. Side. hx of asthma. pt denies any difficulty swallowin &/or other s/s medics present. pt. took benadryl 25mg - 1215 today, and again around 1400 today. 1415: 117/82; 69 16

Patient experienced syncope after administration of her first COVID vaccine. Her mother is a physician and was present, providing care for her by fanning, comforting and helping her to lie down on the floor next to the waiting chairs. The patient did not faint. She did experience what appeared to be heavy breathing and light-headedness. We provided an ice pack from the immunization cart. The mother stated that the patient experiences this reaction every time she receives a vaccine due to her fear of needles. After about 30 minutes the patient was up and smiling. The family was thankful for our concern and help.

i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium

After 4/5 hours I started getting hives all over my body, when I?d touched something I got hives in that part of my body or when something would touch my skin hives would appear and itch. Shortness of breath also increased as I got hives.

Dizzy 15 minutes into the vaccine. No Benadryl was given due to patient driving alone. Shallow respiration to deep breaths.

Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient was found by EMS in cardiac arrest. EMS was unable to get return of spontaneous circulation.

Patient states she is having chest pain, sob, and dizziness. Did not resolve after 30 min wait. Transported to ED. Provider notified.

Two small hives on left side of neck, fatigue, headaches, body aches, increase in tachycardia symptoms, shortness of breath. Tachycardia was treated in ER with IV saline.

Patient felt anxious prior to coming for vaccine due to last minute sign up. Right after getting the vaccine she experienced her throat tightening - stated she felt off- was shaky, lightheaded and heart racing. She came to the observation station- while sitting for observation she felt she wanted to get away from everyone else and came to the check in desk. Her symptoms started to subside when I escorted her to the recliner. I gave her some Gatorade bP 90/60 pulse 80. She was feeling less anxious O2 sat done at 11:51 99 % she stated she was feeling fine . repeat BP 104/60 p 60 at noon. I checked with lead at the clinic who agreed she should stay till 12:10 She felt fine when she left this nurse discussed the plan if she needed help would be to go to urgent care or call police if it was urgent.

Post Covid vaccine while in observation area patient complained of heart beating fast, some difficulty breathing, feeling anxious. Skin was warm and clammy, vital signs taken, O2 sat 100% and she developed hives on her upper chest and neck area. Benadryl 12.5 mg given x 2 , 5 minutes apart. EMS was called and patient transported to Hospital for further evaluation.

Hives and itching on left arm. Mild shortness of breath but no wheezing, facial or mouth swelling and no difficulty swallowing. O2 sat 99% on room air. Given 50 mg of Benadryl, EMS called and transported to ED in stable condition

3 hours after vaccination the following symptoms presented: vomiting, diarrhea, chills, light headedness, dehydration. overnight after vaccination: labored breathing next morning 8am after vaccination: itchy, irritated rash on face and neck. significant swelling of vaccinated arm front top of elbow to top of shoulder area. These symptoms had to be treated by oral corticosteroids.

Caller states that she received her 1st Pfzier vaccine on 03/31/2021. At approx 4:00 pm, noted " chest heaviness, swelling of her throat with a cough". Appears to be in no acute distress, denies difficulty of breathing and able to speak in clear, complete sentences. Instructed to seek emergency care for an evaluation.

Approximately 10 minutes after receiving the shot, I started to have a bit of swelling in my throat that was almost identical to the reactions I get from foods I am allergic to with my Oral Allergy Syndrome. Another 10-15 minutes later, it had gotten worse to the point where it was harder to swallow, plus I was a bit lightheaded and my mouth was itchy. The people monitoring the post vaccine waiting section didn?t want me walking around, so they sent someone to my car to get my liquid Benadryl, which is what I take for similar reactions to foods. I took about 50-75 mg worth and waited for an additional hour or so until the swelling had gone down mostly. Now (at almost 7 pm on the same day), I still have a tiny bit of swelling in addition to the ?normal? vaccine side effects, tiredness, soreness in my whole body, headache, pain at injection site.

30 min after vaccine - had tingling of hands/feet (history of this in past not pertaining to vaccine) approx 1 1/2 hours after vaccine had sensation of throat fullness/tightness - took 50mg of Benadryl and called health center who advised immediate evaluation. At the time I saw her (almost 3 hours from time of vaccine) - she had some erythema at injection site otherwise I saw no identifiable urticaria, stridor, oropharyngeal edema. VSS and physical exam otherwise normal.

About 4 minutes after vaccination, patient began complaining of throat tightening and trouble talking. I called 911 and described symptoms and asked if I should administer generic Epipen - advised to administer so I administered. EMS came and took patient to ER.

Patient reports itchy tongue ad throat, feeling a slight tightness in her throat and dizziness within minutes after receiving her 1st Pfizer vaccine on April 1, 2021. Patient reports having an allergic reaction to a chemo medication but could not remember the name. Patient was administered 50mg benadryl by EMS. Vitals were taken and within normal limits. Patient did not appear in any distress and texting during her examination. Throat was without erythema and swelling. Patient reported some relief of her symptoms after 10 minutes of Benadryl but not resolved. Patient was later transported to hospital by EMS for further evaluation.

Hospitalization with pneumonia and E coli sepsis on 4/2/2021 Symptoms started with sore arm on 3/30/2021. Patient called healthcare provider on 3/31/2021 because patient developed headache, myalgias, fatigue, fever to 100. On 4/2/2021, patient presented to ER and admitted to hospital with fever, chills, shortness of breath, productive cough, labored breathing. CXR showed left upper lobe pneumonia and small pleural effusion. Blood culture subsequently grew E. coli. Work up for source of E. coli is ongoing including CT scan due to patient's history of rectal inflammation and presacral abscess several months back.

My throat / tongue swelled, difficultly breathing and swallowing (anaphylaxis). Urgent care rushed me in and gave me dexamethasone in my right arm to stop the swelling as well as Tylenol. It took about a full week to completely feel normal, mild anxiety attacks happened. But after one week felt good again.

After vaccination, felt tightness in throat, similar to GERD, and then had an anxiety reaction. Skin appeared flushed. BP elevated and pulse was regular, 120 beats. O2 saturation= 98%. With relaxation techniques pulse and BP came down, but skin remained flushed. Benadryl 50mg IM given in left deltoid by APRN. At 5:30 pm, pulse was 85. Parents were contacted and arrived to clinic to drive the patient home. Advised to come accompanied by parent for dose #2.

After 5 minutes my arm started burning. Then I got cold sweats. After 20 minutes I was struggling to breathe. It felt like something was sitting on my chest. My lips and throat also got very itchy. I went over to a paramedic who gave me IV benadryl and something for nausea. My blood pressure and HR were initially high but lowered. My O2 was fine. Then I got really light headed and my tongue, throat, and whole face got more itchy. I then went to the ER and got epipen intramusclarly in the ambulance. At the hospital I got steroids and an IV bag. Around 3:30 I started to feel normal again. I stayed under observation for 4 hours. THen got discharged with a prescription of steroids.

Patient complaints included dizziness and flushness. She appeared drowsy as well. Onset of symptoms occurred within 10 minutes after vaccination. I continued to monitor the patient and took her blood pressure (128/77, HR 80). Over the next 2 minutes, she then complained that her throat was sore and started to feel tight. At that time, I informed that patient that I was going to administer a dose of Epinephrine. She was responsive and understood. I called for medical attention and the paramedics arrived to take over patient's care.

Sweating, difficulty breathing, increased heartbeat, passing out, nausea. Given water and crackers, was coached on breathing Recovered breathing and conscious within 2 min. Was held longer in order to be monitored for any repeat symptoms was released after 40 min

Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appeared pale Patient provided water and seen by medical team Patients blood pressure was 86/59 and heart rate 97, patient provided with water Patient advised to be seen in hospital, patient refused medical transport and signed AMA form Patient agreed to go to hospital , driven by boyfriend

Pt developed SOB 20 minutes after vaccine injection. On site paramedics administered benadryl. Pt minimally improved, was treated with epipen, IV steroids, nausea medication and transported to Hospital ED. She was treated in the ED, observed for 4 hours, then discharged with Medrol Dose pack.

Chills, vomiting on and off for about 12 hours, severe body aches, on and off fever, nose bleeds, fatigue and shortness of breath.

Patient received her first dose of Pfizer vaccine at 1500, she waited her required 15 minute observation time, was feeling fine and was released by the NP. Patients mother drove her back at approximately 1530 reporting difficulty breathing, throat tightness, numbness and tingling or her face and tongue swelling. RN assessed patient and administered 0.3mg of EPI and EMS was called per protocol. Patient reported some resolution after EPI was given. EMS transported patient to ER for further evaluation.

Saturday morning, the arm felt sore - I did notice a little red spot. I felt fatigue and a slight headache. Saturday night to Sunday morning , the spot got bigger (on the injection site). I drew a circle around it. It got a little bigger on Sunday. They other symptoms subsided at the end of Sunday. The redness didn't seem to be going away on the injection site. On Monday, I just had the red arm and it hurt pretty bad to touch. It was tender and warm to the touch. I was at work and I felt shortness of breath just walking down the hall. I took my pulse while I was standing still and it was about 120. Near the afternoon, I was instructed to go to URGENT CARE to get it checked out. Closer to the afternoon, I started noticing that the heartrate (on my watch) it got to 164. I went to URGENT CARE and they stated it was a normal reaction to vaccine but because of my tachycardia they wanted to send me to Hospital ER. At ER they weren't worried about injection site (still pretty painful) they were worried about how fast my heartrate was going. The wanted me. The injection site and the tachycardia was back to normal.

Patient loss consciousness. Vaccine administered around 1240, approximately at 1250 patient pass out. Observer called for help and EMS was activated at 1250. Patient was flushed and not breathing, observer pushed EpiPen 0.3mL (Lot #0FM200 Exp: OCT2021)for 10 seconds at 1252. Patient woke up, helped arrived and was moved into private patient room. Fire was called at 1254 arrived at 1303. Vital signs taken at 1258 BP: 71/39 HR:73 O2: 100% Temp:98.7 degrees Celsius. Second Vital signs taken at 1300 BP: 86/49 HR:97 O2: 99% Temp:98.7 degrees Celsius. Patient stated before passing out symptoms of light headedness and heart racing and flushed. Patient improving symptoms, transported to the Hospital at 1307.

Tech administered 2nd Covd vaccine to patient. After approximately 5-10 minutes, the patient called back to the pharmacy to let us know she was reacting to the vaccine. She was having difficulty breathing, shaking, and felt lightheaded. The pharmacy tech called 911. The pharmacist explained the epi-pen and the patient said she wasn't ready. We waited until she was ready for administration and practiced some deep breaking to help her relax. At 10:04am the patient said that she was ready for the injection and the epi-pen was administered. She felt an improvement in breathing after about 60 seconds and it continued to improve. The patient was turned over to the paramedics and transported to hospital. the hospital where she was monitored and released later in the afternoon. Her physician was contacted and the reaction was put in her chart.

Pt reports lightheadedness, tongue swelling, and difficulty breathing after receiving her vaccine. She denies itching/rash on skin, but reports "itchy/tingling" pharynx. On exam, there was no wheezing, no rash. Epipen administered to R thigh @ 11:36am Pt transported to ED by EMS at 12:05pm Vitals as follows: 11:25am HR- 63 RR- 20 BP- 109/73 SPO2- 98 11:30 am HR- 67 RR- 20 BP- 115/74 SPO2- 97 11:36am HR- 79 BP- 110/75 SPO2- 99 11:38am HR- 103 BP- 111/76 SPO2- 97 11:41am HR- 79 BP- 107/73 SPO2- 98 11:46am HR- 85 BP- 111/72 SPO2- 97 11:51am HR- 87 BP- 111/75 SPO2- 99 12:00pm HR- 79 BP- 136/76 SPO2- 99

patient reported tightened airway, lightheaded BP 129/79 99%, reports she has anxiety attacks, emotional reassurance given. Tolerating H2O At 1322 patient reports feeling much better 114/83 78.

Patient with a history of anaphylactic reaction to Advil developed a possible biphasic allergic reaction to Pfizer Covid vaccine (lot EN6208) given on 3/17. Patient initially had urticarial rash on 3/19 and it was treated with Benadryl and Solu-medrol. Patient was discharged on daily prednisone. However, patient returned on 3/21 with facial swelling, chest and throat tightness and shortness of breath. Prior to ED arrival, patient self-treated with EpiPen. At the ED, Benadryl, Pepcid, and Solu-medrol were given and continued for 2 days during hospitalization. No further respiratory distress developed, but the patient still had intermittent itching and rash. Patient was discharged on tapered prednisone, Benadryl as needed and Pepcid.

Patient was administered vaccine on 05-01-2021 in the afternoon and she reported that she started having adverse effects the next day (05-02-2021) and reported us this afternoon around 3 pm. Patient developed pain in the chest and it aggravates with breathing. Pt was advised to contact her PCP and go to ER if any of the symptoms worsen.

About 12 hours after receiving the vaccine I had a coldness in my chest. It feels sharp to breath and like I'm taking in a large gust of freezing cold air.

She reports that she immediately felt itching and a tightness in her throat. She presents here complaining of the same symptoms. She reports itching affecting the left arm only. She denies any pain. She reports that she is able to breathe easily, but feels like her throat is tight. Patient reports history of allergic reaction to vaccinations when she was a young child, but cannot remember any specifics about the events because of her age at that time. She has no other complaints at this time. Presents here with chief complaint of possible allergic reaction to Covid vaccination. Patient does not have any urticaria, oropharynx is patent, there is no perioral or periorbital swelling, oxygen saturation is good and breath sounds are equal bilaterally. I do not feel that anaphylactic reaction is occurring and do not feel that epinephrine treatment was necessary during emergency department visit today. Patient is treated with prednisone in the emergency department today. She reports improvement of her symptoms after medication is administered. Patient will be discharged home with instructions to use Benadryl as needed for continued symptoms.

The patient stated that she had not received a vaccine in several years but that the last time she did, she blacked out for maybe 30 seconds and felt dizzy. She states she thinks it was because she did not eat that day and stood up too quickly because she felt ok after. I notified (pharmacist) to be on stand by in case any incidence occurred and we had smelling salts and epipen on hand. I had the patient sit in the vaccine chair afterwards and about 3 minutes later, she started screaming to the top of her lungs that she felt like she was going to die. She screamed that she couldn't breathe and that her chest and head were "killing her". She kept screaming to remove the vaccine out of her arm (the liquid). Her eyes were starting to roll, but I knew she was breathing because she was screaming to not let her die. Her mother was with her and was very nervous and wanted emergency services, so We called 911. I took the girls hands and asked her to look me in the eyes and follow my deep breaths, because I began to think it was more of a panic attack. She followed by breaths and regained some composure but was sweating profusely, so I began fanning her. After a while of talking her through taking deep breaths and assuring her she was breathing and we had emergency services on the way, she began to calm down. EMS showed up about 15-20 minutes later and she declined to go with them. I stayed with the patient the entire time. She did not faint. I believe she just had a panic attack from working herself up about the vaccine. She was a little scared since she had fainted with the last vaccine.

Has intractable epilepsy, she usually has 5-6 seizures per day that are generally brief myoclonic-astatic type of seizures. The day after received her second dose of COVID19 vaccine she had an increase in seizure frequency. By 4/25/2021, she started to develop fevers and new type of seizure with more body twitching and stiffening of her arms. She was admitted to Hospital in on 4/27/2021 with fever, status epilepticus, found to have an aspiration pneumonia. She required antiepileptic medication dose adjustment with addition of Valproic acid to her drug regimen, but this caused excessive sedation. She was discharged from hospital on 5/14/2021. Status epilepticus did resolve and she was more alert by the end of hospitalization.

4 days after first shot, she called me complaining of bad back pain. She was going to her family doctor the next day for her 21 yr old well visit and was going to get it checked out then. She had a complete physical and was cleared even her lungs were clear and she was good. Tuesday night April 13th at 10pm, she told me she had "air bubbles" in her chest. I said you mean indigestion, take tums I said. She said not mom, actual air bubbles and they are popping in my chest. I said you just got your physical, you are fine. They Thursday night April 15th she started having difficulty breathing and was out of breath. She went to urgent care on April 16th because she felt awful and they saw in an X-ray that she had a "cyst" in her upper right part of her lung and her lung was about to collapse. Sent her home on bed rest with a stereos and 2 inhalers. We got her Friday night from college because the pain in her back and now her chest was worse. Took her to ER and she had a collared lung and pneuomothroax. She was admitted to the hospital and they tried to see if the lung would heal itself. It did not. They had to do surgery to repair the hole. When they were in there they saw a cobblestone texture where the hole was an they removed that texture and repaired the hole. She has never had a lung issue. Ever. She is also the 3rd person in my family to have had an adverse reaction to the shot. 6 of us vaccinated and 3 with injuries.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe

Patient called pharmacy about 6 hours after her vaccination, stating she was having chest pain and discomfort and shortness of breath. Pharmacist recommended patient seek emergency care to get checked out and patient agreed.

Two weeks after first COVID vaccine patient experienced an acute onset of chest pain, dizziness, head pressure, SOB, fast/irregular heart rate, high blood pressure, sensitivity to light, weakness and blackening of vision field.

PATIENT PASSOUT AFTER VACCINE WAS ADMINISTER. SHE COMPLAINED OF SOB BEFORE PASSING OUT. EPIPEN WAS ADMINISTERED AT 12;35 AND EMT ARRIVED AT 12:44. PATIENT RECOVERED AND REFUSE GOING TO THE HOSPITAL.

Symptoms were undiagnosed but correlated to minor myocarditis which included shortness of breath due to chest pain in the heart area, lasted for about 12 hours and treated with 600 MG of ibuprofen, stopped shortly after treatment.

Heart palpitations, multiple PVCs, chest pain that returned, dyspnea, fatigue, loss of appetite. I was hospitalized for 4 days and am still recovering. I continued my course of treatment for pericarditis, increased the dose of ibuprofen, use lidocaine patches, and was put on prednisone. I used a heart monitor for a month and have had abnormal heart beats.

Rapid heartrate (120s), shortness of breath, and palpitations started within 24 hours of second vaccination. Went to Urgent Care on Friday, ECG completed. Urgent care sent patient to ER to be evaluated further. ER physician states rapid heartrate and symptoms likely due to the vaccine.

After receiving 2nd dose of the Pfizer Vaccine at 4:00 PM, patient was seated in the waiting area. At exactly 4:05 PM, Patients boyfriend motioned to staff to respond to said patient and asked for water. When staff observed patient, on site RN was motioned over as well. There-in, patient was observed to be pale and sweaty, and she was seated but leaning against boyfriend for support. Upon being asked name, patient stuttered trying to state first name and could only produce ("T" sound with lips) Patient could not speak full word. By this time, blood pressure cuff and Pulse-ox were brought to assess vitals. Blood pressure - 55/35 and Pulse was 49. Respiration was 20 breaths per minute and shallow. Upon observing blood pressure, ambulance was called. Ambulance responded within 5 minutes. During time waiting for ambulance, patient had improvement and was able to state name and location. Patient was given water, could not hold but with assistance from boyfriend, was able to drink through a straw. Upon ambulance arrival, care was transferred and was transported to local hospital.

choking on phlegm; phlegm; Coughing; Serious sinus drainage; Fatigue; could not hold food down; This is a spontaneous report from a contactable consumer. This 21-year-old female consumer (patient) reported for herself: Product detail: product=COVID 19, brand=Phizer Start Date/Time: [Phizer] 2Jun2021 03:30 PM Lot number=Bw0182 Lot unknown=False Dose number=1, Vaccine location=Left arm Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Reported Event: Serious sinus drainage, coughing, fatigue (if I do fall asleep I will wake up choking on flem) can't hold food down Prior to vaccination Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 05Jun2021 If patient recovered: Not recovered If treatment AE: No If covid prior vaccination: Unknown If covid tested post vaccination: No No follow-up attempts are needed. No further information is expected.

throat tightness; Frequent throat clearing; During patient's 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty b; rash; hives; Itching of skin; headaches; This is a spontaneous report from a non-contactable other health care professional. A 21-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in an unspecified anatomical location on unknown date (at the age of 21-year-old), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications have not been provided. During her 15 minutes waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. Patient complained of frequent throat clearing, itching of skin and headaches. Treatment included antihistamines. Follow up response to treatment was excellent. Patient on discharge was stable to go home and follow up with PCP. The outcome of all the events were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.

Patient had chest pain, shortness of breath, and a mild increase in her troponin. She was hospitalized for less than 24 hours and received ibuprofen. She was discharged 6/14/21

Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better. (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)

Severe shortness of breath; Wet cough; Weakness; This is a spontaneous report received from a contactable consumer, the patient. A 21-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 as a single dose (at the age of 21-years-old) for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to penicillin. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 08:00, the patient had experienced severe shortness of breath, wet cough and weakness. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe shortness of breath, wet cough, weakness was not resolved at the time of this report. Information on lot/batch number has been requested. No further information is expected.

Dry face; chest was hurting; throat became tight; hives 4 days after the vaccine (just face) right side and then "lingered" to the left side of my face"; This is a spontaneous report from a contactable consumer, the patient. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0169), via an unspecified route of administration, administered in Arm Left on 18Apr2021, as dose 1, single (age at vaccination: 21 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, on 22Apr2021, 4 days after the vaccine, she started experiencing hives (just face) right side and then "lingered" to the left side of her face, which did not hurt but were just really uncomfortable because of the fact that the hives were all over her face. She stated that she did not notice the hives until she touched her face and she took Benadryl (Strength: 25mg tablet, expiration date is Nov2022, only took 1 tablet) to see if the hives would go away and it did not. She reported that, one day after work on 24Apr2021, one week after she received her vaccination, her chest hurt and then her throat felt tight which scared her and since she was driving she went to urgent care. Reportedly, at urgent care she was given a steroid shot which helped it go away. The symptoms lasted one hour and gradually went away. Reportedly, the hives were also ended around the 25Apr2021 or 26Apr2021 after she received the steroid shot to help with her symptoms. She told that the hives went away and was clearing up and then the dry face started on the 29Apr2021 through until around the 03May2021 or 04May2021. The only after effect was her dry face. Since, her face was dry she used Aquaphor and that helped. Outcome: hives were recovered on an unknown date in Apr2021, chest was hurting and throat became tight were recovered on 24Apr2021 and Dry face was recovered on an unknown date in May2021. Follow-up attempts completed. No further information expected.

Extreme vaginal bleeding; Some difficulty in breathing; Prolonged period; Migraines; Dizziness; Nausea; Lower back pain; Abdominal pain; Weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10May2021 (age at vaccination was 21 years) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to Sulfas. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 (age at vaccination was 21 years) as 1st dose, single for COVID-19 immunization. The patient previously took amoxicillin and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was Other. 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, the patient has been tested for COVID-19. The patient underwent lab tests which included Nasal Swab: negative on 21May2021. On 28May2021, patient experienced extreme vaginal bleeding/ prolonged period/ migraines, dizziness, nausea, lower back pain, abdominal pain, some difficulty in breathing and weakness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The device date was reported as 23Jun2021. The case was reported as non-serious. The outcome of events was not resolved. Information on lot/batch number was available.

INCREASED HEARTRATE AND SWELLING OF THROAT. PATIENT CAME TO ME 15 MINUTES AFTER RECEIVING THE VACCINE AT APPROXIMATELY 5:01 PM. SHE STATED THE THROAT CLOSURE WAS GETTING WORSE AND HEART RATE FELT FAST. I TOOK BP TO FIND ELEVATION (DON'T REMEMBER THE EXACT VALUE). HEART RATE WAS 113 BPM AT APROXIMATELY 5:O2. (EMS WAS CALLED). 5:03 ADMINISTERED EPIPEN 0.3 MEDICS ARRIVED AT 5:05PM. PT TAKEN TO HOSPITAL BY MEDICS AT 5:10 PM

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: CALLED EMS TO ATTEND TO PATIENT

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: CALLED EMT PATIENT WAS ATTENDED TO BY EMT

face rash; Increased heart rate; trouble breathing; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 18:15(at the age of 21 years old) as single for COVID-19 immunisation at workplace clinic. Medical history included covid-19 from an unknown date and unknown if ongoing prior to vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 18:30 the patient experienced Increased heart rate, trouble breathing, dizziness, and face rash. Treatment were received for events with allergy medicine. Since the vaccination, the patient was not tested for COVID-19. Outcome of all the events were recovering. Follow-up attempts are completed. No further information is expected.

She stopped breathing; She like passed out but her eyes were still open; her vision started to go; Her vision start to get blurry; She started getting very hot; her vision started to go; Her vision start to get blurry; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-years-old female patient. A 21-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EY0196 and Expiry date was not reported) dose 1 via an unspecified route of administration in Left arm on an unspecified date (21-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history was none. The patient was healthy. Concomitant Medication used for Just birth control (drug name not clarified). On unspecified, same day of vaccination the patient started getting very hot, has stopped breathing, like passed out but her eyes were still open, her vision started to go, her vision start to get blurry. The reporter stated that On unspecified date after 10, 5 minutes when it happened a pharmacy tech did gave her the EpiPen (treatment) because that's how we found out of it she was not with it, she was passed out, she stopped completely. she took the vaccine and they were sitting there you know to wait to make sure she didn't have reactions she started getting very hot. She poured water on herself because she was so hot then her vision started to go and her vision start to get blurry and the patient called the reporter to come stand by her when reporter walked over there she like passed out but her eyes were still open and she was calling my name looking at me but she was looking at me but she wasn't there, she was like looking straight through me. She stopped breathing, it was a horrible experience." The reporter stated that the patient had had a severe reaction after first dose. The reporter stated that She supposed to receive 2nd dose, its the 23rd but she is not getting it. The Reporter stated, "Yes, I would like to speak with somebody in regards to what she went through and what might affect if anything else is going to happened to her." Reporter stated, "So, when I call, I will speak to a medical professional and they'll have this information to discuss it with me and help me you know, because I mean, I wanna know, what I need to pay attention to if she is gonna have more other side effects from this or what." No laboratory tests. The outcome of the events was unknown. Follow-Up: Follow-up attempts are completed. No further information is expected.

My heart beat gets really slow to where it feels like I?m panicking and can?t breathe correctly. My vision will also get fuzzy. My period didn?t come for two months.

Patient developed chest pain on the left side with inhalation. Left shoulder had a sharp dull pain with activity. Symptoms did not improve with ibuprofen. Patient was evaluated in the ED and her EKG came back normal.

Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient asked about possible side effects from vaccine. They were discussed with her. She asked about why she needed to stay15 minutes after vaccination which was stated to assess for possible allergic reaction. Pt reported she had severe panic attacks in the past and that she was then concerned about allergic reaction. She stated she had numbness at her hand which went away after 30 minutes. she was assessed for 30 minutes. Her anxiety deminished and she wanted to leave.

Extreme itching of entire body; Swollen face and throat; Swollen face and throat; entire body slightly puffy; hives on back; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Apr2021 at 17:30(at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD, depression and anxiety. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and depression meds; both from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation and Penicillin on an unknown date for unspecified indication. Prior to the 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 four weeks prior to the vaccination. On 28Apr2021 at 20:30 after 3 hours of vaccination, the patient experienced Extreme itching of entire body, Swollen face and throat, entire body slightly puffy and hives on back. Therapeutic measures were taken as a result of the reported events and included treatment herself with Ibuprofen but hadn't helped yet. The clinical outcome of the Extreme itching of entire body, Swollen face and throat, entire body slightly puffy and hives on back was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

During registration at , , informed that she might be pregnant and was not sure whether it was safe to get the Pfizer vaccine. explained to that she could still get the vaccine even if she was pregnant. But if she had any questions or concerns regarding the vaccine and her pregnancy, she should speak to her healthcare provider first. also told staff that was allergic to Penicillin and nuts. Staff explained to her that she could still get the vaccine, but she would have to sit for 30 minutes in the observation area so that staff could make sure she did not have any adverse reactions. decided to go forward with getting the vaccine. After getting the vaccine from , was directed to sit in the observation area for 30 minutes. During this time, , would periodically check on her to see how she was feeling, and each time said she felt fine. After her 30 minutes were over, told that she felt dizzy. asked if she could stay longer in the observation area as it was unsafe for her to stand up and walk. agreed. Staff offered her some candy and water to drink. After eating some candy, said she felt better. About 6 minutes later, said she was having trouble breathing and that it was getting worse. checked her oxygen level and it was 98. Staff explained to that her blood oxygen level was normal, but said she still couldn't breathe. tried to do some breathing exercises with her. called EMS at 1:50 p.m. and then went outside and waited for them to arrive. then told staff that she was having chest pain and that it hurt. Staff continued to monitor until EMS arrived at 2:07 p.m. They assessed and then transported her to Hospital at 2:20 p.m. to have her further

Patient received the shot, 10 minutes later her mother came to the pharmacy window saying her daughter couldn't breathe. I went to speak to patient and patient said she "couldn't breathe" then lost consciousness shortly thereafter. I injected her with an epipen in her left hip. She regained consciousness about 90 seconds later. Her lips were blue, she was pale, her pulse was strong, and heartbeat rapid. She expressed a phobia of shots before the shot and her mother said she has high anxiety about shots. Was taken away via ambulance.

at 12:24 pm, 10 minutes after receiving vaccine, pt reports feeling dizzy and throat tightness. pt denies short of breath, or any pain 12:29 pm pt evaluated by EMS BP 122/87, P 70, O2 Sat 100% 12:33 pm pt transported to hospital for evaluation

1416 covid vaccine given IM in right deltoid 1434 patient states she isn't feeling well, nauseated, pain at injection site 4/10 on pain scale, itching to right arm. VSS 98% on RA, 86 pulse, 131/82 BP, 98.8 temp. Band-Aid removed. 1434 50mg Benadryl given lot 202906 exp 9/20/23. Sitting in chair with fan. Noted that patient was drinking a energy drink with 300mg caffeine 1/4 gone. 1445 c/o pain in right upper abdomen/lower right rib pain with breathing, "trouble breathing- hard to take deep breaths d/t this pain, a little throat pain, 1449 Dr called/updated orders Tylenol 1000mg PO now. 1456 Tylenol 1000mg given PO with water, c/o dry mouth, throat "tight", Right arm where injection given- c/o pain 8/10 on pain scale. 98.8temp, 126/83 bp, 100% saO2 on RA, states not feeling well. 1502 bilateral lower legs beefy red, capillary refill >8 seconds, pulses present states her feet are tingling. 1500 patient states she doesn't feel well and asks to go to the ER to be evaluated. 1505 99 called and ambulance dispatched 1515 ambulance arrived and assessed patient and at 1521 patient left the facility per ambulance stretcher accompanied by EMT's x2

14:16 COVID vaccine given IM in right deltoid 14:34 Patient states she isn't feeling well, nauseated, pain at injection site 4/10 on pain scale, itching to right arm. VSS 98% on RA, 86 pulse, 131/82 BP, 98.8 temp. BAND AID removed. 14:34 50mg BENADRYL given lot 202906 exp 9/20/23. Sitting in chair with fan. Noted that Pt was drinking a Bang energy drink with 300mg caffeine 1/4 gone. 14:45 c/o pain in right upper abdomen/lower right rib pain with breathing, "trouble breathing- hard to take deep breaths d/t this pain, a little throat pain, 14:49 Dr called/updated orders Tylenol 1000mg PO now. 14:56 Tylenol 1000mg given PO with water, c/o dry mouth, throat "tight", Right arm where injection given- c/o pain 8/10 on pain scale. 98.8temp, 126/83 bp, 100% sa O2 on RA, states not feeling well. 15:02 bilateral lower legs beefy red, capillary refill >8 seconds, pulses present states her feet are tingling. 15:00 Pt states she doesn't feel well and asks to go to the ER to be evaluated. 15:05 Ambulance dispatched. 15:15 Ambulance arrived and assessed Pt and at 15:21 Pt left the facility per ambulance stretcher accompanied by EMT's x2

Approximately 10 minutes after receiving injection, patient reports feeling tightness in her throat. Benadryl 25mg po given & taken to ED via WC.

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium

Shortly after receiving vaccine started feeling foggy. upper lip began to tingle, felt numb, and starting swelling. Started having palpitation and having shortness of breath.

4 hours after receiving my Pfizer COVID vaccination, my chest started to tighten up and I became short of breath. I took some Ibuprofen, but the pain is still there today, and it is hard for me to even walk up the stairs without becoming short of breath or being in pain.

Patient was first presenting chest tightness, chills, cold sweats, and shortness of breath. This all in a time course of one hour. Patient presented wheezing upon auscultation. Epinephrine dose was administered (0.3mg). Patient was monitored and continued with same symptoms. Wheezing did not improve. Second dose of epinephrine was administered sixteen to seventeen minutes prior to second dose (0.3mg).

Got my 2nd does thursday afternoon, Friday I had a fever of 101.3, chills, headache, very weak and tired. I took tylenol and was feeling better on Saturday. Woke up Sunday with a sore throat, red/swollen and this has lingered into today (Monday), throat feeling worse.

Patient received Covid Dose #1 vaccine on 01/25/2021. Patient felt well immediately after receiving vaccine. 30 minutes later, she stood up and started to feel lightheaded, nauseous, and dizzy. She also experienced bilateral leg weakness - legs gave out under when she tried to stand. Feels some subjective shortness of breath. She has experienced similar constellation of symptoms plus palpitations in past related to her tachycardia-induced myopathy. Patient admitted to observation for monitoring same day 1/25/21 at 1618. Patient did well in observation overnight, no acute events. Patient was discharged at 1035am on 1/26/21. Patient instructed to follow up with primary care physician in 1-2 weeks.

Patient developed red blotches anterior base of neck, throat feeling tight. Patient shared has anxiety with receiving vaccines, similar symptoms have happened in the past.

- Needed inhaler each night since - Jan. 25th night was worst yet, took over an hour for inhaler to kick in. Tried steam and heating pad, little improvement - Jan. 26th Took ProAir inhaler at 2pm before shift - Little improvement - Pain still in chest - Called my primary Dr. at 4:30 - Prescribed prednisone and Advair - Thinks vaccine caused inflammatory response - Took prednisone at 8pm - Took Advair around 11 - Took ProAir inhaler around midnight - Heart racing (HR130) - SOB, pain when breathing - Localized to sternum, on either side as if something was grabbing my lungs and squeezing - Feel like lightning coursing thru my veins - Shaky I ended the up in the ER Jan. 26th. * I took prednisone at 8pm * I took Advair at 11pm * I was still having trouble breathing and my last hit of my ProAir had completely worn off * I took my ProAir around midnight * Over the course of the next two hours I was SOB, tachy (HR 130s), hot and cold flashes, pain while breathing, couldn?t catch my breath * My friends took me to the ER around 2am * At the hospital they did a 12 Lead EKG, blood work, labs, 2 chest X-rays, and a COVID-test * They gave me 0.5 mg lorazepam IV * All of my blood work and labs came back normal. * X-rays came back clear * EKG came back fine * Negative COVID test * I took a nap after the lorazepam hit and woke up feeling much better * ER doc thinks my ProAir exacerbated some anxiety because my lungs were clear and no wheezing * Discharged me with a script for lorazepam PRN x10 and instructions to follow up with my primary is back at home. * Doc said I could continue the prednisone and Advair * Woke up today and yesterday feeling better, still some pain when breathing and exhausted. Pain is mostly at top of my lungs, going across my chest. Deep breathing sometimes helps but there?s also pain upon inhalation. * Took the next doses of Advair and my Dexedrine (ADHD meds). Nothing weird yet just drained. They switched my Ventolin inhaler to ProAir, I have been taking it about five times a week so I can workout. When I was on Ventolin I didn?t have any of the side effects I have with ProAir.

Less than five minutes after receiving vaccine reported burning in stomach, followed by dizziness. Patient was then observed to be flushed. Patient then reported " I can't breath". EpiPen was administered into right thigh, oxygen initiated. Patient was mildly hypoxic, O2 saturation noted to be 88% after EpiPen and oxygen saturation increased to 99%. Patient was transported to ED via hospital rapid response team. Upon arrival to ED symptoms had improved. Patient was monitored in ED and discharged to home with short burst of prednisone and EpiPen. Per ED note unclear if event was true allergic reaction or vasovagal response

Stridor, pallor, and reports throat closing up, EpiPen given at 1:08pm and EMS called, improvement noted shortly after Epi administered. B/P 100/50@ 1:18pm, EMS arrived at 1:20pm and at 1:22pm c/o breathing difficulty, chest tightness. Transported to ER

Fatigue; Shortness of breath; Chest pain; Cough; This is a spontaneous report from a contactable consumer. A 22-year-old female patient (daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her daughter had a reaction to the COVID vaccine. The patient received the first dose of the vaccine on 23Dec2020. The adverse reaction has lasted the past three weeks to include fatigue, shortness of breath, chest pain, and cough on unspecified date. The patient is now on inhalers and she was not on inhalers before. The reporter stated that her daughter has been tested for COVID multiple times. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Patient is a registered nurse at facility. She reported having slight itchy lips and scratchy throat after 1st dose. Patient very much wanted full protection that 2nd dose offers in order to be safe and keep family members safe. We discussed the possibility of an increased reaction, but she wanted to go ahead and felt the benefits outweighed the risk. I considered the fact that she is a health care professional, was fully informed and that we were at a skilled nursing facility and were prepared in case she had any reaction. About 10 minutes after vaccination she seemed to be coughing and felt like her throat was maybe swelling. She seemed to be breathing ok, but I asked her to take a Benadryl, which she did. Within 5-10 minutes after that she began shaking and seemed very pale. She said her symptoms were getting worse. I told her I was going to administer an epi-pen dose. 911 was called, I administered the epipen, we had heart rate monitor and pulse ox monitor on patient and she was stable, but scared. EMT's arrived and transported patient to ER. She was later released with Benadryl.

Shortly after the vaccine she had a rash that improved with Benedryl. The day after she received the vaccine she began having a rash, itching, swollen tongue, dry mouth and throat tightness. She went to the ED and received a course of steroids.

I received my second dose of the COVID vaccine around 12:30 pm. At around 4:00 pm, I noticed that my lips were slightly swollen. I went and bought liquid Benadryl. At around 5:45 pm, I took 20ml of the liquid Benadryl. I proceeded to sleep the rest of the night. I woke up around 8:20 am the next morning and noticed that my lips were significantly more swollen. I took 20ml more of the liquid Benadryl and noticed that my tongue was a little swollen as well. At around 9:40 am, I took 20ml more of liquid Benadryl. I noticed no change in my swelling and my throat started to feel like there was a lump. At around 10:20 am, I drove to the emergency room. The doctor noticed swelling in my lips and some in my tongue and throat. I was given cimetidine and methylprednisolone through an IV, which reduced the swelling. I was discharged 2 hours later after the swelling went down and was given 2 prescriptions to take the next 4 days, which were prednisone 20mg (three tablets once a day) and famotidine 20mg (twice a day). There is some swelling in my lips in the morning (for the last two days) until I take the steroids, then it reduces the swelling. The overall cost of the emergency room visit was $1669.17.

Fever (highest- 102.5 F), dizziness, muscle aches/soreness, chills, fatigue, chest pain, shortness of breath, muscle weakness, night sweats, vomiting, fainting

I can not think or remember things my arms go to sleep i cant feel hot and cold i cant drive and i get very winded

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient noted an anaphylactic response to hepatitis b as a baby. Was counseled to wait 30 minutes in pharmacy to be monitored after receiving a vaccine. Around 25 minutes later patient approached pharmacist stating felt tongue tingling. Patient drank some water stated she felt better but in next two minutes noted her throat felt obstructed. Technician called 911. Paramedics arrived within 3 minutes. No epipen was given. Paramedics and immunizing pharmacist both mentioned possible anxiety attack

I tested positive for COVID on March 2, 2021 after having all of the symptoms. I had a body rash, no taste or smell, muscle aches, diarrhea, cough, shortness of breath.

Immediately after injection I had itching down my right arm and three bright red stripes underneath injection site appeared. In the following 10 to 15 minutes my lips started tingling and my throat started to tighten up. The itching finally stopped after 10 minutes. The tingling in my lips and throat tightening occurred with both the first and second dose. The staff kept me for around 45-50 minutes for both doses of the vaccine. When going home I took 2 Benadryl.

Wednesday during the day I noticed a scratchy feeling towards the back of my tongue that I thought was seasonal allergies. Then in the evening, the feeling was more significant and I noticed red bumps on the back of my tongue and inflammation around that area. Woke up Thursday (today) morning with a sore/tender throat and the throat is red and imflamed.

Patient stated she felt as though her breathing was changing. Not sure if it was anxiety or a reaction. Assessed by myself, lungs clear, no throat swelling. Taken back for observation, while in observation, stated throat felt tight. Examined throat, no swelling noted, had physician also check and agreed. pox 98% r-18 120/84 and remained stable throughout obs. Patient stated she felt better, ambulated without difficulty. d/c after 30 minutes.

Appx 5 minutes after receiving vaccine patient became short of breath, felt light headed, developed urticaria over arms and chest, and itchy throat. BP stable initially, no wheezing, however appx 2 minutes later began wheezing/coughing and appearing drowsy. Epinephrine 0.3 mg IM given as well as 50 mg Benedryl IV, 02 by nasal cannula. Patient remained conversant and responsive throughout but drowsy and coughing. BP and SPO2 remained stable until EMS arrived to take to emergency room.

48 hours after vaccine administration developed facial swelling, facial rash, and dyspnea. Given epi pen x 2 and transported to hospital.

Tired during the day, about 14 hours later suddenly very nauseous, light headed, and faint. Developed a fever, and had shortness of breath. The next morning, arm was very sore, still a little light headed, developed a sore throat, and exhausted. Day three only feeling arm soreness and throat still sore.

*TIME OF WRITING IS THE 7th DAY* Onset of incredible fatigue 30 minutes post-vaccination lasting 5 days Fever ranging from 99.6 to 102 which began 5 hours after vaccination and has lasted 7 days post-vaccination Nausea 5 days post-vaccination Headache 7 days post-vaccination Severe arm pain 3 days post-vaccination Eye pain 3 days post-vaccination Intense sweating 7 days post-vaccination Chills 7 days post-vaccination Labored breathing 2nd and 3rd day post-vaccination Significant face swelling 2nd day post-vaccination Decreased mental status 6 days post-vaccination All lymph nodes in neck hard and swollen 7+ days Aggravation of pre-existing sleep paralysis day of vaccination Severe throat pain in the morning, red bumps in back of throat, white pus on tonsils which has worsened and began 1 day after vaccination (antibiotics were prescribed and condition continues to worsen, no one with whom I have been in close contact with has been sick - e.g. boyfriend I kissed the day before vaccine, toddlers I babysat morning before vaccine) - followed eventually by mild cough and congestion

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Severe, Additional Details: Patient had her own Epipen with her since she has many allergies and just had anaphylactic reaction as recently as Monday. She began to feel itchy and had redness, rash after shot during the 30 minute observation period. Epipen was self-administered and emergency services called.

Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 11Mar2021 at 13:00 (Lot Number EN6207), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced brief loss of vision (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, faint (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, short of breath (non-serious) on 11Mar2021 at 13:00 with outcome of unknown, palpitations (non-serious) on 11Mar2021 at 13:00 with outcome of unknown. Therapeutic measures were taken as a result of the events. It was reported that the events were evaluated and advanced life support (ALS) transported the patient to the emergency department (ED). It was unknown if patient was tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.

patient had heavy breathing and pale color upon receiving vaccine. she did not lose consciousness or state difficulty breathing

Fever, Chills, Shaking, VOMITING from 6 pm to 3 AM. Chest tightening, Throat closure, Headache, Body Aches, Severe Abdominal cramps, and Pain. Weakness, to the point of needing assistance to walk, arms tingly and numb.

urticaria - onset at 7:15 (approx 4 hours from time of shot), localized to upper chest and felt hot, right arm sore, had a brief second of dull chest pain (has had before) also had some shortness of breath last night took inhaler and felt better, none currently presented next day over 24 hours from injection - no injection site redness, urticaria on upper chest only, normal airway and lung exam

EMS approached med eval staff regarding 22 yr old female after receiving first dose of Pfizer vaccine @1522 and began complaining of chest tightness /SOB. Does carry hx of asthma/bronchitis and left inhaler in the car. EMS staff administered 2 duoneb treatments without much improvement. Decision was made to transport to hospital setting.

Developed throat tightness followed by chest tightness and then nausea and vomiting. Blood pressure and pulse remained in the normal range. She received epinephrine 0.3mg IM and transported to hospital ER. Felt better by arrival to ER.

4/3/21- 12:00pm shortness of breath and lung pain develop - 9:00pm fever of 102.4 4/4/21- 11:00am nose bleed (first in life not caused by trauma)

Complained of tingling in hands/face. Dizziness when standing. VS pt was verbal with with history of P.O.T.S. Awake and alert x3, no s/s of SOB/resp distress. At 1308: BP 104/76, HR 90, SPO2 90%. At 1317: BP 102/62, HR 85, SPO2 98%, pt complained of tingling/nausea/ ears tingling, awake and alert x 3, c/o throat closing/ tightness. Benadryl was given about 50 mg At 1330: O2 sat 100%, pulse 110, BP 113/72. She stated her throat was closing and she was starting to have difficulties breathing. She mentioned that when she has anxiety she never had tingling and she has no history of allergies

About 10 seconds after receiving her first Pfizer Covid vaccine, she said she had trouble breathing, she mentioned her throat was tingling . She was spitting up mucous but I did not observe any labored breathing or wheezing. We immediately called 911, was read to administer an EpiPen dose, pt wanted to wait for paramedics. When the police arrived, they also did not observe any respiratory distress but offered her O2, then the proceed to take her to Hospital at the pt's request.

Pt experienced some mild SOB. No drooling, swelling, or difficulty speaking. No skin involvement. Pt has hx of asthma. Pt has hx of allergy to shrimp and iodine contrast Instructed to go get albuterol and wait an additional 10 minutes. Pt felt better before she left.

Reading reaction signs and symptoms sign after vaccine. Felt short of breathe and dizzy. Resolved as soon as she arrived at med observation at 14:52. BP at 14:53, HR 61, Resp 16, BP 125/69, SaO2 98%. Kept patient until 15:08. All symptoms still resolved, vitals at 13:08, HR 61, resp 16, BP 115/57, SaO2 99%. Patient released at 15:08 and left via her own vehicle.

Arrived at pharmacy for 1:15 PM vaccine appointment. 10 minutes after vaccine injection, I could not swallow. Throat started to close and feel tight like I could not breathe. Tongue swelled and could not feel tongue while biting down. Chest compression on center chest. Around 1:30 PM I told sister to get a nurse and the nurse said due to my allergic reaction I needed to do the EpiPen. She administered properly in my thigh. About 1:35 PM, symptoms started to go away. Stayed until 1:45 PM and when I left I told the nurse I was leaving. Took 2 Benadryl pills in my car with water.

March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain. March 23, 2021: 2nd dose of Pfizer vaccine. Felt very restless and sick during night, by the next morning symptoms really sat in. March 24, 2021: Went to Urgent Care due to fever. Had COVID-19 test (negative). Very close to passing out there (put head between knees and did not). Was sent to emergency room immediately due to heart rate (high 140s-150s. Highest known was 152 BPM). ER performed following: portable chest x-ray, blood tests, urine tests, EKG. Was told results were all normal with the exception of EKG (not told anything about it, form listed as abnormal). Passed out 2x at hospital. Was given one IV rehydration solution and released that night. Symptoms below lasted for several days: Headache Aches Nausea Aggressive shakes Shortness of breath Confusion Dizziness Site pain (also developed bump under arm) Fever - 103.8 (after 2 Advil, 2 Tylenol, 3 ice packs and eating frozen grapes) Heavy sweats Racing heart Restless March 30, 2021: Still having frequent heart palpitations (they come and go but happen several times during the day. Keep having very high heart rates). Went to doctor. While there, nurse noted irregular heartbeat that sounded like it was ?skipping a beat? and heart rate was also jumping all over the place (high pace, low pace, high, etc.). It was clear something was abnormal. Doctor gave EKG approximately 20 minutes later, EKG looked normal. Was told to come back next morning for blood work and to cut out caffeine. March 31, 2021: Came in for blood work to check thyroid. April 6, 2021: Thyroid results were normal. Still having palpitations among other symptoms (see April 12 for more info) so was told to come in. Was given ?work from home? note and referred to cardiologist. April 12, 2021: Appointment at cardiologist. Still having severe palpitations, occasional dizziness/ lightheadedness, nausea, shortness of breath, exhaustion and chest pain. Heart rate was recorded this day to have gotten up to 139 BPM-- was very high majority of the day. EKG was normal (with exception of high heart rate) but 30 mins later doctor observed high heart rate and abnormal rhythm. Was told to come back in a week and one day for a heart ultrasound and heart monitoring for three days. Still no caffeine intake since 3/30/21. Previous heart rates taken at doctor's visits over the years for comparison below. Never had any prior heart problems whatsoever: 8/29/18: 70 BPM 9/17/18: 88 BPM 10/17/18: 64 BPM 10/31/18: 73 BPM 1/21/19: 78 BPM Note: At this point, I have missed over a week and a half of work, and worked from home for over a week. I'm not any better heart wise at all over the course of three weeks post vaccine.

Guest started hyperventilating after shot, complained of loss of motor function and felt the pain of being paralyzed. And also had hypoxia.

patient reported throat tightness. vitals showed hypotension and tachycardia administered 0.3 Epi IM symptoms improved within 5 minutes. Patient refused transport via EMS but did seek care at ER from which she was discharged without any lingering side effects.

Lightheaded, pulse rose from 72 bmp to 100 bmp 10 minutes after vaccine. Hives and red rash on face, right arm, back, scalp, lips, inner lips/gum line, and back. Rash got worse the day after the second dose and caused an itchiness/ tightness of the chest and throat. Did not feel like my life was threatened so I nursed it at home with antihistamine.

Pt reported dizziness and irregular heartbeat. at 1339.Patient put in anti-gravity chair and given orange juice. Pt vitals assessed: BP 130 mmHg, HR 122 beats/min, SpO2 100%. Patient's extremities were cold upon palpation. patient appeared dazed but was AxO x 4 and able to follow commands. Pt reported similar episode due to irregular heartbeat. Pt reported no pain, throat irritation, chest tightness, and itchiness. Patient offered EMS--pt declined. Patient reassessed in 5 minutes at approx. 1334. Patient reported throat tightness and chest tightness. patient started trembling throughout the body. Pt revealed history of prior hospitalization due to left-sided paralysis. BP 140/80 mmH, HR fluctuating 85-100 beats/minute, and RR 17 breaths/minute. EMS activated. Paramedics arrive at 1411 and assume care. Pt transported to hospital for further care.

Patient stated she felt sudden onset shortness of breath and substernal chest discomfort starting 4/19/2021 just after the noon hour. She presented to the ER at 1:40pm on 4/19/2021. Patient was treated immediatly, including placing patient on 2L O2, EKG performed, labwork drawn, and 1mg/kg lovenox given SQ. Patient taken for CTA of chest, which showed saddle pulmonary embolism. Patient sent for mechanical thrombectomy, which was performed in the evening of 4/19/2021, and patient admitted to Medical Center for follow up care after procedure.

About 20 minutes after injection throat and mouth started to itch. Throat and tongue swelled. Throat was red and scratchy

About 10 minutes after vaccine, I was going out to give another vaccine and saw pt in distress. Got her in vaccination room and got 2 Benadryl from Emergency Bag down her - pt was able to talk but her wheezing was getting progressively worse so we called her emergency person (because she wanted to take herself to ER) to take her and let them know what was happening then I called 911 because even I could tell it was getting worse (Pt was reluctant to take an EpiPen - wanted to wait til it was worse) Dispatch highly recommended EpiPen and since I felt it was getting worse also I gave an EpiPen from Emergency Bag as well. Within 5 minutes pt was clearly doing better. Kept her in room just to stave off gawkers since we had 5 other shots waiting in waiting room - took ambulance about 15 minutes to arrive ... but that gave pt mom time to get to the store and accompany pt to ER with ambulance.

immediate reaction; trouble breathing/shortness of breath, sweating, dizziness, hives, nausea, fast heart rate

About five to ten minutes after I received my first shot, I started to feel like my throat was closing a little. I knew it wasn?t an allergic reaction because I could still speak, but I also became very dizzy and sweaty. I stood up to go see the nurse and she took my blood pressure and it was slightly higher than normal and my heart rate was extremely elevated. I sat down on a stretcher and felt incredibly light headed and gained a metallic taste in my mouth. I also felt very nauseous and started experiencing chest pains. It felt like a panic attack but more severe and more sudden. My throat felt very tight but I could still talk, and my cheeks felt like they were on fire. My face was bright red. They gave me some water and monitored me some more and encouraged me to go to the hospital, but my symptoms subsided after about 35 minutes. After that I just felt tired and didn?t have any more symptoms.

1st reaction Time course-9:50 AM-10 :30 AM (Throat tightness and lips tingling) Doctors gave me Benadryl for symptoms @ vaccination center. 2nd reaction Time course- Around 7:00 PM (Throat tightness, nausea, abdominal pain, numbness in lips) Went to urgent care. Benadryl from earlier may have worn off.

Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was bed ridden through week 3. Symptoms included my body feeling strange, visual disturbances, migraine aura (no previous history of migraines), chest pains, hot breath, temperature changes, faint feeling, fatigue, head pains all around head, pain in spinal chord, pain and numbness on entire body (mostly head), confusion, heat around nape of neck, ringing in ears, nausea, weight loss, strange breathing (not soreness)

I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minutes after administration, an allergic reaction began while I was driving alone in my car. Most notably my blood pressure dropped suddenly, causing me to almost pass out. I stopped driving and my symptoms worsened. Symptoms included shaking, sweating, nausea, confusion, rapid heart rate, red blotchy face, slightly labored breathing, itching and slight swelling of my tongue and lips, anxiety. I could still breathe, so I did not seek treatment, but sat in the parking lot of a medical building for at least an hour for symptoms to subside. Symptoms were acute for about 45 minutes and gradually decreased over four hours. The rest of the day and the next day I felt extremely weak. The following six weeks I continued to have swollen, dry, painful lips every single day and a very itchy rash on my hands and wrists. Occasionally I would wake up with swelling around my eyes. I also had an unusual reaction after eating a salad where my lips swelled even more and became numb, along with an itchy mouth. These long lasting symptoms did not go away until I got a steroid cream from a dermatologist, who denied that my reactions were from the vaccine after talking to me for only five minutes. I just believe that there are many more cases of reactions to the vaccines that have not been reported.

Since my second dose, I've been experiencing migraines, shortness of breath, and an extremely increased heart rate. While attending my routine cycle class (been attending about 3 times a week for several months) I nearly passed out which is extremely unusual. I have also been experiencing a much lighter than usual menstrual cycle. A few days following my vaccination I was also experiencing pain in my left lung (this has since subsided).

On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. While there they got a chest x-ray, ran labs, and did a chest CT. The CT revealed that I had one blood clot in my left lung and two blood clots in my right lung, as well as slight pleural effusion in the right lower lobe. They put me on Xarelto for the next 3-6 months and monthly follow up visits with my primary care provider. I was also given Hydrocodone as need. I experienced extreme pain with breathing and sort of movement for a week and half but currently only have occasional shoulder and back pain usually at the end of the day.

Left face swelling with minimal redness; initial tightness in throat which subsided soon after initiating; BP=124/70, pulse ox=96%, HR=90

Received Moderna first dose and Pfizer for second dose. Arm swelled and red with fever. Vomiting. Vaccination arm numb. Head ache. Shortened breathe.

Patient got her first shot 03/25/21 and the next morning she had some shortness of breath, chest tightness and headaches. It got much wore the next day. She also experienced some dizziness and pre-syncope. EMS was dispatched but did not transport her. Her O2 sat, blood pressure, pulse and temperature were all normal. She then went to a walk in clinic later that day and they told her she had a panic attack. She was still having the shortness of breath and chest tightness. She used her Pro-air and it helped somewhat.

1 pulmonary embolism in the left lung, 2 pulmonary embolisms in my right lung; a slight pleural effusion in the right lower lung; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 13Mar2021 14:00 at 22 years-old, as a single dose for COVID-19 immunisation. Medical history included Known Allergies: Penicillin and COVID-19, both on an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (CAMRESE LO) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin, diphenhydramine (BENADRYL), xylometazoline hydrochloride (SUDAFED), guaifenesin and all experienced allergies. The patient previously received first dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 20Feb2021 14:00 at 22 years old as single dose for COVID-19 immunisation. On 05Apr2021 18:00, the patient experienced 1 pulmonary embolism in the left lung, 2 pulmonary embolisms in the right lung and a slight pleural effusion in the right lower lung. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and considered as a Life threatening illness. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included Xarelto and Hydrocodone. The outcome of the events was recovering.

22 y/o Pt reported to the clinic three hours post vaccine reporting that they felt like someone was choking them. Pt received Benadryl and Epi and was transported.

I woke up the night after the shot with difficulty keeping my breath even and feeling weak which led to pretty high anxiety. This went away after a few hours

body aches, fever, weakness, fatigue, headache, nausea began the following day; then shortness of breath/chest pain/pain with deep breath started 3 days after vaccine. Taken to Hospital ER for evaluation. Labs collected (D dimer, CBC, CMP, Pregnancy test, PT, PTT); CXR done-noted questionable 6mm nodule; CT Scan Chest done-No pulmonary embolism found, no nodule noted-assumed to be shadowing or artifact. Symptoms continued and seen by family NP 4/30/21-wheezing noted to left upper lobe, placed on z pak and albuterol inhaler. Symptoms of shortness of breath, chest pain/pressure with deep breaths continued and started on Prednisone 20mg 5/3/21. Symptoms continued and seen again by family NP 5/7/21. Labwork collected (CBC, CMP, Thyroid panel, D Dimer, CRP, ESR, Covid antibodies) and CXR done. WBC 16 and glucose 130 related to recent steroid use. CXR normal. Covid antibodies positive; ordered PFT's and echo (to be completed 6/4/21). Shortness of breath and pressure with deep breaths continue, slightly improved at this time.

Admit Date: 4/19/2021 Discharge Date: 4/23/2021 S/p 2nd COVID vaccine on 4/17, developed dyspnea on 4/18. COVID PCR+ on 4/19. CRP >200. Patient is a 22 y.o. female with lupus, hx of class IV lupus nephritis on multiple immunosuppressing medications who presented with dyspnea in setting of 2 months of chest pain. Pt reports chest pain, substernal, R sided x2 months. Seen as outpatient previously (February), CTA negative, no effusions at that time. Since then progressively worsening. Yesterday had new and progressively worsening dyspnea. Upon my interview, denies pleuritic pain, not clearly positional, sometimes better with sitting forward, sometimes better when supine. Upon my interview she is very tachypneic so obtaining hx is challenging. She denies anxiety at this time. Denies relief with ativan in the ER. Of note, she received her 2nd COVID vaccination on 4/17, day prior to onset of dyspnea

Patient waiting about 30 mins after vaccination reported shortness of breath and wheezing. Team applied O2 and administered EPI Pen to Left Thigh and transported to the ED in stable condition

First dose Pfizer administered 1158. Patient immediately stated she was not feeling well. Patient described tongue and jaw "tingling", lightheadedness, difficulty speaking, and difficulty swallowing. Patient was noted to be slurring her words. Both hands were also noted to be stiffening with patient stating her hands were "numb", unable to grasp writer's hand, with shaking of legs. Epinephrine was administered at 1203. EMS called at 1204. Vitals at 1205: blood pressure 115/71, HR 128. Patient was still in distress - verbalizing difficulty speaking and swallowing, rapid breathing, legs shaking. A second dose of epinephrine was administered at 1209. Vitals at 1210: blood pressure 115/63, HR 133. Pulse ox at 1214 was 100% with HR of 105. At 1216, patient stated her tongue and jaw were still "tingly" but the lightheadedness, hand numbness, and leg shaking had subsided. Vitals blood pressure 109/65, HR 100. 1220: Tongue and jaw tingling "calming down" per patient. 1223: Patient states "everything is back to normal" No tongue swelling or jaw tingling. Vitals: blood pressure 104/60, HR, 95, oxygen 100%. EMS arrived 1252 - vitals blood pressure 102/64, HR 104. EMS asked patient if she wanted to go the ER, patient declined stating that she feels back to baseline except lethargic post epi. Patient had no complaints at this time. Patient was advised to have Benadryl on hand and to follow up with her PCP or go to the ER if any symptoms of a reaction return. Her fiancee states he will be home with her today.

Within three hours, I had a rash breakout from the left side of my neck to my right side. Two days later when I went back to work, I noticed I was having difficulty breathing which I haven't experienced at work before. I work in manual labor so I am used to strenuous work and exercise. My breathing was fine after two days of taking Benadryl once a day in the evenings and my rash cleared up completely on May 17th.

Throat closing; Shortness of breath; Swollen throat; Dizziness/ Lightheaded; Wheezing; Allergic reaction; had a combination of allergies specially to PEG in the vaccine; This is spontaneous report received from a contactable consumer (patient's mother). A 22-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0151, expiration date unknown) via an unspecified route of administration at left upper arm on 04Apr2021 07:30 AM (reported as 06:30 or 07:30, probably 07:30) at age of 22-year-old at single dose for COVID-19 immunization. Medical history included postural orthostatic tachycardia syndrome (POTS) from Jan2021 and gastro stuff. Patient was previously diagnosed with tachycardia, but this was a misdiagnosis. She had a cardiac implant, but they couldn't figure out what was wrong, so her daughter saw a new cardio, and she has been good. Patient was previously had a reaction to Miralax. Concomitant medications included metoprolol tartrate which was taken for several years for POTS, lorazepam (ATIVAN) for panic attacks (started taking 2-3 years ago, maybe 1.5 years ago, when she went off to college, caller clarified it was 2 years ago), escitalopram oxalate (LEXAPRO) for panic disorder and anxiety (started about two years ago and was off for about a month). There was no additional vaccines administered on same date of the Pfizer Suspect. There was no prior vaccinations (within 4 weeks). Caller stated the patient had a reaction to the first shot of Pfizer COVID-19 vaccine. She had a severe reaction. Patient had a combination of allergies specially to PEG in the vaccine. Patient spent the entire day in urgent care. She had a swollen throat and dizziness right after receiving the vaccine (04Apr2021). She was wheezing and lightheaded. Patient was given an ep-pen and Benadryl. It took a while to bring it down. Patient had Pfizer's COVID 19 vaccine on 04APR2021, and had an immediate allergic reaction including throat closing, wheezing, shortness of breath, dizziness, with the first shot, so caller needed to call to report it, caller's cousin is a pharmacist, and said to call. Patient was not taken to the hospital, caller ended up taking the patient to urgent care, they had talked patient out of it, and the doctor was livid, patient's doctor was working at the site that morning. Caller stated she is a busy worker, and today is the first day she is getting to this, and getting things squared away. She knew her daughter has a 60-day window to decide if she was going to get the second, and she wanted to get it, but the reaction was horrible, it was in her daughter's best interest, they were talking at the hospital, and caller needed to talk to someone to figure it out. Patient's doctor didn't know. Caller's cousin is a pharmacist and talked to them and said, because caller stated her daughter had had a reaction to Miralax, too and her cousin said that has PEG, which her cousin said was what Moderna and Pfizer have, so caller didn't know. Her daughter ended up going to urgent care, stayed there, and was calmer, her vitals settled after the Epi Pen, and caller understood it is the protocol with Epi Pen, that she has to be monitored medically, so patient was monitored at Urgent Care until 1PM, and her daughter was like, it wore her out, so that was the response. Her daughter has recovered completely, but it took a few days, to go back to herself, patient has a cardiac condition, POTS, and gastro stuff, and caller was trying to get her medical stuff squared away, and this definitely didn't help. Caller stated they would be trying to wean her daughter off Metoprolol. caller stated it's Ivabradine, but her daughter has not started it yet, since it has side effects with vision, so her daughter was waiting to go to the eye doctor to take that, so she was taking Metoprolol. Lexapro was stopped trying to get ready for this heart medicine, so they were waiting to figure out all this, before they start that. No further details provided. Caller read from paperwork, which said allergic reaction NOS, drug reaction allergic. Then there was cardio stuff, then it said Cardiac monitoring, oximetry, CBC with automated differential; Hcg beta qualitative urine, IV saline lock. When asked for results, caller said she saw results, but that must be where it's connected with another hospital. Stated she can fax the results. It was reported that patient had a follow up at doctor's office for the events. Event throat closing was reported as serious as medically significant. Onset date of the events was 04Apr2021. Outcome of the events was recovered. Report 1 of 2. Caller was provided with phone number and hours of operation prior to cold transfer onto the line, due to a high call volume, to wait for the next available agent. No follow-up attempts are needed. No further information is expected.

All adverse effects were believed to onset in the first 1-2 days after vaccination, and are still ongoing 10 days later, but not reported to be severe: sore arm, fatigue, nausea, vomiting, chills, fever (mild), shaking, dizziness, syncope ( none recent), wheezing, pain in left trunk area upon deep inhalation (not sharp), cough, sputum that is sometimes brown. The parent came close to taking her to the emergency room earlier on after vaccination, but did not.

Heart racing , fever, and dizziness throughout day. Shortness of breath and chest heaviness from around noon (24 hours after shot) through at least midnight. Took inhaler and advil which helped reduce fever and improved shortness of breath, but was still left with some shortness of breath and all the other symptoms remained

Patient reports chest as feeling tight, had difficulty swallowing and breathing about a day after receiving first dose. She reports feeling like this for a few days, and if she had not gotten better at the time of phone call she would have gone to hospital. She was advised to reach out to her doctor and to go to ER if she experiences any more difficulty breathing.

Shortness of breath and dizziness started May 30th around noon and lasted two days on and off. I would suddenly feel like I wasn't getting enough oxygen even though I was breathing deeply and then need to lie down so I didn't pass out. This happened about 4 times per day lasting about 20 minutes each episode. Not exercising or doing anything out of the ordinary at time of onset. I haven't noticed these symptoms today, so it might be over.

Fatigue, increasing shortness of breath for 1-2 weeks, diagnosed with pulmonary embolus on 6/2/21 in emergency department

Patient started feeling tingling and tightness at the throat, with some tachycardia approximately 20 minutes into the vaccination (Admin: 13:43). Due to area of concern and weight, patient was administered (2) tablets of diphenhydramine 25 mg [Geri-Dryl Allergy Relief by Geri-Care] at 13:07 from our travel clinic's emergency kit. Patient reports that they had tachycardia and nervousness prior to the vaccine by 10 minutes. After further inquiry, patient had a recent asthma attack 3-days ago that was also newly diagnosed then. Patient did not have a rescue inhaler but has a prescription on hand. After, 45 minutes of watchful waiting and 32 fl. oz. of water during observation, patient was "feeling fine" and able to converse normally (with laughter), no lightheadedness or further throat sensations.

I have been feeling very lightheaded and dizzy ever since. This occurs every day. I cannot drink caffeine anymore because I get extra dizzy. My balance is off. I got my heart checked in which I had to wear a heart monitor and get an echo. It came back and nothing is wrong with my heart. I also cannot take a deep breath. I always have shortness of breath. I had three episodes in which I thought I was actually going to pass out and my arms and legs were tingly and I was nauseated. I went to the emergency room and nothing came back from my labs. I am lightheaded when I get up fast. I no longer have nausea and appendages tingle. All of this occurred on the first dose and I did not receive the second dose.

Patient stated that she felt like she was going to pass out and began hyperventilating for roughly 20 seconds. Patient leaned back in chair and closed eyes for about 5 seconds before sitting up straight and stating that she "felt much better." Patient was given a bottle of water and cold compress. Heart rate at that time was 65 bpm. Patient reports severe generalized anxiety, especially to needles. She was observed in waiting area for 30 minutes before leaving with her mother

Shortness of breath; Chest tightness; burning; This is a spontaneous report from a contactable consumer (Patient). A 22-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in right arm on 09Mar2021 (at the age of 22-years-old), as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration, administered in right arm on 16Feb2021 at 12:00 as single dose for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. On 09Mar2021 at 08:00 (same day of vaccination), patient experienced shortness of breath, chest tightness and burning. Patient did not receive any treatment for adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: unknown results (Nasal Swab) on an unspecified date. Patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Myocarditis; abnormal heartbeat; intense chest pain; Shortness of breath; The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 16:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at the age of 22-year-old. Medical history included covid-19 prior to the vaccination. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and levonorgestrel (KYLEENA) (reported as Kyleena IUD). No other vaccine received in four weeks. It was reported that I woke up with intense chest pain two days after the first dose. Thought I was having a heart attack. Now realizing it was Myocarditis. Intense pain when moving and lifting heavy objects. Apple watch detected an abnormal heartbeat which fixed itself later on in the day. I experienced shortness of breath. The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly. The events stated on 24Feb2021 08:00. No treatment received, and outcome of events was recovered with sequelae on unspecified date in 2021. The patient hasn't been tested post vaccination.

After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May). Early June, patient experienced burning chest pain & difficulty breathing. Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL). Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion. Patient was transferred to hospital for higher level of care. Unknown if cardiac effects are related to vaccination or acute disease process.

One hour after getting Pfizer vaccination, patient developed throat swelling and trouble swallowing. She called 911. EMS treated her with epinephrine, benadryl and solumedrol. She was transported to ER and later released.

Patient stated that she felt a "lump and tightness" after 15 minutes of injection in her throat after receiving her first Pfizer covid vaccine. Vital signs taken o2 97%, HR 102, temp 98.4 orally, BP 126/88. Patient seen by PA who stated no swelling in mouth seen, vitals normal. Patient waited an additional 15 minutes. Patient felt better when she left clinic.

About 3 days later, I started noticing shortness of breath. Mine had just caused really bad allergies. I thought it was just my allergies causing the shortness of breath. After my allergies stopped for the season, I was still having shortness of breath. About a week or two after getting my vaccine I started noticing that my dizzy spells started getting worse. I was having light headedness. I was having these beforehand, but after the vaccine they were worse. I would normally just get a little head rush (like standing up too fast), but now my vision starts getting black from the outside coming in. I almost pass out. After about 3-5 seconds, I'm able to gather myself and keep myself from passing out. I also noticed that my heart cannot take as much strain as it used to. I was having palpitations. It feels like it's attempting to stop beating. It now is triggered more easily. It's very hard for me to catch my breath and I get worn out super easily. I went and saw my PCP about 2 weeks ago for a regular routine visit and I informed her about my symptoms. She said everything looked fine and in normal ranges. They sent records to a pap specialist. I am still waiting to hear back from them to do some testing. I also talked with my therapist about some of the issues I've had because we thought it might be anxiety related, but we ruled that out. It is more medical.

Sinus Tachycardia/SVT/Palpitations. Ongoing since January - Racing Heart -Heart beating hard -Shortness of breath -Dizziness

This event occurred today, 25 Jun at approx. 1400 hours. 22 y/o f patient received the 2nd dose of COVID vaccine. Pt had some previous history that rendered her high risk for the vaccine with a 30 min wait time. However, she did not have any contraindications for the vaccine. Pt was advised by her PCM and screener that her reaction may be worse this time and she may not wish to get it. However, pt insisted on completing the series. At around 1400 hrs on 25 Jun, pt complained that she could not feel the arm she received the injection in (left). Pt was brought into the sick waiting area to be escorted to the immunizations area for further evaluation, but pt stated she began to feel weak and lightheaded while walking. Pt was sat down in a reclining chair where she then began to hyperventilate. She was given 2 tabs- 25mg of Benadryl at approx 1405. Approx 3 min later, pt states she felt worse and was having trouble breathing. At approx 1409, pt received, 1 autoinjector of Epinepherine (0.3mg). After the dose of epinephrine pt began to feel nauseous and stated she felt pain when touched. Pt stated it was painful when provider proceeded to take radial pulse to the point pt was shouting in pain. EMS protocol was activated immediately following the epi dose. Approx 1415, Security arrived on scene followed by Fire Dept a few minutes later. Pt was placed on NRB at 8 lpm. At approx 1420, pt was given second dose of 0.3mg of epinephrine. At approx 1425 EMS services arrived on scene. Pt was then transferred to EMS personnel and pt was taken to ER with spouse.

doctor told her that it was an adverse reaction to the vaccine and not to get the second dose; She's been sleeping for days so she is not feeling well; She's been sleeping for days so she is not feeling well; Broke out in hives and hives went around her mouth; Throat was getting swollen; This is a spontaneous report from a contactable consumer (parent). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported; Expiration Date: Aug2021, patient was 22-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 15Jun2021 at 08:00 as single dose for covid-19 immunisation. No medical history was reported. Concomitant medication(s) included spironolactone and birth control (unspecified). Reported that caller was not sure about lot number, it just says EW, it could be 0 or it could be an O, it just says EW it might be 0, its just say EW0178 or O187, I am not sure. It was reported that caller reported on behalf of patient and stated that caller and her daughter got a vaccine on Tuesday morning and Tuesday afternoon, she broke out in hives and I had to take her to the emergency room and get her shot of epinephrine (Treatment) and they put her prednisone (Treatment) on because her hives were around to her mouth and throat was getting swollen and their doctor told her that it was an adverse reaction to the vaccine and not to get the second dose and they told us to call an report it. she's been sleeping for days so she is not feeling well. Patient was about about 5 (feet) 7 (inches) and about 200 (pounds) and she will be 23 on Saturday. Patient not received prior Vaccination within four weeks. On 15Jun2021, the patient experienced broke out in hives and hives went around her mouth, throat was getting swollen, on an unspecified date, She won't be getting her second dose, she's been sleeping for days so she is not feeling well. Reporter seriousness for Broke out in hives and hives went around her mouth, Throat was getting swollen, she's been sleeping for days so she is not feeling well was unspecified. Patient visit emergency room after the Broke out in hives and hives went around her mouth, Throat was getting swollen. Reported that the hives went away, and they have not come back, she just went all off. Reported that doctor said that we should call because she has definitely a serious reaction so, she won't be getting her second dose, but I will. Patient received treatment for event (broke out in hives and hives went around her mouth and throat was getting swollen). The outcome of event (broke out in hives and hives went around her mouth) was recovered on an unspecified date in 2021 and the outcome of events (Throat was getting swollen, she's been sleeping for days so she is not feeling well) was unknown. Information about lot/batch number has been requested.

Chest pain, upper back pain, shortness of breath, O2 at 90% on room air, pain radiating from injection site down arm, headache, pain down left side of neck, nausea, UTI, rash

Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts to close in I couldn't breathe; I have a lot of trouble in breathing; I couldn't eat; I couldn't sleep; I was very dizzy; I had a lot of vomiting; I couldn't even swallow; My neck was really getting swollen; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 5EW0182), via an unspecified route of administration on 03May2021 (at the age of 22-years-old) as a single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her shot right in, "my breaths starts to close in I couldn't breathe", "I couldn't eat", "I couldn't sleep", "I was very dizzy", "I had a lot of vomiting" and it was basically not good. Then she went to the urgent care because "I couldn't even swallow", "my neck was really getting swollen" and "neck was chocking I feel like that I have taken a pill and it stuck in a throat" and then "I had fever", chills and a lot of hard time. When paraphrased the above concern, the patient stated, and then "I have a lot of trouble in breathing". She received the second dose on 24May2021. The patient stated, the only thing that they gave her was Ibuprofen because they say, that's the only thing that they could give her. The outcome of all the events was unknown. Follow-up attempts completed. No further information expected.

15 seconds after second dose, could not breathe, nausea, dizziness, lost completely feeling in both arms, side cramps, chest tightness, uncontrollable shaking, feeling super cold. Vision suddenly got narrow , began seeing stars, black patches Got an epipen injected and was finally able to breathe. Paramedics arrived and took vitals and I stayed for 45 mins until vitals were back to normal. Suggested I drive in the ambulance to the ER to be monitored but it wasn?t bad enough for me to ride. Someone separately drove me to the hospital just in case and I was ok.

The first dose I experienced flu symptoms with a body ache/chills/headache that lasted for about 2-3 days. 2nd dose, next day had a fever/chills/headache/body aches, a few days later experienced shortness in my breath, numbness, and pain in both legs, extreme lower back pain and abdominal pain/cramping and the pain is still there, I have 2 swollen lymph nodes located in my groin area. I have seen the Dr a few times and had a CT scan. They discovered I have an enlarged liver/swollen spleen that they found a blood clot, the doctor has me taking aspirin for 3 months, and will need to follow up with another CT scan

High fever, extreme chills, body aches, numbness in my arms and legs, nausea, difficulty breathing lasted for 4 days after second dose. After the second dose I am still missing my period and my hair is falling out in large clumps.

3/15/21: began feeling short of breath with any exertion as well as having tachycardia. Went to get covid tested and was negative, vitals were heart rate 169 at and they sent me to an ER to be evaluated for possible . While at Hospital my heart rate continued to be 150-160 while resting and elevated with movement. D dimer was elevated at 1.67. CT angiogram of Pulmonary arteries was negative. Troponin was negative x3. Wbc were 3.08. EKG showed sinus tachycardia with possible left atrial enlargement. Tested again for covid and was negative. Hospitalized for 1 night for observation. Discharged 3/16/21 with a 1 month heart monitor. Had follow up visit with PCP on 3/19/21. Heart rate in office was 120s. EKG was performed, lying down my heart rate dropped to 70s. Orthostatic vitals were obtained. Heart rate increased with sitting and standing and blood pressure continued to decrease. Magnesium level and echocardiogram were then obtained and both came back normal. I had to be off of work for over a month due to heart rate and symptoms with it. 3/28/21: covid test performed, negative for 3rd time. 4/1/21: tilt table exam performed. Heart rate laying was 100, tilted up went well over 170 with almost passing out and shaking uncontrollably in the first 7 minutes of the test. Cardiologist ruled it as inappropriate sinus tachycardia. 4/20/21: office visit with cardiologist. Cardiologist notes, "Impression inappropriate sinus tachycardia with hypersensitivity of sinus node. Post viral syndrome without evidence of flu or Covid with negative testing. History of being previously vaccinated." Cardiologist stated to me it was most likely vaccination related since he has seen cases like this recently. Had to be put on beta blocker atenolol 12.5 mg and still taking it to this day. Heart rate still occasionally increases to 140s while on medication but is overall controlled.

Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.

Since July 4th I have felt as though I can't breathe, exercise is difficult and I haven't been sleeping because it's harder to breathe when I lay down. I have chest tightness and pain.

Immediately upon administration of covid19 vaccination, patient became flushed (face and arms), dizzy and nauseous. Patient also reported vision changes (seeing spots) Flushing resolved in about 5 minutes and nausea/dizziness in about 10-15 minutes while patient was monitored by pharmacy staff. Patient reported heavy breathing at this time believed due to anxiety but was continued to be monitored by staff. After about 20 minutes patient was able to stand briefly and moved to another chair to relax and to continue monitoring. At this time most symptoms had resolved but patient still reported feeling uneasy and a little disoriented. Water was provided and pharmacy staff continued to sit with patient until patient felt that she had calmed down and reported no further adverse conditions. After sitting for another 10 minutes patient stood on her own, was stable and felt comfortable returning to work.

I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just from laying down and it is a daily struggle to do everyday things like walking because I get short of breath really easily after I had the vaccine done. It has been 3 and a half months now and I am still struggling trying to recover. My treatment right now is that my pulmonologist put me on Symbicort to see if it could give me a little bit of relief and I am still being seen by the cardiologist as well, and I am also using my rescue inhaler Albuterol HFA more often than before. I am taking Singulair and I was also put on a heart monitor for 2 days to check my heart rhythm to see if that has anything to do with the chest pains I have been feeling

Eyelids started to swell up/swell up a little bit; Eyes were still a little puffy; My eyelids started to get hives; My lips started tingling; my throat start to tighten; This happened after my first dose that my immune system is just more hypersensitive to my allergies; This is a spontaneous report from a contactable consumer (patient). A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 16Mar2021 10:00 (age at vaccination was 22 years) (Batch/Lot number: EL8982) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergies to pure soy (ie. Soybeans, soy milk), pollen, itchy red eyes and eyelid probably due to mild to moderate pollen allergies. There were no concomitant medications. 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. Patient reported that before getting the vaccine at 10AM, she woke up with itchy red eyes and eyelid probably due to mild to moderate pollen allergies. On 17May2021 (The next day at 3pm), after patient got the first dose her eyelids started to swell up so she took Benadryl that night. 48 hours after the first dose (17Mar2021 at 15:00), her eyes were still a little puffy so she took 2 Benadryl. At around 6-7pm, eyelids started to get hives and swell up a little bit and about an hour later lips started tingling and felt her throat started to tighten. She immediately took another Benadryl and went to the hospital as the swelling started to subside. Patient was possibly thinking that maybe since that happened after her first dose that her immune system was just more hypersensitive to her allergies. The adverse events required emergency room/department or urgent care and Physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Covid test: negative on 18Mar2021. Therapeutic measures were taken as a result of the events with diphenhydramine (BENADRYL) and prednisone (DELTASONE). The outcome of the events was recovering. Follow up attempts are needed; Additional information has been requested. Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.

Patient calls in reporting new fast breathing, fever, diarrhea, vomiting, chills, muscle aches, shaking/chills

I began to have paresthesias in my lower extremities, which progressed to saddle anesthesia over about a week?s time. I then developed acute urinary retention. I could also not have a bowel movement at that time. In the ER, I was cathed and they also performed an enema, believing I was constipated but nothing came out, leading me to believe that it was a loss of nerve function. They also performed an emergency MRI which showed no nerve compression (ruling out cauda equina syndrome). I left because I believed I could urinate at home. I was not able to urinate until mid morning the next day. After this, I was seen by a neurologist who believed I may have multiple sclerosis. However, my work up came back negative. At the same time, the paresthesias continued to ascend into my hands and I could not sit due to overwhelming pain and saddle anesthesia/LE parenthesis. As this began to resolve, I woke up from sleep multiple times in a row for 3 nights gasping for air because I stopped breathing spontaneously (even with sitting up and changing positions). I recovered after this symptom resolved and have been completely fine since. I am a PA student and I truly believe that I had a Guillian Barre type reaction to the vaccine.

tightness in throat and lump in throat/had a tightness and lump in her throat; tightness in throat and lump in throat/had a tightness and lump in her throat; allergic reaction like rash, tightness in throat, and lump in throat; allergic reaction like rash/red rash on her chest and rash was on her arms too; cheeks were flushed; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for 3 patients. This is the first of 3 reports. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular in the right deltoid, first dose on 27Dec2020 14:15 at a single dose for covid-19 prevention. Medical history included ongoing asthma and reactive airway which she was diagnosed when she was like 5 years old (2002). Concomitant medication included albuterol [salbutamol] for asthma which started when she was 8 years old or so. The patient wanted to know if she can receive the second dose of covid vaccine after experiencing symptoms of allergic reaction like rash, tightness in throat, and lump in throat. She wanted to know the ingredients and specific proteins in the covid vaccine. The patient received the COVID Vaccine and she developed a reaction. On 27Dec2020, she had a red rash on her chest, and her cheeks were flushed, and the rash was on her arms too, and she had a tightness and lump in her throat, it was not painful to swallow but she could feel the pressure with swallowing. She stated that she did not experience shortness of breath, but regardless, she was seen in the ER and she was given IV SOLUMEDROL, and BENADRYL, and she was watched for 5 or 6 hours and then she was sent home with an Epi Pen, around the clock Benadryl, and prednisone. She asked the ER doctors if they thought it was okay for her to receive the second dose of the product, and they told her to contact employee health for that question. She mentioned that she contacted that employee health and was told to contact her primary care provide which she did. Her primary care doctor instructed the caller to call Pfizer and gather some more information regarding ingredients, as the she may have had the reaction to a particular protein filler. She was also wondering if this is a known reaction to the product. She received the vaccine on 27Dec2020 at 2:15 PM. She reported that the red rash on her chest and arms, and her cheeks being flushed, resolved yesterday after receiving IV BENADRYL. Had a tightness and lump in her throat which was still ongoing, and it was kind of off and on and when the she takes Benadryl it goes away. She reported that this one is medically significant because even though she did not have shortness of breath, it could have affected her airway. She confirmed that she received no other vaccines on the same day as the COVID vaccine. The outcome of the events 'had a tightness and lump in her throat', allergic reaction was not recovered (a s reported); while recovered on 27Dec2020 for allergic reaction like rash/red rash on her chest and rash was on her arms too and cheeks were flushed.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events throat tightness, sensation of foreign body, allergy to vaccine, rash erythematous and flushing cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-2020517134 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.

Tingling and numbness of tongue, throat and lips Facial and neck itch and redness Minimum difficulty breathing

Within 24 minutes of vaccine, developed shortness of breath, hives, and itching. This was self treated with diphenhydramine, famotidine, and albuterol. EpiPen was not utilized. Patient did speak with allergist. Slowly recovered over next 4 hours until full recover.

Shortness of breath, hives, and itching. Took benadryl, famotidine, Xyzal at time of reaction. Also 4 puffs on ventolin. Symptoms slowly improved over 4 hours. Epiniphrine not administered.

Within 10 minutes of receiving vaccine, patient reported dizziness, headache, SOB, & "hard to swallow," light-headed, was diaphoretic. Was seen in ED, given oral Benadryl, Epinephrine, Zofran. Monitored in the ED for 5/12 hours, then discharged to home.

Itchiness, chest pain, cough, chills, sneezing, body aches, headaches, shortness of breath, fatigue and spitting up flem.

Presented to ED 1/3/2021 Tachycardia, fever, headache and myalgia. Complaints of shortness of breath.

Approximately 1 hour after receiving the vaccine I developed tachycardia that ranged between 130 and 95, this lasted from 01/08/2021 until 01/09 ~10 AM. On 01/08 ~5 PM I began to develop a fever that reached a peak of 102.4 at 4am (01/09), despite taking 1000 mg of acetaminophen every 6 hours. Last fever recorded 01/09 ~9PM of 99.5 (while still taking 1000 mg of acetaminophen every 6 hours). Additional symptoms have been severe nausea, dizziness, lightheadedness, bilateral lower back pain with some mild bruising to the kidney region, difficulty breathing, chest pressure, shortness of breath along with a cough upon exertion (developed ~6 PM 01/08), which is still present today (01/10 1:25 PM), and an erythematous rash that covers the anterior side of the right forearm, from wrist to elbow (first noticed on 01/10 ~11 AM).

Headache, nausea, body aches, tightness of chest, shallow breaths/shortness of breath, light headed, fatigue.

Patient was screened for COVID-29 vaccine and since no contra indications was given vaccine around 1:10 pm. Around 1:30 pm patient told facility staff she was feeling numbness, tingling, short of breath, weakness, dizziness and felt like fainting. The patient appeared shaky, and clammy. Blood pressure taken at 1:35 pm was 172/100 mmHg, then repeated 168/101 mmhg, then 164/106 mmHg. Facility staff called EMS and they arrived and assessed patient. BP reading 160/100 mmHg, HR 120 bpm, and O2 SAT was 100%. Patient was taken to ER at 1:55 pm. Patient was alert and answering questions.

headache soon after vaccine (gone ), hard to take a deep breath(denies anaphylaxis), wheezing with activity, coughing, fatigue later the same day as vaccine

after 10', felt short of breath and anxious. Transferred to ED: sx resolved after arrival/. No intervention - Observation for 4 hrs

1/13/2021 7pm: nausea headache runny nose 730pm-7am: throwing up headache runny nose 1/14/2021 8am -3pm nausea, minor headace,stuffy/runny nose 4pm-7pm throwing up, headache sore throat runny nose exhaustion loss of apatite trouble breathing

sinus tachycardia for 2 hours, rate up to 171. required ER visit for 2.5 hours. associated dyspnea and delayed onset rash later in day. Not given epinephrine. treated with IV saline and observation. Symptoms began within 1 minute of administration of IM vaccine

Approximately 30 minutes after receiving vaccine, pt. started complaining of feeling short of breath, lightheaded, and fatigued. No other symptoms noted at this time. Assessed per health professionals. Blood pressure: 153/103, heart rate: 91, and O2 sats: 100% on room air. No Benadryl or Epinephrine given. Pt. requested to be seen by emergency room - friend came and picked pt. up and took to emergency room.

Patient got her 1st COVID shot around 1:30. States she was a little itchy at injection sight about 1 hr after. Around 5pm when leaving work felt like she wasn't swallowing like normal and her throat felt a bit swollen. She works in our clinic and presented to the nurses before leaving work. Injection site without redness, swelling or rash. no rash anywhere else. Throat didn't appear swollen. Able to speak and swallow. No drooling noted. Provider assessed patient. 50 mg oral Benadryl given at 5:05pm and monitored. No worsening symptoms. Patient said completed resolved by 7pm. Nothing ever got worse. She spelt well and woke the next morning with no complaints.

Patient with chest tightness, generalized fatigue, and mild shortness of breath 24 hours after receiving the COVID-19 vaccine We will obtain chest x-ray, EKG, and lab work All results reviewed in detail and with the patient Patient states that she is feeling better and she is pleased at the results Patient's oxygen saturation is 99 to 100% throughout her ED course

Per email received on 1/18-So I had my first dose of Pfizer?s covid vaccine last Friday (3pm). I experienced several side effects that day: lightheadedness, dizziness, fainting, nausea, throat constriction leading to shortness of breath and difficulty in swallowing, hives, flushed face, and fatigue. The throat constriction honestly frightened me and I almost went to the ER, but it eventually went away. For Saturday and Sunday, I developed fever, muscle ache, and extreme fatigue. Today, I thought it would get better but I still have fever and the extreme fatigue has not gone away. And unfortunately, as I am typing this, I think my tongue is getting quite swollen and is making it uncomfortable to breathe and swallow

Received the vaccine at 10:52am, and was observed for 15 minutes in the clinic. After leaving the clinic, she noted slight shortness of breath on her way to her car a few blocks away. While in the car on the way home around 11:57am, she developed severe headache, nausea, chest pain, chest tightness and shortness of breath. Chest tightness is "terrible." History of asthma but has no recent exacerbation in last 3 years. Referred to urgent care at Cancer Center, which has emergency room capabilities.

Approximately 15 minutes after the vaccination the patient reported dizziness and possible rash on her upper chest. It was difficult to assess if the rash was truly a rash or it was simply skin lesions that were already present (patient claimed she did not know). It did not resemble a maculopapular rash. It marginally resembled minor hives/urticaria. Patient did not report any localized symptoms at injection site. Patient was informed to remain seated and that her vitals would be taken and she would be further observed. Then about 10 minutes after this (25 minutes after vaccination), patient reported difficulty breathing. Facial redness was noted at this point and patient's breathing sounded difficult. Emergency medical services were called and EpiPen was administered at this point. Patient began to tremble and pace of breathing increased. Emergency medical technicians arrived, took vitals / EKG, and assessed the patient. EMT assessment did not reveal urticaria. EMT instructed patient to control her breathing. The EMTs believe that it may not have been a true reaction but rather the patient may have been suffering from an anxiety attack. Patient was then taken to local ER for further evaluation.

Nausea the morning after. Not a sore throat but it feels like my throat is slightly swollen. I can still drink and swallow just fine.

10 minutes after the vaccine was administered i had an allergic reaction, headache, a fever and pain in the arm where the vaccine was put. The next day I woke up with faint symptoms of covid 19, pain in the chest, a little difficulty breathing, headache, dry cough and diarrhea. After a couple of days everything was fine.

1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free

throat felt like it was closing up; had issues swallowing; it feels like her throat will close up and open up; felt dizzy; shaky; nauseous; extremely tired; had a strong headache; It's like she is having allergy and hay fever type symptoms; It's like she is having allergy and hay fever type symptoms; The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.; feels like she has a big lump in the middle and sides of her throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL1283, via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she got the Covid vaccine on Saturday, 09Jan2021, and immediately her throat felt like it was closing up, she was instantly reacting to the vaccine. Since then, she has had issues swallowing; it feels like her throat will close up and open up. She also felt dizzy, shaky, nauseous, extremely tired, and had a strong headache. She stated that diphenhydramine (BENADRYL) helps a lot with the throat symptoms and as long as she takes it, she feels almost normal but as soon as it is out of her system, it starts again. It's like she is having allergy and hay fever type symptoms. The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat. She just came back from the emergency room and they gave her diphenhydramine. She wanted to know if she should she get the second vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and throat tightness cannot be excluded based on a compatible temporal relation. 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.

Migraine afternoon of 1/25/2021. She then experienced feelings of nausea, mouth-watering, feeling overheated. While resting during the onset of these symptoms she then felt like she couldn't breath, experiencing pain in the sides of her chest. The next symptoms that occurred were angioedema to the face, she described her eyes getting so puffy she couldn't see. She also described her skin getting reddened and itching all over. She took Benadryl at home and started to feel better in about 1 hour.

12 hours post-administration; lethargic, malaise, lack of appetite, headache 16 hours post; chills, body aches, nausea 20 hours post; wheezing

Day of vaccination: body aches, chills, fatigue Day 1 after vaccination: nasal congestion, sore throat, fever, fatigue, body aches. Day 2 after vaccination: short of breath, fatigue, loss of voice

facial flushing, light-headed, and mild shortness of breath (which patient attributes to generalized anxiety disorder). Given Benadryl 12.5 mg.

First 2 days after vaccination, I had some injection site pain that was improving. Day 5 after vaccination, I developed lymphadenopathy on my left side with swelling into the chest area developing on day 6. Day 8 after vaccination, my injection site turned red and itchy and I began to have trouble breathing. I went to urgent care. I saw P. A. She said that it was more likely that the difficulty breathing would be due to my asthma, but she could not recommend whether or not I should receive my second dose. She proscribed 20mg of Prednisone and refilled my albuterol prescription. About 20 hours later, my breathing is still difficult and my arm still itches. We also discussed that the respiratory symptoms could be caused or exasperated by COVID-19, so I am waiting on results from a covid test.

The employee reported to the Observer RN for skin redness from neck to chest and down to body/trunk; also "feel throat tightness". She was taken to Emergency Room for further evaluation.

wheezing/ shortness of breath and vomiting--started after 20 minutes of vaccination and later headaches, fatigue

Both my first and second vaccines I have and am now experiencing heart problems and troubles breathing. I'm having chest pain and my arm feels like the achy pain of putting ice on a broken bone. The first vaccine I felt the pain start in my collar bone in the vein and move down. 2nd vaccine I feel like I've been running a marathon and feel pain in my chest. Fatigue both times.

Approximately 1 minute after receiving injection, patient reports itchiness, throat & lips swelling. EpiPen administered in observation & patient immediately transferred to Emergency Department. In the ER, patient was given famotidine, diphenhydramine & prednisone. @1230 in the ER, patient reports increase in itchiness and lips/throat swelling and feeling of return of symptoms. 2nd dose of epinephrine 0.3 mg administered intramuscularly. Pt was admitted for observation with plans to discharge if symptoms resolve with no return.

Symptoms: 01/29/2021 @ 11:21 AM: Shortness of breath, chest pain, and weakness. Two hours later, chest pain began to feel like chest tightness. Continued for the rest of the day. 01/30/2021: Mild irritation when breathing. Getting out of breath when minimal effort in an activity. A sensation of an increased heartbeat when in reality, it would be 92 BMP. General weakness and dizziness. 01/31/2021: Same symptoms as mentioned. While taking a deep breath, I feel a mild pain around my heart.

Client was sitting for 30 min after receiving COVID-19 vaccine #1--due to her history of anaphylaxis with Bactrim. After about 20 minutes client states that her face and tongue was becoming tingly. EMS was on-site and began monitoring her. For about 5 minutes, client states that she did not feel worse just "numb/tingly feeling face", client then began to cough and state that she was having difficulty breathing. EMS administered 1 EpiPen injection into her thigh and then transported her to a local hospital.

Throat tightness, dry throat; BP 116/64, HR 53. O2 sat, 100%. One hour later, throat tightness resolved.

shortness of breath. tingling in hands and lips hyperventilation. states similar to prior vaso vagal episodes that are triggered by stress

Approximately 28min after vaccine administration, pt. was noted to have red/swollen face & SOB. Pt reported hx of severe asthma. Epi pen administered by clinic RN and pt took own albuterol inhaler at 1322. 911 called. pt reported some improvement of SOB after meds, but continued w/cough and increased work of breathing. VS showed tachycardia and hypertension after epi administration. Pt reported improvements in face swelling and throat tightness after epi administration but still appeared to have labored and tachypneic breathing despite O2 sats 98-100%. Pt placed on 2L O2 via face mask to decrease work of breathing. Pt remained A&O, but developed rigors after epi administration. Paramedics and EMS arrived at approx 1328. Pt was subsequently transported to ED for further eval per EMS report.

The shot went in my arm and I immediately started feeling itchy. Before the needle was out, I knew something was wrong but almost didn?t believe how fast it happened. My throat started itching and swelling shut. I was in full blown anaphylactic shock in less than 2 minutes. I got an EpiPen shot in the parking lot and was admitted into the hospital where I continued having various reactions. A week after the shot, I?m still breaking out in hives uncontrollably.

CLIENT BEING OBSERVED 15 POST VACCINATION BY EMS. COMPLAINED OF NAUSEA, CHILLS, WEAKNESS, DIZZINESS AND QUESTIONABLE THROAT TIGHTNESS. TRANSPORTED TO HOSPITAL FOR FURTHER OBSERVATION

Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; This is a spontaneous report from a contactable consumer (Patient) A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot Lot EL9262) on 28Jan2021 at 09:30 at single dose in Right arm for COVID-19 immunization. Patient was not pregnant. Medical history included High Blood pressure.No known allergy. Concomitant medication included irbesartan. On 28Jan2021 the patient experienced swelling of throat area and face and rash on right side of throat but went away over time. Events required Doctor/other healthcare professional office/clinic visit. Patient was teated with Benadryl. Final outcome of all the events was recovering.

Felt like her throat was closing and was having check tightness in the lower rib area. Her heartrate was 136 and an elevated blood pressure (149/112). Went to the ER for further care.

Suddenly low blood pressure, resulting in headache, dizziness, weakness, difficulty seeing, feeling short of breath, and feeling faint.

29 minutes after being given the vaccine my tongue started itching and swelled up a bit, my mouth felt dry, my face became a bit reddened, puffy, and itchy, my throat began to swell a bit and my chest felt tight, giving me some discomfort when it came to breathing. I let the nurses who were keeping an eye on those waiting for 15/30 minutes know that I was having a reaction. I waited 1 more minute, and when my throat felt tighter and I had a bit more difficulty breathing, I took 1 Benadryl tablet, and waited 2 minutes, and when the symptoms were still worsening slowly, I took a second Benadryl tablet and after a few minutes my symptoms started to go away. I waited another 10 minutes and then went home when it seemed that my symptoms were going away. At 6:45pm on 2/21/2021 my throat and chest started feeling tight again and gave me mild breathing discomfort, so I took another Benadryl tablet, a few minutes later my face began to itchy and my mouth felt dry and my tongue felt a bit swollen, whereupon I took a second Benadryl tablet at 6:56pm, and then felt a wave of nausea. At 6:59pm, the feeling of tightness had not abated, but also hadn't worsened noticeably, and the itching feeling began to spread from my face to my ears and down my neck. At 7:04pm the tightness of my throat and chest began to increase some, and I started to feel some anxiety. At 7:11pm I inhaled two puffs from an albuterol inhaler used for treating asthma as my throat and chest were continuing to slowly get tighter. At 7:26pm I still felt itchy and my throat and chest still felt tight, but it wasn't noticeably worse. At 7:35pm, my throat began to feel tight enough to give me noticeable discomfort while breathing and for me to make a slight wheezing sound while breathing, and my tongue felt like it swelled a bit more, and my mouth still felt dry. At 7:51pm the Benadryl made me feel sleepy, but had no effect on my itchy skin or tightness of throat or chest. 8:00pm, my throat and chest felt tighter and I started having some difficulty swallowing and I felt very warm. 8:05pm, I had a lot of difficulty swallowing and had trouble breathing, so I went to the Emergency Room and was given an Epinephrine shot and sent home after an hour of observation.

Pt arrived for 2nd dose of vaccine today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose. 12:20- Pt given 2nd dose of vaccine by this nurse and began monitoring on stretcher. 12:33-Pt stated she was experiencing some dizziness and itching to the left posterior neck 1235-Pt stated she was now experiencing itching to the back and noticed some increased work of breathing and redness to her left side of the neck. Patient stated: " Hard to breath and it feels like I am unable to take a deep breath." 1237-Provider and medics on duty notified and patient assessed and patient's VSS and lungs clear to auscultation. Provider ordered Benadryl 25mg oral liquid to be given to the patient. 1237: Patient given Benadryl 25mg Benadryl by nurse. Patient observation continued and it was found that after calling patient's mother that the patient did have a reaction to the Typhoid Vaccine in the past with a noted PEG Allergy. Patient denies any other allergies but does take allergy injections and her last dose was 2/8/21. Provider spoke with patient and patient's mother who came to pick up the patient that the recommendation at this point would be to follow up with either Urgent care of Emergency room due to the known PEG Allergy. Mother arrived and pt was to be transported via private vehicle to Urgent care. Patient strongly encourage to establish with a PCP and after speaking with the Lead provider it was noted that the patient could go home with mother but monitoring should occur at home and the patient should take another dose of Benadryl 25mg four house after the initial dose of Benadryl. Patient and mother educated of this and communicated understanding. 1337: Provider gave detailed discharge instruction to the patient and when also when to follow up if any swelling, increased itching, hives, or worsening of shortness of breath should occur. Pt should take additional precautionary dose of Benadryl 25mg at 1630. 13:40-Patient denied any further itching and redness had decreased. Patient discharged home with mother and mother also stated that if needed there is an Epi Pen in the house and readily available if needed.

After my first dose, I had a sore arm for a few days. After my second dose, I had a sore arm for the rest of that day, and the next day I experienced many symptoms. In the morning, I was extremely tired and nauseous. By the afternoon, I had a headache and my whole body ached. In the evening, my injection arm was swollen and red, and my chest ached and made it harder to breath or sit up. I was bed ridden and unable to get up for a couple hours because it hurt too much. After some rest, water, and aspirin, I was able to get up late that night the day after my second dose. Two days after my second dose, I felt much better without any symptoms.

Complaints of numbness to hands from knees down bilaterally after Covid vaccine. No shortness of breath. Itching left side of cheek- mild throat tightness. Received Benadryl P.O. 25 mg and Decadron 10 mg P.O. Observed for 2 hours ? no reoccurrence of symptoms.

5 minutes after the shot, pt started to complained of tightness in the throat and difficulty breathing, EpiPen was administer and 911 was called for the patient. patient is now recovering in the hospital. Doctor believes that effect is psychosomatic.

I got chills on and off through the day starting at noon. At 10 pm in a matter of a second I went from wide awake to barely able to keep my eyes open and feeling like I got hit by a truck. I felt like I could not get in enough air when breathing. I would breath in and I felt like my lungs would feel the way you feel when you stretch the day or 2 after working out super intensely

started as itching on neck, then progressed to coughing and chest tightness approx 1 hour after receiving the vaccine, then progressed to shortness of breath. Benadryl given initially. epidural pen used with progression of symptoms, as well as Pepcid and prednisone.

Around 1815, pt began to have numbness and tingling in left arm (arm vaccine was given), felt swelling in lymph nodes and neck, 1 or 2 small hives around left neck with some redness, then about 1820 felt "throat puffy"/swelling and slight trouble swallowing. Denies trouble breathing. Pt was conscious and stating she overall felt ok despite the above symptoms but Emergency Team called, pt was taken to ER.

23 yo F with h/o POTS who was feeling fine until about 25 minutes after the vaccine at which time she developed shortness of breath, chest tightness, flushing sensation, lightheadedness with sense of impending doom and abdominal cramping. Reported she felt similar to when her POTS flares up, but that only occurs with standing which she hadn't done. HR 126 and BP 174/93 and repeat was 132 and 152/113. Oropharynx appeared normal but she appeared pale and very weak, and slumped over in the seat of the car. 911 called and EpiPen and IM Benadryl given with some improvement of symptoms. BP continued to be hypertensive and HR tachycardic. O2 sats remained stable at 99%. With her overall symptoms, concern for anaphylaxis, although her symptoms were likely multifactorial - POTS, anxiety.

I got my vaccine on 3/19 at 10am. My 6:30 pm on 3/19 my face got dark red, almost purple and started to swell. I went to and urgent care where they gave me a 50 mg shot of Benadryl. AFter about 20 minutes the reaction was getting better so they released me to go home. They told me to continue taking the Benadryl every 4-6 hours for the next 2-3 days. I did as directed for through the night and the next day. Around 6:30 pm on 3/20 I started feeling very tired, shaky, and dazed. My about 9:00 that evening I began to feel swelling in my throat/tongue. I then went to the emergency room and where they gave me another 50 mg shot of Benadryl and a 6 mg shot of Decadron. They monitored me for a couple hours and the swelling in my mouth had gone down and the rash that had also reappeared had gone down. They sent me home with a prescription for Prednisone 10mg 4 pills a day for 4 days and told me to continue the Benadryl. I took the Prednisone and Benadryl for all day 3/21 and was feeling better. When I woke up on 3/22, my chest and arms had a rash on them. I took a Benadryl around 7:30 and Prednisone around 8:30. I went to work and around 10:30 my face started getting red and swelling again. I contacted my dermatologist who did skin patch testing and got an appoint for 3/22 at 1:45. She extended the Prednisone out to 12 days and told me to switch to Zytrec during the day and I will follow up on three weeks.

throat and mouth tightening 8 minutes after injection of vaccine, difficulty talking, body tremors, and hive-like rash (patchy red blotches, not raised/swollen or itchy) appeared across chest and around the injection site. Took 25 mg liquid benadryl within a few minutes of reaction beginning. Took five minutes for sensation in mouth and throat to subside, rash cleared in about twenty and blood pressure came down.

At 1010, reports feeling like her throat is swollen. No SOB, able to swallow and drink water. No signs of distress. Pox 100, BP145/72. Continued to monitor, checking pox and BP every 5 minutes x 3 - stable. No increase or decrease in symptoms reported. 50 mg benadryl liquid given PO at 1033. Continued to monitor. No change in symptoms, Vital signs stable. 1050- reports slight decrease in symptom. VSS, no SOB, no distress. Taking PO without difficulty. 1051- DC back to work at the hospital with coworker present. Instructed to report to the emergency department immediately with any increase in symptoms. When she returns for her second dose, informed that she should plan to stay for monitoring for an extended period of time.

Patient received vaccine at 2:13 PM and waited in the pharmacy for 30 minutes based on allergy history. Patient felt fine when she left the pharmacy and headed home. 20-30 minutes after she left the pharmacy she began to feel that she was having trouble swallowing and eventually noticed that she was having trouble breathing and had bumps on her tongue as well as swollen lips. She drove to the ER and arrived at 3:50 PM where they administered her EpiPen along with benadryl and prednisone. She felt better within 15-20 minutes of EpiPen administration and remained in the hospital for 4 hours until her blood pressure was stable. She is still taking prednisone and has not had any other issues since ER discharge.

About 10 minutes after administration of COVID-19 vaccine, began to have acute onset of shortness of breath, difficulty breathing and heart racing. Patient states she has a history of anaphylaxis with exposure to tree nuts and a food additive and self-administered EpiPen just prior to ED arrival. Patient states that after administration of EpiPen resolution of all symptoms. ED treatment: Prednisone 60mg PO x1 dose Benadryl 50mg capsule PO x1 dose Pepcid 20mg tablet PO x1 dose

While waiting in after the vaccination I experience the slightest discomfort with my breathing but thought it might be related to double masking. Upon driving home, I realized I had non-itchy and non-painful hives on the upper portion of my right cheek and the lower jaw on the left side. As time progressed, the hives disappeared from left side and moved down the right side of my face. After it passed on the right side it reappeared on the left side and followed the same pattern. My dermatographia also returned on my chest and I haven't had an episode of it for over year. The roof of my mouth was also itchy. All hives, itchy mouth, and slight breathing discomfort passed by 7 pm without the use of an antihistamine. No other signs of allergic reaction has been noted since. Breathing concerns passed the quickest (after 2 or so hours), then itchy mouth, and last the non-itchy hives. Other than that, I experienced the common side effect of body aches during the night and pain in vaccinated arm.

Pt vaccinated @1430. 1436 pt c/o Itching, tingling to mouth and nose and one side of throat, nausea. Pt given Benadryl 50mg PO. Bp 166/81, P 98, SPO2 99%, mild wheezing auscultated. Car seat leaned back, MD consulted. Pt has hx blood clot Oct 2021, currently on Lovenox BID. Pt used her personnal inhailer she had in car. Hx of anaphalaxis with bee stings, Fentanyl, Hydrocodone. EMS called, on site <5min, care transfered, pt being taken to local ER. Pt advised to consult PCP to determine if she should get 2nd dose. RN

Pt noticed dry throat and tickling in throat, came to staff in Observation area, noted to have dry constant cough with audible wheeze, hives to lower face/neck. Pt A&Ox3, calm, skin warm and dry Given Benadryl 50mg PO at 1335 Given Epi pen 0.3mg to R)thigh at 1336 Used own Albuterol MDE, 2 puffs at 1338 using a spacer. BP-138/92, P-125, R-18, O2 sat-98% RA at 1338 1345-O2-98%, R-20, P-125, Local fire Department and paramedics on scene. Pt awake and alert, reports breathing felt easier. Ambulated to Medic cot, and was transported to Hospital

Patient stated she felt short of breath, developed chest tightness, became diaphoretic immediately after vaccine administration. Patient also reported light-headedness. 50 mg oral diphenhydramine was given and patient was sent to the emergency room for further evaluation.

Allergic reaction similar to one from food allergy--mild but distressing internal throat swelling and itchiness as well as difficulty swallowing. Started about 15 mins after vaccine, with 1 adult Benadryl pill taken approx. 30 mins after, and a 2nd pill taken 20 mins after that as there was no change. Symptoms ended about 30 mins after the 2nd Benadryl was taken.

Allergic reaction with symptoms similar to that of food allergy reaction. Mild to moderate throat swelling and difficulty swallowing starting approx. 10 mins after the vaccine. Took 1 Zyrtec 15 mins after reaction started, and a second Zyrtec 30 mins after that. Symptoms are still ongoing as of now, 5 hours after start time, but are low-level.

23 yo FM who received first dose of Pfizer vaccine and then was noted to have shortness of breath and complaining tongue closing sensation immediately after at Vaccine Clinic --I was called to evaluate the patient. When I arrived patient was laying down on a chair with a friend, shaking with seizure like activity but alert and oriented to person place and time. Upon my arrival she was shaking, vomited x 1 and then complained about chest pain. Vitals upon my arrival: HR 58, o2 100% RR appeared to be around 22-24 (hyperventilating) BP 88 systolic (manual)--repeated by medics upon arrival minutes later 110/72. Given throat closing sensation, vomiting, shortness of breath I advised to call 911 and ordered Epinephrine x 1 which was given by RN immediately. Pt was then placed on the grown chin up, she continued to shake throughout entire body but continued to be alert and oriented. Medics then arrived on seen, started an IV, glucose by medics 84, IVF started by medics. Pt was transported to ER via medics. Pt is not a patient, last visit 2017. Pt did state she has hx of POTS and DRESS syndrome to Lamictal. Reports taking cetirizine this AM, Zofran and Oxycodone and Baclofen (prescribed by external PCP?). Prior to transport to ER pt continued to be alert oriented, but shaking and twitching throughout her body. MD verbally communicated to patient to not receive the 2nd dose given her severe anaphylaxis like reaction to the first dose of the vaccine. Pt can be referred to allergist after ER follow up by PCP. Denied pregnancy.

patient reported nausea to staff, lead RN was called. Diaphoresis was immediately noted patient was tachypneic and anxious, denied throat swelling reported "heavy chest" has a couple "tics" tremors reported this to be someone normal. HR elevated to 130, ems called with patients permission. 2 minutes later patient lost consciousness and epi was administered. EMS updated. Patient brought to hospital via EMS

1.RASH AND ITCHING ON UPPER EYELIDS 12:30 PM 2. ONGOING FRONTAL HEADACHE PAIN RADIATES TO BASE OF NECK AND SKULL AT PAIN LEVEL 10+ /GREATER @ 4PM, ONGOING BODY RASH WITH ITCHING, AND REDNESS UPPER EYELIDS, FACE, CHIN, CHEEKS, LOWER FOREARM, BACK, AND ENTIRE BODY. 3. THROAT FEELING THICK AND ABNORMAL 4.FACIAL SWELLING NECK AREA UNDER CHIN, BACK OF NECK, UPPER ARMS AND LOWER ARMS, UPPER BACK ACROSS SHOULDERS, AND ENTIRE BODY TENDER TOUCH. 5. BILATERAL SWELLING OF THIGHS AND LOWER LEGS CALF AND ANKLES 6. BREATHING FELT LIKE RECOVERING FROM AN ASTHMA ATTACK 7. BLURRED VISION, VISION FELT WEAK 8. FATIGUE TREATMENT OF CARE: WENT TO URGENT CARE FACILITY LOCATED IN ON . RECEIVED IM INJECTIONS OF BENADRYL 50MG IN BUTTOCK AND SOLUMEDROL (STERIOD) INJECTION IN OPPOSITE BUTTOCKS. ON 08APRIL21: PT RECEIVED ZYRTEC PO, BENADRYL 50MG AT BEDTIME FOR ITCHING AND RASH, PREDNISOID 08APRIL202: PATIENT EXPERIENCED NAUSEA AND VOMITING AT 8PM, ON 09APRIL2021 PT C/O ZONING OUT MEMORY FOGGY AND FEELS LIKE SHE IS NOT WITH IT. 10APRIL: RASH CONTINUES TO SPREAD ON FACE, CHIN, UNDER CHIN AND NECK. FRONTAL HEADACHE CONTINUES, NECK SWOLLEN AND SHARP PAIN ON RIGHT SIDE OF NECK AND LOWER JAW. LYMPH GLAND FEELS SWOLLEN ON RIGHT SIDE OF NE``

Patient starting feeling anxious as she came to the observation area. Hyperventalating and diaphoretic, pale

Cold sweats, vomiting, tingling and numbness in arms and legs, inability to breathe, clouded vision, difficulty hearing (this lasted approximately 5-10 minutes and was roughly 10 minutes after receiving my first dose of the vaccine)

i received the vaccine at 3pm on monday april 12th. i started shaking less than 5 minutes after i received the dose and my throat started to swell and i couldn?t swallow. they placed me under observation for 30 minutes and gave me water?saying that ?i might just be afraid of the needle and not to worry, this is an abnormally normal reaction to a new vaccine.? after 30 minutes a man walked over to me and said ?oh you?re still here?? and chuckled. they then told me i would be fine after a while and to leave. i started walking down the sidewalk and almost passed out so i called an uber to take me to the nearest urgent care. i arrived at urgent care around 4pm unable to swallow and having a reaction to the vaccine. they saw me immediately and gave me 3 50mg of prednisone and a benadryl and placed me under observation for 45 minutes. he said i looked better and i even felt marginally better. i called another uber and when i was almost home my tongue started to go numb as well as my lips and my breathing was becoming constricted. i had the uber driver pull over as i had to sit on the sidewalk and get some air. i then called another uber to the hospital because my symptoms were becoming increasingly more alarming. Hospital admitted me and gave me a shot of epinephrine and IV fluids and kept me under observation for 6 hours. they discharged me a little after midnight with a prescription for prednisone, epinephrine, and benadryl. if i had been administered epinephrine at the vaccine site on monday and not been told i was just squeamish by the male air force cadets?i probably wouldn?t still be short of breath, painfully swallowing, and bedridden.

Flush red rash on face and neck, Hot to touch on face, itchy throat and mouth, Slight shortness of breath, and itchy face/skin and eyes started around 1830 hours and is still active at time of filing at 2032 hours

Heart racing, feeling as though her throat was closing, vital signs normal, clear lung sounds, PT drinking well, talking without difficulty

Beginning on Saturday after my first dose, I had a dull pain in my lower left side of my lung. The pain increased and became a surrounding pain on my entire left lung. The pain was severe. I was diagnosed with pleurisy on Monday by my doctor.

I am just reporting that I contracted COVID-19 after receiving the Pfizer vaccination. I never had a fever or cough. The only symptoms I had were congestion, headache, mild shortness of breath. It almost felt like a sinus infection. I also loss my taste/smell about 4 to 5 days after testing positive.

Hospital course: 23 yo female with no significant PMH presenting to the ED with right sided CP, worse with deep inspiration. Received 2nd covid vaccination last week- mild reaction with fever thereafter. She had w/u in the ED including an EKG with inferior and septal TWI and trop of 1.61. CTA chest was negative. She was admitted. After admit, troponin trended up (1.61--3.71--4.93). CRP 49.1, ESR 21. Echo showed apex hypokinesis so with TWI on EKG and elevated trop, cardiology elected for LHC. This was normal. Cardiac MRI showed myopericarditis. She was started on high dose ASA, colchicine and bblocker for this. Likely viral etiology (Covid, Resp 4 plex negative). Trop trended down on 4/13 (CRP still rising). Cardiology was ok with discharge. Will need 2 weeks of ASA and 3 months of colchicine. No strenuous activities for that time frame. She is getting her Masters in music/violin and did not need a return to school note. Feeling somewhat better at discharge- rated pain 6/10. Internal Medicine followup in 1 week Cardiology followup in 2 months

4/21/2021, Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, she experienced an adverse reaction with the following symptoms: Itchy throat and a " feeling of pressure to her throat". Assessment : Time of assessment 356pm. Alert and oriented and no visual swelling to face or throat. Actions taken: Vitals sign taken, form obtained and completed by RN. Family member to transport patient home. 330pm- 137/90, P- 61, O2- 100%, 335PM_ bp- 129/81, p- 64, o2- 100%, AT 340- bp- 130/91, p- 56, o2- 100 %, 407PM- bp- 113/97, p- 61, o2- 100%, 450PM- 132/81, p- 60, o2- 100% Medications administered: Benadryl 25 mg 1 po x2 at 330pm and 354pm, famotidine 20 mg 1 po x 1 at 427pm. Disposition: Reports no further symptoms of adverse reaction after observation for 60 , patient is doing virtual visit with PCP while in clinic at 456pm. minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Immunizations Administered, Pfizer COVID-19 Vaccine,4/21/2021 2:49 PM,0.3 mL, 2/25/2020, Intramuscular.

24 hours after receiving vaccine, the left side of my face experienced mild swelling (it should be noted I received the injection in my left arm). I experienced heavy allergy symptoms including redness and swelling in left eye, watery eyes particularly in left eye, runny nose and pain particularly in left nostril, heaviness of breath, tiredness. I think it is of note that as of writing this, I have not received commonly reported symptoms of fever, chills and nausea in conjunction with the reported adverse symptoms.

Muscle aches, chills, fever, dizziness, chest tightness, trouble breathing, fatigue. Started in the middle of the night after the vaccine and lasted the whole next day, although symptoms were worst in the morning and gradually improved as the day went on.

After taking my medicine that day I started to receive head aches, body cramps, asthma flareups, extreme jitters, nausea/vomiting, over heating, chills and dizziness I Just had the second dose and notice the same reactions as last time taking place an hour after I had taken my medication that day (Nausea, lightheadedness/dizziness, chills asthma flare ups and cramps) . For both of these instances I took Dayquil and had to take and albuterol sulfate treatment on my nebulizer for the asthma attack. During the first shot: The jitters, body aches and overheating continued throughout the night but subsided 12 hours later at 3PM the next day. For the second shot the symptoms didn't last as long with them subsiding around 4am

3/11/21-post vaccination, slight SOB, substernal chest pain 'burning', vision blurred, O2-4lpm/NC, SaO2 99%, VS WNL- BP 152/80, HR 84, assessment completed pt remained stable throughout. Ct requested to be transported to the hosp, ct states in ER, post vaccination, was given epi, s/s resolved in 2-3hrs, ct decided to not get the 2nd dose due to her reaction.

Dyspnea and pleuritic chest pain onset 4/22-23, prompting presentation to ED. Found in ED on 4/24 to have central R pulmonary embolus extending into interlobar, segmental, subsegmental branches of RUL & RLL, mild R heart enlargement without evidence to suggest RH strain, and mild pneumomediastinum most notable at the thoracic inlet. Tolerating RA. Started on AC with heparin drip, transitioned to xarelto at discharge.

Client complain of dizziness, chest pain and hard to breath. Seen by EMS, took vitals signs no further treatment required. Stayed for 30 min , left building in no distress accompanied by mother.

1-5 minutes after both shots: sensation of mild swelling in throat, in addition to mild dizziness/faintness which passed after 5-10 minutes (no phobia of needles). Feeling of swelling in throat/difficulty swallowing lasted until about 4 hours after vaccine was given, and was more intense after second dose, though not enough to seek medical attention. In addition, after the second dose, a feeling of prickling/heat on skin, which began within 1-5 minutes of receiving the vaccine and lasted for about 5 minutes after symptoms began. No respiratory effects. No other symptoms which resembled an allergic reaction (itchy mouth, rash, adrenaline rush, etc.)

Hot flashes, severe body aches all over, armpit pain on arm of injection, watery diarrhea, cramping, painful deep breaths.

Post vaccine pt felt slight dizziness and warmth in face and neck followed by shallow breathing. Reports feeling better when moved to medical observation area. Vitals obtained and monitored: 1614 LYING BP 123/77 HR 85 RR 16 SpO2 100% 1621 LYING BP 114/75 HR 84 RR 14 Sp02 99% 1632 Standing BP 117/72 HR 77 RR 14 SpO2 95%

I received the Pfizer second dose on May 5th and started to have an allergic reaction on May 6th at 02:32. I was not able to attend classes due to muscle pain, headache and nausea. I was having some sort of fever where I felt hot but my body was cold. I slept for the majority of the day. Around 16:35, when I woke up, I noticed a rash and that my body was feeling swollen. I took 2 Benadryl gel pills at 18:03. I felt some difficulty breathing, and itching sensation all over my body and still had a lot of tension on the left side of my jaw. I went out to eat with my boyfriend, because we had plans and he had also complained of having some cold chills from the vaccine, and he noticed that I had red marks on my hands. By May 7 10:05 I called off of work to go my doctor, because I had massive splotches of raised itchy hives all over my body. It was confirmed that I was having an allergic reaction and I received a steroid shot in my upper gluteal muscle, as well as Famotidine 20mg twice daily for 5 days and Prednisone 20mg twice daily for 5 days.

PATIENT RECEIVED FIRST DOSE OF PFZIER COVID 19 VACCINE AND WITHIN MINUTES OF RECEIVING, RETURNED TO PHARMACY SAYING SHE FELT VERY DIZZY AND LIKE SHE WAS GOING TO PASS OUT. PHARMACIST HELPED PATIENT TO A CHAIR AND CALLED 911. PATIENT REPORTED SYMPTOMS OF DIZZINESS, TROUBLE SEEING, SWEATING, NAUSEA, AND FELT HARD TO BREATHE. EPI WAS NOT GIVEN/INDICATED. EMS ARRIVED WITH 10 MINUTES AND TOOK VITALS. PATIENT OPTED TO BEING TRANSPORTED FOR FURTHER EVALUATION. OUTCOME IS UNKNOWN.

From ED note: Briefly, this is a 23-year-old female with past medical history of not allergies, asthma who presents for evaluation of shortness of breath, nausea and chest discomfort following Covid vaccine 30 minutes prior to presentation. Patient received her first dose of Pfizer Covid vaccine this morning, was observed and ultimately started to drive home with mother when she developed shortness of breath, nausea and chest discomfort. These have been progressive. She reports she is not taking her Flovent. No vomiting, no rash, no weakness, headache or dizziness. Remainder of history per note above. Vital signs as noted above (tachycardia, tachypneic). On physical exam, the patient is anxious appearing, hyperventilating; HEENT exam with MMM, clear conjunctivae, normal TMs & clear oropharynx without uvular swelling or edema; neck is supple; cardiovascular exam is stable with regular rhythm, mild tachycardia, no murmurs; pulmonary exam is clear to auscultation bilaterally, good aeration, no wheezes; abdomen is soft, non-tender & non-distended; neurologic exam nonfocal, moves all four extremities, 5/5 strength in upper and lower extremities, carpal spasm of bilateral hands (L>R). My impression is that this patient is having a panic attack given her rapid onset of hyperventilation, chest discomfort, and bilateral carpal spasms. Carpal spasms improved with controlled breathing. Considered anaphylaxis given patient's history, but absolutely no wheezing, rash or significant GI symptoms; no hypoxia; no hypotension. Epi-pen at bedside, but not given. Considered asthma, but no wheezing - patient is not wheezing and has good aeration on exam, she is requesting albuterol, which I think will help with her anxiety surrounding this - 2 puffs given. No evidence of persistent tachycardia to suggest PE (no OCPS). Initial ECG with sinus arrhythmia, one PVC, slightly prolonged QTc 477 - will check repeat. Patient briefly on NRB for comfort - slowly able to be weaned off and during observation in ED, symptoms improving but not completely resolved. Repeat ECG w/ NSR, slightly prolonged QTc 460. Given persistence of symptoms, patient given epi-pen and had almost complete resolution of symptoms within 10 minutes. We will plan to observe for 4 hours post-epi administration. Recommended discussion of second COVID vaccine with primary care provider but may have to avoid given this could have represented a serious allergic reaction. Recommend follow-up with PCP/cardiology for repeat EKG. Admit to Ed Observation Status Diagnosis: Allergic reaction Goals of observation: (1) Ensure continued improvement of symptoms, (2) Improved HR Interventions: (1) CRM, (2) Close monitoring, (3) Frequent exams 5/7/2021 15:00 23-year-old female received COVID-19 vaccine today and after which developed shortness of breath. Initially felt this was anxiety however symptoms persisted. Treated with albuterol as well as epinephrine and observed. Developed shortness of breath and complaints of chest pain after approximately 3 hours of observation. Repeat EKG obtained and is normal. Labs were obtained which demonstrated normal CBC. Normal D-dimer. Normal electrolytes but an elevated TSH (known hyperthyroidism). Treated with cetirizine and steroids with improvement of her symptoms. Discharged with PCP follow-up in 2 days.

At 2 AM I woke up with a tight and heavy chest. It was difficult to breathe and I used an oximeter to check my O2, which showed 99% saturation. I checked my temperature but that was normal, around 97 F. I tried different positions to make breathing easier but the pressure would not lift. Around 3 AM I used my (expired) inhaler. Almost immediately I could feel my chest getting lighter. I used my inhaler again around 10 am. The chest tightness did not lift a noticable amount until around 2 PM. By 5 PM all tightness had subsided.

INTERIM HISTORY (04/02/2021). 1st dose of Pfizer COVID vaccine on April 2, 2021. Urticaria then flared 11 days following vaccine . Developed more hives during the day. Severe hives and lip swelling then occurred 2 weeks following vaccine. Hives associated with a lot of flushing and were very uncomfortable, burning. Hives did not respond to benadryl or benadryl spray like they usually do. Sunday April 18th patient fainted two times One time she fell, another time she sat down in a chair. Went to ED on Monday April 19th 2021. Driving home from a friends house when skin became very itchy. Then broke out in hives covering entire body. Hives started in trunk and spread to neck/extremities. She later noticed GI issues and then eventually trouble breathing. ED history noted c/o tongue swelling, throat tightness, chest pain and shortness of breath. This was her worst reaction to date since starting her current medication regimen. Called friend to watch her dog and went to ER when she developed trouble breathing. She did not want to use epi pen if she did not absolutely need to use it. They did not end up giving her epi in the ER per her request. She was given IV pepcid and fluids; tryptase level was drawn. Symptoms improved with treatment. Next day she had transient hives but no hives since. Still with some intermittent flushing. Over the last few days she has noticed more uncomfortable flushing of her face . Not something that happens normally. She is not sure if she should get the 2nd COVID vaccine but would feel better if she had both. She had COVID infection in March 2020. She was symptomatic but did not require hospitalization. Rapid antibody test negative in July 2020 at urgent care center in LI.

increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; Abdominal burning/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; vomiting since the day after the vaccine; Chills; body shakes; periods of chest tightness; shortness of breath; unable to keep food or fluid down; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at Left arm on 25Apr2021 15:15 at first dose, single for COVID-19 immunization in Pharmacy or Drug Store. Medical history included Major depressive disorder, General anxiety disorder and Known allergies to Z-Pak. concomitant medication was none (the patient was not received any medication within 2 weeks of vaccination). Patient was not Pregnant at Time of Vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported on 26Apr2021 16:45, patient experienced intense abdominal cramping and vomiting since the day after the vaccine. Chills, body shakes, and periods of chest tightness and shortness of breath. patient was unable to keep food or fluid down until she received a prescription for Ondansetron from her doctor. Abdominal burning/cramps were at an 8 on the pain scale during the worst periods. Also an increase in anxiety to the point of panic attack occurring on 28Apr2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the adverse event included Ondansetron and Proair inhaler. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Day 1 (day of vaccine): weakness, shortness of breath, arm swelling, headache, fatigue, fever Day 2: face and mouth swelling, sore throat, fever Day 3: sore throat, lightheadedness, fever Day 4: no symptoms

Fever, chills, shortness of breath persisting over a week after the vaccine; Fever, chills, shortness of breath persisting over a week after the vaccine; Fever, chills, shortness of breath persisting over a week after the vaccine; This is a spontaneous report from a non-contactable other hcp. A 23-years-old no pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Apr2021 16:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, shortness of breath persisting over a week after the vaccine on 28Apr2021 with outcome of unknown. The event shortness of breath result in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Events are non serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

The night of vaccine, started with fever, aches and sweats, all resolved by 5/11/21. on 5/12/21 chest pain and difficulty breathing began. Was admitted to Hospital that night.

Injection site reaction onset about 3 hours following the vaccination. These symptoms include deltoid muscle pain, deltoid swelling, as well as left scapular and trapezius pain. Exacerbation of asthma 7 hours after vaccination with wheezing, cough with secretions, chest and back pain. Woke up the next morning (5/21) at 8am with 100.7°F fever, body aches, headache, chills, worsened cough with secretions, nausea, chest tightness, chest pain, neck pain, back pain, body aches, and loss of appetite. Injection site symptoms remained the same. After an urgent care visit with a negative covid test, I purchased Severe Cold and Flu medication as well as VapoRub to help relieve my symptoms. I took these as advised per the packaging and my symptoms eased some. On 5/22 I woke up with neck pain, headache and mild cough with no fever and less chest tightness. Injection site and surrounding muscles are still sore but the swelling has gone down.

One day after I received the Pfizer shot, in my left arm, I started to experience sharp chest pains. I was not able to take deep breaths without shooting pain, and the left side of my chest was sore. The sharp chest pain lasted for a day, but I am still experiencing soreness.

the back of her tongue felt numb/developed a numb tongue; throat was itchy then sore/her throat was sore and itchy; throat was itchy then sore/her throat was sore and itchy; chest pain; not quite normal breathing/uncomfortable breathing/heavy breathing that was more of an irregular breathing; Fatigue; her lungs felt swollen; This is a spontaneous report from a Pfizer-sponsored program via a consumer reported for a patient (reporter's mother). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 17Apr2021 (Lot Number: EW0162) (at the age of 23-year-old) as single dose for covid-19 immunization. Medical history included asthma and diagnosed at age 2, allergy and allergy to bull dogs. Concomitant medications included budesonid taken for allergy, start and stop date were not reported; formoterol fumarate dihydrate taken for allergy, start and stop date were not reported. The patient experienced her lungs felt swollen in Apr2021, the back of her tongue felt numb/developed a numb tongue on 17Apr2021, throat was itchy then sore/her throat was sore and itchy on 17Apr2021, chest pain on 17Apr2021, not quite normal breathing/uncomfortable breathing/heavy breathing that was more of an irregular breathing/out of breath walking up the steps on 17Apr2021 and fatigue on 17Apr2021. A family member had some reaction to the first pfizer covid-19 vaccine. Wanted to know where can she find information to determine if the second vaccine shot is safe. 40 minutes from the time of the injection the back of her tongue felt numb and her throat was itchy then sore. About 40 minutes after that those symptoms went away. Later in the day she had chest pain and not quite normal breathing. After using her asthma inhaler twice in a short time this dissapated. Fatigue remained for about a week. Her daughter was prescribed Metronidazole 500mg (she initially thought it was penicillin) and the packaging information of the antibiotic says not to receive any vaccines. She was scheduled for her second dose next Tuesday (18May2021) and wanted to know if it would this be applicable to the Pfizer BioNTech Covid 19 vaccine. Mother calling on behalf of daughter who received the first dose of the Pfizer BioNTech Covid 19 vaccine on 17Apr2021. She was told to wait 30 minutes after the vaccine and was okay, however after 40 minutes after the vaccine she developed a numb tongue, her throat was sore and itchy. This subsided within about 30 minutes (also reported as 40 minutes). About 4 hours after the vaccine she developed chest pain and uncomfortable breathing. Her daughter states her lungs felt swollen, and was out of breath walking up the steps. She did use her AuviQ and albuterol inhaler and the first dose of AuviQ didn't work so she repeated it and it helped. She called the doctor and used her peak flow meter and the doctor on call stated that her reading was okay and did not need further medical attention. After that evening those side effects went away. Caller has a past medical history of asthma and allergies to bulldogs. If she was even around someone who has been near a bull dog she will develop chest symptoms. Mother spoke with CDC and they told her as long as her daughter didn't go to the ER it was okay for her to receive the vaccine and wanted to know if she get her second dose of the Pfizer BioNTech Covid 19 vaccine. She is scheduled to receive it next Tuesday (18May2021). Her doctor said that some people react to the polyethylene glycol and want to know if she could get tested for that. After the patient received the vaccine, her tongue was numb and her throat was sore and itchy but it went away. This started 40 minutes after the patient received the vaccine. 4 hours after the patient received the vaccine, she had chest pain and heavy breathing. The caller is nervous because the patient has only had this chest pain during a severe allergic reaction in the past. The patient do about the second dose. The patient was also prescribed an antibiotic this week and the antibiotic paperwork said not to have any vaccines while taking that product. The patient is due for the second dose of the vaccine this week, is it okay to get because she will still be on the penicillin. This event happened after receiving the first dose of the vaccine on 17Apr2021. The patient also had fatigue for a week. The patient had the heavy breathing that was more of an irregular breathing. The patient's lungs felt swollen, it felt like there was weight on her chest, it was uncomfortable breathing. The caller felt out of breath walking up the steps. The caller used her inhaler twice. The patient underwent lab test included investigations: the on call doctor had the patient do the peak flow meter and it was fine, over 550 on 17Apr2021. No more information was available. The doctor also had the patient press her chest to see if there was pain when she touched it and there was not so the on call doctor felt comfortable not making the patient go to the emergency room. Caller reports that her daughter received her first vaccine dose on 17Apr2021 and afterwards experienced a severe reaction with symptoms including, tongue swelling, sore throat, and Chest pain. Caller reported that it didn't getm severe enough for her to need an Epi pen. Caller reports that they have an appointment to see her doctor as well, for further discussion. She calls today to ask if symptoms with the second dose are expected to be worse than they were with the first shot and timing of the second dose. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID- 19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event her lungs felt swollen was unknown, the event fatigue was recovered in Apr2021, the other events was recovered on 17Apr2021. Information on lot/batch is available; further information has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) three days after receiving vaccine with dry cough for 24 hours, home oxygen saturations 85-95%, and family diagnosed with COVID-19 the week prior. On exam congestion and shortness of breath noted. Vital signs within normal ranges. Discharged to home medically stable.

Pt presented to ED at apx 1pm on 5/28/21 with signs of anaphylaxis. Swollen upper and lower lips, sensation of swollen throat, and facial swelling, with urticarial lesions to upper chest wall and arms. No GI symptoms. No hypotension. Received 0.3mg IM epinephrine, 50mg IV benadryl, 125mg IV solumedrol, and 20mg IV pepcid. Symptoms slowly resolved over 3-4 hours. Pt could not recall any other now inciting event or product other than vaccine she had yesterday around 4pm. No reaction to first pfizer vaccine noted.

Chest tightness; hard to breathe; Vomiting; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 25Feb2021 11:00 (Batch/Lot Number: EL3247) as single dose, for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. Patient received first dose of bnt162b2 for covid-19 immunisation on 04Feb2021 01:00 PM (Lot number: EL3247) in left arm. On 26Feb2021 01:45 AM, patient experienced chest tightness to the point it was hard to breathe and vomiting also occurred. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

At 10:35 attendee had complaints of nausea and dry heaves. Fireman notified. Vital signs at 10:37: blood pressure 148/84, pulse 79, temperature 97.8F, respirations 22, O2 sats 100% on room air. Attendee had complaints of throat feels tight and attendee noted to have jittery hands. Cold pack applied to back of neck. Attendee provided with emesis bag. Attendee had only dry heaves. Vital signs at 10:45am, Blood pressure 119/83, pulse 72. Attendee reported feeling better and declined trip to urgent care/hospital. Attendee instructed to go to urgent care and/or primary care physician if has further symptoms or concerns. Attendee declined further assistance and left fire station at approximately 1100AM.

Pt had a scheduled appt at 1235 pm for her 2nd dose of pfizer covid vaccine on 6/4/21 at our store . Pt stated that she had some "chest tightness" shortly after the first dose (~4/24/21). After reviewing VAR filled out by patient today, I consulted with pt about having a reaction to the first dose. Pt stated that EMS observed her for 30 minutes after the 1st vaccination and patient self-reports that she recovered without the use of an epi pen (pt does carry an epipen on her at all times) within that 30 minute window and was allowed to leave. We administered 2nd dose with the understanding that patient recovered from 1st dose with no breathing difficulties or swelling of tongue or throat (just chest tightness as reported by pt). After administering the second dose today, Pt began to show signs of an allergic reaction ~ 5 minutes after administration and we administered the epi-pen and 911 was called. Observed that pt vomited and complained of chest tightness, tight throat , difficulty breathing and being hot and "sleepy" after second shot. Pt appeared to be alert and oriented and was sitting in a chair. EMS arrived and pt is now under their care. We dont know the lot number of the 1st covid vaccination but the lot used today was EW0167 with an expiration of 8/31/21.

?Pfizer-BioNTech Covid 19 Vaccine EUA? The night of getting the first shot I barely slept because I had chills all night long & my entire body was so sore it hurt to lay in any position. In the morning, I still had extreme muscle pain all over. I was extremely light headed & dizzy, I had a throbbing headache so I took 2 aleve pills. I was getting super nauseous and almost passed out while trying to get to my bathroom just in time to throw up only water. Just before throwing up my vision went fuzzy, my ears were ringing, I was dripping sweat, it was getting hard to breathe, & my hands were shaking. After taking a cold shower, laying down, & drinking some water I feel a bit better but not 100% normal.

2/23 vaccination Within 12 hours, I started shaking, spiked fever, HR increase, SOB, out of body experience, scary experience. Called 911 transported to ER. Monitored cardiac unit for 24 hours, HA. Two months of HAs. I went home and I don't recall exact how everything transpired. I do remember they wanted follow up with PCP. I developed blood clots in R arm, platelets were high since getting vaccinated. *originally diagnosed with colitis but now diagnosed with Chrohns disease. 1/16 I did have a personal injury in a parking lot that exacerbated the issues, I was vaccinated after. *In transition with new doctors now and have not really discussed the potential of this being caused by vaccine, focused more on pain management. **before this vaccine, I was relatively healthy before, no issues.

During monitoring period post initial Pfizer COVID-19 vaccine, pt experienced lip swelling, "ball in throat," itching, lightheaded, sweaty, then chills, dizziness, fatigue, tachycardia, heaviness all over. Medications Given: Epi-Pen injection 0.3ml SC in left thigh, Benadryl 25mg IM for itching given before and after Epi-Pen due to severe itching/rash. Patient has had severe anaphylactic reactions to other vaccines previously that was not disclosed during intake. Patient remained in extended Observation for over 2 hours. VS: 140/82, P-79, Resp 17, O2 97% on RA. Refused to transfer to ER after observation. Later presented to ER with swollen eyes and SOB, rashes, sore throat and took fexofenadine at home. Given additional diphenhydramine 25mg IV and methylprednisolone 125mg IV. Discharged from ED with medrol dosepak.

Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: Patient had COVID in January & had dyspnea that required rescue inhaler. 2 days after 1st shot, patient had dyspnea that required rescue inhaler use once & dyspnea never happened again. Doesn't sound like a true allergic reaction since nothing else happened & dysnpea didn't return. Patient didn't see MD.

ED visit, Non-prescription medication, Prescription medication Anaphylaxis Received this first dose at theme park . PMHx of POTS syndrome who presents to the ED with c/o allergic reaction. Patient reports she received her first COVID vaccination dose earlier today (Pfizer) and about 20 minutes after her vaccine, she developed a flushed face with heart palpitations, chest tightness and shortness of breath. After EMS arrival, she received 0.3mg epinephrine with 50mg Benadryl with improvement in her symptoms. She otherwise denies any fevers, cough or nausea, vomiting or diarrhea. EKG 12 lead; also received Famotidine 20 mg injection/oral, Prednisone 20 mg, Solu-medrol

This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 (Batch/Lot Number: EN 6202) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included known allergies Pollen from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO); ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL 9264), administered in right arm on 08Feb2021 09:30AM, as a SINGLE DOSE for COVID-19 immunization. Patient did not take other vaccine in four weeks. Patient did not diagnose with covid prior to vaccination. No covid tested post vaccination. Several hours after the vaccine, on 01Mar2021 22:00 patient took tylenol to relieve symptoms associated with a slight fever (99.6 F). Fifteen minutes after taking tylenol, the interior and exterior of my throat became very itchy. patient began to cough and feel restrictions in her throat. Symptoms did not subside until after taking benadryl. The outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.

Patient complained of feeling dizzy, itchy throat and feeling numb, chest tightness and difficulty breathing. Patient was given benadryl 12.5mg/5ml (given 30ml) initially but patient complained of difficulty breathing at that time she was given epipen injection 0.3mg. EMS was called and patient was taken to a local hospital

PATIENT DEVELOPED SMALL RASHES THROUGHOUT THE BODY, SLIGHT DIFFICULTY BREATHING AT BEDTIME AND COULDNT SLEEP ON BACK, HAD TO SLEEP SIDEWAYS.

Pain in chest, fast heartbeat and shortness of breath. Pain began 6-28-21 at 5pm and has persisted through today 6-29-21.

some shortness of breath; Chills; body aches (in the chest and the back of the neck; soreness at injection site; Chest ache; increase in shortness of breath (having difficulty standing up and moving around; increase in shortness of breath (having difficulty standing up and moving around; This is a spontaneous report from a contactable consumer (patient self-reported). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8729 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 09Apr2021 at 01:30 PM (age at vaccination: 23 years), as a single dose for COVID-19 immunization at school or student health clinic. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies and allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 19Mar2021 at 01:30 PM (age at vaccination: 23 years), as a single dose for COVID-19 immunization at school or student health clinic. The patient did not receive any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 10Apr2021, the patient experienced chills, body aches (in the chest and the back of the neck), soreness at injection site, some shortness of breath, chest ache, increase in shortness of breath (having difficulty standing up and moving around). The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the adverse event. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts completed. No further information expected.

More difficulty breathing/ just taking a breath seems more difficult; Light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant patient female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613), via an unspecified route of administration in the right arm on 23Mar2021 at 12:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and ADHD. The patient was not aware of medications, food or other products allergies. Concomitant medication included lisdexamfetamine (VYVANSE), fluoxetine (PROZAC), mirtazapine (MANUFACTURER UNKNOWN) and clonazepam (CLONAPIN); all for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced light-headedness and more difficulty in breathing. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events difficult breathing and light headedness were not recovered. No follow-up attempts are needed. No further information is expected.

asthma attack; throat began to tighten / throat remained constricted; feel itchy; Dryness of throat; hives; extreme fatigue; nausea; mild fever; high BP; dehydrated; This is a spontaneous report form a contactable consumer (patient herself). A 23-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0179) via an unspecified route of administration in right arm on 26May2021 10:00 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included asthma. Patient was highly allergic to wasp venom, mild allergy to other insect venom. The concomitant medications included ascorbic acid (VITAMIN C ACID). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in right arm on 05May2021 11:00 as dose 1, single for COVID-19 immunization. Patient did not have any reaction upon first dose. On 26May2021 at 10:10, 10 minutes after receiving vaccine patient experienced dryness of throat which was ignored on account of hot weather. Approximately 20 minutes after receiving vaccine, throat began to tighten and she began to feel itchy. Within 10 minutes afterwards, she experienced an asthma attack which she treated with a Ventolin inhaler. However, her throat remained constricted and hives began to develop. She dissolved 2000 mg of vitamin C in water and drank it after which these symptoms began to recede. She also took 1 dose of Histal medication. Over the following 36 hours she experienced extreme fatigue and nausea, accompanied by a mild fever and persistent itching. She visited centre for diagnosis and was informed that she had a high BP and was dehydrated. She was released 4 hours later and placed on steroids to aid in combatting any remaining histamines. Patient received treatment as ventolin, steroids, Benadryl. The reported seriousness was life threatening. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was recovering. Follow up attempts are needed. Further information has been requested.

Flashes (feeling like muscle tensing but muscles aren?t actually tensed, disorientation, pressure on brain) immediately after both Pfizer doses. Heart palpitations 2 weeks after 2nd dose - diagnosed as iron deficiency. Started taking multivitamin/mineral pills with iron and had horrible reaction (felt like it was hard to breath, extreme fatigue and couldn?t even sit up, extreme nausea) went to ER and blood/ekg/chest X-ray all normal. Let go and during the night had blood rushing, neck swelling, flicking lights when eyes closed. Tried 2 different iron pills, same reaction. Went to Er again and all tests negative. Trying to supplement iron through food (week 4-now). In beginning, week 4 - not getting enough iron from food and constantly feeling short of breath and blood rushing (felt like a lot of blood was being pumped at a time even though pulse was normal). Found iron fortified cereal and it helped shortness of breath, but re-triggered flashes. Flashes getting worse in intensity, length, and frequency. Exertion also shortness of breath and not oxygenating properly walking fat and doing anything more exertional.

Shortness of breath for about 6 hours on 05/04/2021; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 23 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other vaccine in four weeks. Concomitant medication included norethindrone acetate (5mg Tablet) taken for an unspecified indication, start and stop date were not reported. On 04May2021 20:00, the patient experienced shortness of breath for about 6 hours. There was no treatment for the event. 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 event not recovered. Information on Lot/Batch number has been requested.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose :04/12/21pfizer,Lot# EW0150 2nd dose: 05/05/21,Pfizer,Lot# ER8736 Diagnosed covid positive:07/16/2021 Exposure:Travel Symptoms:SOB, cough,fatigue,muscle ache,chills, fever. sore throat.

Severe head pain lower right side of skull. Naseua, blurred vision and light sensitivity. Head pain does not go away with advil. Feels different than a normal headache. Short of breath.

Started having chest pain almost immediately the same day. The pain in my heart has become more frequent. The Pain feels deep within my heart. I also feel discomfort in my chest almost all day like my chest is too small for my heart. Breathless. It feels like having a heart attack 3 - 4 times in a week.

flu like symptoms fever, chills which then progressed to headache , rapid heart rate, chest tightness and worsening shortness of breath the next day , patient was advised to seek medical attention at urgent care

Really lethargic and fatigued; Tested positive for the Covid virus; Tested positive for the Covid virus; Can't taste or smell; Can't taste or smell; Horrible stomach ache; Diarrhea; Exhausted/really lethargic and fatigued; Felt ill, run down and not herself; Voice was gone and was very cracky; Did not feel good; Throat sore and vocal cords hurting; Throat sore and vocal cords hurting; Freezing cold and had the chills; Freezing cold and had the chills; Woke up in a puddle of sweat and hair was soaking wet and dripping; Nose really runny and super congested; Nose really runny and super congested; Deep cough/a little cough; Feels nauseas; Her energy was very low; She thought she caught the flu and was not thinking that it was Covid; freezing and shaking; She didn't have an appetite the first couple of days; She felt horrible in her chest and it was hard to breathe; Chest sore and felt like pressure on her chest; Chest sore and felt like pressure on her chest; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient). This 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration Arm Left on 25Feb2021 14:00 at age of 23 year-old (Lot: EL9267) as DOSE 1, SINGLE, Arm Left on 19Mar2021 11:00 at age of 23 year-old at DOSE 2, SINGLE (Lot # EN6208) for covid-19 immunisation. Medical history included none. Concomitant Products included ongoing lisdexamfetamine mesilate (VYVANSE) Has been taking since grade 10 at Believes it is 40mg, once daily for Attention deficit hyperactivity disorder. No prior vaccinations within 4 weeks.On 09Jul2021, she tested positive for Covid-19. States that she does not know the exact strain that it was. She is trying to get genome sequencing done so that they can find out. She has one but, she is (withheld) and has a PCP back home. She hasn't given them any info about her having Covid yet. She hasn't called her physician. She saw someone in the clinic. She hasn't told them yet, so she wants to call them first. In the clinic, they assumed it was as sinus infection and the prescribed her with Amoxicillin. She was taking it last week when she didn't know that she had it yet. She is still taking it right now. They gave her nasal spray and she did that for 2 days completely and it is clear now. She had every possible symptom she can think of. On Tuesday, 06Jul2021, she woke up with a horrible stomach ache and diarrhea. When she got to campus, she was more exhausted on 06Jul2021 and just felt ill and run down, not herself on 06Jul2021. Her voice was so gone. She did not feel good on 06Jul2021. She felt like that is probably because she took the vaccine while she was sick. She had all this work to do, so she went through it. She took her Vyvanse medication instead of resting and it almost masked the symptoms but, she felt ok for an hour, then all of a sudden she had to go to bed because she felt so sick. She just thought it was food she had eaten because of her birthday. She had eaten cake and a whole lot of junk food. She usually eats really healthy. She went to clinic that morning to see patients. She also had no voice and it was very crackly/ Voice was gone and was very cracky on 06Jul2021. Her throat didn't hurt, it was just very sore and her vocal chords were hurting on 06Jul2021. It hurt to talk. Those were the only 2 symptoms she had the first day. She felt ill, fatigued and her body started to hurt and she felt really tired. She came home and didn't feel like she usually did. She just felt really sick. She could taste and smell, it was all still there. She is still getting the runs though out the day. She was with family and 2 friends and did not pass anything on to them. They are all vaccinated. That night, she was exhausted and went to bed early, then she was freezing cold, had the chills but didn't take her temperature in Jul2021. She took Nyquil and Dayquil. She woke up again at night and was freezing and shaking and Woke up in a puddle of sweat and hair was soaking wet and dripping in Jul2021. She felt horrible. She thought she caught the flu and was not thinking that it was Covid in Jul2021. That day, she kind of tried to get though school and do work online. She was feeling really crummy. All of those symptoms, she had the next couple of days. Then her Nose really runny and super congested in Jul2021. her throat didn't really hurt but she had a kind of deep cough in Jul2021. This was the last night before she saw the doctor. She had tried going for testing the day before but the lines were 3 hours. She booked a test and a doctor's appointment for the next day because she thought she caught the cold or flu. One night, she woke up again and it was the same, with chills and sweat but, her chest was really sore. It felt like pressure on her chest in Jul2021. It felt not normal, like it was maybe a variant. She was super contagious and vaccines may not be fully effective against them. She felt horrible in her chest and it was hard to breathe in Jul2021. When going up and down the stairs, she would get really tired and was out of breath. She tested at the Drive through. It was a nasal swab in each nostril. That night, 08Jul2021, when she had dinner, she couldn't taste anything or smell anything on 08Jul2021. She thought, it must be Covid. The next day, she went to the clinic and saw a Nurse Practitioner. She made her put her head down to see if there was pressure in the sinuses. She tested her breathing and her lungs, everything was clear. She didn't really think it was Covid. She put her on amoxicillin and has been taking that ever since. She tested positive (09Jul2021) was when she was starting to feel better but really, she was still tired and exhausted. Her energy was very low in Jul2021. She was only really sick for 3 full days. On Saturday, she was really lethargic on 10Jul2021 and fatigued. She knew she was getting better, just not 100 percent. When she knew that it was Covid, if it wasn't for the vaccine, she didn't think she would be able to tough it out. She still can't taste or smell at the moment. She is in self isolation. She feels completely normal. If she hadn't gotten the Covid test, she would have never thought that it was Covid. She feels 90% right now. She is back to studying. Horrible stomach ache and Diarrhea: Did not last very long, would say, like 30 minutes and then it passed. Still has diarrhea every morning but it may because of the amoxicillin. Lethargy and fatigue and all of the other symptoms: They were all on 6Jul2021, 7Jul2021 and 8Jul2021. On 9Jul2021, she started to get better. Treatment included Before Friday, when she saw the Nurse practitioner on 9Jul2021, she started taking the Flonase. She only did it a couple of times. It was fluticasone propionate, Flonase nasal spray and Sodium chloride nasal spray, 1 spray in each nostril. She only did it 3 times since she got it. Her nose was really runny through out the time and super congested. The only thing is that her stomach feels a little nauseous and has a little cough. Her cough has gotten way better, so much better. The nausea/ Feels nauseas didn't happen that often in Jul2021. She didn't have an appetite the first couple of days in Jul2021. Just today, she is a little nauseated but, it may not be Covid. No Emergency Room and Physician Office. She went to the clinic. She barely had any symptoms from the second dose. She looks like she has Covid and it is not good. Was tested prior to getting the vaccine and was negative. Outcome of the event Tested positive for the Covid virus, Nose really runny and super congested, Nose really runny and super congested was unknown. Outcome of the event hard to breathe, Exhausted/really lethargic and fatigued, Felt ill, run down and not herself, Voice was gone and was very cracky, Did not feel good, Throat sore and vocal cords hurting, Freezing cold and had the chills, Woke up in a puddle of sweat and hair was soaking wet and dripping, Deep cough/a little cough, Really lethargic and fatigued, Chest sore and felt like pressure on her chest, Feels nauseas, Her energy was very low, She thought she caught the flu and was not thinking that it was Covid, freezing and shaking, She didn't have an appetite the first couple of days was recovering. Outcome of the event Horrible stomach ache was recovered in Jul2021. Outcome of the event Diarrhea, Can't taste or smell was not recovered. (Parent) Evaluation Comment: Pfizer withheld reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment actionis required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6208 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EN6208 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for an adverse event requested by safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EL1283 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EL1283, fill lot EL1281, and the bulk formulated drug product lot EL1279. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed. Follow-up attempts are completed. No further information is expected.

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.

Pfizer-BioNTech COVID-19 VACCINE EUA; Throat swelling/closing up; SOB, dizziness 15 min post injection; lasting about 5 min but dizziness remains

Dec 26th I woke up and I had a severe cough shortness of breath and chills I took sudafed and it helped a little but I was just sore and the 27th we went to an urgent care and tested positive for Covid I felt better by the 31st. I received my second covid shot and I had a fever 102.8 but I havent had symptoms since then

Increased heart rate of 124; clammy hands; nausea; calf pain; extreme muscle and joint pain; extreme muscle and joint pain; shortness of breath; coughing; chest pain; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number was unknown, via an unspecified route of administration in the left arm, on 30Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included asthma and drug hypersensitivity to sulfa. The patient was not pregnant. The patient had not received any other vaccines in four weeks prior to Covid vaccine. The patient's concomitant medications included birth control and multivitamin, both unspecified. The patient experienced increased heart rate of 124, clammy hands, nausea, calf pain, extreme muscle and joint pain, shortness of breath, coughing and chest pain, all on 02Jan2021 12:00 PM with outcome of recovering. The events are reported as non-serious with no treatment received. The patient had no covid prior vaccination. She was not tested for covid post vaccination. Information on the lot/batch number has been requested.

also had a very hoarse voice; throat starting feeling a little tight; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient received first dose of BNT162B2 (Lot number: EK9231), intramuscular on 31Dec2020 15:45 at single dose in the left arm for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and seasonal allergies from an unknown date. Concomitant medication included azithromycin. The patient previously took penicillin and experienced allergies. The patient was not pregnant at the time of vaccination. The 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. Since the vaccination, the patient had not been tested for COVID-19. It was reported that within 10 minutes of receiving the vaccine on 31Dec2020, the patient's throat started feeling a little tight. However, she did not have trouble breathing. The feeling continued for the next 3 hours. She also had a very hoarse voice. The ER suggested that she will be seen. They did an exam and gave her Benadryl which completely resolved her symptoms. The events resulted in emergency room/department or urgent care.

Approx 10-15 post vaccine, employee said she felt lightheaded and like her heart was racing. Within 10 minutes she said she felt difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee was transported to the Emergency Dep't and then to intensive care. She was placed on an Epi drip.

At approximately 11pm felt dizziness and coworker followed her home. When arriving home noticed facial swelling, some shortness of breath, itchy neck, "jittery", and swollen throat. Taken by boyfriend to ED at approximately 12am on 12/17/2020. Given Epipen, diphenhydramine, famotidine, and methylprednisolone. Remained in observation for a few hours and went home as all reaction had ceased.

Low-grade fever: 100 F less than 12 hours after, broke next morning Headache: Right after vaccination, still occurring Blurry vision: 1 hour after vaccination, ended around 5-6 hours later Sore arm: Right after vaccination, still occurring Body aches: Day after vaccination, still occurring Body chills: Less than 12 hours later, still occurring Out of breath: Day after vaccination, still occurring

Migraine (not responsive to medicines), dizziness, chest pain, tachycardia, shortness of breath, back pain.

Client reported severe allergy to seafood and some medications, but did not list them. Denied allergies to vaccine ingredients. Reports she spoke with her healthcare provider and was told there was no concern about this vaccine. Received vaccine and within a few minutes red blotchy hives spread up her arms, neck and torso. EMS responded. Client reported this was a common response for her and stated she has had about 8 similar episodes over the last several months. After about 20 minutes the rash continued. No difficulty breathing had occurred, however the client then reported that occasionally some tightness in her breathing occurred after about 45 minutes. After initially declining to be transported to the ER, she agreed to be transported to be monitored. Client declined the use of the stretcher and walked out with EMS to be transported to the ER for observation.

45 min after vaccination pt felt she had some tightness in the throat and chest. Unable to differentiate if was caused by her anxiety or the vaccine. After exam in clinic felt improved but still given Benadryl and monitored , no worsening symptoms felt all sx had resolved at the time of discharge

Patient received Pfizer vaccinations on 12/29/20 and 1/19/21. She woke up on 1/20 with hot flashes, fatigue and chills. Later in the day she developed a headache. This morning (1/22) as she was walking to her car to go to work she developed dyspnea and palpitations. She had a portable pulse ox and noted HR was 125 and PO2 97%. She went to ED, COVID neg, d-dimer positive, CT chest negative for PE. Potassium was low. Patient was discharged home.